BEAUTY AND THE BAR A WAR PAINT TALKBACK ON COSMETIC AND PERSONAL CARE PRODUCTS LAW

JUNE 7, 2017

Beauty and the Bar: A War Paint Talkback on Cosmetic and Personal Care Products Law

Based on the story of the rivalry between cosmetics pioneers Helena Rubinstein and Elizabeth Arden, War Paint just might be the first musical ever to explore the history of beauty industry regulation through songs about Senate hearings, rights of publicity, and trademarks in colors. What makes this play particularly timely is that Congress is considering comprehensive legal reform for the cosmetics and personal care products sector. Are the concerns that gave rise to the current regulatory framework still relevant? What are the differences between how the Food & Drug Administration and the Federal Trade Commission regulate this industry? Do the proposed House and Senate bills equally provide for consumer safety? And what are implications of legal reform for today’s cosmetics entrepreneurs and established brands?

Topics for discussion include the following:

• Issues leading to the enactment of the Federal Food, Drug, and Cosmetic Act, • The current legal framework governing FDA and FTC oversight of cosmetics and personal care products, • Legal considerations in designing entertainment based on businesses and their founders, • The implications of evolving technology, marketing, mass communication, and consumer demographics for regulation and enforcement, and • Contrasting approaches to legal reform in recently introduced legislation, the Cosmetic Modernization Amendments of 2017 (H.R. 575) and the Personal Care Products Safety Act (S. 1113) SPEAKERS’ BIOGRAPHIES NICK BARNHORST Legal Counsel, Fresh

Nick Barnhorst is Vice President, Legal Counsel for Fresh, Inc., a leading luxury beauty and skin care company based in New York City. He previously served as Associate General Counsel for Sharp Electronics and spent eight years in private practice as a litigator and trademark practitioner. Mr. Barnhorst serves as Fresh's sole in-house legal representative and advises the company on all legal matters, including global intellectual property protection, domestic litigation, and day-to-day operational matters. He is admitted to practice in New York and California. Mr. Barnhorst received a B.S. of Economic, Marketing and Business Administration from the University of Pennsylvania, The Wharton School, a J.D. from Marquette University Law School, and a MBA from Marquette University. He is admitted to practice in New York, California, and Wisconsin.

CLAIRE BING Director of Regulatory, Tarte Cosmetics

Claire Bing is the Director of Regulatory for tarte cosmetics, the leader in high-performance natural beauty. Since joining tarte in 2012, Claire’s role has grown along with the company as she and her team have led tarte’s regulatory expansion into new international markets in Southeast Asia, Australia, the Middle East, and the European Union. Today, Claire is responsible for overseeing all regulatory, testing and quality assurance for new product development, as well as continued compliance with the FDA, FTC and other external supervisory bodies in the US and abroad. Her prior work experience includes production documentation and quality assurance across the pharmaceutical and food industries, as well as microbial pathogenesis research at Nationwide Children’s Hospital. Claire earned her B.S. in Microbiology and B.A. in History of Art from The Ohio State University, and is passionate about volunteering for humans rights organizations, such as the Salvation Army and Human Rights Campaign.

ANNIE UGURLAYAN Senior Staff Attorney, National Advertising Division

Annie Ugurlayan is a Senior Staff Attorney at the National Advertising Division. Since 2003, she has handled over 250 cases and has successfully argued appeals before the National Advertising Review Board. Annie is also a frequent lecturer at conferences nationwide and abroad, particularly on cosmetics and anti-aging claims on which she has developed an expertise. Annie has authored or co-authored seven publications during her time at NAD. Annie is actively involved in various bar associations, serves on the Board of Directors of the New York Women’s Bar Association Foundation and is a Fellow of the American Bar Foundation. She is fluent in French and Armenian and proficient in Romanian. Annie is a graduate of Hamilton College (B.A., magna cum laude -- French and World Politics) and Hofstra University School of Law. She is admitted to practice in New York. JEFF TREXLER, Esq.

Jeff Trexler teaches the Fashion Ethics, Sustainability, and Development course at Fordham University School of Law. He is an attorney and consultant whose clients include fashion brands, nonprofits, and social ventures. He has worked with organizations around the world on issues ranging from tax exemption and corporate compliance to intellectual property and communications strategy. His publications address a wide range of topics, including complexity theory and social enterprise, business ethics, copyright, and more.

Trexler previously served as a chaired professor and executive director of the Wilson Center for Social Entrepreneurship at Pace University and taught nonprofit organizations at Yale, SMU and Saint Louis University. Trexler holds a J.D. from Yale Law School and a Ph.D. in American Religious History from Duke University. He is admitted to practice in New York. SELECTED READINGS

. SELECTED READINGS

U.S. Food & Drug Administration, FDA Authority Over Cosmetics: How Cosmetics Are Not FDA Approved, but Are FDA-Regulated (May 24, 2017).

Federal Trade Commission, FTC Approves Final Order Settling Charges that L’Oréal USA, Inc. Made Deceptive Advertising Claims for its Anti-Aging Cosmetics (Sept. 26, 2014).

Ruth deForest Lamb, AMERICAN CHAMBER OF HORRORS: THE TRUTH ABOUT FOOD AND DRUGS (1936).

Nicole Urbanowiez, Safe Cosmetics Modernization Act is on a Roll, Pete Sessions, U.S. Congressman Representing the 32nd District of Texas, https://sessions.house.gov (May 24, 2017).

Cosmetics Modernization Amendments of 2017, H.R. 575, 115th Cong. (2017).

Senators Introduce Bill to Strengthen Personal Care Product Oversight, United States Senator for California Dianne Feinstein, https://feinstein.senate.gov (Apr. 20, 2015).

Personal Care Products Safety Act, S. 1014, 115th Cong. (2017).

Exploring Current Practices in Cosmetic Development and Safety: Hearing Before the Senate Committee on Health, Education, Labor and Pensions, 114th Cong. (September 22, 2016) (statement by Sen. Dianne Feinstein).

Exploring Current Practices in Cosmetic Development and Safety: Hearing Before the Senate Committee on Health, Education, Labor and Pensions, 114th Cong. (September 22, 2016) (statement by Sen. Susan Collins). 1

FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated

The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.

The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/default.htm) (FD&C Act) and the Fair Packaging and Labeling Act (/RegulatoryInformation/LawsEnforcedbyFDA/ucm148722.htm) (FPLA). FDA regulates cosmetics under the authority of these laws.

In the United States, federal laws are enacted by Congress. In order to make the laws work on a day-to-day level, Congress authorizes certain government agencies. such as FDA, to create regulations. A change in FDA's legal authority over cosmetics would require Congress to change the law.

What kinds of products are "cosmetics" under the law? What does the law say about the safety and labeling of cosmetics? Does FDA approve cosmetics before they go on the market? Who is responsible for substantiating the safety of cosmetics? Can FDA order the recall of a hazardous cosmetic from the market? What actions can FDA take against companies or individuals who market adulterated cosmetics? Can FDA inspect cosmetics manufacturers? Does FDA test cosmetics or recommend testing labs? Do cosmetics companies need to register with FDA or get an FDA license to operate? 2

What kinds of products are “cosmetics” under the law? The FD&C Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FD&C Act, sec. 201(i)). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. It does not include soap. (To learn what products are considered "soap" for regulatory purposes, see "Soap (/Cosmetics/ProductsIngredients/Products/ucm115449.htm)."

But, if the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug (/Drugs/default.htm) (FD&C Act, 201(g)), or in some cases a medical device (/MedicalDevices/default.htm) (FD&C Act, 201(h)), even if it affects the appearance. Other “personal care products” may be regulated as dietary supplements or as consumer products. To learn more, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) (/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm)” and “Cosmetics Q&A: Personal Care Products (/Cosmetics/ResourcesForYou/Consumers/ucm136560.htm).”

The information presented here applies only to the regulation of products that are cosmetics as defined by the FD&C Act.

What does the law say about the safety and labeling of cosmetics? The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce.

“Adulteration” refers to violations involving product composition--whether they result from ingredients, contaminants, processing, packaging, or shipping and handling. Under the FD&C Act, a cosmetic is adulterated if--

"it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual" (with an exception made for coal-tar hair dyes (/Cosmetics/ProductsIngredients/Products/ucm143066.htm)); "it consists in whole or in part of any filthy, putrid, or decomposed substance"; "it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health"; "its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health"; or except for coal-tar hair dyes, "it is, or it bears or contains, a color additive (http://www.fda.gov/ForIndustry/ColorAdditives/default.htm) which is unsafe within the meaning of section 721(a)" of the FD&C Act. (FD&C Act, sec. 601)

“Misbranding” refers to violations involving improperly labeled or deceptively packaged products. Under the FD&C Act, a cosmetic is misbranded if--

"its labeling is false or misleading in any particular"; its label does not include all required information. (An exemption may apply to cosmetics that are to be processed, labeled, or repacked at an establishment other than where they were originally processed or packed; see Title 21, Code of Federal Regulations, section 701.9 (http://www.ecfr.gov/cgi-bin/text-idx? c=ecfr&sid=2840d521290f433ef8e5afed3f64c86f&rgn=div8&view=text&node=21:7.0.1.2.11.1.1.4&idno=21).) the required information is not adequately prominent and conspicuous; "its container is so made, formed, or filled as to be misleading"; 3

it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and "its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970." (FD&C Act, sec. 602)

Under the FD&C Act, a product also may be misbranded due to failure to provide material facts. This means, for example, any directions for safe use and warning statements needed to ensure a product's safe use.

In addition, under the authority of the FPLA, FDA requires a list of ingredients for cosmetics marketed on a retail basis to consumers (Title 21, Code of Federal Regulations (CFR), section 701.3). Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act. (FPLA, section 1456) This requirement does not apply to cosmetics distributed solely for professional use, institutional use (such as in schools or the workplace), or as free samples or hotel amenities.

FDA can take action against cosmetics on the market that are in violation of these laws, as well as companies and individuals who market such products.

Does FDA approve cosmetics before they go on the market? FDA's legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.

In general, except for color additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic, provided that--

the ingredient and the finished cosmetic are safe under labeled or customary conditions of use, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.

Who is responsible for substantiating the safety of cosmetics? Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA.

FDA has consistently advised manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that "the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information." (Federal Register, March 3, 1975, page 8916).

In addition, regulations prohibit or restrict the use of several ingredients (http://www.ecfr.gov/cgi-bin/text-idx? c=ecfr&sid=c108128827d21f2d274e894731665ef4&rgn=div6&view=text&node=21:7.0.1.2.10.2&idno=21) in cosmetic products and require warning statements (http://www.ecfr.gov/cgi-bin/text-idx? c=ecfr&sid=aadbdaab4e1af3d1fe1661346e5d07c4&rgn=div5&view=text&node=21:7.0.1.2.14&idno=21) on the labels of certain types of cosmetics. 4

Can FDA order the recall of a hazardous cosmetic from the market? Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective (21 CFR 7.40(a). FDA is not authorized to order recalls of cosmetics, but we do monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request. To learn more, see “FDA Recall Policy for Cosmetics (/Cosmetics/ComplianceEnforcement/RecallsAlerts/ucm173559.htm).”

What actions can FDA take against companies or individuals who market adulterated or misbranded cosmetics? FDA may take regulatory action if we have reliable information indicating that a cosmetic is adulterated or misbranded. For example, FDA can pursue action through the Department of Justice (http://www.justice.gov) in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, FDA may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Cosmetics that are not in compliance with the law may be subject to seizure. “Seizure” means that the government takes possession of property from someone who has violated the law, or is suspected of doing so. FDA also may initiate criminal action against a person violating the law.

In addition, FDA works closely with U.S. Customs and Border Protection (http://www.cbp.gov) to monitor imports. Under section 801(a) of the FD&C Act, imported cosmetics are subject to review by FDA at the time of entry through U.S. Customs. Products that do not comply with FDA laws and regulations are subject to refusal of admission into the United States. They must be brought into compliance (if possible), destroyed, or re-exported. FDA does not inspect every shipment of cosmetics that comes into this country, but imported cosmetics are still subject to the laws we enforce, even if they are not inspected upon entry. To learn more, see “Information for Cosmetics Importers (/Cosmetics/InternationalActivities/Importers/default.htm).”

FDA takes regulatory action based upon agency priorities, consistent with public health concerns and available resources.

Can FDA inspect cosmetics manufacturers? FDA can and does inspect cosmetic manufacturing facilities (/Cosmetics/ComplianceEnforcement/ucm136455.htm) to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.

Does FDA test cosmetics or recommend testing labs? Although FD&C Act does not subject cosmetics to premarket approval by FDA, we do collect samples for examination and analysis as part of cosmetic facility inspections, import inspections, and follow-up to complaints of adverse events associated with their use. FDA may also conduct research on cosmetic products and ingredients to address safety concerns.

FDA does not function as a private testing laboratory, and in order to avoid even the perception of conflict of interest, we do not recommend private laboratories to consumers or manufacturers for sample analysis.

Do cosmetics firms need to register with FDA or get an FDA license to operate? Under the law, manufacturers are not required to register their cosmetic establishments or file their product formulations with FDA, and no registration number is required to import cosmetics (/Cosmetics/InternationalActivities/Importers/default.htm) into the United States. 5

However, we encourage cosmetic firms to participate in FDA's Voluntary Cosmetic Registration Program (VCRP) using the online registration system. Cosmetic manufacturers, distributors, and packers can file information on their products that are currently being marketed to consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP database. To learn more and access this program, see Voluntary Cosmetic Registration Program (VCRP) (/Cosmetics/RegistrationProgram/default.htm).

March 3, 2005; updated August 3, 2013 6

FTC Approves Final Order Settling Charges that L’Oréal USA, Inc. Made Deceptive Advertising Claims for its Anti-Aging Cosmetics

FOR YOUR INFORMATION

September 26, 2014

TAGS: Bureau of Consumer Protection Consumer Protection Advertising and Marketing Health Claims

Following a public comment period, the Federal Trade Commission has approved a final order settling charges that cosmetics company L’Oréal USA, Inc. made deceptive advertising claims about its Lancôme Génifique and L’Oréal Paris Youth Code skincare products.

According to the FTC’s complaint, announced in June 2014, L’Oréal made false and unsubstantiated claims that its Génifique and Youth Code products provided anti­aging benefits by targeting users’ genes. In national advertising campaigns, L’Oréal claimed that its Génifique products were “clinically proven” to “boost genes’ activity and stimulate the production of youth proteins” that would cause “visibly younger skin in just 7 days.” Similarly, for its Youth Code products, L’Oréal touted the “new era of skincare: gene science,” and that consumers could “crack the code to younger acting skin.”

Under the final order, L’Oréal is prohibited from claiming that any Lancôme brand or L’Oréal Paris brand facial skincare product targets or boosts the activity of genes to make skin look or act younger, or respond five times faster to aggressors like stress, fatigue, and aging, unless the company has competent and reliable scientific evidence substantiating such claims. The final order also bars the company from claiming that certain Lancôme brand and L’Oréal Paris brand products affect genes, unless the claims are supported by competent and reliable scientific evidence. Finally, L’Oréal is prohibited from making claims about these products that misrepresent the results of any test or study.

The Commission vote approving the final order and responses to members of the public who submitted comments was 4­0­1, with Commissioner Terrell McSweeny not participating. (FTC File No. 132­3016; the staff contact is Elizabeth Nach, Bureau of Consumer Protection, 202­326­2611)

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1­877­FTC­HELP (1­877­382­4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources. EXHIBIT A S ENT T PA L mnkes. NA elt IO Genifique T we ocnl of l NA a · R Genifique TE IN your supply 7 at - t counte1~ the 1 difference yo 7-dny a come DAYTRIAL n ftu waits RESEARCH What a A & OF ~ Experience t J • . s ty i ns. l i ro • a she 11f u days. I ote q r ., ini 7 days. l p j, ' m i in • - , 7 . d :.. 1 ,., ts . u thfu ed l F ance ed v youth ce ; n o ar •• yo it • r n e p of efi p l"' r ts resu ,. m I , just i r-· ap E . ,_. . ion T is n h i n i prese k in "'" skin r S i tically TRA uJ a N he CIM genes roduct • t m , ony a ilf•• ft CE i o N e p dr '"'' sh s ... skin u , Ml th "''' ' your t-from-with age, • ' powerful C li CO " t " h have. Reactivate ' m If " it G ate #t . l ~' for even s "' l N to W I a fl y l . gly mu youth: ""'"" ' g AT ' PM CO •f~i>.'f n sti s V ns orl i ' i i PARIS born h l rhQ looks even ,. Ch1ut onishin and genes t• 1 r younger n and nis AC skin i st " 2 !Jfl o prote • A sk were ty i AM ic ast l, f UTH ~M.Iu,h u your f ly i y. O t .-u,r•,.ll"* com you . 1J activ your Y Use of ct m e '"'' soft, nous l ~ fe i II. speci r ~· lro eau y ' e visibly GENIFIQUE in U.N n um b P skin I l fi . rigin If Lt e o genes' lancom •-. gly is • f,.l i proven. th 100% tt n st oduce i ry See .. r y e a cushio e ,- r • p ll LAN ak oo t .fiiMt- ver lt' It,., h mo , e v ca t , b , es h a co m n w t urns: e t e lini is o r t e Youth N '.A•t•WIIU B D A I#HI.IoloOin C G lea r _, z -I -I ,l:. 11 ~ r r m m m m m m m )> )> )> )> z z z 0 0 0 0 0 -I -I -I c 0 0 0 0 0 0 0 (J) ,l:. :::0 :::0 11 11 0 I~ I "'Tl 0 EXHIBIT B )> 0 0 z "'Tl 0 m z -l )> r -l :::0 m )> s:-l m z -l :::0 m 0 c m (f) -l m 0

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Safe Cosmetics Modernization Act is on a Roll

April 28, 2016 | In The News By Nicole Urbanowicz

Support for H.R. 4075 (https://www.congress.gov/bill/114th-congress/house-bill/4075/all-info), the Safe Cosmetics Modernization Act, is gaining momentum with recent backing from two U.S. congressional leaders, including a democratic co-sponsor. The Independent Cosmetic Manufacturers & Distributors (ICMAD) is applauding the progress.

Since the bill’s introduction on Nov. 18, 2015, by U.S. Representative Pete Sessions (RTX-32nd District), two additional members of Congress have signed on as co-sponsors: U.S. Representative Bill Flores (R-TX-17th District) and U.S. Representative Eddie Bernice Johnson (D-TX-30th District).

Critical Cosmetics Legislation Advances

“We commend the progress made by Congressman Sessions in bringing this critical cosmetics legislation forward and applaud Congressman Flores and Congresswoman Johnson for adding their strong voices to the effort,” said Pamela Busiek, ICMAD's president and CEO. “We welcome and encourage a united front from our policymakers to continue to find common ground on this reform that impacts a multi-billion-dollar U.S. industry.”

H.R. 4075 modernizes and improves the Food and Drug Administration's ability to ensure the safety of cosmetic products by examining ingredient safety, establishing manufacturing processes and tracking and quickly addressing adverse health impacts from potentially unsafe products and requiring that all manufacturers be registered with the FDA.

Industry Impact

ICMAD, which supports the legislation on behalf of its members representing small, independent and entrepreneurial cosmetics companies, said the bill will further allow the FDA to align its powers (http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm) with U.S.'s trading partners in the international market while meeting consumer demand for distributing the best information on the safety of cosmetic products.

This legislation increases consumer protections on cosmetics, while empowering small and entrepreneurial cosmetics enterprises in the U.S. to compete on the national and international stage through national uniformity of regulation, Busiek added.

Earlier, ICMAD indicated its lack of support for the Cosmetics and Personal Care Products Safety Act (http://www.cosmeticsandtoiletries.com/regulatory/region/northamerica/ICMAD-Rejects-Feinstein-Bill-for- Restraining-Innovation-305731751.html), introduced April 21 by Sen. Dianne Feinstein (D-CA) and Sen. Susan Collins (R-ME), its co-sponsor. The Feinstein Bill requires the FDA to review chemicals used in products and provide clear guidance on their safety, although ICMAD said that particular bill places too large a burden on small business, restrains innovation in the cosmetics and personal care industry, and does not provide appropriate and significant national uniformity. 71

I

115TH CONGRESS 1ST SESSION H. R. 575

To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic manufac- turing establishments, the submission of cosmetic and ingredient state- ments, and the reporting of serious cosmetic adverse events, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JANUARY 13, 2017 Mr. SESSIONS introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the reg- istration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events, and for other purposes.

1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE AND REFERENCES.

4 (a) SHORT TITLE.—This Act may be cited as the 5 ‘‘Cosmetic Modernization Amendments of 2017’’.

VerDate Sep 11 2014 23:55 Jan 27, 2017 Jkt 069200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H575.IH H575 SSpencer on DSK4SPTVN1PROD with BILLS 72 2

1 (b) REFERENCES TO THE FEDERAL FOOD, DRUG,

2 AND COSMETIC ACT.—Except as otherwise specified, 3 whenever in this Act an amendment is expressed in terms 4 of an amendment to a section or other provision, the ref- 5 erence shall be considered to be made to a section or other 6 provision of the Federal Food, Drug, and Cosmetic Act 7 (21 U.S.C. 301 et seq.).

8 SEC. 2. TABLE OF CONTENTS. 9 The table of contents for this Act is as follows:

Sec. 1. Short title and references. Sec. 2. Table of contents. Sec. 3. Definitions. Sec. 4. Registration of cosmetic manufacturing establishments. Sec. 5. Cosmetic and ingredient statement. Sec. 6. Serious and unexpected adverse event reporting for cosmetics. Sec. 7. Good manufacturing practice. Sec. 8. Safety substantiation for cosmetic ingredients and nonfunctional con- stituents. Sec. 9. National Cosmetic Regulatory Databank. Sec. 10. Special rules. Sec. 11. Prohibited acts. Sec. 12. National uniformity for cosmetics. Sec. 13. Importation. Sec. 14. Effective dates.

10 SEC. 3. DEFINITIONS. 11 Chapter VI (21 U.S.C. 361 et seq.) is amended by 12 adding at the end the following:

13 ‘‘SEC. 604. DEFINITIONS. 14 ‘‘In this chapter:

15 ‘‘(1) COSMETIC.—Notwithstanding section 16 201(i), for purposes of this section and sections 17 601(f), 605, 606, 607, 608, and 801(a), the term

•HR 575 IH

VerDate Sep 11 2014 23:55 Jan 27, 2017 Jkt 069200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H575.IH H575 SSpencer on DSK4SPTVN1PROD with BILLS 73 3 1 ‘cosmetic’ includes only articles described in section 2 201(i)(1).

3 ‘‘(2) ESTABLISHMENT.— 4 ‘‘(A) The term ‘establishment’ means a 5 place of business where a cosmetic is manufac- 6 tured, without further processing outside or 7 within the United States. 8 ‘‘(B) A cosmetic shall not be considered to 9 have undergone further processing for purposes 10 of subparagraph (A) solely on the basis that 11 packaging or other labeling was added or 12 changed or that any similar activity of a de 13 minimis nature was carried out with respect to 14 the cosmetic. 15 ‘‘(C) The term ‘domestic establishment’ 16 means an establishment location in any State. 17 ‘‘(D) The term ‘foreign establishment’ 18 means an establishment location outside the 19 United States.

20 ‘‘(3) SAFE; SAFETY.— 21 ‘‘(A) The terms ‘safe’ and ‘safety’, with re- 22 spect to a cosmetic, mean the cosmetic does not 23 present a significant risk of serious illness or 24 injury to humans under the conditions of use 25 recommended or suggested in the labeling of

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12 SEC. 4. REGISTRATION OF COSMETIC MANUFACTURING ES-

13 TABLISHMENTS. 14 Chapter VI (21 U.S.C. 361 et seq.), as amended by 15 section 3, is further amended by adding at the end the 16 following:

17 ‘‘SEC. 605. REGISTRATION OF COSMETIC MANUFACTURING

18 ESTABLISHMENTS.

19 ‘‘(a) IN GENERAL.—

20 ‘‘(1) REGISTRATION.—The Secretary shall by 21 regulation require that every domestic and foreign 22 establishment engaged in the manufacture of a cos- 23 metic intended to be sold in the United States that 24 is not exempt under subsection (e) be registered with 25 the Secretary within 60 business days after the first

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17 ‘‘(2) UNIQUE NUMBER.—The Secretary shall 18 establish and provide to each registrant under this 19 section a unique cosmetic establishment registration 20 number within 15 business days after receiving the 21 registration. If the Secretary does not provide a 22 unique cosmetic establishment registration number 23 within such 15 business days, any requirement 24 under this Act for such number shall be deemed to 25 be inapplicable until 30 business days after such

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8 ‘‘(b) MAINTENANCE.—The information required in a 9 registration under subsection (a) or in an existing reg- 10 istration under subsection (e)(1)(A) shall be maintained 11 as current and accurate by the registrant by withdrawing 12 or amending the registration within 60 business days after 13 the information becomes no longer current and accurate.

14 ‘‘(c) ENFORCEMENT.—The Secretary shall enforce 15 this section under section 301(eee) and shall not suspend 16 or revoke a registration under this section.

17 ‘‘(d) LIST.—The Secretary shall compile and main- 18 tain an up-to-date and publicly available electronic list of 19 establishments that are registered under this section.

20 ‘‘(e) EXEMPTIONS.—

21 ‘‘(1) IN GENERAL.—Registration under sub- 22 section (a) shall not be required for any entity based 23 on such entity operating as— 24 ‘‘(A) an establishment that as of the date 25 of enactment of this section is registered as a

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12 ‘‘(2) ADDITIONAL EXEMPTIONS.—The Sec- 13 retary may supplement the list of exemptions under 14 paragraph (1) with additional exemptions for per- 15 sons and activities where the cost of compliance ex- 16 ceeds the safety benefit to the public.’’.

17 SEC. 5. COSMETIC AND INGREDIENT STATEMENT. 18 Chapter VI (21 U.S.C. 361 et seq.), as amended by 19 sections 3 and 4, is further amended by adding at the end 20 the following:

21 ‘‘SEC. 606. COSMETIC AND INGREDIENT STATEMENT.

22 ‘‘(a) IN GENERAL.—The Secretary shall by regula- 23 tion require that every domestic establishment and foreign 24 establishment engaged in the manufacture of a cosmetic 25 intended to be sold in the United States submit to the

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9 ‘‘(b) UNIQUE NUMBER.—The Secretary shall estab- 10 lish and provide to the office submitting a statement re- 11 quired by subsection (a) a unique cosmetic and ingredient 12 statement number within 15 business days after receiving 13 the statement. If the Secretary does not provide a unique 14 cosmetic and ingredient statement number within such 15- 15 business-day period, any requirement under this Act for 16 such number shall be deemed to be inapplicable until the 17 date that is 30 business days after such number is received 18 by the office that submitted the statement. The unique 19 cosmetic and ingredient statement number shall not be re- 20 quired to be included in cosmetic labeling.

21 ‘‘(c) CHANGE IN LABELING.—An establishment shall 22 not be required to submit a new or revised statement 23 under subsection (a) because of a change in labeling ex- 24 cept to the extent necessary to maintain the accuracy of

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3 ‘‘(d) NAME OF INGREDIENT.—For purposes of this 4 section and cosmetic ingredient labeling under section 5 701.3 of title 21, Code of Federal Regulations (as in effect 6 on the date of enactment of the Cosmetic Modernization 7 Amendments of 2017 and including any successor regula- 8 tions), the name of a cosmetic ingredient shall be the 9 name, if any, in the most recent edition of the Inter- 10 national Cosmetic Ingredient Dictionary, unless the Sec- 11 retary by regulation establishes a different name for the 12 ingredient.

13 ‘‘(e) MAINTENANCE.—The information required in a 14 statement submitted to the Secretary under subsection (a) 15 or in an existing statement under subsection (g)(1) shall 16 be maintained as current and accurate by the office that 17 filed the statement by withdrawing or amending the state- 18 ment within 60 business days after the information be- 19 comes no longer current and accurate, except that no 20 amendment shall be required for a change in the order 21 of predominance of the ingredients or for any other type 22 or category of change for which the costs of amending the 23 statement exceed the safety benefit to the public.

24 ‘‘(f) ENFORCEMENT.—The Secretary shall enforce 25 subsections (a) and (e) under section 301(fff) and shall

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3 ‘‘(g) LIST.—The Secretary shall compile and main- 4 tain an up-to-date and publicly available electronic list of 5 cosmetics and ingredients for which statements are sub- 6 mitted under this section. A statement submitted pursuant 7 to this section shall not be subject to disclosure under sec- 8 tion 552 of title 5, United States Code. The Secretary may 9 make publicly available information derived from such 10 statements that discloses the names of ingredients used 11 in cosmetics and the number of cosmetics in which a spe- 12 cific ingredient is used, but may not make publicly avail- 13 able any information that relates to any ingredient that 14 is exempt from public disclosure under section 720.8 of 15 title 21, Code of Federal Regulations (as in effect on the 16 date of enactment of the Cosmetic Modernization Amend- 17 ments of 2017 and including any successor regulations), 18 or that discloses at what establishment a cosmetic is man- 19 ufactured. At the written request of the director of a State 20 agency responsible for regulating the safety of cosmetics 21 stating good cause therefor, the Secretary may disclose to 22 such official confidential business and trade secret infor- 23 mation contained in a statement and such official and 24 other State employees who have access to such informa- 25 tion shall then be subject to the provisions of section

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4 ‘‘(h) EXEMPTIONS.—Submission of a statement 5 under subsection (a) shall not be required— 6 ‘‘(1) for a cosmetic for which as of the date of 7 enactment of this section a cosmetic ingredient 8 statement has been submitted to the Secretary 9 under part 710 of title 21, Code of Federal Regula- 10 tions (as in effect on the date of enactment of the 11 Cosmetic Modernization Amendments of 2017); 12 ‘‘(2) for a cosmetic ingredient exempt from 13 public disclosure under section 720.8 of title 21, 14 Code of Federal Regulations (as in effect on the 15 date of enactment of the Cosmetic Modernization 16 Amendments of 2017 and including any successor 17 regulations); or 18 ‘‘(3) by an entity to the extent such entity is 19 exempted by section 605(e) from registration under 20 section 605.’’.

21 SEC. 6. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-

22 PORTING FOR COSMETICS.

23 (a) IN GENERAL.—Chapter VI (21 U.S.C. 361 et 24 seq.), as amended by sections 3, 4, and 5, is further 25 amended by adding at the end the following:

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2 PORTING FOR COSMETICS.

3 ‘‘(a) IN GENERAL.—The Secretary shall by regula- 4 tion require that a domestic or foreign manufacturer, 5 packer, or distributor whose name appears on the label 6 pursuant to section 602(b)(1) of a cosmetic marketed in 7 the United States submit to the Secretary under sub- 8 section (b) a report containing— 9 ‘‘(1) information received concerning any seri- 10 ous and unexpected adverse event in the United 11 States allegedly associated with the use of the cos- 12 metic for which it is reasonably likely that the ad- 13 verse event was caused by the cosmetic when used 14 as recommended or suggested in the labeling; and 15 ‘‘(2) a copy of the label for the cosmetic.

16 ‘‘(b) SUBMISSION OF REPORTS.—A report on an ad- 17 verse event under subsection (a) shall be submitted to the 18 Secretary not later than 15 business days after informa- 19 tion concerning the adverse event is received at the place 20 of business labeled on the cosmetic pursuant to section 21 602(b)(1).

22 ‘‘(c) REQUIRED CONTENTS.—A report under sub- 23 section (a) shall include all of the following information: 24 ‘‘(1) An identifiable patient. 25 ‘‘(2) An identifiable reporter. 26 ‘‘(3) A suspect cosmetic or component thereof.

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2 ‘‘(d) ADDITIONAL CONTENTS; SUPPLEMENTAL RE-

3 PORTING.—The person submitting a report under sub- 4 section (a) may— 5 ‘‘(1) include pertinent information in addition 6 to the information listed in subsection (c); and 7 ‘‘(2) after submitting the initial report, supple- 8 ment the report with additional information.

9 ‘‘(e) SPECIAL RULES.—

10 ‘‘(1) PROTECTED INFORMATION.—A serious 11 and unexpected adverse event report (including all 12 information submitted in the initial report or added 13 later) submitted under subsection (a)— 14 ‘‘(A) shall be considered to be a safety re- 15 port under section 756 that is subject to the 16 provisions of that section; and 17 ‘‘(B) shall be considered to be a record 18 about an individual under section 552a of title 19 5, United States Code, and a medical or similar 20 file the disclosure of which would constitute a 21 violation of section 552 of such title 5, and 22 shall not be publicly disclosed unless all person- 23 ally identifiable information is redacted.

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1 ‘‘(2) NO TREATMENT AS ADMISSION.—The sub- 2 mission of a serious and unexpected adverse event 3 report in compliance with subsection (a)— 4 ‘‘(A) shall not be construed as an admis- 5 sion that the cosmetic involved caused or con- 6 tributed to the adverse event; and 7 ‘‘(B) may be accompanied by a statement 8 that denies that the report constitutes an ad- 9 mission that the cosmetic involved caused or 10 contributed to the adverse event.

11 ‘‘(3) INCLUSION OF STATEMENT IN PUBLIC DIS-

12 CLOSURE.—In releasing any report under subsection 13 (a) or portion thereof for public disclosure, the Sec- 14 retary shall include any statement under paragraph 15 (2)(B).

16 ‘‘(f) LABELING.—The label of a cosmetic shall bear 17 the domestic telephone number, email address, or mailing 18 address through which the person whose name and place 19 of business appear on the label may receive a report of 20 a serious adverse event.

21 ‘‘(g) EXEMPTION.—The Secretary may, by regula- 22 tion, establish an exemption to the requirements under 23 subsections (b) and (d) if the Secretary determines that 24 such exemption would have no adverse effect on public 25 health.

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1 ‘‘(h) DEFINITIONS.—In this section: 2 ‘‘(1) The term ‘serious’, with respect to an ad- 3 verse event, means— 4 ‘‘(A) resulting in— 5 ‘‘(i) death; 6 ‘‘(ii) a life-threatening experience; 7 ‘‘(iii) inpatient hospitalization; 8 ‘‘(iv) a persistent and significant dis- 9 ability or incapacity; 10 ‘‘(v) a congenital anomaly or birth de- 11 fect; or 12 ‘‘(vi) permanent disfiguration; or 13 ‘‘(B) requiring, based on reasonable med- 14 ical judgment, a medical or surgical interven- 15 tion to prevent an outcome described under 16 subparagraph (A). 17 ‘‘(2) The term ‘unexpected’, with respect to an 18 adverse event, means not identified on the cosmetic 19 label.’’.

20 (b) MISBRANDING.—Section 602 of the Federal 21 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend- 22 ed by adding at the end the following: 23 ‘‘(g) If it is a cosmetic that is marketed in the United 24 States, unless the label of such cosmetic includes a domes- 25 tic address or domestic phone number through which a

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5 SEC. 7. GOOD MANUFACTURING PRACTICE.

6 (a) PROHIBITION.—Section 601 (21 U.S.C. 361) is 7 amended by adding at the end the following: 8 ‘‘(f) If it has been manufactured under conditions 9 that do not satisfy the principles and standards for good 10 manufacturing practice established under section 608 and 11 as a result presents a significant risk of serious adverse 12 health consequences or death to humans.’’.

13 (b) PRINCIPLES AND STANDARDS.—Chapter VI (21 14 U.S.C. 361 et seq.), as amended by sections 3, 4, 5, and 15 6, is further amended by adding at the end the following:

16 ‘‘SEC. 608. GOOD MANUFACTURING PRACTICE.

17 ‘‘(a) IN GENERAL.—The Secretary may by regulation 18 establish principles and standards for good manufacturing 19 practice for the manufacture of cosmetics in accordance 20 with paragraphs (a) and (d) of section 601.

21 ‘‘(b) NOTICE AND COMMENT.—A regulation under 22 subsection (a) shall be promulgated only after providing 23 notice and an opportunity for comment in accordance with 24 chapter 5 of title 5, United States Code.

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1 ‘‘(c) GOOD MANUFACTURING PRACTICES OF OTHER

2 PARTIES.—A manufacturer shall not be responsible under 3 section 601(f) or this section for the good manufacturing 4 practice of its suppliers. A distributor shall not be respon- 5 sible under section 601(f) or this section for the good man- 6 ufacturing practice of its manufacturers.’’.

7 SEC. 8. SAFETY SUBSTANTIATION FOR COSMETIC INGREDI-

8 ENTS AND NONFUNCTIONAL CONSTITUENTS. 9 Chapter VI (21 U.S.C. 361 et seq.), as amended by 10 sections 3, 4, 5, 6, and 7, is further amended by adding 11 at the end the following:

12 ‘‘SEC. 609. COSMETIC INGREDIENTS AND NONFUNCTIONAL

13 CONSTITUENTS THAT ARE SAFE FOR USE IN

14 COSMETICS.

15 ‘‘(a) IN GENERAL.—A manufacturer or distributor of 16 a cosmetic may rely on this section to substantiate the 17 safety of such cosmetic.

18 ‘‘(b) SAFE INGREDIENTS.—Unless and until prohib- 19 ited or limited by the Secretary by regulation, the fol- 20 lowing ingredients are deemed to be adequately substan- 21 tiated for safe use in cosmetics subject to the requirements 22 of good manufacturing practice: 23 ‘‘(1) Color additives approved by the Secretary 24 for use in cosmetics, within any limits established in 25 such approval.

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15 ‘‘(c) SAFE NONFUNCTIONAL CONSTITUENTS.—

16 ‘‘(1) DEFINITION.—A nonfunctional constituent 17 in a cosmetic is any substance that— 18 ‘‘(A) has not been intentionally added as a 19 separate substance; and 20 ‘‘(B) serves no technical or cosmetic func- 21 tion in the cosmetic.

22 ‘‘(2) ADEQUATE SUBSTANTIATION.—The fol- 23 lowing nonfunctional constituents are deemed to be 24 adequately substantiated for safe use in cosmetics, 25 subject to the requirements of good manufacturing

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1 ‘‘(d) CENTER.—The Secretary shall establish a pro- 2 gram within the center of the Food and Drug Administra- 3 tion with primary responsibility for regulating cosmetics 4 to evaluate and make determinations, by regulation, on 5 the safe use of cosmetics and ingredients and nonfunc- 6 tional constituents thereof.

7 ‘‘(e) APPLICATION; PREEMPTION.—A safety deter- 8 mination accepted or made by the Secretary or established 9 under this section shall apply in every State. No State may 10 establish or enforce a safety determination for a cosmetic 11 or an ingredient or nonfunctional constituent of a cos- 12 metic.

13 ‘‘(f) EFFECTIVE DATE OF REGULATIONS.—Any reg- 14 ulation or guidance by the Secretary pursuant to this sec- 15 tion concerning the safety of a cosmetic or an ingredient 16 or nonfunctional constituent of a cosmetic shall apply be- 17 ginning no earlier than the date that is 2 years after the 18 date on which such regulation or guidance is issued as 19 final, unless the Secretary determines, after public notice 20 and an opportunity for public comment, that an earlier 21 date of applicability is required to prevent serious adverse 22 health consequences or death to humans.’’.

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5 ‘‘SEC. 610. NATIONAL COSMETIC REGULATORY DATABANK.

6 ‘‘(a) IN GENERAL.—For the purpose of consolidating 7 information pertaining to the regulation of cosmetic safe- 8 ty, the Secretary shall establish and maintain in the center 9 of the Food and Drug Administration with primary re- 10 sponsibility for regulating cosmetics a database, to be 11 known as the National Cosmetic Regulatory Databank, 12 containing— 13 ‘‘(1) the information submitted to the Secretary 14 under sections 605, 606, 607, and 609; and 15 ‘‘(2) such other information pertaining to the 16 regulation of cosmetics as the Secretary deems ap- 17 propriate.

18 ‘‘(b) AVAILABILITY.—In the case of information in 19 the National Cosmetic Regulatory Databank that is not 20 subject to public disclosure under section 552 of title 5, 21 United States Code, the Secretary may nonetheless dis- 22 close such information to the director of a State agency 23 on written request by such director demonstrating good 24 cause for the disclosure. A director receiving information 25 pursuant to the preceding sentence shall agree to limit to 26 the disclosure of such information by State officials and

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6 ‘‘(c) PREEMPTION.—No State or political subdivision 7 thereof may require submission of information that is 8 available in the National Cosmetic Regulatory Databank, 9 whether in the same or a different format.’’.

10 SEC. 10. SPECIAL RULES.

11 (a) CERTAIN RULES.—Chapter VI (21 U.S.C. 361 et 12 seq.), as amended by sections 3, 4, 5, 6, 7, 8, and 9, is 13 further amended by adding at the end the following:

14 ‘‘SEC. 611. SPECIAL RULES.

15 ‘‘(a) CONTRACTORS.—The person described in sec- 16 tion 607(f) with respect to a cosmetic (referred to in this 17 section as the ‘responsible party’) may, by agreement, au- 18 thorize a manufacturer, distributor, or packer of the cos- 19 metic or a third-party contractor to submit any required 20 report of a serious and unexpected adverse event (as such 21 term is used in section 607) so long as the responsible 22 party directs to the manufacturer, distributor, packer, or 23 third-party contractor all such adverse events associated 24 with such cosmetic that are reported to the responsible

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3 ‘‘(b) EXEMPTIONS.—The Secretary, on the Sec- 4 retary’s own initiative or in response to a petition, may 5 establish exemptions from the requirements of sections 6 601(f), 605, 606, 607, and 608— 7 ‘‘(1) for the efficient and cost-effective imple- 8 mentation of such requirements; or 9 ‘‘(2) where the cost of compliance exceeds the 10 safety benefit to the public.’’.

11 (b) COSMETIC DEFINITION.—Section 201(i) (21 12 U.S.C. 321(i)) is amended by adding at the end the fol- 13 lowing: ‘‘An article described in subparagraph (1) that is 14 intended only for topical external use to alter the appear- 15 ance by temporarily affecting the structure or any function 16 of the human skin, and that is not the subject of an ap- 17 proved new drug application under section 505, shall, for 18 purposes of this Act, be treated only as a cosmetic and 19 not a drug.’’.

20 (c) COLOR ADDITIVES.—Section 721(f) (21 U.S.C. 21 379e(f)) is amended— 22 (1) by striking ‘‘(f) The Secretary shall’’ and 23 inserting ‘‘(f)(1) The Secretary shall’’; and 24 (2) by adding at the end the following:

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11 SEC. 11. PROHIBITED ACTS.

12 (a) IN GENERAL.—Section 301 (21 U.S.C. 331) is 13 amended by adding at the end the following: 14 ‘‘(eee) The failure to register a cosmetic establish- 15 ment as required under section 605 or to maintain the 16 registration current and accurate. 17 ‘‘(fff) The failure to submit a cosmetic and ingredient 18 statement as required under section 606 or to maintain 19 the statement current and accurate. 20 ‘‘(ggg) The failure to submit a serious and unex- 21 pected adverse event report, or to include on the label of 22 a cosmetic the domestic telephone number, email address, 23 or mailing address through which a report of a serious 24 adverse event may be received, as required under section 25 607.’’.

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1 (b) INFORMATION SECURITY.—Section 301(j) (21 2 U.S.C. 331(j)) is amended by inserting ‘‘605, 606, 609,’’ 3 after ‘‘573,’’.

4 SEC. 12. NATIONAL UNIFORMITY FOR COSMETICS. 5 Section 752 (21 U.S.C. 379s) is amended— 6 (1) by amending the section heading to read as

7 follows: ‘‘NATIONAL UNIFORMITY FOR COS-

8 METICS’’; 9 (2) by amending subsection (a) to read as fol- 10 lows:

11 ‘‘(a) IN GENERAL.—Except as provided in subsection 12 (b) or (d) of this section, no State or political subdivision 13 of a State may establish or continue in effect any require- 14 ment for labeling or packaging of a cosmetic.’’; 15 (3) by amending subsection (c) to read as fol- 16 lows:

17 ‘‘(c) COSMETIC SAFETY.—No State or political sub- 18 division of a State may establish or continue in effect any 19 law, regulation, order, or other requirement— 20 ‘‘(1) relating directly or indirectly to, or relying 21 upon, a human health or safety evaluation of a non- 22 functional cosmetic constituent, cosmetic ingredient, 23 or cosmetic (as defined in section 201(i)(1)), or re- 24 lating in any way to the safety standard and the 25 human health-based requirements, evaluations, and

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16 SEC. 13. IMPORTATION. 17 Section 801(a) (21 U.S.C. 381(a)) is amended by 18 adding at the end the following: ‘‘If a cosmetic is being 19 imported or offered for import into the United States and 20 the importer does not present both the unique cosmetic 21 establishment registration number required under section 22 605 for the establishment that performs the final portion 23 of the manufacturing operation and the unique cosmetic 24 and ingredient statement number required under section 25 606 for the cosmetic, or the registration or statement

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3 SEC. 14. EFFECTIVE DATES. 4 (a)(1) The amendments made by sections 4, 5, 6, and 5 13 of this Act apply beginning on the later date of— 6 (A) the date that is one year after the Sec- 7 retary of Health and Human Services promulgates 8 final regulations implementing such amendments; or 9 (B) the date that is one year after the Sec- 10 retary of Health and Human Services publishes a 11 notice in the Federal Register determining that an 12 effective electronic system has been established and 13 is fully operational for— 14 (i) the submission of cosmetic manufac- 15 turing establishment registrations, cosmetic and 16 ingredient statements, and reports of serious 17 cosmetic adverse events; and 18 (ii) the National Cosmetic Regulatory 19 Databank. 20 (2) Until the date applicable under paragraph (1), 21 the voluntary establishment registration and voluntary in- 22 gredient listing programs established in parts 710 and 720 23 of title 21, Code of Federal Regulations (as in effect on 24 the date of enactment of this Act), shall remain effective

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PRESS RELEASES

Senators Introduce Bill to Strengthen Personal Care Product Oversight

Apr 20 2015

Washington—Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) today introduced the Personal Care Products Safety Act (https://www.feinstein.senate.gov/public/index.cfm/? a=les.serve&File_id=445a9268-4964-4de0-89f9-4caf577099f2) to protect consumers and streamline industry compliance by strengthening the Food and Drug Administration’s (FDA) authority to regulate the ingredients in personal care products. While the personal care products industry is projected to exceed $60 billion in U.S. revenue this year, federal regulations on these products have not been updated in 75 years.

The bill, which is the result of numerous discussions with stakeholders and extensive consultation with the FDA, is supported by the following companies:

Personal Care Products Council (a trade association representing more than 600 companies in the industry) Johnson & Johnson (brands include Neutrogena, Aveeno, Clean & Clear, Lubriderm, Johnson’s baby products) Procter & Gamble (brands include Pantene, Head & Shoulders, Clairol, Herbal Essences, Secret, Dolce & Gabbana, Gucci, Ivory, Cover Girl, Olay, Sebastian Professional, Vidal Sassoon) Revlon (brands include Revlon, Almay, Mitchum) Estee Lauder (brands include Estée Lauder, Clinique, Origins, Tommy Hilger, MAC, La Mer, Bobbi Brown, Donna Karan, Aveda, Michael Kors) Unilever (brands include Dove, Tresemme, Lever, St. Ives, Noxzema, Nexxus, Pond’s, Suave, Sunsilk, Vaseline, Degree) L’Oreal (brands include L’Oréal Paris, Lancome, Giorgio Armani, Yves Saint Laurent, Kiehl’s, Essie, Garnier, Maybelline-New York, Vichy, La Roche-Posay, The Body Shop, Redken)

The bill is also supported by the following consumer groups:

Environmental Working Group Society for Women’s Health Research National Alliance for Hispanic Health HealthyWomen Endocrine Society National Psoriasis Foundation 103 “From shampoo to lotion, the use of personal care products is widespread, however, there are very few protections in place to ensure their safety,” said Senator Feinstein. “Europe has a robust system, which includes consumer protections like product registration and ingredient reviews. I am pleased to be introducing this bipartisan legislation with Senator Collins that will require FDA to review chemicals used in these products and provide clear guidance on their safety. In addition, the legislation has broad support from companies and consumer groups alike.”

“I am pleased to be working with Senator Feinstein on legislation to modernize FDA regulation of cosmetics and personal care products, which are widely used by consumers often on a daily basis,” said Senator Collins. “By improving FDA oversight of the ingredients in cosmetics and personal care products, this legislation aims to protect consumers while also providing regulatory certainty for manufacturers, enabling them to plan for the future.”

Consumer and health advocates are concerned about the use and concentration of some chemicals in personal care products. For example, according to the Centers for Disease Control and Prevention, short-term exposure to formaldehyde, which is used in smoothing hair treatments, has been reported to cause a range of negative health effects. Initially, these can include headaches and shortness of breath in consumers and the professionals who apply the chemicals. However, long-term exposure to formaldehyde has been associated with increased risk of cancer, and the Occupational Safety and Health Administration requires salon owners to provide their workers with protective equipment, including masks and goggles, when applying this chemical.

In another example, propyl paraben, which is used as a preservative in a wide range of products, mimics estrogen and may be appropriate only in certain concentrations. According to scientic studies, chemicals that mimic estrogen can disrupt the endocrine system and have been linked to a wide range of health effects, including reproductive system disorders.

The bill would require the FDA to evaluate a minimum of ve ingredients per year to determine their safety and appropriate use – the two chemicals mentioned above are among those to be reviewed in the rst year. The review process set forth in the bill would provide companies with clear guidance about whether ingredients should continue to be used and if so, what the concentration levels should be and whether consumer warnings are needed. For example, a chemical may be deemed inappropriate for use in children’s products, or appropriate for professional application only.

The rst set of chemicals for review includes:

Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion Lead acetate, which is used as a color additive in hair dyes Methylene glycol/formaldehyde, which is used in hair treatments Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers

The bill would provide streamlined federal standards so that the personal care products industry knows what to expect and companies can plan for the future with certainty. 104 The Personal Care Products Safety Act would also:

Provide the FDA the authority to order recalls of certain personal care products that threaten consumer safety. Provide the FDA the authority to require labeling of products that include ingredients not appropriate for children and those that should be professionally administered. Complete label information, including ingredients and product warnings, would also be required to be posted online since approximately 40 percent of personal care products are purchased over the Internet. Require companies to provide contact information on their products for consumers and report serious adverse events to the FDA within 15 days, including death, hospitalization and disgurement. Health effects that could have resulted in hospitalization without early intervention would also be required to be reported. Require manufacturers to register annually with the FDA and provide the agency with information on the ingredients used in their personal care products. Direct the FDA to issue regulations on Good Manufacturing Practices for personal care products.

To fund these new oversight activities, the bill would authorize the FDA to collect user-fees from personal care products manufacturers similar to what is done for medications and medical devices.

### 105

II

115TH CONGRESS 1ST SESSION S. 1113

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics.

IN THE SENATE OF THE UNITED STATES

MAY 11, 2017 Mrs. FEINSTEIN (for herself and Ms. COLLINS) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions

A BILL To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics.

1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the 5 ‘‘Personal Care Products Safety Act’’.

6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—COSMETIC SAFETY Sec. 101. Registration of cosmetics facilities and cosmetic ingredient state- ments.

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TITLE II—FEES RELATED TO COSMETIC SAFETY Sec. 201. Findings. Sec. 202. Authority to assess and use cosmetic safety fees. Sec. 203. Direct hiring authority to support activities related to cosmetics. 1 TITLE I—COSMETIC SAFETY

2 SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND

3 COSMETIC INGREDIENT STATEMENTS.

4 (a) AMENDMENTS.—Chapter VI of the Federal Food, 5 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend- 6 ed by adding at the end the following:

7 ‘‘SEC. 604. DEFINITIONS. 8 ‘‘In this chapter:

9 ‘‘(1) COSMETIC FORMULATION.—The term ‘cos- 10 metic formulation’ means a preparation of cosmetic 11 raw materials with a qualitatively and quantitatively 12 set composition.

13 ‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 14 product’ means a cosmetic comprised of a specified 15 set of ingredients, which may come in a range of

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3 ‘‘(3) FACILITY.—The term ‘facility’ includes 4 any factory, warehouse, or establishment (including 5 a factory, warehouse, or establishment of an im- 6 porter) that manufactures, processes, packs, or holds 7 cosmetic products or cosmetic formulations, or any 8 other entity whose name and address appear on the 9 label of a cosmetic product. Such term does not in- 10 clude— 11 ‘‘(A) beauty shops and salons that do not 12 otherwise manufacture, process, or package cos- 13 metics at that location; 14 ‘‘(B) cosmetic product retailers, including 15 individual sales representatives, retail distribu- 16 tion facilities, and pharmacies, that do not oth- 17 erwise manufacture, process, or package cos- 18 metics at that location; 19 ‘‘(C) hospitals, physicians’ offices, and 20 health care clinics; 21 ‘‘(D) public health agencies and other non- 22 profit entities that provide cosmetics directly to 23 the consumer; 24 ‘‘(E) hotels and other entities that provide 25 complimentary cosmetics to guests;

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17 ‘‘(4) FOREIGN FACILITY.—The term ‘foreign fa- 18 cility’ means a facility that manufactures, processes, 19 packs, or holds, a cosmetic formulation or cosmetic 20 product that is exported to the United States with- 21 out further processing or packaging inside the 22 United States. A cosmetic is not considered to have 23 undergone further processing or packaging for pur- 24 poses of this definition solely on the basis that label- 25 ing was added or that any similar activity of a de

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3 ‘‘(5) NON-FUNCTIONAL CONSTITUENT.—The 4 term ‘non-functional constituent’ means any sub- 5 stance that is an incidental component of an ingre- 6 dient, a breakdown product of an ingredient or a by- 7 product of the manufacturing process that has not 8 been intentionally added as a separate substance and 9 serves no technical function in the cosmetic.

10 ‘‘(6) RESPONSIBLE PERSON.—The term ‘re- 11 sponsible person’ means— 12 ‘‘(A) the brand owner who is the domestic 13 or foreign manufacturer, packer, or entity 14 whose name appears on a cosmetic product 15 label of a cosmetic product distributed in the 16 United States, except for entities described in 17 subparagraphs (A) through (G) of paragraph 18 (3); or 19 ‘‘(B) a contract manufacturer who provides 20 cosmetic products to the entities described in 21 subparagraphs (A) through (G) of paragraph 22 (3).’’.

23 ‘‘SEC. 605. REGISTRATION OF COSMETIC FACILITIES.

24 ‘‘(a) REGISTRATION AND FEES FOR EXISTING MAN-

25 UFACTURING OR PROCESSING OF COSMETICS.—

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1 ‘‘(1) REGISTRATION, IN GENERAL.—Not later 2 than December 1, 2017, and at a similar time in 3 each subsequent year, as determined by the Food 4 and Drug Administration, each responsible person 5 engaged in manufacturing or processing a cosmetic 6 product or a cosmetic formulation distributed in the 7 United States shall register all of the responsible 8 person’s facilities with the Food and Drug Adminis- 9 tration.

10 ‘‘(2) FEES.—If the average gross annual sales 11 in the United States of cosmetic products of all of 12 the responsible person’s facilities registered under 13 paragraph (1) for the previous 3-year period is 14 greater than $2,000,000, a registration shall not be 15 complete under this subsection until the responsible 16 person has paid any registration fee required under 17 section 744L.

18 ‘‘(b) REGISTRATION FOR EXISTING PACKING OR

19 HOLDING OF COSMETICS.—Not later than December 1, 20 2017, and at a similar time once every 3 years thereafter, 21 as determined by the Food and Drug Administration, each 22 person who owns or operates a cosmetic facility or facili- 23 ties engaged in packing or holding a cosmetic product dis- 24 tributed in the United States shall register each such facil- 25 ity with the Food and Drug Administration.

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1 ‘‘(c) REGISTRATION BY NEW FACILITIES.—Any facil- 2 ity first engaging after the date of enactment of the Per- 3 sonal Care Products Safety Act in an activity that would 4 require it to register under subsection (a) or (b) shall reg- 5 ister with the Food and Drug Administration within 60 6 days of first engaging in such activity, and thereafter in 7 accordance with subsection (a) or (b).

8 ‘‘(d) CHANGES TO INFORMATION.—A registrant who 9 has submitted a registration under this section shall notify 10 the Food and Drug Administration of any change to the 11 information required under subsection (a) or (b) not later 12 than 60 days after the date of such change, unless other- 13 wise specified by the Food and Drug Administration.

14 ‘‘(e) FORMAT; CONTENTS.—

15 ‘‘(1) ELECTRONIC FORMAT.—Each registration 16 shall be submitted using an electronic format, as 17 specified in a registration form provided by the Food 18 and Drug Administration.

19 ‘‘(2) CONTENTS.—

20 ‘‘(A) IN GENERAL.—The registration shall 21 contain the following information: 22 ‘‘(i) Each facility’s name and full ad- 23 dress, identifying the precise physical loca- 24 tion of the facility.

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20 ‘‘(B) SMALL BUSINESSES.—

21 ‘‘(i) REQUIREMENTS.—In the case of 22 a registrant described in clause (ii), the 23 registration shall contain the following in- 24 formation:

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14 ‘‘(ii) SMALL BUSINESS REG-

15 ISTRANTS.—A registrant described in this 16 clause is a domestic registrant— 17 ‘‘(I) whose average gross annual 18 sales in the United States of cosmetic 19 products for the previous 3-year pe- 20 riod is between $500,000 and 21 $2,000,000 (or between $1,000,000 22 and $2,000,000 in the case of sales of 23 cosmetic products produced in a pri- 24 vate residence); and 25 ‘‘(II) who does not produce—

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12 ‘‘(3) ABBREVIATED REGISTRATION.—The Food 13 and Drug Administration shall provide for an abbre- 14 viated registration renewal process for any registrant 15 that has not had any changes to the required infor- 16 mation with respect to the facility or facilities in- 17 volved since the registrant submitted the preceding 18 registration.

19 ‘‘(f) INCOMPLETE OR INACCURATE REGISTRATION.—

20 ‘‘(1) IN GENERAL.—Not earlier than 10 days 21 after providing notice of the intent to cancel a reg- 22 istration and the basis for such cancellation, the 23 Food and Drug Administration may cancel a reg- 24 istration under this section if the Food and Drug 25 Administration has reasonable grounds to believe

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4 ‘‘(2) TIMELY UPDATE OR CORRECTION.—If, not 5 later than 7 days after receipt of a notice of intent 6 to cancel, the sponsor corrects the registration in ac- 7 cordance with the basis for the cancellation, and the 8 required registration fee, if any, is paid, the Food 9 and Drug Administration shall not cancel such reg- 10 istration.

11 ‘‘(g) UNIQUE IDENTIFIER.—At the time of the initial 12 registration of any cosmetic facility under this section, the 13 Food and Drug Administration shall assign a unique iden- 14 tifier to the facility.

15 ‘‘(h) REGISTRY OF FACILITIES.—

16 ‘‘(1) IN GENERAL.—The Food and Drug Ad- 17 ministration shall compile, maintain, and update a 18 registry of facilities that are registered under this 19 section, and shall remove from such registry the 20 name of any facility whose registration under this 21 section is cancelled. The registry shall be publicly 22 available.

23 ‘‘(2) PUBLIC AVAILABILITY EXCEPTIONS.—In- 24 formation derived from the registry or registration 25 documents that discloses the residential address of a

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5 ‘‘SEC. 606. COSMETIC INGREDIENT STATEMENTS.

6 ‘‘(a) IN GENERAL.—For each cosmetic product, the 7 responsible person shall submit to the Food and Drug Ad- 8 ministration a cosmetic ingredient statement, at such time 9 and in such manner as the Food and Drug Administration 10 may prescribe. The cosmetic ingredient statement shall 11 not become effective until the responsible person pays any 12 applicable fee required under section 744L.

13 ‘‘(b) SUBMISSION OF A COSMETIC INGREDIENT

14 STATEMENT.—

15 ‘‘(1) EXISTING COSMETIC PRODUCTS.—In the 16 case of a cosmetic product that is marketed on the 17 date of enactment of the Personal Care Products 18 Safety Act, the responsible person shall submit a 19 cosmetic ingredient statement not later than Decem- 20 ber 1, 2017. The responsible person shall submit to 21 the Food and Drug Administration a renewal of 22 such statement on a yearly basis.

23 ‘‘(2) COSMETIC INGREDIENT STATEMENT FOR

24 NEW COSMETIC PRODUCTS.—

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1 ‘‘(A) IN GENERAL.—Except as provided 2 under subparagraph (B), in the case of a cos- 3 metic product that is first marketed after the 4 date of enactment of the Personal Care Prod- 5 ucts Safety Act or a cosmetic product that is 6 reformulated after such date of enactment, the 7 responsible person shall submit a cosmetic in- 8 gredient statement to the Food and Drug Ad- 9 ministration within 60 days of first marketing 10 the new cosmetic product or the reformulated 11 cosmetic product, and annually thereafter.

12 ‘‘(B) SMALL BUSINESSES.—The Food and 13 Drug Administration shall allow a responsible 14 person that is a business that meets the appli- 15 cable industry-based small business size stand- 16 ard established by the Administrator of the 17 Small Business Administration under section 3 18 of the Small Business Act to have a period 19 longer than 60 days to submit an initial new 20 cosmetic ingredient statement under subpara- 21 graph (A). Such responsible person shall submit 22 a cosmetic ingredient statement annually there- 23 after.

24 ‘‘(C) DEFINITION.—A cosmetic product 25 shall not be considered first marketed or refor-

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16 ‘‘(c) FORMAT; CONTENTS.—

17 ‘‘(1) FORM.—For each cosmetic product, the 18 cosmetic ingredient statement shall be submitted 19 using an electronic format, as specified in a cosmetic 20 and ingredient form provided by the Food and Drug 21 Administration.

22 ‘‘(2) CONTENTS.—The cosmetic ingredient 23 statement shall include the following information: 24 ‘‘(A) The unique identifier, assigned under 25 section 605(g), as applicable, of—

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6 ‘‘(3) ADDITIONAL INFORMATION.—In the case 7 of a cosmetic ingredient statement that includes a 8 list of fragrances or flavors that are purchased from 9 a fragrance or flavor supplier as described in para- 10 graph (2)(E)(i), upon request by the Food and Drug 11 Administration, the fragrance or flavor supplier shall 12 submit to the Food and Drug Administration the 13 complete list of ingredients in specific fragrances, or 14 flavors not later than 30 days after receiving such 15 request.

16 ‘‘(d) INCOMPLETE OR INACCURATE COSMETIC IN-

17 GREDIENT STATEMENT.—

18 ‘‘(1) IN GENERAL.—Not earlier than 10 days 19 after providing notice to the responsible person of 20 the intent to cancel the cosmetic ingredient state- 21 ment and the basis for such cancellation, the Food 22 and Drug Administration may nullify a cosmetic in- 23 gredient statement filed under this section if the 24 Food and Drug Administration has reasonable 25 grounds to believe that the cosmetic ingredient state-

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4 ‘‘(2) TIMELY UPDATE OR CORRECTION.—If the 5 cosmetic ingredient statement is appropriately up- 6 dated or corrected not later than 7 days after notice 7 is provided under paragraph (1), the Food and Drug 8 Administration shall not nullify such cosmetic ingre- 9 dient statement.

10 ‘‘(e) ADDITIONAL REQUIREMENTS.—

11 ‘‘(1) SAFETY REQUIREMENTS.—In filing each 12 cosmetic ingredient statement cosmetic product, the 13 responsible person shall include an attestation that 14 the safety of the product, including the individual in- 15 gredients of such product and the product as a 16 whole, has been substantiated in accordance with 17 section 609. In the case of a cosmetic ingredient 18 statement that includes a range of possible amounts 19 (as described in subsection (c)(2)(E)), the respon- 20 sible person shall include an attestation that such 21 person has substantiated the safety of the product 22 and its ingredients in accordance with the require- 23 ments of section 609.

24 ‘‘(2) ABBREVIATED FILING.—The Food and 25 Drug Administration shall provide for an abbre-

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4 ‘‘(3) CHANGES TO INFORMATION.—

5 ‘‘(A) IN GENERAL.—Except as provided in 6 subparagraph (B), the responsible person shall 7 notify the Food and Drug Administration with- 8 in 60 days of any change to the information re- 9 quired to be in a cosmetic ingredient statement, 10 including discontinuation of the manufacture of 11 a cosmetic product, except that notification 12 under this paragraph is not required for a 13 change in— 14 ‘‘(i) the amount of an existing ingre- 15 dient if it is within the range previously re- 16 ported under subsection (c)(2)(E); or 17 ‘‘(ii) the addition or subtraction of a 18 fragrance, flavor or color, or such other 19 interchangeable ingredients specified by 20 the Food and Drug Administration in reg- 21 ulations or guidance, previously reported 22 as a potential ingredient under subsection 23 (c)(2)(E), if, in the case of an addition of 24 such an ingredient, the amount is within 25 the range previously reported.

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1 ‘‘(B) EXCEPTIONS.—

2 ‘‘(i) SMALL BUSINESSES.—The Food 3 and Drug Administration shall allow a re- 4 sponsible person that is a business that 5 meets the applicable industry-based small 6 business size standard established by the 7 Administrator of the Small Business Ad- 8 ministration under section 3 of the Small 9 Business Act to have a period longer than 10 60 days, but not longer than the next an- 11 nual registration deadline under section 12 605(a)(1), to submit any change to the in- 13 formation required to be in a cosmetic in- 14 gredient statement as described in sub- 15 paragraph (A).

16 ‘‘(ii) OTHER BUSINESSES.—Any busi- 17 ness that has an average of not more than 18 $2,000,000 in annual domestic cosmetic 19 sales over the previous 3 years is not re- 20 quired to report the discontinuation of the 21 manufacture of a cosmetic product or cos- 22 metic product category as described in sub- 23 paragraph (A) until the next annual reg- 24 istration period under section 605.

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1 ‘‘(f) COSMETIC PRODUCTS LIST.—At the time of the 2 initial submission of any cosmetic ingredient statement 3 under this section, the Food and Drug Administration 4 shall assign a unique cosmetic product listing number to 5 the cosmetic ingredient statement. Based on such cosmetic 6 ingredient statements, the Food and Drug Administration 7 shall compile and maintain a list of cosmetic products dis- 8 tributed in the United States, including the ingredients 9 of each such product, and shall make available such list 10 to any State, upon request. Information disclosed to a 11 State that is exempt from disclosure under section 12 552(b)(4) of title 5, United States Code, shall be treated 13 as a trade secret and confidential information by the 14 State.

15 ‘‘SEC. 607. SUSPENSION OF REGISTRATION OR COSMETIC

16 INGREDIENT STATEMENT.

17 ‘‘(a) SUSPENSION OF REGISTRATION OF A FACIL-

18 ITY.—If the Food and Drug Administration determines 19 that a cosmetic formulation or cosmetic product manufac- 20 tured, processed, packed, or held by a registered facility 21 and distributed in the United States has a reasonable 22 probability of causing serious adverse health consequences 23 or death to humans, and the Food and Drug Administra- 24 tion has a reasonable belief that other products manufac- 25 tured or processed by the facility may be similarly affected

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6 ‘‘(b) SUSPENSION OF COSMETIC INGREDIENT STATE-

7 MENT.—If the Food and Drug Administration determines 8 that a cosmetic product manufactured in a registered fa- 9 cility has a reasonable probability of causing serious ad- 10 verse health consequences or death to humans, the Food 11 and Drug Administration may suspend the cosmetic ingre- 12 dient statement of that product.

13 ‘‘(c) NOTICE OF SUSPENSION.—Before suspending a 14 facility registration or a cosmetic ingredient statement 15 under this section, the Food and Drug Administration 16 shall provide— 17 ‘‘(1) notice to the facility registrant of the cos- 18 metic product or formulation or other responsible 19 person, as appropriate, of the intent to suspend the 20 facility registration or the cosmetic ingredient state- 21 ment, which shall specify the basis of the determina- 22 tion by the Food and Drug Administration that the 23 facility or the cosmetic ingredient should be sus- 24 pended and recommendations for specific actions to 25 avoid suspension; and

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6 ‘‘(d) REINSTATEMENT.—Upon a determination by 7 the Food and Drug Administration that adequate grounds 8 do not exist to continue the suspension actions, the Food 9 and Drug Administration shall promptly vacate the sus- 10 pension and reinstate the registration of the facility or the 11 cosmetic ingredient statement.

12 ‘‘(e) EFFECT OF SUSPENSION.—

13 ‘‘(1) REGISTRATION.—If the registration of a 14 facility is suspended under this section, no person 15 shall introduce or deliver for introduction into inter- 16 state commerce cosmetics or cosmetic products from 17 such facility.

18 ‘‘(2) COSMETIC INGREDIENT STATEMENT.—If 19 the cosmetic ingredient statement for a cosmetic 20 product is suspended under this section, no person 21 shall introduce or deliver for introduction into inter- 22 state commerce any cosmetic product that is the 23 subject of such statement.

24 ‘‘(f) NO DELEGATION.—The authority conferred by 25 this section to issue an order to suspend a registration

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3 SEC. 102. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL

4 CONSTITUENTS; SAFETY OF FINISHED PROD-

5 UCTS.

6 (a) AMENDMENTS.—Chapter VI of the Federal Food, 7 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 8 amended by section 101, is further amended by adding 9 at the end the following:

10 ‘‘SEC. 608. REVIEW OF INGREDIENTS AND NON-FUNC-

11 TIONAL CONSTITUENTS.

12 ‘‘(a) INGREDIENTS AND NON-FUNCTIONAL CON-

13 STITUENTS SUBJECT TO REVIEW.—

14 ‘‘(1) IN GENERAL.—Beginning in fiscal year 15 2018, the Food and Drug Administration shall re- 16 view the safety of the cosmetic ingredients and non- 17 functional constituents under paragraph (3), as 18 modified under subsection (c), if applicable, and 19 issue an order under subsection (d) with respect to 20 the use of each such ingredient and presence of each 21 such non-functional constituent.

22 ‘‘(2) PUBLIC NOTICE AND COMMENT.—At the 23 initiation of the review of each cosmetic ingredient 24 or non-functional constituent, the Food and Drug 25 Administration shall open a docket for the submis-

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5 ‘‘(3) COSMETIC INGREDIENTS.—

6 ‘‘(A) INGREDIENTS TO BE CONSIDERED IN

7 FIRST YEAR.—During fiscal year 2018, the 8 Food and Drug Administration shall initiate the 9 review for safety of the following cosmetic in- 10 gredients: 11 ‘‘(i) Diazolidinyl urea. 12 ‘‘(ii) Lead acetate. 13 ‘‘(iii) Methylene glycol/methanediol/ 14 formaldehyde. 15 ‘‘(iv) Propyl paraben. 16 ‘‘(v) Quaternium-15.

17 ‘‘(B) INGREDIENTS TO BE CONSIDERED IN

18 SUBSEQUENT YEARS.—

19 ‘‘(i) IN GENERAL.—Beginning in fis- 20 cal year 2019, the Food and Drug Admin- 21 istration shall annually select and complete 22 a review of at least 5 cosmetic ingredients 23 or non-functional constituents that were 24 not reviewed in the prior 3 years from a 25 list determined in consultation with indus-

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8 ‘‘(ii) CONSIDERATIONS.—The deter- 9 mination of which ingredients or functional 10 ingredients will be reviewed in a given year 11 shall be publicized in annual reports to 12 Congress and the public, in accordance 13 with section 618, and subject to consulta- 14 tion as provided for in clause (iii). The re- 15 view of any cosmetic ingredient or non- 16 functional constituent shall commence with 17 a public announcement by the Food and 18 Drug Administration and the opening of a 19 docket as required under paragraph (2).

20 ‘‘(iii) CONSULTATION.—The Food and 21 Drug Administration shall establish a Cos- 22 metics Safety Advisory Committee, which 23 shall include equal numbers of individuals 24 from the cosmetics industry and consumer 25 groups, and other individuals, as the Food

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16 ‘‘(4) COMMENT PERIOD.—As part of the annual 17 reporting to Congress and the public under section 18 618, the Food and Drug Administration shall solicit 19 public comment on which cosmetic ingredients or 20 non-functional constituents on the list are of great- 21 est interest to be reviewed next for early review and 22 which additional cosmetic ingredients or non-func- 23 tional constituents should be added to the list. The 24 public may submit comments to the Food and Drug 25 Administration at any time during the year regard-

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5 ‘‘(b) LIST.—The Food and Drug Administration 6 shall maintain a list, posted on the Internet website of the 7 Food and Drug Administration, of the cosmetic ingredi- 8 ents and non-functional constituents for which final orders 9 have been issued under subsection (d)(3), the finding 10 made for each such ingredient or non-functional con- 11 stituent under subsection (d)(4), as modified by any order 12 under subsection (f), if applicable, and, if applicable, com- 13 pliance dates that are the subject of a final order under 14 subsection (e).

15 ‘‘(c) INITIATIVE OF THE FDA.—The Food and Drug 16 Administration may at any time, after consultation with 17 the Cosmetics Safety Advisory Committee, propose the 18 issuance of an order on the safety of a cosmetic ingredient 19 or non-functional constituent that was not previously list- 20 ed in subsection (a) or under section 618(a)(3). The Food 21 and Drug Administration shall follow the same procedures 22 and policies for review of any cosmetic ingredient or non- 23 functional constituent so proposed as for the ingredients 24 and constituents reviewed pursuant to subsection (a).

25 ‘‘(d) DETERMINATION ON SAFETY.—

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1 ‘‘(1) INITIAL PROPOSED ADMINISTRATIVE

2 ORDER.—Following consideration of data and com- 3 ments to the public docket and any other informa- 4 tion before the Food and Drug Administration, the 5 Food and Drug Administration shall determine 6 whether there is adequate evidence to make an ini- 7 tial finding on the safety of the ingredient or non- 8 functional constituent. If the Food and Drug Ad- 9 ministration determines that there is adequate evi- 10 dence, the Food and Drug Administration shall issue 11 a proposed administrative order and shall post such 12 order on the Internet website of the Food and Drug 13 Administration, notwithstanding subchapter II of 14 chapter 5 of title 5, United States Code.

15 ‘‘(2) PUBLIC COMMENT.—Upon publication of 16 the proposed administrative order described in para- 17 graph (1), the Food and Drug Administration shall 18 open a docket for the submission of public comment. 19 The Food and Drug Administration shall provide 30 20 days for public comment following publication of the 21 proposed administrative order.

22 ‘‘(3) FINAL ADMINISTRATIVE ORDER.—Fol- 23 lowing the public comment period described in para- 24 graph (2) and consideration of comments to the pub- 25 lic docket and any other information before the Food

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12 ‘‘(4) DETERMINATIONS.—In the proposed ad- 13 ministrative order or the final administrative order, 14 as applicable, the Food and Drug Administration 15 shall make a determination that the ingredient or 16 non-functional constituent is— 17 ‘‘(A) safe in cosmetic products under speci- 18 fied conditions of use or tolerances; 19 ‘‘(B) safe in cosmetic products without the 20 need for specified conditions of use or toler- 21 ances; or 22 ‘‘(C) not safe in cosmetic products.

23 ‘‘(5) CONDITIONS OF USE AND TOLERANCES.— 24 An order under paragraph (4)(A) shall include such 25 conditions on the use of an ingredient or such toler-

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24 ‘‘(6) PUBLIC NOTICE.—A final order under this 25 subsection shall set forth the determination of the

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8 ‘‘(e) ORDER.—

9 ‘‘(1) IN GENERAL.—If the Food and Drug Ad- 10 ministration issues a final administrative order 11 under subparagraph (A) or (C) of subsection (d)(4), 12 the Food and Drug Administration shall, at the 13 same time as publication of the notice under sub- 14 section (d)(6), publish a proposed order identifying 15 dates by which use of the ingredient or non-func- 16 tional constituent in cosmetic products shall comply 17 with the final administrative order, and provide 60 18 days for public comment, including comment on 19 whether compliance is feasible within the proposed 20 dates. After considering comments on the proposed 21 order, the Food and Drug Administration shall pub- 22 lish in the Federal Register a final order.

23 ‘‘(2) CONTENT.—The public notice information 24 regarding the final order under paragraph (1) shall 25 include a summary that is written in plain and un-

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8 ‘‘(f) MODIFICATION OF AN ORDER.—An order issued 9 under subsection (d) or (e) may be modified or revoked 10 by the Food and Drug Administration on the initiative of 11 the Food and Drug Administration or in response to a 12 petition.

13 ‘‘(g) INADEQUATE EVIDENCE.—

14 ‘‘(1) NOTICE; EXTENSION.—If the Food and 15 Drug Administration determines that the available 16 data and information are not adequate to make a 17 proposed or final determination regarding safety 18 under subsection (d)(4), with respect to a cosmetic 19 ingredient or non-functional constituent, the Food 20 and Drug Administration shall— 21 ‘‘(A) publish such finding on the Internet 22 website of the Food and Drug Administration 23 not later than 90 days after the close of the rel- 24 evant comment period for the ingredient or 25 non-functional constituent under subsection

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1 ‘‘(2) DETERMINATION; ORDER.—

2 ‘‘(A) INADEQUATE DATA AND INFORMA-

3 TION.—If the Food and Drug Administration 4 determines, after considering any additional 5 data and information submitted under para- 6 graph (1)(B), that the available data and infor- 7 mation still are not adequate to make a deter- 8 mination regarding safety under subsection 9 (d)(4), the Food and Drug Administration 10 shall, within 90 days of the close of the addi- 11 tional time period provided under paragraph 12 (1)(B), issue a proposed order or a final admin- 13 istrative order— 14 ‘‘(i) making a determination that the 15 ingredient or non-functional constituent 16 has not been shown to be safe in cosmetic 17 products; and 18 ‘‘(ii) explaining why the available data 19 and information are not adequate to assess 20 the safety of the ingredient or non-func- 21 tional constituent.

22 ‘‘(B) ADEQUATE DATA AND INFORMA-

23 TION.—If the Food and Drug Administration 24 determines, after considering any additional 25 data and information submitted under para-

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10 ‘‘(h) SAFETY ASSESSMENT.—

11 ‘‘(1) IN GENERAL.—In assessing the safety of 12 an ingredient or non-functional constituent, the 13 Food and Drug Administration shall consider wheth- 14 er there is adequate evidence to support a reasonable 15 certainty among competent scientists that the ingre- 16 dient is not harmful under the recommended or sug- 17 gested conditions of use or customary or usual use, 18 or that a non-functional constituent is not harmful 19 under the recommended or suggested tolerance levels 20 or the level at which it is customarily or usually 21 present. The Food and Drug Administration may 22 not consider an ingredient or non-functional con- 23 stituent harmful solely because it can cause minor 24 adverse health reactions, such as minor transient al-

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3 ‘‘(2) FACTORS.—In assessing the safety of an 4 ingredient or non-functional constituent, the Food 5 and Drug Administration shall consider, among 6 other relevant factors, the following: 7 ‘‘(A) The probable human exposure to the 8 ingredient or non-functional constituent from 9 expected use in cosmetics. 10 ‘‘(B) The probable cumulative and aggre- 11 gate effect in humans of relevant exposure to 12 the ingredient or non-functional constituent or 13 to any chemically or pharmacologically related 14 substances from use in cosmetics or other prod- 15 ucts with similar routes of exposure under rec- 16 ommended or suggested conditions of use or 17 their customary use, to the extent adequate 18 data is available for analysis. In appropriate 19 cases, the Food and Drug Administration may 20 consider available information on the total expo- 21 sure to an ingredient or non-functional con- 22 stituent from all sources. 23 ‘‘(C) Whether warnings or recommenda- 24 tions in a product label required under section 25 614, as part of any conditions of use or toler-

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5 ‘‘(3) DATA AND INFORMATION.—

6 ‘‘(A) REQUIRED INFORMATION.—A deter- 7 mination that an ingredient or non-functional 8 constituent is safe in cosmetics shall be based 9 upon adequate evidence submitted or otherwise 10 known to the Food and Drug Administration, 11 which shall include full reports of all available 12 studies, published or unpublished, that are ade- 13 quately designed to show whether the ingredient 14 or non-functional constituent is safe. Such stud- 15 ies may include in vitro and in silico studies 16 and epidemiological studies, biomonitoring stud- 17 ies, and studies focused on various points dur- 18 ing the lifespan of the subject, that use scientif- 19 ically valid methodology.

20 ‘‘(B) ADDITIONAL RELEVANT INFORMA-

21 TION.—The Food and Drug Administration 22 shall consider any other relevant information 23 related to the safety of the ingredient or non- 24 functional constituent, including— 25 ‘‘(i) adverse event reports;

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17 ‘‘SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS.

18 ‘‘(a) DETERMINATION.—

19 ‘‘(1) IN GENERAL.—Each responsible person 20 for a finished cosmetic product, before first intro- 21 ducing or delivering for introduction into interstate 22 commerce, or, in the case of such a product in inter- 23 state commerce on the date of enactment of the Per- 24 sonal Care Products Safety Act, not later than the 25 date on which registration is first required under

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9 ‘‘(2) NEW INFORMATION.—If new information 10 relevant to the determination becomes available, the 11 responsible person shall promptly update the deter- 12 mination to address that information.

13 ‘‘(3) SAFETY WITH RESPECT TO RANGES OF

14 POSSIBLE AMOUNTS.—In the case of a cosmetic 15 product for which there is a range of possible 16 amounts of cosmetic ingredients included in the cos- 17 metic ingredient statement, as described in section 18 606(c)(2)(E), the safety determination under para- 19 graph (1) shall include substantiation of the safety 20 of the full range in the finished product.

21 ‘‘(4) SMALL BUSINESSES.—A small business 22 registrant (as defined in section 605(e)(2)(B)(ii)) 23 may satisfy the requirements of this section by using 24 the ingredients in concentrations recommended by 25 available medical or scientific guidelines, or cosmetic

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4 ‘‘(b) PRESUMPTION OF ADEQUATE EVIDENCE.—

5 ‘‘(1) IN GENERAL.—Except as provided in sub- 6 section (c), a determination made under subsection 7 (a) shall be presumed to be based on adequate evi- 8 dence if it is supported by— 9 ‘‘(A) with respect to each ingredient in the 10 finished product— 11 ‘‘(i) references to an official statement 12 by one or more expert medical or scientific 13 bodies that the ingredient is safe under the 14 conditions of use recommended or sug- 15 gested in the product’s labeling; or 16 ‘‘(ii) appropriate safety testing of the 17 ingredient; and 18 ‘‘(B) appropriate safety substantiation of 19 the finished product beyond the safety substan- 20 tiation of individual ingredients and consider- 21 ation of the combination of ingredients.

22 ‘‘(2) STATEMENT OF AN EXPERT MEDICAL OR

23 SCIENTIFIC BODY.—For purposes of this section, a 24 statement of an expert medical or scientific body is 25 an official statement of that body, if—

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14 ‘‘(c) REBUTTAL OF PRESUMPTION.—Notwith- 15 standing subsection (b), a determination under subsection 16 (a) will not be presumed to be based on adequate evidence 17 if— 18 ‘‘(1) the Food and Drug Administration issues 19 an order under section 608 that an ingredient or 20 non-functional constituent in the finished product is 21 not safe under the product’s conditions of use or 22 customary or usual use; or 23 ‘‘(2) the Food and Drug Administration has 24 provided the manufacturer with notice that—

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8 ‘‘(d) TIMELY UPDATE.—Upon notice of inadequate 9 evidence under subsection (c), the responsible person shall 10 have 10 days to submit additional evidence to the Food 11 and Drug Administration regarding the safety of an ingre- 12 dient, non-functional constituent, or the entire cosmetic 13 product, and the Food and Drug Administration shall 14 have 30 days from the date of receipt of such additional 15 evidence to provide the responsible person with notice that 16 the criteria under subsection (b) have been met or not met.

17 ‘‘(e) RECORDS MAINTENANCE.—The responsible per- 18 son shall maintain records documenting the determination 19 required under this section and the information on which 20 such determination is based until 5 years after the fin- 21 ished product is no longer marketed, except that a respon- 22 sible person for a domestic company whose sales are under 23 $2,000,000 per year shall maintain such records for at 24 least 2 years after the finished product is no longer mar- 25 keted.

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1 ‘‘(f) SUBMISSION OF RECORDS.—

2 ‘‘(1) IN GENERAL.—The records required under 3 subsection (e) shall, upon the written request of the 4 Food and Drug Administration to the responsible 5 person, be provided to the Food and Drug Adminis- 6 tration within a reasonable timeframe not to exceed 7 60 days, in either electronic or paper form.

8 ‘‘(2) CRITERIA.—The Food and Drug Adminis- 9 tration may require records under paragraph (1) 10 if— 11 ‘‘(A) the Food and Drug Administration 12 has a reasonable belief, described in written no- 13 tice, that— 14 ‘‘(i) the finished product may be 15 harmful based on adverse event reports or 16 other scientific information; 17 ‘‘(ii) scientific information raises cred- 18 ible and relevant questions about the safe- 19 ty of the product or any of its ingredients; 20 ‘‘(iii) the responsible person has not 21 made the determination required under 22 subsection (a), or such determination is 23 not supported by adequate evidence; or 24 ‘‘(iv) one or more of the criteria to es- 25 tablish a presumption of adequate evidence

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13 ‘‘(g) GUIDANCE AND REGULATIONS.—

14 ‘‘(1) IN GENERAL.—The Food and Drug Ad- 15 ministration shall issue guidance describing the evi- 16 dence necessary to support a determination under 17 subsection (a), and may, by regulation, establish ex- 18 emptions to the requirements of this section, if the 19 Food and Drug Administration determines that such 20 exemptions are supported by adequate evidence and 21 would have no adverse effect on public health.

22 ‘‘(2) SMALL BUSINESSES.—The Food and Drug 23 Administration shall, after consultation with the 24 Small Business Administration and small businesses 25 that manufacture cosmetics, provide additional guid-

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6 (b) EFFECTIVE DATE.—Section 609 of the Federal 7 Food, Drug, and Cosmetic Act, as added by subsection 8 (a), shall take effect 180 days after the date of enactment 9 of this Act.

10 SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS-

11 METICS.

12 (a) IN GENERAL.—Chapter VI of the Federal Food, 13 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 14 amended by section 102, is further amended by adding 15 at the end the following:

16 ‘‘SEC. 610. GOOD MANUFACTURING PRACTICES FOR COS-

17 METICS.

18 ‘‘(a) IN GENERAL.—The Food and Drug Administra- 19 tion shall review national and international standards for 20 cosmetic good manufacturing practices that are in exist- 21 ence on the date of enactment of the Personal Care Prod- 22 ucts Safety Act and shall develop and implement, through 23 regulations, standards consistent, to the extent the Food 24 and Drug Administration determines practicable and ap- 25 propriate, with such national and international standards

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4 ‘‘(b) CONSULTATION.—The standards under sub- 5 section (a) shall include simplified good manufacturing 6 practices for small businesses that take into account the 7 size and scope of the business, developed in consultation 8 with the Small Business Administration.

9 ‘‘(c) TIMEFRAME.—The Food and Drug Administra- 10 tion shall publish a proposed rule described in subsection 11 (a) not later than 18 months after the date of enactment 12 of the Personal Care Products Safety Act and shall pub- 13 lish a final such rule not later than 3 years after such 14 date of enactment.’’.

15 (b) EFFECTIVE DATE FOR COSMETIC MANUFACTUR-

16 ERS.—

17 (1) LARGE BUSINESSES.—For businesses of a 18 size greater than the Small Business Administra- 19 tion’s standard for a small business, section 610 of 20 the Federal Food, Drug, and Cosmetic Act (as 21 added by subsection (a)) shall take effect beginning 22 180 days after the date on which the Food and 23 Drug Administration makes effective cosmetic good 24 manufacturing practices.

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1 (2) SMALL BUSINESSES.—For businesses of a 2 size that meets the Small Business Administration’s 3 standard for a small business, section 610 of the 4 Federal Food, Drug, and Cosmetic Act (as added by 5 subsection (a)) shall take effect beginning 2 years 6 after the date the Food and Drug Administration 7 makes effective cosmetic good manufacturing prac- 8 tices.

9 SEC. 104. ADVERSE EVENT REPORTS. 10 Chapter VI of the Federal Food, Drug, and Cosmetic 11 Act (21 U.S.C. 361 et seq.), as amended by section 12 103(a), is further amended by adding at the end the fol- 13 lowing:

14 ‘‘SEC. 611. ADVERSE EVENT REPORTING FOR COSMETICS.

15 ‘‘(a) IN GENERAL.—With respect to any cosmetic 16 product distributed in the United States, the responsible 17 person shall submit to the Food and Drug Administration 18 a report of any serious adverse event associated with such 19 cosmetic product, when used in the United States, accom- 20 panied by a copy of the label on or with the retail pack- 21 aging of the cosmetic, any new medical information, re- 22 lated to a submitted serious adverse event report that is 23 received by the responsible person, and an annual report 24 for all adverse events received by the responsible person.

25 ‘‘(b) DEFINITIONS.—In this section:

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21 ‘‘(c) SUBMISSION OF REPORTS.—

22 ‘‘(1) SERIOUS ADVERSE EVENT REPORTS.—Ex- 23 cept as provided in paragraph (2), with respect to a 24 cosmetic product distributed in the United States, 25 the responsible person shall submit a serious adverse

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10 ‘‘(2) NEW MEDICAL INFORMATION.—The re- 11 sponsible person shall submit to the Food and Drug 12 Administration any new medical information, related 13 to a submitted serious adverse event report that is 14 received by the responsible person within 1 year of 15 the initial report, and shall submit such information 16 not later than 15 business days after the new infor- 17 mation is received by the responsible person.

18 ‘‘(3) ANNUAL REPORT.—

19 ‘‘(A) IN GENERAL.—Not later than March 20 1 of each year, except as provided under sub- 21 paragraph (C), the responsible person shall sub- 22 mit an electronic report for the prior calendar 23 year for each cosmetic product marketed during 24 that year.

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1 ‘‘(B) CONTENTS.—Each report under this 2 paragraph shall contain a summary of all ad- 3 verse events received during the reporting pe- 4 riod, a complete list of individual reports, and 5 an estimate of the total number of product 6 units estimated to have been distributed to con- 7 sumers during such period. The report shall not 8 include consumer complaints that are solely re- 9 garding efficacy and do not contain any infor- 10 mation about an adverse event. The Food and 11 Drug Administration shall further specify the 12 contents of the annual electronic report by reg- 13 ulation or guidance.

14 ‘‘(C) SMALL BUSINESS EXCEPTION.—In 15 the case of a domestic facility for which the av- 16 erage gross annual sales in cosmetic products in 17 the United States over the previous 3-year pe- 18 riod is not more than $2,000,000, the respon- 19 sible person is not required to submit an annual 20 report under this paragraph.

21 ‘‘(4) EXEMPTION.—The Food and Drug Ad- 22 ministration may establish by regulation an exemp- 23 tion to any of the requirements under this sub- 24 section if the Food and Drug Administration deter- 25 mines that such exemption is supported by adequate

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3 ‘‘(d) REQUIREMENTS.—

4 ‘‘(1) IN GENERAL.—Each serious adverse event 5 report under this section shall be submitted to the 6 Food and Drug Administration using an electronic 7 system of the Food and Drug Administration. The 8 Food and Drug Administration shall make such elec- 9 tronic system available not later than 1 year after 10 the date of enactment of the Personal Care Products 11 Safety Act.

12 ‘‘(2) MODIFICATION.—The format of the re- 13 porting system may be modified by the Food and 14 Drug Administration and the reports may include 15 additional information. The Food and Drug Admin- 16 istration may, in guidance, further specify the for- 17 mat and contents of required reports.

18 ‘‘(3) SCOPE OF SERIOUS ADVERSE EVENT RE-

19 PORT.—A serious adverse event report (including all 20 information submitted in the initial report or added 21 later) submitted to the Food and Drug Administra- 22 tion under subsection (a) includes— 23 ‘‘(A) a report under section 756 with re- 24 spect to safety and related to a specific cos- 25 metic product;

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12 ‘‘(4) RESPONSIBILITY TO GATHER INFORMA-

13 TION.—After an individual initiates the reporting of 14 a serious adverse event, the responsible person for 15 the cosmetic product shall actively gather all of the 16 information to complete and file the report with the 17 Food and Drug Administration.

18 ‘‘(5) NO ADVERSE EVENTS TO REPORT.—The 19 Food and Drug Administration shall provide an op- 20 tion as part of the electronic registration process for 21 the responsible person to indicate if such responsible 22 person had no adverse events to report over the pre- 23 vious year. With respect to a responsible person who 24 received no adverse event reports for a year, the an- 25 nual adverse event report requirement may be met

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3 ‘‘(e) LIMITATION WITH RESPECT TO ADVERSE

4 EVENT REPORTS.—The submission of an adverse event 5 report in compliance with subsection (a) shall not con- 6 stitute an admission that the cosmetic involved caused or 7 contributed to the adverse event.

8 ‘‘(f) CONTACT INFORMATION.—The label of a cos- 9 metic shall bear the domestic telephone number or elec- 10 tronic contact information, and it is encouraged that the 11 label include both the telephone number and electronic 12 contact information, through which the responsible person 13 may receive a report of an adverse event.

14 ‘‘(g) MAINTENANCE OF RECORDS.—The responsible 15 person shall maintain records related to each report of an 16 adverse event received by the responsible person for a pe- 17 riod of 6 years.

18 ‘‘(h) AVAILABILITY TO STATES.—The Food and 19 Drug Administration shall make available records sub- 20 mitted under this section to any State, upon request. In- 21 formation disclosed to a State that is exempt from disclo- 22 sure under section 552(b)(4) of title 5, United States 23 Code, shall be treated as a trade secret and confidential 24 information by the State.

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1 ‘‘(i) EFFECTIVE DATE OF REQUIREMENT WITH RE-

2 SPECT TO SERIOUS ADVERSE EVENTS.—The requirement 3 under this section to report serious adverse events shall 4 become effective on the date that the Food and Drug Ad- 5 ministration publicizes the availability of the electronic 6 system described in subsection (d)(1).’’.

7 SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AU-

8 THORITY. 9 Chapter VI of the Federal Food, Drug, and Cosmetic 10 Act (21 U.S.C. 361 et seq.), as amended by section 104, 11 is further amended by adding at the end the following:

12 ‘‘SEC. 612. INSPECTION OF COSMETIC RECORDS.

13 ‘‘(a) INSPECTION OF RECORDS.—Each manufac- 14 turer, processor, packer, or holder of a cosmetic shall, at 15 the request of an officer or employee duly designated by 16 the Food and Drug Administration, permit such officer 17 or employee, upon presentation of appropriate credentials 18 and written notice to such person, at reasonable times and 19 within reasonable limits and in a reasonable manner, to 20 have access to and copy— 21 ‘‘(1) all records maintained under section 611 22 and in accordance with the rules promulgated by the 23 Food and Drug Administration under section 610, 24 as applicable; and

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16 ‘‘(b) EXCLUSIONS.—No inspection authorized by this 17 section shall extend to financial data, pricing data, per- 18 sonnel data (other than data as to qualification of tech- 19 nical and professional personnel performing functions sub- 20 ject to this Act), research data (other than safety data), 21 or sales data other than shipment data.

22 ‘‘(c) SCOPE.—The requirements under subsection (a) 23 apply to records maintained by or on behalf of such person 24 in any format (including paper and electronic formats) 25 and at any location.

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1 ‘‘(d) PROTECTION OF SENSITIVE INFORMATION.— 2 The Food and Drug Administration shall take appropriate 3 measures to ensure that there are effective procedures to 4 prevent the unauthorized disclosure of any trade secret or 5 confidential information that is obtained by the Food and 6 Drug Administration pursuant to this section. Information 7 disclosed to a State that is exempt from disclosure under 8 section 552(b)(4) of title 5, United States Code, shall be 9 treated as a trade secret and confidential information by 10 the State.

11 ‘‘(e) LIMITATIONS.—This section shall not be con- 12 strued— 13 ‘‘(1) to limit the authority of the Food and 14 Drug Administration to inspect records or to require 15 establishment and maintenance of records under any 16 other provision of this Act; or 17 ‘‘(2) to have any legal effect on section 552 of 18 title 5, United States Code, or section 1905 of title 19 18, United States Code.’’.

20 ‘‘SEC. 613. MANDATORY RECALL AUTHORITY.

21 ‘‘(a) VOLUNTARY PROCEDURES.—If the Food and 22 Drug Administration determines that there is a reasonable 23 probability that a cosmetic is adulterated under section 24 601 or misbranded under section 602 and the use of or 25 exposure to such cosmetic is likely to cause serious adverse

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5 ‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE

6 DISTRIBUTION AND GIVE NOTICE.—

7 ‘‘(1) IN GENERAL.—If the responsible person 8 refuses to or does not voluntarily cease distribution 9 or recall such cosmetic within the time and in the 10 manner prescribed by the Food and Drug Adminis- 11 tration, the Food and Drug Administration may 12 order such person to— 13 ‘‘(A) immediately cease distribution of 14 such cosmetic; and 15 ‘‘(B) as applicable, immediately notify all 16 persons— 17 ‘‘(i) manufacturing, processing, pack- 18 ing, transporting, holding, receiving, dis- 19 tributing, or importing and selling such 20 cosmetic; and 21 ‘‘(ii) to which such cosmetic has been 22 distributed, transported, or sold, 23 to immediately cease distribution of such cos- 24 metic.

25 ‘‘(2) REQUIRED ADDITIONAL INFORMATION.—

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1 ‘‘(A) IN GENERAL.—If a cosmetic covered 2 by a recall order issued under paragraph (1)(B) 3 has been distributed to a warehouse-based 4 third-party logistics provider without providing 5 such provider sufficient information to know or 6 reasonably determine the precise identity of 7 such cosmetic covered by a recall order that is 8 in its possession, the notice provided by the re- 9 sponsible person subject to the order issued 10 under paragraph (1)(B) shall include such in- 11 formation as is necessary for the warehouse- 12 based third-party logistics provider to identify 13 the cosmetic.

14 ‘‘(B) RULES OF CONSTRUCTION.—Nothing 15 in this paragraph shall be construed— 16 ‘‘(i) to exempt a warehouse-based 17 third-party logistics provider from the re- 18 quirements of this chapter, including the 19 requirements of this section and section 20 612; or 21 ‘‘(ii) to exempt a warehouse-based 22 third-party logistics provider from being 23 the subject of a mandatory recall order.

24 ‘‘(3) DETERMINATION TO LIMIT AREAS AF-

25 FECTED.—If the Food and Drug Administration re-

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7 ‘‘(c) HEARING ON ORDER.—The Food and Drug Ad- 8 ministration shall provide the responsible party subject to 9 an order under subsection (b) with an opportunity for an 10 informal hearing, to be held as soon as possible, but not 11 later than 2 days after the issuance of the order, on the 12 actions required by the order and on why the cosmetic that 13 is the subject of the order should not be recalled.

14 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA-

15 TION OF ORDER.—

16 ‘‘(1) AMENDMENT OF ORDER.—If, after pro- 17 viding opportunity for an informal hearing under 18 subsection (c), the Food and Drug Administration 19 determines that removal of the cosmetic from com- 20 merce is necessary, the Food and Drug Administra- 21 tion shall, as appropriate— 22 ‘‘(A) amend the order to require recall of 23 such cosmetic or other appropriate action; 24 ‘‘(B) specify a timetable in which the recall 25 shall occur;

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7 ‘‘(2) VACATING OF ORDER.—If, after such hear- 8 ing, the Food and Drug Administration determines 9 that adequate grounds do not exist to continue the 10 actions required by the order, or that such actions 11 should be modified, the Food and Drug Administra- 12 tion shall vacate the order or modify the order.

13 ‘‘(e) COOPERATION AND CONSULTATION.—The Food 14 and Drug Administration shall work with State and local 15 public health officials in carrying out this section, as ap- 16 propriate.

17 ‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 18 under this section, the Food and Drug Administration 19 shall— 20 ‘‘(1) ensure that a press release is published re- 21 garding the recall, and that alerts and public notices 22 are issued, as appropriate, in order to provide notifi- 23 cation—

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17 ‘‘(g) NO DELEGATION.—The authority conferred by 18 this section to order a recall or vacate a recall order shall 19 not be delegated to any officer or employee other than the 20 Commissioner.

21 ‘‘(h) EFFECT.—Nothing in this section shall affect 22 the authority of the Food and Drug Administration to re- 23 quest or participate in a voluntary recall, or to issue an 24 order to cease distribution or to recall under any other

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3 SEC. 106. LABELING.

4 (a) IN GENERAL.—Chapter VI of the Federal Food, 5 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 6 amended by section 105, is further amended by adding 7 at the end the following:

8 ‘‘SEC. 614. LABELING.

9 ‘‘(a) SAFETY REVIEW AND LABELING.—Following a 10 review of cosmetic ingredients that determines that warn- 11 ings are required to help ensure safe use of cosmetic prod- 12 ucts under section 608(d)(5), the Food and Drug Admin- 13 istration shall require labeling of cosmetics that are not 14 appropriate for use in the entire population, including 15 warnings that vulnerable populations, such as children or 16 pregnant women, should limit or avoid using the product.

17 ‘‘(b) COSMETIC PRODUCTS FOR PROFESSIONAL

18 USE.—

19 ‘‘(1) DEFINITION OF PROFESSIONAL.—With re- 20 spect to cosmetics, the term ‘professional’ means an 21 individual who— 22 ‘‘(A) is licensed by an official State author- 23 ity to practice in the field of cosmetology, nail 24 care, barbering, or esthetics;

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5 ‘‘(2) LISTING OF INGREDIENTS.—Cosmetic 6 products used and sold by professionals shall list all 7 ingredients and warnings, as required for other cos- 8 metic products under this chapter.

9 ‘‘(3) PROFESSIONAL USE LABELING.—In the 10 case of a cosmetic product intended to be used only 11 by a professional on account of a specific ingredient 12 or increased concentration of an ingredient that re- 13 quires safe handling by trained professionals, the 14 product shall bear a statement as follows: ‘To be Ad- 15 ministered Only by Licensed Professionals’.

16 ‘‘(c) REQUIREMENTS.—

17 ‘‘(1) DISPLAY.—A warning required under sub- 18 section (a) and a statement required under sub- 19 section (b)(3) shall be prominently displayed— 20 ‘‘(A) in the primary language used on the 21 label; and 22 ‘‘(B) in conspicuous and legible type in 23 contrast by typography, layout, or color with 24 other material printed or displayed on the label.

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1 ‘‘(2) MINIMUM WARNING REQUIREMENTS.—A 2 responsible person may include on the labeling any 3 additional warnings in addition to the minimum 4 warnings required under subsection (a).

5 ‘‘(d) INTERNET SALES.—In the case of Internet sales 6 of cosmetics, each Internet website offering a cosmetic 7 product for sale to consumers shall provide the same infor- 8 mation that is included on the packaging of the cosmetic 9 product as regularly available through in-person sales, ex- 10 cept information that is unique to a single cosmetic prod- 11 uct sold in a retail facility, such as a lot number or expira- 12 tion date, and the warnings and statements described in 13 subsection (c) shall be prominently and conspicuously dis- 14 played on the website.

15 ‘‘(e) CONTACT INFORMATION.—The label on each 16 cosmetic shall bear the domestic telephone number or elec- 17 tronic contact information, and it is encouraged that the 18 label include both the telephone number and electronic 19 contact information, that consumers may use to contact 20 the responsible person with respect to adverse events. The 21 contact number shall provide a means for consumers to 22 obtain additional information about ingredients in a cos- 23 metic, including the ability to ask if a specific ingredient 24 may be present that is not listed on the label, including 25 whether a specific ingredient may be contained in the fra-

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7 (b) EFFECTIVE DATE.—Section 614 of the Federal 8 Food, Drug, and Cosmetic Act, as added by subsection 9 (a), shall take effect on the date that is 1 year after the 10 date of enactment of this Act.

11 SEC. 107. COAL TAR CHEMICALS. 12 Chapter VI of the Federal Food, Drug, and Cosmetic 13 Act (21 U.S.C. 361 et seq.), as amended by section 106, 14 is further amended by adding at the end the following:

15 ‘‘SEC. 615. COAL TAR CHEMICALS. 16 ‘‘Specific chemicals in coal tar hair dyes may be se- 17 lected and reviewed under section 608.’’.

18 SEC. 108. ANIMAL TESTING ALTERNATIVES. 19 Chapter VI of the Federal Food, Drug, and Cosmetic 20 Act (21 U.S.C. 361 et seq.), as amended by section 107, 21 is further amended by adding the following:

22 ‘‘SEC. 616. ANIMAL TESTING ALTERNATIVES.

23 ‘‘(a) IN GENERAL.—To minimize the use of animal 24 testing for safety of cosmetic ingredients, non-functional

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21 ‘‘(b) GUIDANCE.—Not later than 3 years after the 22 date of enactment of the Personal Care Products Safety 23 Act, the Food and Drug Administration shall issue guid- 24 ance on the acceptability of scientifically reliable and rel- 25 evant alternatives to animal testing for the safety of cos-

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5 ‘‘(c) RESOURCES REGARDING ANIMAL TESTING AL-

6 TERNATIVES.—Not later than 180 days after the date of 7 enactment of the Personal Care Products Safety Act, the 8 Food and Drug Administration shall provide information 9 on the Internet website of the Food and Drug Administra- 10 tion regarding resources available for information about 11 non-animal methods, and methods that reduce animal 12 usage, in testing for the safety of cosmetic ingredients, 13 non-functional constituents, and finished cosmetic prod- 14 ucts.’’.

15 SEC. 109. PREEMPTION. 16 Chapter VI of the Federal Food, Drug, and Cosmetic 17 Act (21 U.S.C. 361 et seq.), as amended by section 108, 18 is further amended by adding the following:

19 ‘‘SEC. 617. PREEMPTION.

20 ‘‘(a) IN GENERAL.—No State or political subdivision 21 of a State may establish or continue in effect any require- 22 ment for cosmetics, other than a requirement that is in 23 full effect and implemented on the date of enactment of 24 the Personal Care Products Safety Act—

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10 ‘‘(b) SAFETY OF COSMETIC INGREDIENTS AND NON-

11 FUNCTIONAL CONSTITUENTS.—

12 ‘‘(1) DELAYED EFFECT OF NEW STATE RE-

13 QUIREMENTS.—

14 ‘‘(A) IN GENERAL.—From the date that 15 the Food and Drug Administration has made 16 public the final selection of a cosmetic ingre- 17 dient or non-functional constituent to be re- 18 viewed in the coming year under section 19 608(a)(3)(B) and opened the public comment 20 period under section 608(a)(2), until the date 21 that is one year after the Food and Drug Ad- 22 ministration has made public such selection, no 23 State or political subdivision of a State may es- 24 tablish any new requirement related to such

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3 ‘‘(B) INITIAL REVIEW.—With respect to 4 the cosmetic ingredients to be reviewed in the 5 first year, in accordance with section 6 608(a)(3)(A), for the 1-year period beginning 7 on the date that is 6 months after the date of 8 enactment of the Personal Care Products Safe- 9 ty Act, no State or political subdivision of a 10 State may establish any new requirement re- 11 lated to such cosmetic ingredient or non-func- 12 tional constituent.

13 ‘‘(2) SCOPE.—Subsection (a)(2) shall not be 14 construed to affect the authority of a State or polit- 15 ical subdivision of a State with respect to any re- 16 quirement for the safety of a cosmetic ingredient or 17 non-functional constituent that is unrelated to the 18 scope of the safety assessment under section 608.

19 ‘‘(3) SENSE OF CONGRESS.—It is the sense of 20 Congress that a State or political subdivision that 21 regulates the safety of cosmetics with respect to the 22 health of humans beyond the scope of section 608 23 should utilize the safety assessment criteria de- 24 scribed in section 608(h).

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1 ‘‘(c) STATE REQUIREMENT THAT ISINFULL EF-

2 FECT AND IMPLEMENTED.—For purposes of this section:

3 ‘‘(1) STATE REQUIREMENT.—A State require- 4 ment includes a State requirement that is adopted 5 by a State public initiative or referendum.

6 ‘‘(2) FULL EFFECT AND IMPLEMENTED.—The 7 term ‘full effect and implemented’ includes require- 8 ments of States that are implemented after the date 9 of enactment of the Personal Care Products Safety 10 Act, if such requirements are under a law that was 11 in effect, or a lawful program that was established 12 and functioning, prior to the date of enactment of 13 the Personal Care Products Safety Act.

14 ‘‘(d) LIMITATION.—Nothing in the amendments to 15 this Act made by the Personal Care Products Safety Act 16 shall be construed to preempt any State statute, public 17 initiative, referendum, or other State action, except as ex- 18 pressly provided in this section.

19 ‘‘(e) SAVINGS.—Nothing in the amendments to this 20 Act made by the Personal Care Products Safety Act, nor 21 any standard, rule, requirement, regulation, adverse event 22 report, safety assessment, safety determination, scientific 23 assessment, or order issued or implemented pursuant to 24 such amendments, shall be construed to modify or other- 25 wise affect, preempt, or displace any cause of action or

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4 SEC. 110. REPORTING. 5 Chapter VI of the Federal Food, Drug, and Cosmetic 6 Act (21 U.S.C. 361 et seq.), as amended by section 109, 7 is further amended by adding at the end the following:

8 ‘‘SEC. 618. REPORTING.

9 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 10 year 2018, and not later than 60 days prior to the end 11 of each fiscal year for which fees are collected under sec- 12 tion 744L, the Food and Drug Administration shall pre- 13 pare and submit to Congress a report concerning the 14 progress of the Food and Drug Administration in achiev- 15 ing the objectives of the Personal Care Products Safety 16 Act during such fiscal year and the future plans of the 17 Food and Drug Administration for meeting the objectives. 18 The annual report for a fiscal year shall include— 19 ‘‘(1) the number of registered facilities and cos- 20 metic ingredient statements on file with the Food 21 and Drug Administration; 22 ‘‘(2) identification of the cosmetic ingredients 23 and non-functional constituents that have been fully 24 reviewed for safety by the Food and Drug Adminis-

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21 ‘‘(b) PUBLIC AVAILABILITY.—The Food and Drug 22 Administration shall make the reports required under sub- 23 section (a) available to the public on the Internet website 24 of the Food and Drug Administration on the date of sub- 25 mission of such reports to Congress.

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1 ‘‘(c) PUBLIC INPUT ON SAFETY REVIEW.—Upon re- 2 lease of the report described in subsection (a), the Food 3 and Drug Administration shall provide the public with an 4 opportunity to provide feedback, at any time during the 5 year, on subsection (a)(3) by— 6 ‘‘(1) providing an electronic portal, upon release 7 of the report, enabling the public to— 8 ‘‘(A) comment on the cosmetic ingredients 9 or non-functional constituents under review for 10 the current year; 11 ‘‘(B) recommend additional cosmetic ingre- 12 dients and non-functional constituents to be 13 considered for review for safety in future years; 14 and 15 ‘‘(C) comment on the priorities for the spe- 16 cific cosmetic ingredients and non-functional 17 constituents that the Food and Drug Adminis- 18 tration anticipates will be reviewed in the next 19 fiscal year; 20 ‘‘(2) announcing on the Internet website of the 21 Food and Drug Administration, within the first 30 22 days of the new fiscal year, any amendments to the 23 list of cosmetic ingredients and non-functional con- 24 stituents submitted pursuant to subsection (a)(3)

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9 SEC. 111. SMALL BUSINESSES. 10 Chapter VI of the Federal Food, Drug, and Cosmetic 11 Act (21 U.S.C. 361 et seq.), as amended by section 110, 12 is further amended by adding at the end the following:

13 ‘‘SEC. 619. SMALL BUSINESSES. 14 ‘‘The Commissioner, in coordination with the Admin- 15 istrator of the Small Business Administration, shall pro- 16 vide technical assistance, such as guidance and expertise, 17 to small businesses regarding compliance with the Per- 18 sonal Care Products Safety Act, including the amend- 19 ments made by such Act.’’.

20 SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COS-

21 METICS. 22 Chapter VI of the Federal Food, Drug, and Cosmetic 23 Act (21 U.S.C. 361 et seq.), as amended by section 111, 24 is further amended by adding at the end the following:

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2 COSMETICS. 3 ‘‘In the case of a cosmetic product or a facility that 4 is subject to the requirements under this chapter and 5 chapter V, if any requirement under chapter V with re- 6 spect to such cosmetic or facility is substantially similar 7 to a requirement under this chapter, the cosmetic product 8 or facility shall be deemed to be in compliance with the 9 applicable requirement under this chapter if such product 10 or facility is in compliance with such substantially similar 11 requirement under chapter V, provided that the product 12 or facility has not obtained a waiver from the requirement 13 under chapter V. In the case of a cosmetic product or fa- 14 cility that is subject to, and in compliance with, a fee 15 under subchapter C of chapter VII, other than a fee under 16 part 10 of such subchapter, any fee under such part 10 17 shall be waived with respect to such cosmetic product or 18 facility (with respect to cosmetic products).’’.

19 SEC. 113. ENFORCEMENT.

20 (a) PROHIBITED ACTS.—Section 301 of the Federal 21 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend- 22 ed— 23 (1) in subsection (e)— 24 (A) by striking ‘‘504, 564,’’ and inserting 25 ‘‘504, 564, 611, 612,’’; and

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19 (b) ADULTERATION.—Section 601 of the Federal 20 Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amend- 21 ed by adding at the end the following: 22 ‘‘(f) If the methods used in, or the facilities or con- 23 trols used for, its manufacture, processing, packing, or 24 holding do not conform to current good manufacturing

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14 (c) MISBRANDING.—Section 602 of the Federal 15 Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend- 16 ed— 17 (1) in subsection (b)— 18 (A) by striking ‘‘and (2)’’ and inserting 19 ‘‘(2)’’; and 20 (B) by inserting ‘‘; and (3) a domestic ad- 21 dress or a domestic telephone number, and it is 22 encouraged that the label include both a domes- 23 tic address and a domestic telephone number, 24 through which the responsible person may re- 25 ceive a report of an adverse event associated

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11 (d) GUIDANCE.—Not later than 1 year after the date 12 of enactment of this Act, the Food and Drug Administra- 13 tion shall issue guidance that defines the circumstances 14 that would constitute delaying, denying, or limiting inspec- 15 tion, or refusing to permit entry or inspection, for pur- 16 poses of section 602(g) of the Federal Food, Drug, and 17 Cosmetic Act, as added by subsection (c)(2).

18 (e) IMPORTS.—Section 801(a) of the Federal Food, 19 Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— 20 (1) by striking ‘‘section 760 or 761’’ the first, 21 third, and fourth place such term appears and in- 22 serting ‘‘section 611, 760, or 761’’; and 23 (2) by striking ‘‘760 or 761)’’ and inserting 24 ‘‘604, 760, or 761)’’.

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1 (f) FACTORY INSPECTION.—Section 704(a)(1) of the 2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3 374(a)(1)) is amended by inserting after the third sen- 4 tence the following: ‘‘In the case of any person who manu- 5 factures, processes, packs, holds, distributes, or imports 6 a cosmetic product, or distributes a cosmetic product and 7 affixes its name on the cosmetic label, the inspection shall 8 extend to all records and other information described in 9 section 612 (regarding inspection of cosmetic records), 10 when the standard for records inspections under para- 11 graph (1) or (2) of subsection (a) of such section applies, 12 subject to the limitations under subsections (d) and (e) 13 of such section.’’.

14 SEC. 114. CONSUMER INFORMATION. 15 The Food and Drug Administration shall post on its 16 Internet website information for consumers regarding— 17 (1) final orders regarding the safety of a cos- 18 metic ingredient or non-functional constituent under 19 section 608(d)(3) of the Federal Food, Drug, and 20 Cosmetic Act; 21 (2) cosmetic product recalls (including vol- 22 untary and mandatory recalls); and 23 (3) identified counterfeit cosmetic products.

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3 SEC. 201. FINDINGS. 4 Congress finds that the fees authorized by the 5 amendments made by this title will be dedicated to cos- 6 metic safety activities, as set forth in the goals identified 7 for purposes of part 10 of subchapter C of chapter VII 8 of the Federal Food, Drug, and Cosmetic Act, in the let- 9 ters from the Secretary of Health and Human Services 10 to the Chairman of the Committee on Health, Education, 11 Labor, and Pensions of the Senate and the Chairman of 12 the Committee on Energy and Commerce of the House 13 of Representatives, as set forth in the Congressional 14 Record.

15 SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFE-

16 TY FEES. 17 Subchapter C of chapter VII of the Federal Food, 18 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 19 amended by adding at the end the following:

20 ‘‘PART 10—FEES RELATING TO COSMETICS

21 ‘‘SEC. 744L. REGISTRATION FEE.

22 ‘‘(a) ASSESSMENT AND COLLECTION.—

23 ‘‘(1) IN GENERAL.—Beginning in fiscal year 24 2018, the Food and Drug Administration shall as- 25 sess and collect an annual fee from every responsible

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10 ‘‘(2) PAYABLE DATE.—A fee under this section 11 shall be payable during the period of initial registra- 12 tion and on the date of registration each year there- 13 after as prescribed in section 605(a)(1).

14 ‘‘(b) DEFINITIONS.—In this section:

15 ‘‘(1) ADJUSTMENT FACTOR.—The term ‘adjust- 16 ment factor’ applicable to a fiscal year means the 17 Consumer Price Index for all urban consumers (all 18 items; United States city average) for October of the 19 preceding fiscal year divided by such index for Octo- 20 ber 2017.

21 ‘‘(2) AFFILIATE.—The term ‘affiliate’ means 22 any business entity that has a relationship with a 23 second business entity if, directly or indirectly— 24 ‘‘(A) one business entity controls, or has 25 power to control, the other business entity; or

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3 ‘‘(3) COSMETIC PRODUCT.—The term ‘cosmetic 4 product’ has the meaning given such term in section 5 604(2).

6 ‘‘(4) COSMETIC SAFETY ACTIVITIES.—The term 7 ‘cosmetic safety activities’— 8 ‘‘(A) means activities related to compliance 9 by registrants under section 605 with the re- 10 quirements of this Act with respect to cos- 11 metics, including— 12 ‘‘(i) administrative activities, such as 13 information technology support, human re- 14 sources, financial management, the admin- 15 istration and maintenance of the cosmetic 16 registration system and the cosmetic ingre- 17 dient statement system under sections 605 18 and 606, and fee assessment and collection 19 under this section; and 20 ‘‘(ii) implementation and enforcement 21 activities, such as the establishment of 22 good manufacturing practices, the review 23 of adverse event reports, inspection plan- 24 ning and inspections, and use of enforce- 25 ment tools; and

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5 ‘‘(5) GROSS ANNUAL SALES.—The term ‘gross 6 annual sales’ means the average United States gross 7 annual sales for the previous 3-year period of cos- 8 metics for a registrant, including the sales of all of 9 its affiliates, as reported in the registration under 10 section 605.

11 ‘‘(c) FEE SETTING AND AMOUNTS.—

12 ‘‘(1) IN GENERAL.—Subject to subsection (d), 13 the Food and Drug Administration shall establish 14 the fees to be collected under this section for each 15 fiscal year after fiscal year 2018, based on the meth- 16 odology described in paragraph (3)(B), and shall 17 publish such fees in a Federal Register notice not 18 later than 60 days before the beginning of each such 19 fiscal year.

20 ‘‘(2) FEE EXEMPTION.—Any registrant whose 21 gross annual sales of cosmetic products in the 3-year 22 period immediately preceding the fiscal year for 23 which the annual fee will be paid was not more than 24 $2,000,000, shall be exempt from registration fees 25 under this section for that fiscal year.

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1 ‘‘(3) ANNUAL FEE SETTING.—

2 ‘‘(A) FISCAL YEAR 2018.—For fiscal year 3 2018, to generate a total estimated revenue 4 amount of $20,600,000, the amount of the reg- 5 istration fee under subsection (a) shall be as 6 follows:

7 ‘‘(i) TIER I–A.—For a registrant that 8 has gross annual sales of $5,000,000,000 9 or more in 2017, $1,350,000.

10 ‘‘(ii) TIER I–B.—For a registrant that 11 has gross annual sales of at least 12 $4,000,000,000 per annum but less than 13 $5,000,000,000 in 2017, $850,000.

14 ‘‘(iii) TIER II–A.—For a registrant 15 that has gross annual sales of at least 16 $3,000,000,000 per annum but less than 17 $4,000,000,000 in 2017, $730,000.

18 ‘‘(iv) TIER II–B.—For a registrant 19 that has gross annual sales of at least 20 $2,000,000,000 per annum but less than 21 $3,000,000,000 in 2017, $610,000.

22 ‘‘(v) TIER III–A.—For a registrant 23 that has gross annual sales of at least 24 $1,000,000,000 per annum but less than 25 $2,000,000,000 in 2017, $500,000.

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1 ‘‘(vi) TIER III–B.—For a registrant 2 that has gross annual sales of at least 3 $500,000,000 per annum but less than 4 $1,000,000,000 in 2017, $395,000.

5 ‘‘(vii) TIER IV–A.—For a registrant 6 that has gross annual sales of at least 7 $200,000,000 per annum but less than 8 $500,000,000 in 2017, $325,000.

9 ‘‘(viii) TIER IV–B.—For a registrant 10 that has gross annual sales of at least 11 $100,000,000 per annum but less than 12 $200,000,000 in 2017, $275,000.

13 ‘‘(ix) TIER V–A.—For a registrant 14 that has gross annual sales of at least 15 $80,000,000 per annum but less than 16 $100,000,000 in 2017, $185,000.

17 ‘‘(x) TIER V–B.—For a registrant that 18 has gross annual sales of at least 19 $60,000,000 per annum but less than 20 $80,000,000 in 2017, $95,000.

21 ‘‘(xi) TIER VI–A.—For a registrant 22 that has gross annual sales of at least 23 $40,000,000 per annum but less than 24 $60,000,000 in 2017, $15,000.

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1 ‘‘(xii) TIER IV–B.—For a registrant 2 that has gross annual sales of at least 3 $20,000,000 per annum but less than 4 $40,000,000 in 2017, $12,000.

5 ‘‘(xiii) TIER VII–A.—For a registrant 6 that has gross annual sales of at least 7 $10,000,000 per annum but less than 8 $20,000,000 in 2017, $500.

9 ‘‘(xiv) TIER VII–B.—For a registrant 10 that has gross annual sales of at least 11 $5,000,000 per annum but less than 12 $10,000,000 in 2017, $350.

13 ‘‘(xv) TIER VIII–A.—For a registrant 14 that has gross annual sales of at least 15 $2,000,000 per annum but less than 16 $5,000,000 in 2017, $250.

17 ‘‘(B) FISCAL YEARS 2019–2024.—For fiscal 18 years 2019 through 2024, fees under subsection 19 (a) shall be established to generate a total esti- 20 mated revenue amount of $20,600,000, as ad- 21 justed by subsection (d). Of that amount:

22 ‘‘(i) TIER I–A.—Registrants that have 23 gross annual sales of $5,000,000,000 or 24 more in the fiscal year immediately pre- 25 ceding the fiscal year in which the annual

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3 ‘‘(ii) TIER I–B.—Registrants that 4 have gross annual sales of at least 5 $4,000,000,000 per annum but less than 6 $5,000,000,000 in the fiscal year imme- 7 diately preceding the fiscal year in which 8 the annual fee will be paid, shall be re- 9 sponsible, collectively, for 4.1 percent.

10 ‘‘(iii) TIER II–A.—Registrants that 11 have gross annual sales of at least 12 $3,000,000,000 per annum but less than 13 $4,000,000,000 in the fiscal year imme- 14 diately preceding the fiscal year in which 15 the annual fee will be paid, shall be re- 16 sponsible, collectively, for 3.5 percent.

17 ‘‘(iv) TIER II–B.—Registrants that 18 have gross annual sales of at least 19 $2,000,000,000 per annum but less than 20 $3,000,000,000 in the fiscal year imme- 21 diately preceding the fiscal year in which 22 the annual fee will be paid, shall be re- 23 sponsible, collectively, for 2.9 percent.

24 ‘‘(v) TIER III–A.—Registrants that 25 have gross annual sales of at least

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6 ‘‘(vi) TIER III–B.—Registrants that 7 have gross annual sales of at least 8 $500,000,000 per annum but less than 9 $1,000,000,000 in the fiscal year imme- 10 diately preceding the fiscal year in which 11 the annual fee will be paid, shall be re- 12 sponsible, collectively, for 13.4 percent.

13 ‘‘(vii) TIER IV–A.—Registrants that 14 have gross annual sales of at least 15 $200,000,000 per annum but less than 16 $500,000,000 in the fiscal year imme- 17 diately preceding the fiscal year in which 18 the annual fee will be paid, shall be re- 19 sponsible, collectively, for 15.8 percent.

20 ‘‘(viii) TIER IV–B.—Registrants that 21 have gross annual sales of at least 22 $100,000,000 per annum but less than 23 $200,000,000 in the fiscal year imme- 24 diately preceding the fiscal year in which

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3 ‘‘(ix) TIER V–A.—Registrants that 4 have gross annual sales of at least 5 $80,000,000 per annum but less than 6 $100,000,000 in the fiscal year imme- 7 diately preceding the fiscal year in which 8 the annual fee will be paid, shall be re- 9 sponsible, collectively, for 9 percent.

10 ‘‘(x) TIER V–B.—Registrants that 11 have gross annual sales of at least 12 $60,000,000 per annum but less than 13 $80,000,000 in the fiscal year immediately 14 preceding the fiscal year in which the an- 15 nual fee will be paid, shall be responsible, 16 collectively, for 6.9 percent.

17 ‘‘(xi) TIER VI–A.—Registrants that 18 have gross annual sales of at least 19 $40,000,000 per annum but less than 20 $60,000,000 in the fiscal year immediately 21 preceding the fiscal year in which the an- 22 nual fee will be paid, shall be responsible, 23 collectively, for 5.1 percent.

24 ‘‘(xii) TIER VI–B.—Registrants that 25 have gross annual sales of at least

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6 ‘‘(xiii) TIER VII–A.—Registrants that 7 have gross annual sales of at least 8 $10,000,000 per annum but less than 9 $20,000,000 in the fiscal year immediately 10 preceding the fiscal year in which the an- 11 nual fee will be paid, shall be responsible, 12 collectively, for 1.2 percent.

13 ‘‘(xiv) TIER VII–B.—Registrants that 14 have gross annual sales of at least 15 $5,000,000 per annum but less than 16 $10,000,000 in the fiscal year immediately 17 preceding the fiscal year in which the an- 18 nual fee will be paid, shall be responsible, 19 collectively, for 1.2 percent, except that no 20 such registrant shall be responsible for 21 more than $350 per fiscal year.

22 ‘‘(xv) TIER VIII–A.—Registrants that 23 have gross annual sales of at least 24 $2,000,000 per annum but less than 25 $5,000,000 in the fiscal year immediately

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6 ‘‘(d) ADJUSTMENTS.—

7 ‘‘(1) INFLATION ADJUSTMENT.—

8 ‘‘(A) IN GENERAL.—For fiscal year 2019 9 and each subsequent fiscal year, the revenues 10 and fee amounts under subsection (c)(3)(B) 11 shall be adjusted by the Food and Drug Admin- 12 istration in the annual Federal Register notice 13 establishing fees in subsection (c)(1), by an 14 amount equal to the sum of— 15 ‘‘(i) one; 16 ‘‘(ii) the average annual percent 17 change in the cost, per full-time equivalent 18 position of the Food and Drug Administra- 19 tion, of all personnel compensation and 20 benefits paid with respect to such positions 21 for the first 3 of the preceding 4 fiscal 22 years for which data are available, multi- 23 plied by the average proportion of per- 24 sonnel compensation and benefits costs to 25 total Food and Drug Administration costs

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16 ‘‘(B) COMPOUNDED BASIS.—The adjust- 17 ment made each fiscal year under this sub- 18 section shall be added on a compounded basis 19 to the sum of all adjustments made each fiscal 20 year after fiscal year 2018 under this sub- 21 section.

22 ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal 23 year 2024, the Food and Drug Administration may, 24 in addition to adjustments under paragraph (1), fur- 25 ther increase the fee revenues and fees established in

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13 ‘‘(3) WORKLOAD ADJUSTMENT.—

14 ‘‘(A) IN GENERAL.—For fiscal year 2019 15 and each subsequent fiscal year, after fee reve- 16 nues established in subsection (c)(3)(B) are ad- 17 justed for a fiscal year for inflation in accord- 18 ance with paragraph (1), the fee revenues shall 19 be adjusted further for each fiscal year to re- 20 flect changes in the workload of the Food and 21 Drug Administration for actual changes in 22 workload volume due to the process of reviewing 23 cosmetic ingredients or non-functional constitu- 24 ents not listed under section 608(b).

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1 ‘‘(B) DETERMINATION OF ADJUSTMENT.— 2 The adjustment shall be determined by the 3 Food and Drug Administration based on the 4 workload in the most recent 1-year period for 5 which workload data is available. The Food and 6 Drug Administration shall publish in the Fed- 7 eral Register the fee revenues and fees resulting 8 from the adjustment and the supporting meth- 9 odologies.

10 ‘‘(C) MINIMUM REVENUES.—The adjust- 11 ment shall not result in fee revenues for a fiscal 12 year that are less than the sum of the amount 13 under subsection (c)(3)(B), as adjusted for in- 14 flation under subparagraph (1).

15 ‘‘(e) LIMITATIONS.—

16 ‘‘(1) IN GENERAL.—With respect to the amount 17 that, under the salaries and expenses account of the 18 Food and Drug Administration, is appropriated for 19 a fiscal year for the cosmetics program in the Center 20 for Food Safety and Applied Nutrition and related 21 field activities, fees may not be assessed under sub- 22 section (a) for the fiscal year unless the amount so 23 appropriated for the fiscal year (excluding the 24 amount of fees appropriated for the fiscal year), is 25 equal to or greater than that assessed for fiscal year

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3 ‘‘(2) AUTHORITY.—If the Food and Drug Ad- 4 ministration does not assess fees under subsection 5 (a) during any portion of a fiscal year because of 6 paragraph (1) and if at a later date in such fiscal 7 year the Food and Drug Administration may assess 8 such fees, the Food and Drug Administration may 9 assess and collect such fees, without any modifica- 10 tion in the rate, for registration under section 605 11 at any time in such fiscal year.

12 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.—

13 ‘‘(1) IN GENERAL.—Fees authorized under sub- 14 section (a) shall be collected and available for obliga- 15 tion only to the extent and in the amount provided 16 in advance in appropriations Acts. Such fees are au- 17 thorized to remain available until expended. Such 18 sums as may be necessary may be transferred from 19 the Food and Drug Administration salaries and ex- 20 penses appropriation account without fiscal year lim- 21 itation to such appropriation account for salaries 22 and expenses with such fiscal year limitation. The 23 sums transferred shall be available solely for cos- 24 metic safety activities.

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1 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

2 ACTS.—

3 ‘‘(A) IN GENERAL.—Subject to subpara- 4 graphs (C) and (D), the fees authorized by this 5 section shall be collected and available in each 6 fiscal year in an amount not to exceed the 7 amount specified in appropriation Acts, or oth- 8 erwise made available for obligation for such 9 fiscal year.

10 ‘‘(B) USE OF FEES AND LIMITATION.— 11 The fees authorized by this section shall be col- 12 lected and available only to defray the costs of 13 cosmetic safety activities.

14 ‘‘(C) FEE COLLECTIONS DURING FIRST

15 PROGRAM YEAR.—Until the date of enactment 16 of an Act making appropriations through Sep- 17 tember 30, 2017, for the salaries and expenses 18 account of the Food and Drug Administration, 19 fees authorized by this section for fiscal year 20 2018 may be collected and shall be credited to 21 such account to remain available until ex- 22 pended. Fees collected under this subparagraph 23 shall be considered discretionary for purposes of 24 the Balanced Budget and Emergency Deficit 25 Control Act of 1985.

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1 ‘‘(D) REIMBURSEMENT OF START-UP

2 AMOUNTS.—Any amounts allocated to establish 3 programs under sections 605 and 606, prior to 4 collection of fees, may be reimbursed through 5 any appropriated fees collected under this sec- 6 tion, in such manner as the Food and Drug Ad- 7 ministration determines appropriate. Any 8 amounts reimbursed under this subparagraph 9 shall be available for the programs and activi- 10 ties for which funds allocated to establish the 11 programs were available, prior to such alloca- 12 tion, until the end of the fiscal year in which 13 the reimbursement occurs, notwithstanding any 14 otherwise applicable limits on amounts for such 15 program or activities for a fiscal year.

16 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 17 For each of fiscal years 2018 through 2024, there 18 are authorized to be appropriated for fees under this 19 section $20,600,000, as adjusted by subsection (d).

20 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

21 OF COLLECTION SHORTFALLS.—

22 ‘‘(A) OFFSET OF OVERCOLLECTIONS.—If 23 the sum of the cumulative amount of fees col- 24 lected under this section for the fiscal years 25 2018 through 2022 exceeds the cumulative

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10 ‘‘(B) RECOVERY OF COLLECTION SHORT-

11 FALLS.— 12 ‘‘(i) 2020.—For fiscal year 2020, the 13 amount of fees otherwise authorized to be 14 collected under this section shall be in- 15 creased by the amount, if any, by which 16 the amount collected under this section 17 and appropriated for fiscal year 2018 falls 18 below the amount of fees authorized for 19 fiscal year 2018 under paragraph (3). 20 ‘‘(ii) 2021.—For fiscal year 2021, the 21 amount of fees otherwise authorized to be 22 collected under this section shall be in- 23 creased by the amount, if any, by which 24 the amount collected under this section 25 and appropriated for fiscal year 2019 falls

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3 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.—The Food 4 and Drug Administration shall not consider a registration 5 submitted to be complete until such fee under subsection 6 (a) is paid. Until the fee is paid, the registration is incom- 7 plete and the registrant is deemed to have failed to reg- 8 ister in accordance with section 605.

9 ‘‘(h) FALSE STATEMENTS.—Any statement or rep- 10 resentation made to the Food and Drug Administration 11 shall be subject to section 1001 of title 18, United States 12 Code.

13 ‘‘(i) COLLECTION OF UNPAID FEES.—In any case 14 where the Food and Drug Administration does not receive 15 payment of a fee assessed under subsection (a), such fee 16 shall be treated as a claim of the United States Govern- 17 ment subject to subchapter II of chapter 37 of title 31, 18 United States Code.

19 ‘‘(j) CONSTRUCTION.—This section may not be con- 20 strued to require that the number of full-time equivalent 21 positions in the Department of Health and Human Serv- 22 ices, for officers, employees, and advisory committees not 23 engaged in cosmetic activities, be reduced to offset the 24 number of officers, employees, and advisory committees so 25 engaged.

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1 ‘‘(k) RECORDS.—Each facility shall retain all records 2 necessary to demonstrate the facility’s gross annual sales 3 for at least 2 fiscal years after such information is re- 4 ported in the facility’s registration. Such records shall be 5 made available to the Food and Drug Administration for 6 review and duplication upon request of the Food and Drug 7 Administration.’’.

8 SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVI-

9 TIES RELATED TO COSMETICS. 10 Part 10 of subchapter C of chapter VII of the Fed- 11 eral Food, Drug, and Cosmetic Act, as added by section 12 202, is amended by inserting after section 744L the fol- 13 lowing:

14 ‘‘SEC. 744M. DIRECT HIRING AUTHORITY TO SUPPORT AC-

15 TIVITIES RELATED TO COSMETICS.

16 ‘‘(a) IN GENERAL.—The Food and Drug Administra- 17 tion shall have direct hiring authority with respect to the 18 appointment of employees into the competitive service or 19 the excepted service to administer the amendments made 20 by title I of the Personal Care Products Safety Act.

21 ‘‘(b) SUNSET.—The authority under subsection (a) 22 shall terminate on the date that is 3 years after the date 23 of enactment of such title.’’. Æ

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Senator Dianne Feinstein Personal Care Products Hearing September 22, 2016

Thank you very much Mr. Chairman, and thank you so much for scheduling this hearing. It’s much appreciated. I also want to thank my cosponsor. Thank you so much, Susan, for working together with me on this.

I’d like to acknowledge just a few who are in the audience today, including representatives from Johnson and Johnson—maker of brands including Neutrogena, Aveeno, and Johnson’s baby products; Procter and Gamble—maker of brands such as Pantene, Head and Shoulders, Clairol, Secret, and Olay; and Revlon.

We also have representatives from science and consumer groups, including the Endocrine Society, Good Housekeeping Institute, and Environmental Working Group, who have a member on the panel.

Mr. Chairman, the laws governing the safety of personal care products, which every American uses every day, have not been really updated since 1938.

So let me begin: Our skin is our largest organ and many ingredients contained in these products—whether it be lotion, shampoo or deodorant—are quickly absorbed by the skin.

Think about it for a moment: Nicotine patches to help people stop smoking and pain patches deliver potent drugs through the skin. The chemicals in personal care products are also absorbed—even through our nails. 209

There is increasing evidence that certain ingredients in personal care products are linked to a range of health concerns, ranging from reproductive issues, such as fertility problems and miscarriage, to cancer.

I’d like to touch on just a couple examples:

It was formaldehyde that brought me to this issue and watching Brazilian blowouts being administered in cramped quarters in beauty salons. Formaldehyde can cause shortness of breath, headaches and dizziness in the short-term. And in the long- term it’s been linked to cancer.

Also, Gel-nail polishes. They last longer, often contain a number of concerning chemicals, including what’s been called the “toxic trio”.

Manicurists who apply these polishes are at increased risk. They work long hours and breathe fumes all day. In some salons, there can be very poor ventilation. This can lead to health issues like respiratory difficulties and even fertility problems.

To remove this long-lasting polish, nails must be soaked in acetone—another chemical considered to be potentially hazardous by the Occupational Safety and Health Administration.

Because of outdated safety rules, the FDA has prohibited or restricted only 11 substances, including mercury and chloroform, from use in personal care products.

In contrast, the European Union has had an ingredient review process for personal care products in place for decades. The EU has banned more than 1,300 210 chemicals from personal care products and restricted an additional 256. In addition, additives and colors may only be used if they are preapproved.

More than eight years ago now, I started working on legislation to update the safety rules for personal care products.

And about three years ago we found there was increased concern and a willingness among stakeholders to come together.

I spoke with a man by the name of Leonard Lauder, the chairman of the Estee Lauder companies and a long-time friend. I asked him, “What do you think of this?” And he said, “I think it might be a very good idea”.

So in the process of developing this legislation we consulted:  companies, large and small,  doctors,  consumer advocates,  patient advocates,  scientists, and  the Food and Drug Administration.

It took countless hours of calls and meetings from my staff, but Senator Collins and I were able to put together then the first bill introduced on this subject to have bipartisan support, as well as support from a wide-ranging coalition of companies and consumer and health organizations. 211

Let me name just a few:  L’Oreal, which makes Garnier, Mabelline, Lancome, Redken, Keihl’s, Essie, and the Body Shop products  Unilever, with brands such as Dove, Suave, and Vaseline  California Baby, a popular natural children’s brand  March of Dimes  Society for Women’s Health Research  American Cancer Society

Those are just some of the 17 companies, representing over 160 brands, and 24 organizations that have come together to form exactly the type of broad coalition needed to get a bill done.

Now let me say for a moment what the bill does. The Personal Care Products Safety Act would give FDA the authority to review five ingredients in personal care products each year to determine if they’re safe. FDA may review additional ingredients if needed.

The bill lists the first five chemicals to be reviewed. And they were chosen based on extensive consultation with companies, health advocates and scientists. There’s agreement from all sides that these ingredients should be independently reviewed.

After the first five ingredients, FDA would choose chemicals to review based on feedback from scientists, health advocates and companies.

 Lead acetate, which is used as a color additive in hair dyes is one of the five. 212

 Methylene glycol or formaldehyde, used in Brazilian blowouts, is one of the five.

The next three chemicals to be reviewed are endocrine disruptors. Overexposure to these chemicals is linked to a range of health problems, including impacts on the immune system, healthy pregnancies, fertility, and even some cancers.

They are used as preservatives in a wide range of products including shampoo, conditioner, lotion, bubble bath, and deodorant. They are:  Diazolidinyl urea  Propyl paraben  Quaternium-15

The ingredient review process would provide a uniform safety standard for ingredients used by the industry and give consumers the confidence that the products they and their families use are safe.

One point I want to stress: independent review of ingredients isn’t just something health and consumer organizations want. It’s also something we’ve learned companies want.

With minimal regulation, companies are left to make their own decisions about potentially harmful ingredients. Do they use the ingredient or not? Do they use just a very small amount of the ingredient? Having an independent arbiter answer these questions is good for the industry.

The bill would also: 213

 Require companies to report serious health events- WEN as Senator Bennet mentioned might well be one of them- brought to their attention to the FDA within 15 days.

 Provide the FDA with mandatory recall authority.

 Require manufacturer to register with the FDA and provide ingredient information.

 And, FDA would issue Good Manufacturing Practices to ensure products are being produced safely.

Mr. Chairman, personal care products safety is an issue that affects us all- male, female, and juvenile- and it needs to be taken seriously.

So I hope that your committee will take the steps to move this bill forward. I want to thank you and the senators here today to listen to this testimony.

Thank you very much Mr. Chairman. 214

Statement of Senator Susan M. Collins Senate Committee on Health, Education, Labor and Pensions September 22, 2016

“Exploring Current Practices in Cosmetic Development and Safety”

Chairman Alexander and Ranking Member Murray, thank you for holding this hearing and for inviting Senator Feinstein and me to testify on the important topic of the safety of personal care products.

As Senator Feinstein noted, Americans use a variety of personal care products daily, from shampoos and lotions to cosmetics and deodorants. Consumers should be able to know whether the products that they are applying to their (or their children’s) skin and hair are safe.

While many companies have made a strong commitment to safety on a voluntary basis, under current law, the Food and Drug Administration has surprisingly very little authority to protect consumer safety, lacking even mandatory recall authority when a product is found to be harmful.

This summer, we were alarmed to learn the devastating account of a nine-year-old girl who lost all her hair after using a WEN hair product. It has come to light that the company received 21,000 consumer reports of harmful effects, while the FDA had received a mere 127 reports at the time the agency announced in July it would investigate claims of hair loss, hair breakage, balding, itching, and rashes (that number has since grown to more than 1,000 reports). It is deeply troubling that a personal care products company is not required to tell the FDA about adverse events.

Understandably, there is significant concern from consumers, salon workers, manufacturers, and health professionals that the current system is failing. I am particularly concerned about the impact on children and on professionals like hair stylists who may be exposed to potentially harmful ingredients in products they use every work day.

To help address this issue, I have joined Senator Feinstein in introducing the bipartisan Personal Care Products Safety Act, which would modernize our woefully outdated federal regulatory system. Our bill, which is the product of consultations with a wide range of stakeholders, would give the FDA broader oversight by setting up a basic regulatory structure, with registration of manufacturers and products, ingredient review by FDA, and a uniform national standard. With the news that a bipartisan House companion bill has been released, we are encouraged that this effort is resonating.

While our bill is endorsed by a diverse and growing coalition of companies (small and large), as well as consumer and health organizations, some small, artisan soap and homemade cosmetic producers have expressed concern. Given this, I’d like to clear up some misconceptions about our bill and mention provisions that aim to help protect small companies. 215

First, only soap products that make cosmetic claims would be included in the new system. Second, individuals or small companies selling less than $100,000 in products annually would not be required to register with the FDA. For companies selling between $100,000 and $500,000, there would be a simplified registration process and no user fee. A user fee would kick in when average sales from the previous three years reach between $500,000 and $2.5 million, but that fee would be no more than $250 annually. The user fee schedule, similar to that which already exists for drug and device companies and helps to avoid cost for taxpayers, would increase as the size of a company grows. Finally, the FDA and Small Business Administration must help ensure that compliance is simple and easy to understand. I am always concerned by overly burdensome federal regulation on our nation’s small businesses. We remain open to ways to improve the bill.

Mr. Chairman, thank you for the opportunity to testify today. By modernizing the oversight of personal care products that are so widely used by so many Americans, consumers will be better informed and protected. THANKS