Food, Dietary Supplement & Cosmetics Regulatory Update

Issue Number 2 | March 2014

Top Stories

FDA Extends Comment Period for Proposed Rule on Intentional Adulteration and Accompanying Risk Analysis On March 24, FDA announced that it would extend the comment period for its proposed rule on intentional adulteration and the accompanying risk assessment document. The proposed rule and the risk assessment were published in the December 24, 2013 Federal Register with a 100-day comment period. However, in response to stakeholder concerns that more time is needed to evaluate the proposed rule, due to the inherent complexity and unique nature of food defense issues, FDA granted a 90-day extension to June 30, 2014. Because the risk assessment is directly related to the proposed rule, FDA also extended the comment period for the risk assessment document.

The proposed rule, which would not apply to farms or animal food, would require every food facility to have a written food defense plan addressing "significant vulnerabilities" in its particular food production processes. In addition, facilities would be required to identify and implement strategies to address the identified vulnerabilities, establish monitoring procedures and corrective actions, verify the system is working, and ensure training of personnel assigned to each vulnerable area. Comments due June 30 to Docket FDA-2013-N-1563.

FDA Seeks Input on Information to be Submitted to FDA's Reportable Food Registry and Used to Notify Consumers in Grocery Stores On March 26, FDA issued an advance notice of proposed rulemaking seeking input to assist FDA in implementing section 211 of the Food Safety Modernization Act ("FSMA"). Section 211 added new provisions to the Portable Food Registry requirements of the Federal Food, Drug, and Cosmetic Act. The amendments are intended to notify consumers about foodborne illness. Under section 211, industry may be required to submit to FDA "consumer-oriented" information regarding a "reportable food" (not including fruits and vegetables that are raw agricultural commodities). The information must enable a consumer to identify whether that consumer possesses any reported food. Section 211 also directs FDA to use this information to create and post one-page consumer notification summaries on FDA's website. Some grocery store chains would have additional display requirements for such notices.

FDA is soliciting input to determine, among other things: the type of information that should be required for consumer notifications; the format in which to present the information; what types of establishments should be considered "grocery stores"; how grocery stores should be informed of notices posted on FDA's website; what constitutes prominent display of information by a grocery store; the impact of the requirements on grocery stores; whether consumers should be notified that this information will not be generated for dietary supplements, infant formula, and certain fruits and vegetables; and if FDA should require industry to submit consumer- oriented information to FDA, even if the food will not be available for sale to consumers at the retail level.

The Federal Register Notice is available here. Comments due June 9.

Cosmetics Content on FDA.gov Reorganized FDA's Center for Food Safety and Applied Nutrition has reorganized the cosmetics content of the FDA website to provide easier navigation for consumers and other stakeholders. The revamped website features a "Navigate the Cosmetics Section" box on the www.fda.gov/cosmetics homepage with new section titles that group cosmetics-related web content into logical categories intended to help users locate information more quickly. The website also contains additional resources, such as pages for health-care professionals, salon professionals, and small businesses.

HHS and FDA Sued Over Food Additives Rule The 1997 proposed rule on substances generally recognized as safe ("GRAS") is the target of a recent lawsuit by food safety advocates who want the agency to revert to an earlier, more stringent petition process that required published studies in support of new food additives. FDA began accepting notices before finalizing the rule more than a decade ago and states, "the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS." The Center for Food Safety, plaintiffs in the lawsuit, claim "FDA no longer conducts its own detailed analysis to evaluate the data" and "no longer affirms whether or not a substance's use is GRAS at all." Specifically, the lawsuit raises concerns about Volatile Oil of Mustard (a potential human carcinogen), Olestra (an indigestible fat substitute), and Quorn (a fungus-based meat substitute).

According to FDA, "[a] company can make an independent GRAS determination without notifying FDA. However, the agency does have a voluntary GRAS notification program whereby a company can inform FDA of the company's determination. FDA maintains an inventory of such GRAS Notices on its website, allowing the public to confirm whether FDA has filed and responded to a GRAS notice." Food makers and ingredient developers generally self-certify safety through the Flavor and Extract Manufacturers Association, a private organization. In addition to CFS's lawsuit, the recent controversy over Sweetmyx, an artificial sweetener, has elevated concerns about lack of FDA oversight in the GRAS approval process.

Federal Court Finds that California's Sherman Law Authorizes Criminal Penalties on Consumers Who Possess Misbranded Foods On March 21, Magistrate Judge Grewal (N.D. California, San Jose Division) denied a motion to strike allegations that consumers may have acted unlawfully by purchasing allegedly misbranded foods. Under California's Sherman Law, which regulates the labeling of food, it is "unlawful for any person to ... hold ... any food that is misbranded." The plaintiffs, consumers, had alleged that certain products that they had purchased were misbranded under federal and California standards. The plaintiffs further claimed that they were injured because of the allegedly illegal nature of the purchase transaction. Although the court admitted that the defendant's arguments "may resonate with certain notions of common sense," it denied defendant's motion to strike because, under the letter of California law, "Plaintiffs [consumers] could, in fact, be arrested and prosecuted for unlawful possession of misbranded goods."

California Beef Recall Highlights Lack of Restaurant Oversight The recall of nearly nine million pounds of beef earlier this year highlighted the different treatment of meat in grocery stores versus restaurants. In 2008, USDA began publishing the lists of retailers that sell food products subject to recall as a part of recall notices, but the notices to consumers do not include restaurants that may hold, and potentially serve, the meat. USDA's explanation for not identifying the restaurants is that identifying the meat would not protect consumers who have likely already eaten the tainted food. But recent CDC statistics indicate that a significant majority of foodborne illness is connected to restaurants or delis. One potential benefit to including restaurants in the list is that it would permit linking illness reports to particular recalled foods rather than attributing incidents to restaurant mishandling.

Other News FDA To Hold April 4, 2014 Public Meeting on Environmental Impact Statement for FSMA Produce Safety Rule

FDA Likely to Stand Firm on Proposed "Added Sugar" Labeling Requirements

FDA Announces New Reporting Tool for Livestock Animal Food Problems

FDA Clarifies Sweetmyx GRAS determination

Government Scientists' Study Suggests BPA Is Safe as Currently Used

Study Questions Link Between Fat and Heart Disease

Regulatory Updates FDA Extends Comment Period and Announces Public Meeting for FSMA Produce Rule EIS In the March 11 Federal Register, FDA extended the public scoping period for the Environmental Impact Statement ("EIS") associated with the proposed rule to establish standards for growing, harvesting, packing, and holding of produce for human consumption. Comments due April 18.

FDA Extends Comment Period on Proposed Rule on Intentional Adulteration and Accompanying Risk Assessment In the March 25 Federal Register, FDA extended to June 30 the comment period for its proposed rule on "Focused Mitigation Strategies to Protect Food Against Intentional Adulteration," and the associated Draft Qualitative Risk Assessment, published in the December 24, 2013 Federal Register. Comments due June 30.

FDA Announces New Food Additive Petition for Chromium Propionate for Chicken Feed In the March 10 Federal Register, FDA announced that Kemin Industries, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of chromium propionate as a source of chromium in broiler feed. Comments due April 9.

FDA Rejects Objections to Vitamin D2 Regulation In the March 11 Federal Register, FDA rejected the objections it received on the final rule authorizing vitamin D2 bakers' yeast as a source of vitamin D2 and leavening agent in yeast-leavened baked products.

FDA Issues Direct Final Rule on New Animal Drug Application Confidentiality On March 17, in a pair of Federal Register notices, FDA amended its regulation on the confidentiality of data and information for new animal drug applications to permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision-making in the approval of new animal drugs. If FDA receives significant adverse comments on the new rule, it will withdraw the Direct Final Rule and continue to receive comments on the Proposed Rule. Comments due June 2.

FDA Withdraws NADA and ANANDAs at Sponsors' Requests In the March 20 Federal Register, FDA withdrew approval of a new animal drug application ("NADA") and two abbreviated new animal drug applications ("ANADAs") for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.

FDA Amends Animal Drug Regulations to Reflect Change in Sponsor for 110 Approved NADAs In the March 11 Federal Register, FDA announced a technical amendment to its animal drug regulations to reflect a change of sponsor for 110 NADAs and 14 approved ANADAs for new animal drug for use in animal feed from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc.

FDA Amends Regulations for Food Additives in Swine Feed—Benzoic Acid In the March 13 Federal Register, FDA finalized its amendments to the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of benzoic acid as an acidifying agent in swine feed. This action is in response to a food additive petition filed by DSM Nutritional Products.

USDA Will Renew National Organic Standards Board Charter In the March 12 Federal Register, USDA announced its intent to renew the Charter of the National Organic Standards Board ("NOSB"); the current charter expires on May 10. The USDA is also requesting nominations to fill four upcoming vacancies on the NOSB. Nominations must be postmarked on or before May 15.

USDA Proposes Rule to Revise Pistachio Aflatoxin Sampling Regulations In the March 18 Federal Register, USDA's Agricultural Marketing Service ("AMS") announced a proposed rule and invited comments on revisions to the aflatoxin sampling regulations currently prescribed under the California, Arizona, and New Mexico pistachio marketing order. The order regulates the handling of pistachios and would allow the use of mechanical samplers (auto- samplers) for in-line sampling as a method to obtain samples for aflatoxin analysis. Comments due April 17.

USDA Determines BASF's Genetically Engineered Soybean No Longer a Regulated Article In the March 18 Federal Register, USDA's Animal and Plant Health Inspection Service ("APHIS") determined that a GE soybean genetically engineered by BASF Plant Sciences, LP for resistance to imidazolinone herbicides is no longer a regulated article under its regulations governing the introduction of certain genetically engineered organisms.

USDA Extends Dairy Forward Pricing Program In the March 21 Federal Register, AMS issued a final rule extending the Diary Forward Pricing Program in accordance with the 2014 Farm Bill.

USDA Adds Arkansas as Primary Peanut Producer In the March 21 Federal Register, AMS issued a final rule adding Arkansas as a primary peanut-producing State under the Peanut Promotion, Research, and Information Order.

USDA Issues Final Rule to Allow Importation of Fruit from Malaysia In the March 19 Federal Register, APHIS issued a final rule amending the fruits and vegetables regulations to allow the importation of fresh jackfruit, pineapple, and starfruit from Malaysia into the continental United States. The rule also lists conditions of entry to prevent against the introduction of pests.

USDA Announces Decreased Assessment Rate for Olives Grown in California In the March 14 Federal Register AMS decreased the assessment rate established for the California Olive Committee from $21.16 to $15.21 per ton of assessable olives handled. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.

USDA's AMS Issued Referendum Orders for the Following:

Texas Onion Growers California Walnut Growers Spearmint Oil (comments due March 31) Florida Citrus Growers

FDA announced the opportunity to comment on the following proposed information collections:

Importer's Entry Notice (comments due April 14). Extension and revision of a currently approved collection on "Laboratory Approval Programs" (comments due May 19).

FDA announced that OMB has approved the following proposed information collections:

Premarket Notification for a New Dietary Ingredient. Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition. Designation of New Animal Drugs for Minor Use or Minor Species—Final Rule. Eye Tracking Experimental Studies To Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys.

USDA announced the opportunity to comment on the following proposed information collections:

Special Nutrition Program Operations Study—Year 3 (comments due April 17). Extension of Approval of Information Collection on South American Cactus Moth Quarantine and Regulations (comments due May 12). Extension for AMS's Child Nutrition Labeling Program collection (comments due May 12). AMS Web-Based Supply Chain Management Commodity Offer Form (comments due May 13). AMS Dairy Request for Applicant Form required for AMS Dairy Grading Branch to set up accounts to allow applicants to do business with AMS Dairy Grading Branch (comments due May 13). National Organic Program; Organic Certification Cost-Share Programs (comments due May 16). Emergency approval for a new information collection under the Farmers' Market and Local Food Promotion Program (comments due May 19).

USDA announced that OMB has approved its proposed information collection for Procedures for the Safe Processing and Importing of Fish and Fishery Products.

Upcoming Meetings, Workshops, and Conferences

USDA's Farm Service Agency will host a 2014 Farm Bill Implementation Listening Session. March 27 in Washington, D.C. Written comments due April 2.

FDA will hold a public EIS-scoping meeting for the FSMA Produce Rule. April 4 in College Park, MD.

The annual Food Safety Summit will host four certification programs in HACCP, Seafood HACCP, Food Fraud, and ServSafe in addition to a variety of speakers and exhibitors. April 7–10 in Baltimore, MD.

The National Organic Standards Board will hold its annual meeting on April 29–May 2 in San Antonio, TX. Written comments and signup for oral public comments due April 8.

Enforcement Updates