In This Issue of the AHPA Report

The Official Publication of the American Herbal Products Association August 2010 www.ahpa.org Volume 25, Number 8

In this issue of the AHPA Report

You Need to Know 2 • New Members • Botanical Safety Handbook Revision Process Reaches Milestone; Support Needed to Reach Fundraising Target • AHPA Staff Contribute to ODS Publication on Dietary Supplement Ingredients • Upcoming AHPA Seminar Microscopic Identification of Popular Botanical Materials

Special Topics 6 • Report of July 13, 2010 Meeting of the AHPA Board • How Big is the Global Trade of Medicinal and Aromatic Plants and Extracts? by Josef Brinckmann

Legal & Regulatory 9 • Government Gets Tough with Purveyors of Drug-Spiked “Dietary Supplements” by Anthony L. Young, AHPA General Counsel, and Michael McGuffin, AHPA President • 52 New Proposition 65 Complaints Filed Against Supplement Companies; Settlements Now Exceed $4 Million by Michael McGuffin, AHPA President • FDA’s Moore Clarifies Statement on NDI Enforcement By Anthony L. Young, AHPA General Counsel • Warning Letter Addresses Unpermitted Irradiation, Labeling of Excipients in Extracts, and Application of Food cGMP to Ingredient Suppliers By Anthony Young, Kleinfeld, Kaplan and Becker, LLP, AHPA General Counsel • Safe Cosmetics Act Introduced in U.S. House By Stacy L. Ehrlich, Kleinfeld, Kaplan and Becker, LLP

Communications Update 16 • AHPA Media Scan: Notable “Herbal Headlines”

Calendar of Botanical Events 17

Botanical Science Update 20 • Meetings Attended USP Nomenclature Workshop and Expert Committee Meetings • Literature Citations Further research on topical aloe vera for burns and wound healing Aloe vera food and supplement ingredient reviews Hawthorn for heart health? You Need to Know Botanical Safety Handbook Revision Process Reaches Milestone; Support New Members Needed to Reach Fundraising Target  Purest Colloids’ mission is to produce the finest colloidal AHPA’s Botanical Safety Handbook, first published in 1997, has been products, therefore providing the highest level of effective- undergoing substantial revision over the last three years. The initial ness. Purest Colloids offers superior metal colloid products phase of the revision process, consisting of a broad literature search for use as dietary supplements. To maintain a robust im- for each of over 500 herbs and review by an Expert Advisory Council mune system for optimum health, Mesocolloids contain to establish classifications for overall safety and for potential herb- minerals in trace amounts that our bodies can use. Our drug interactions, was completed at a teleconference meeting on products are in the forefront of quality and effectiveness be- June 25, 2010. cause we maximize the Particle Surface Area of the nanome- ter-sized particles. For quality and safety all Mesocolloids are Revision of the Botanical Safety Handbook has progressed under manufactured in an FDA Registered Facility. Website: www. the direction of the AHPA Foundation for Education and Research purestcolloids.com. on Botanicals (the AHPA-ERB Foundation). The AHPA-ERB Foundation is a 501(c)(3) foundation organized to perform the  Stiebs is devoted to sourcing, processing and delivering the charitable, educational and scientific functions of the American world’s finest plant-based products. The company strives to Herbal Products Association (AHPA). meet its motto, Nature Elevated, by procuring the world’s finest ingredients for health and wellness based products and Zoë Gardner, M.S., a research fellow at the Medicinal Plant Program processing them in the cleanest, purest, most flavorful and at the University of Massachusetts, and Michael McGuffin, AHPA’s functional way possible, using the latest technology available. president, are the editors of the revised document. The Expert Advisory Council consists of Roy Upton, RH (AHG), D. Ayu.; Stiebs was formed in 2005 with the intent of becoming a Soaring Bear, Ph.D.; David Winston, RH (AHG); Daniel Gagnon, leading industrial supplier for pomegranate juice concen- RH (AHG); Aviva Romm, CPM RH (AHG), M.D.; Mary Hardy, trate. Building on that foundation, Stiebs has built a world- M.D.; and Tieraona Low Dog, M.D. Invited reviewers are David class processing infrastructure coupled with a worldwide Bechtel, Ph.D., DABT and Leslie Beyer, M.S., DABT. procurement and partnership network and has become a recognized industry leader in the area of superfruits with its fo- “The AHPA Foundation greatly appreciates the diligence of all of cus on sustainability, market knowledge, and scientifically the experts who have devoted their time to this important project,” supported ingredients. noted Garry Pay, the foundation’s chair. “In addition, the generosity of the many companies and individuals who have provided financial The company offers a full line of fruit based ingredients in- support for this work is a clear indication of the herb industry’s ac- cluding pomegranate, maqui berry, prickly pear cactus fruit, goji, mangosteen, acai, grape, tart cherry, passion fruit, kiwi, knowledgement of the value of this document,” he added. and blood orange as single strength juices, juice concentrates, Thanks to contributions already made in support of the revision (see purees, extracts, powders, and pomegranate arils sold to sidebar on next page), the foundation is less than $30,000 from its food, beverage, dietary supplement, and cosmetic companies. fundraising goal. Please consider making a donation to this Website: www.stiebs.com.  important work today by contacting Michael McGuffin at [email protected].

The AHPA Report, the official voice of the American AHPA Staff Send inquiries, comments or requests to: Herbal Products Association (AHPA), is published monthly as a service to AHPA members and friends Michael McGuffin, President American Herbal of the herbal products industry. The material [email protected] Products Association contained in this publication is for the information 8630 Fenton Street, Suite 918 of AHPA members. Although the information Steven Dentali, PhD, Chief Science Officer [email protected] Silver Spring, MD 20910 is believed to be correct, AHPA disclaims all Phone: 301-588-1171 responsibility for any damage or liability that Devon Powell, Chief Operations Officer Fax: 301-588-1174 may result from any reliance on the information [email protected] Email: [email protected] contained in this publication. Website: www.ahpa.org Articles may not be reproduced or reprinted without written permission from AHPA. © copyright 2010, AHPA

August 2010 • Page The second edition of the Botanical Safety Handbook will represent Financial sponsors of the a significant modification from the first edition. The editors of the Botanical Safety Handbook, 2nd edition (to date) original edition relied heavily on secondary references, and fewer $25,000+ than 300 publications were identified in that work’s bibliography. NIH Office of Dietary Supplements By comparison, as many as 35,000 references were reviewed for the University of Massachusetts Medicinal Plant Program revised edition, and over 8,000 will be cited in the text. $10,000+ “Research on herbal ingredients has accelerated dramatically in the Herbs, Etc. last several years,” commented Gardner, the revised text’s co-editor. $5,000+ “Our compilation and review of this emerging data, along with old- Aveda, Nature’s Way er data that is now more easily accessible, will serve as the basis for an authoritative resource that will benefit consumers of herbal sup- $2,500+ plements as well as provide important data to health care providers CRC Insurance, Emerson Ecologics, General Nutrition who now lack adequate information on the herbs used by so many Centers (GNC), Herb Pharm, Michael McGuffin (AHPA), Pacific Nutritional, Inc. of their patients.” $1,000+ Additional work is now underway to complete the text, and publica- Arise & Shine, Herbalist & Alchemist, Mountain Rose Herbs, tion by CRC Press is projected for 2011, in both print and electronic NOW Foods, Jim Prochnow (Greenberg Traurig), formats. Systemic Formulas, Traditional Medicinals, Vitality Works “AHPA has been broadly credited for publishing the first edition of $500+ the Botanical Safety Handbook over a decade ago, at a time when it Jon Benninger (Virgo Publishing), was difficult to find accurate information on herbal safety issues,” Steven Dentali (AHPA), Greg Doherty (Poms & Associates), commented AHPA’s McGuffin. “The current revision of this semi- Frontier Natural Products, New Chapter nal text will reflect AHPA’s continued commitment to providing ac- $100+ curate information about the safe oral use of herbs in a practical and Cindy Angerhofer (Aveda), accessible format.”  Mary Beth Watkins (Nutraceutical Corporation)

August 2010 • Page AHPA Staff Contribute to ODS Publication anyone interested in a scientific and balanced presentation of both on Dietary Supplement Ingredients the science behind and the possible benefits (or not) of dietary supplements.” The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) recently announced the publication of its The title is available from Informa Healthcare Books at a retail price Encyclopedia of Dietary Supplements, 2nd Edition. This new edition of $1,000. AHPA members will receive a 15% discount by ordering contains chapters on several botanicals, including aloe vera, bilberry, online at http://www.informahealthcarebooks.com/ and using coupon  bitter orange, black cohosh, kava, and saw palmetto. AHPA Chief code “COLLEAGUE” (case sensitive). Science Officer Steven Dentali, Ph.D. and Chief Operations Officer Devon Powell contributed as co-authors of the aloe vera chapter. Upcoming AHPA Seminar Peer reviewed by experts, chapters include information on chemistry, pre-clinical and clinical literature, regulatory status and refer- Microscopic Identification of Popular ences to relevant literature. “AHPA is proud to have contributed to Botanical Materials this project,” said Dr. Dentali. “Having clear and consistent infor- The federal current good manufacturing practice (cGMP) regula- mation on botanicals in an authoritative publication such as this tion (21 CFR 111) requires that all dietary ingredients be tested or will greatly benefit consumers and the supplement industry.” examined to verify identity prior to use in a finished product. In or- According to the publisher, the book “presents peer-reviewed, objec- der to assist manufacturers and suppliers in meeting this require- tive entries that rigorously examine the most significant scientific ment, AHPA will present a 2-day, hands-on, educational training research, and thereby provides evidence-based information on the program, “Microscopic Identification of Popular Botanical major vitamin and mineral micronutrients, single herbs and botani- Materials.” The program is scheduled on the weekend of November cals, phytochemicals, and other bioactive preparations.” Describing 13-14 at the University of Southern California’s School of Pharmacy the work as “useful to a broad spectrum of healthcare professionals, in Los Angeles. researchers and educated, health-conscious consumers,” the pub- Information will be presented in morphological groups such as lisher also states that the new edition “is the definitive guide for barks, roots, leaves, seeds, etc., and their characteristic microscopic

August 2010 • Page components. The basic structure of the various tissue types will be discussed and identified using actual examples from a vast database of microscopic botanical images. Information will be briefly reviewed regarding equipment, chemicals and supplies needed to start with if time permits and/or if requested. Participants will spend a significant amount of time during the program conducting hands-on training using a microscope. The program’s overall goal is to have participants leave with the experience necessary to confidently conduct microscopic analysis on a variety of popular botanical ingredients.

PROGRAM GOALS

 Give beginning to intermediate microscopist the skills and ability to confidently and competently analyze popular botanical ingredients often used in commercial products

 Provide hands-on experience. The majority of the program will be spent on actual, hands-on use of the microscope and the analysis of botanical materials, including:

 Sample preparation and review

 Identification of adulterated materials, including common fillers used to cut materials (flow agents & soluble excipients)

 Connecting the dots: Comparing a certificate of analysis and specifications to microscopic analytical results

 General background on microscopy and use of a microscope

 Identification of appropriate reference resources

 Voucher specimens

 Published references

WHO SHOULD ATTEND? Laboratory personnel, QA/QC personnel, dietary supplement companies looking for economical means to comply with the GMP requirements regarding establishing identity, or anyone with an interest in utilizing microscopy as a tool for the identification of botanicals.

CLICK HERE TO REGISTER & FOR MORE INFORMATION

(or paste this link into your browser: https://connect.computility.com/ form/index.php?id=b64669fcc8ab9bdbe576f8f1532e5bac) 

August 2010 • Page Special Topics food will cause serious adverse health consequences or death to humans or animals.  Tentative support for S. 510, the FDA Food Safety Modernization Report of July 13, 2010 Meeting Act, conditional upon specific changes to that legislation prior to its passage. Changes should include, at a minimum, establish- of the AHPA Board ment of a requirement for FDA to determine that an article may The AHPA Board of Trustees convened a regular meeting via tele- present a health risk in order to subject such product to adminis- conference on July 13, 2010. The board reviewed the organization’s trative detention; and exemption from proposed HACCP (Hazard financial condition, received reports from numerous AHPA Analysis Critical Control Point) requirements not only for dietary committees, and considered several policy issues. The board adopted supplement firms that comply with 21 CFR 111 (dietary supple- the following actions: ment good manufacturing regulation), but also for such compli-  Approval of the addition of bilberry fruit extract adulterated with ant dietary ingredient companies and supplement and ingredient red dye #2 (amaranth dye), and of Hoodia gordonii aerial parts companies that meet a manufacturing standard that is at least as powder adulterated with various powders, possibly including stringent as 21 CFR 111. Opuntia spp. and other Hoodia species, to AHPA’s known  Authorization of an expenditure to create a record of the history of adulterants guidance policy. animal feeding studies undertaken by the National Toxicology  Establishment of a policy to refuse AHPA membership to appli- Program (NTP) involving herbs or constituents of herbs. The board cants for which review of a representative portion of the compa- also authorized AHPA staff to request that NTP communicate to ny’s labels or labeling identifies instances in which a specific clearly state that a finding of “clear evidence of carcinogenic activ- disease is named and an explicit claim is made that the product ity” in an NTP conducted animal feeding study is not in and of cures, treats or prevents a specifically named disease. The board itself evidence that a tested substance causes cancer. also determined that this policy does not extend to perceived  In response to a report of a recall of Polygonum officinalis, authori- implicit claims to cure, treat, or prevent a disease. zation to communicate accurate information to Chinese regula-  Authorization to make specific recommendations to the Food and tory authorities regarding U.S. regulations for sulfite labeling as it Drug Administration (FDA) for actions that the agency should applies to exported Chinese herbs and to request that these agen- consider to combat adulteration of products marketed as dietary cies communicate this information to exporters. supplements but containing undeclared drug ingredients. The  Adoption of a formal charter for the AHPA Cannabis Committee, board identified specific ideas, as recommended by a working as founded by the board at its March 2010 meeting. In addition, group of the AHPA Government Relations Committee, to com- and on the committee’s recommendation, the board agreed to take municate to FDA, including: continued publicity by FDA of appropriate action to affect federal regulation and/or federal legisla- their enforcement actions; establishment of Import Alerts on tion to allow cultivation of industrial hemp (defined as Cannabis violators’ imports; FDA identification of drugs as “contaminants spp. with a very low level (< 0.3 percent) of the known psychotro- that may adulterate” products in certain classes; and a call for the pic compounds) in the United States. It was also agreed that con- agency to bring more criminal actions against perpetrators of sideration of formal support for any specific legislation in this such adulteration. matter will need to be determined by further AHPA board review.  Support for federal legislation to grant FDA mandatory recall  Appointment of Bill Egloff (Crane Herbs) as the chair of the authority for foods, including dietary supplements, if the agency Chinese Herbal Products Committee. Bill has served as the determines that there is a reasonable probability that use of such committee’s co-chair for several years. 

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DBA-A - AHPA Ad.indd 1 7/20/2010 10:42:42 AM August 2010 • Page The following article appears, along with its accompanying table, as the For import / export trade analysis, various Crude Drugs (botanical Introduction to the June 2010 edition of Medicinal Plants and Extracts raw materials) may be classified within several different HS Code (Issue No. 35), a quarterly bulletin produced by Market News Service Chapters including 07 and 08, but most species are grouped in (MNS), Division of Market Development, International Trade Centre Chapters 09 (e.g. 0902 through 0910), 12 (e.g. 1210, 1211, and (ITC), The Joint Agency of the World Trade Organization and The 1212), 13 (e.g. 1301.20 and 1301.90), 14 (e.g. 1404.10 and United Nations. 1404.90) and 40 (e.g. 4001.30), among others, depending on the The article was written by Josef Brinckmann, and is reprinted here species, plant part, and trade form. Extracts are generally classified with permission of the ITC. AHPA appreciates the generosity of both within HS Code Chapter 13 (e.g. 1302.19) but some also occur in Mr. Brinckmann and ITC for making this information available to HS Code Chapter 21 (e.g. 2101.20) as well as in HS Code Chapters its members. 32 and 33. Essential oils and extracted oleoresins are classified within HS Code Chapter 33 (e.g. 3301). Finished herbal medicinal More information about ITC’s MNS can be seen at http://www.intracen. products are generally categorized under HS Code Chapter 30. org/market-news. Subscription inquiries should be addressed to mns- [email protected]. But, all of the import / export trade databases in the world won’t tell you how big the informal trade sector is. In some countries, the domestic consumption of MAPs, from wild-collection or farming at How big is the global trade of medicinal the household or village level or traded locally, may be as significant and aromatic plants and extracts? as the export trade. The amounts bought and sold locally are not recorded in database unless they are major commodity crops and a The numbers are all over the place, aren’t they? Every market analyst governmental agency keeps tally on annual planting and harvest seems to arrive at a different total. The estimates on the size of the amounts. Domestic consumption of medicinal plants in countries global trade vary so greatly that it is difficult for experts to sort out. like China and India may be higher than exported amounts. Such estimates are sometimes used as factual data by project manag- It is too early in 2010 to capture the total 2009 exports from all ers and policy makers to support the aims of development projects countries because some countries have not yet reported their final for production and export promotion. Of course the size of the 2009 trade data. Total 2009 trade data may not be evaluable until global market depends on the inclusion and exclusion criteria. end of 2010 or early 2011. However several of the major producing Analysis is carried out using Harmonized System Tariff Codes (HS and exporting countries have published their data which is analyzed Codes) as entered in various national or international trade in this MNS 35 [Ed. note: The June 2010 issue]. As a basis of com- databases. parison, and using the aforementioned inclusion criteria, we can A major confounding factor in the analysis of the global botanical provide an estimate of the total 2008 export trade of natural botani- trade is that different analysts often employ different criteria as to cal ingredients in terms of value (USD). Table 1 on the following which HS Codes qualify for inclusion in the final analysis. Most bo- page shows a total global export value of over USD $31.24 billion tanicals have multiple end-uses. There is no single classification in when including botanical raw materials (medicinal, culinary and ar- the tariff schedules and import / export trade databases for medici- omatic plants), herbal extracts, essential oils and extracted oleores- nal and aromatic plants (MAPs) and/or other botanical natural in- ins, exudates (balsams, natural gums, resins, saps), and selected fatty gredients (e.g. essential oils, extracts, exudates, fatty oils, gums, oils, seaweeds and algae. resins). Thus they are not coherently grouped within a single chap- J. Brinckmann ter or commodity classification. Botanical raw materials and/or their extracted or processed forms occur scattered throughout HS Chapters 07, 08, 09, 12, 13, 14, 15, 18, 21, 32, 33 and 40, depend- [Ed. note: Other sections of MNS 35 look at the available export value ing on their perceived or primary end-use and on the plant part and and volume of some of the largest producers and exporters of natural in- the processed trade form. An expert in the commercially-traded gredients, from Asia (People’s Republic of China, Republic of India, forms of botanicals would need to carefully study each of the tariff Republic of Indonesia and Malaysia), Africa (Arab Republic of Egypt, schedule chapters in order to selectively pull out the most relevant Kingdom of Morocco and Republic of South Africa), and South America codes for inclusion. Additionally, each national database employs (Argentine Republic, Federative Republic of Brazil and Republic of different nomenclature, using local vernacular. In some cases differ- Chile); and at the 2009 import value and volume of some of the largest ent countries classify the very same botanical ingredient in com- importers, consumers, processors and re-exporters of natural ingredients pletely different chapters of their respective tariff schedules and in Europe (French Republic, Federal Republic of Germany and Italian commodity classifications. Republic) and North America (United States of America).] 

August 2010 • Page Table 1: Natural Botanical Ingredients 2008 Total World Export Value (USD) / Top 5 Exporters

2008 HS Total Export Code Commodity Group Description Top 5 Exporters (or re-exporters!!) Value USD TOTAL 31,243,336,755

0902 Tea leaf 5,417,378,710 Sri Lanka, Kenya, China, India, UK 1804 Cocoa butter, fat and oil 4,316,043,464 Netherlands, Malaysia, France, Indonesia, Côte d’Ivoire Herbal extracts and vegetable saps; pectic substances, pectinates and 1302 pectates; agar-agar, carrageenan and other mucilages and thickeners, 4,226,496,511 Germany, USA, China, India, Denmark whether or not modified, derived from vegetable products.

Essential oils (terpeneless or not), including concretes and absolutes; 3301 resinoids; extracted oleoresins; concentrates of essential oils in fats, 2,825,572,041 USA, India, France, Brazil, Indonesia in fixed oils, in waxes or the like, obtained by enfleurage or maceration

Pepper of the genus Piper; dried or crushed or ground fruits of the genus 0904 2,138,510,119 India, Viet Nam, China, Indonesia, Peru Capsicum or of the genus Pimenta Plants and parts of plants, of a kind used primarily in pharmacy or 1211 1,789,872,486 China, India, Germany, USA, Poland perfumery, or for insecticidal, fungicidal or similar purposes, fresh or dried 151311 Coconut (copra) oil, crude 1,440,436,975 Philippines, Indonesia, Netherlands, Malaysia, Bulgaria 0910 Ginger, saffron, turmeric (curcuma), thyme and other spices 1,435,640,626 China, Bhutan, India, Netherlands, Spain Fixed vegetable fats & oils (e.g. hemp oil, jojoba oil) & their fractions, 151590 1,092,932,355 USA, Italy, UAE, France, Denmark whether/not refined but not chemically modified Coconut oil, other than crude, & fractions thereof , whether/not refined 151319 978,582,891 Philippines, Indonesia, Netherlands, Malaysia, Germany but not chemically modified 210120 Tea leaf and maté extracts, essences and concentrates 894,893,493 Netherlands, USA, Germany, Ireland, Canada Canada, Belgium, Russian Federation, USA, 1204 Linseed (flax seed), whether or not broken 726,256,503 Netherlands 1210 Hop strobile 702,100,720 Germany, USA, Czech Republic, Slovenia, UK Seaweeds & other algae (e.g. kelp), fresh/chilled/frozen/dried, 121220 581,041,694 China, Indonesia, South Korea, Chile, Japan whether/not ground 0909 Aniseed, star anise, fennel, coriander, cumin or caraway 480,253,015 India, Bulgaria, China, Turkey, UAE 0908 Nutmeg, mace and cardamoms 393,362,894 Guatemala, Indonesia, Netherlands, India, Singapore Vegetable products. (excl. of 1404.20), n.e.s.o.i. (e.g. alkanet root, 140490 339,508,245 Netherlands, Ethiopia, Kenya, Mexico, Peru annatto seed, betel leaf, loofah) 130120 Gum arabic 297,435,109 France, Sudan, Nigeria, UK, USA Tanning extracts of vegetable origin (e.g. myrobalan extract, quebracho 3201 290,734,338 Argentina, Brazil, South Africa, Indonesia, Italy bark extract) Natural gums (excl. of 1301.20), resins, gum-resins & oleoresins (e.g., 130190 232,440,891 India, USA, Singapore, Thailand, Germany boswellia, myrrh, olibanum) 0906 Cinnamon and cinnamon-tree flowers 203,117,244 Sri Lanka, Indonesia, China, Viet Nam, Netherlands 0907 Clove flower bud and stems 147,920,075 Sri Lanka, Madagascar, Singapore, Brazil, Tanzania 0905 Vanilla fruit 121,252,790 Madagascar, France, Germany, India, Canada 0903 Maté leaf 86,940,282 Brazil, Argentina, Germany, Uruguay, Paraguay 081400 Peel of citrus fruit (e.g. orange peel) or melons 71,722,525 Zimbabwe, Mexico, Spain, Peru, USA 400130 Balata, gutta-percha, guayule, chicle & similar natural gums 8,757,259 Singapore, Indonesia, USA, Guatemala, Mexico Raw veg. materials of a kind used primarily in dyeing (e.g. amla fruit; 140410 4,133,500 India, Yemen, Other Asia n.e.s., Indonesia, Morocco myrobalans; henna leaf)

August 2010 • Page Legal & Regulatory counterfeit and unapproved weight loss medication. The government alleges that the two, a Chinese national and a resident of Government Gets Tough with Purveyors Plano, Texas, imported and distributed products labeled with names of Drug-Spiked “Dietary Supplements” such as “2 Day Diet”, “Meitzitang”, and “Superslim” that were by Anthony L. Young, AHPA General Counsel, found by FDA to contain the weight loss drug sibutramine as an and Michael McGuffin, AHPA President undeclared ingredient. Two of these were among 28 such products identified by FDA in a December 22, 2008 consumer advisory, a list Using their substantial enforcement powers, FDA and the that FDA has now expanded to include 72 products. FDA’s press Department of Justice have brought criminal actions against an release on these arrests is posted here: http://www.fda.gov/ICECI/ Orange County, California man and his daughter for distributing CriminalInvestigations/ucm206314.htm. misbranded drugs called “Vitalex” (or “Vitalex for men” and “Vitalex These aggressive enforcement actions are of particular interest in for women”). The products were labeled as consisting of Chinese light of a statement made by Dr. Joshua Sharfstein, FDA Principal herbs and were marketed as “all-natural” versions of sexual enhance- Deputy Commissioner, before the Senate Special Committee on ment drugs such as Viagra®. It is alleged that these products were Aging on May 26, 2010. At the committee’s hearing, Sharfstein not spiked with “real” Viagra (i.e., sildenafil citrate) but with ana- identified the area of dietary supplement regulation “that gives the logs, which means that the ingredients were untested, unapproved FDA the most concern” as “without question … the pharmaceutical new drugs. See FDA’s press release here: http://www.fda.gov/ICECI/ spiking of dietary supplements because we’re talking about very seri- CriminalInvestigations/ucm209275.htm ous risk and injuries that can happen to people.” (See AHPA Report, In a separate case, FDA and other United States law enforcement July 2010, pages 3-5 for a full report of Sharfstein’s May testimony officials arrested two people and charged them with illegally trafficking at this hearing).

This is not the same product as Vitalex™ sold under the MMS Pro The dietary supplement industry clearly shares Dr. Sharfstein’s con- brand as a standardized extract of chaste tree fruit (Vitex agnus-castus). cern for consumers of drug-spiked products, and also recognizes the

August 2010 • Page damage to the reputation of this trade that occurs when adulterated products masquerade as dietary supplements. There is no doubt that Prop 65: A Quick Summary adding an undeclared drug ingredient to a product is illegal, and Consumer goods sold in California, with certain exceptions, these recent actions show that FDA is proceeding to bring alleged are subject to Proposition 65, the Safe Drinking Water and criminals to justice when they are identified. These cases are felony Toxic Enforcement Act of 1986. The regulations that have indictments, and it appears from the allegations that these individu- been implemented in the years since this law was passed place als knew that they were distributing spiked products. But they are a specific labeling requirements on products sold in the state if warning as well to companies that may inadvertently market prod- the product contains chemicals listed by the state as carcino- ucts in these categories that contain drugs due to illegal actions by a gens or reproductive toxicants above specified limits. Failure to remote manufacturer. The Federal Food, Drug, and Cosmetic Act is provide such warnings can result in action by the California a strict criminal liability statute, and just distributing an adulterated Attorney General or by “any person in the public interest.” or misbranded product is a crime. Lead is listed under Proposition 65 both as a carcinogen and as FDA now has a website that consolidates all of the alleged “dietary a reproductive toxin, with a no significant risk level (NSRL, supplements” that are spiked drugs, found at http://www.fda.gov/ relevant to carcinogens) of 15 mcg/day and a maximum allow- Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/ able daily level (MADL, for reproductive toxins) of just 0.5 MedicationHealthFraud/ucm207647.htm. As this list grows, FDA mcg. Most actions against supplement companies have focused might well need to use its strict criminal liability powers to assure just on the MADL, and products that present more than 0.5 that this practice of drug-spiking does not continue to put consumers mcg of lead at the highest labeled daily consumption level at risk. And because this is an international problem, do not be sur- must provide a “clear and reasonable” warning that it “contains prised if Interpol and other international law enforcement agencies a chemical known to the State of California to cause birth begin to move in concert against those who are perpetrating it.  defects.” The earliest supplement-related Proposition 65 complaints, 52 New Proposition 65 Complaints filed in 1996 and 1997, were focused on nationally sold calci- Filed Against Supplement Companies; um products, including both supplements and OTC antacids. Settlements Now Exceed $4 Million These actions led to a settlement with the attorney general that by Michael McGuffin, AHPA President established a naturally-occurring tolerance of 1.0 mcg of lead after April 1, 1999, and since that time calcium products have In a striking increase in attention to the dietary supplement catego- been able to bear as much as 1.5 mcg per daily serving (the ry, a private plaintiff in California has issued a Notice of Violation MADL plus the naturally-occurring amount) without requir- to each of 52 dietary supplement marketers since May to inform ing any consumer warning. Though this decision was limited them of purported noncompliance with the State’s Proposition 65. to the handful of settling companies, it has nonetheless served The plaintiff, the Environmental Research Center in San Diego, al- as something of an industry standard for products that contain leges that one or more products marketed by each of these compa- calcium for over a decade. But the attorney general informed nies are “exposing people to lead,” and in one case “to arsenic,” but the settling parties in May 2009 of its intention to seek to have “failed to provide a … clear and reasonable … warning” to modify this agreement in light of new evidence on the normal consumer, as required by this law. range of lead in multivitamin-mineral products. The first Proposition 65 notices against dietary supplement compa- Not all Notices of Violation lead to settlements or even to for- nies were filed in December 1996 when 6 companies marketing ei- mal complaints by the plaintiff. In some cases, the Attorney ther calcium supplements or OTC antacids were confronted due to General acts to bring complaints against companies that re- the inadvertent lead content of these products. (See sidebar for more ceived notice from a private plaintiff, and did so against 56 details on these cases and for a short review of Proposition 65 as it supplement brands that were identified as noncompliant due may apply to supplement marketers.) In the intervening years until to lead in their products as recently as December 2008. (See May, 2010 there have been 129 notices issued to supplement brands the January 2009 AHPA Report, pages 3-4). claiming that the targeted products contained lead, and sometimes AHPA provides as a member benefit an authoritative docu- arsenic, cadmium or mercury. The 52 new notices, all issued be- ment with important information to assist in complying with tween May 24 and July 9, thus represent in this six-week period this law (McGuffin M and Norris T. December 2008. nearly 30 percent of all such Proposition 65 notices ever issued to Background on California Proposition 65: Issues related to supplement brands and focused on heavy metals. heavy metals and herbal products.) Contact Michael McGuffin Only about 40 of the Proposition 65 notices filed to date against ([email protected]) to request a copy of this document. supplement companies have been followed up with complaints and

August 2010 • Page 10 reached settlements. The cumulative total for all settled cases has now reached over $4.6 million, and the cost borne by individual companies have ranged as high as $685,000. These fees have been paid to cover civil penalties, as additional payments that may be di- rected to non-profit organizations, and to reimburse plaintiffs’ legal expenses. The notices filed in the past few months by the Environmental Research Center appear to be focused on different products and channels of trade than earlier notices. For example, many of these were sent to companies that distribute through direct selling to consumers rather than through retail stores, a channel of distribution that has been largely overlooked until this time. In addition, the plaintiff identified not only tablet and capsule products, but also di- rected considerable attention to protein powders and fruit-based liquids sold in large-format bottles or cans. Because the limits im- posed by Proposition 65 on quantities of listed chemicals are calcu- lated on daily consumption, the concentration of any such chemical must be lower in any product that is consumed in a large daily quantity. Companies that sell dietary supplements in California can best pro- tect themselves from Proposition 65 complaints by analyzing their products for chemicals that the state has listed under this law. As it is lead that has been identified by plaintiffs as the main focus of their attention to this class, marketers in California will regret being the second person to know how much lead is in their product if a plaintiff is the first. 

Lead in conventional foods: an emerging Prop 65 target For more than a decade, AHPA and its members have learned to deal with the Proposition 65 ramifications of lead in herbal products and other dietary supplements. Though a number of complaints were filed against marketers of nutrition bars in 2002 and of vinegar (especially balsamic vinegar) beginning in 2003, until now there has been little attention to the presence of this ubiquitous heavy metal in conventional foods. There are now signs that the plaintiffs’ bar has recognized that lead may also be present in conventional foods at a daily consumption level above the 0.5 mcg that triggers a warning requirement as a reproductive toxin. Notices of Violation were issued in June by the Environmental Law Foundation alleging failure to warn of the presence of lead in 125 specific fruit juice and canned fruit products, including many nationally-distributed brands. The same private plaintiff also sent notices to 17 companies that market protein powders, largely based on whey protein, as foods rather than as dietary supplements. Contact Michael McGuffin [email protected] ( g) if you would like to receive copies of these notices.

August 2010 • Page 11 FDA’s Moore Clarifies Statement These statements were quite strong and seemed to indicate a change on NDI Enforcement in enforcement strategy by FDA. In the usual course, FDA uses warning letters to induce compliance rather than court enforce- By Anthony L. Young, AHPA General Counsel ment, because court enforcement utilizes substantially more of the An article in the June 21, 2010 edition of “The Tan Sheet” reported agency’s scarce enforcement resources. So in my role as AHPA on comments made by the Food and Drug Administration’s Dr. General Counsel I asked Dr. Moore for clarification and received Robert Moore at the Drug Information Association’s annual meet- the following response: ing on June 15. The article was headlined, “FDA Will Enforce NDI “It is a not quite accurate rendition of what I said. What I said was Notification Requirement Without Warning,” and generated anxi- that we typically issue warning letters to encourage voluntary com- ety by some who thought this represented a shift in FDA’s long- pliance – but, nothing precludes us from going directly to a judicial standing enforcement policies with regard to new dietary ingredi- action in cases where we believe that a WL [Warning Letter] isn’t the ents (NDIs). Dr. Moore’s presentation was of particular interest in appropriate first step or in instances where we have already publicly light of recent comments made by Dr. Joshua Sharfstein, FDA put the word out that particular ingredients are NDIs that require Principal Deputy Commissioner, on the agency’s intention to complete notices – that is, not everyone could necessarily rely on getting a WL NDI guidance as a priority (see AHPA Report, July 2010, page 4). first if we have already sent out a slew to others and that action on Dr. Moore’s title is Supervisor of the Regulations Implementation our part did not appear to have worked to induce voluntary Team at FDA’s Division of Dietary Supplement Programs. He was compliance. quoted in the June 21 article as stating, “Once there is [an NDI] “And yes, I did say that it would be likely that, given that the pur- guidance then there is a lot of low hanging fruit for us to pick” from pose of enforcement actions is to induce voluntary compliance, we an enforcement perspective. He was further quoted as saying that likely would try to pick targets that would be more likely to result in such enforcement “simply will be judicial actions from square one” the rest of the industry sitting up and taking notice. I don’t know and “won’t be preceded by warning letters,” and that, “FDA takes that that is anything new.” enforcement action ... to induce voluntary compliance on the part Forewarned is forearmed. Manufacturers and distributors of dietary of regulated industry, and you get more bang for your buck the big- supplements know best whether they are utilizing new dietary ingredients ger and more prominent the examples.”

Support Safety by Supporting the Botanical Safety Handbook Revision

AHPA’s Botanical Safety Handbook is a reference book that provides safety information on more than 600 species in trade as ingredients in dietary supplements. An essential reference for healthcare providers, consumers, retailers and manufacturers of herbal products, its safety classifications are frequently cited in other publications.

Time for an update v Significant herbal research has been published since the BSH was published in 1997 v A number of new ingredients are now on the market.

The revision will be based upon comprehensive literature reviews for each herb, historical uses and traditional knowledge, and case reports of adverse reactions and herb-drug interactions, herb-drug interaction studies, metabolism studies, toxicology studies and clinical trials. The BSH revision is to be completed over a three-year period, and seed money for the project has been pledged by the Office of Dietary Supplements at the National Institutes of Health, the University of Massachusetts, and individual and corporate contributions to the AHPA-ERB Foundation.

Pledge your tax-deductible contribution today! Contact Michael McGuffin at [email protected].

August 2010 • Page 12 that might be at enforcement risk once an NDI guidance comes out. or exemption in effect.” FDA went on to note that there is “no regu- At a recent Food and Drug Law Institute luncheon, FDA Deputy lation or exemption in effect pursuant … for spirulina powder (see Commissioner for Foods Michael Taylor reaffirmed that NDI guid- 21 CFR 179.26)” and that “your spirulina powder is adulterated ance is a high priority for FDA. Taylor was FDA Deputy Commissioner under section 402(a)(7) of the Act because it received radiation for Policy at the time the Dietary Supplement Health and Education treatment and there is no FDA regulation or exemption permitting Act was under consideration by Congress and became law.  the use of radiation for this product.” As a matter of background, the issue of irradiation of dietary ingre- Warning Letter Addresses Unpermitted dients is pending before FDA. FDA noted this in the June 2007 Irradiation, Labeling of Excipients in preamble to its issuance of the final rule on current good manufac- Extracts, and Application of Food cGMP turing practice (cGMP) for dietary supplements: to Ingredient Suppliers “Under section 201(s) of the act, irradiation intended for use in By Anthony Young, Kleinfeld, Kaplan and Becker, LLP, producing, manufacturing, packing, processing, preparing, treating, AHPA General Counsel packaging, transporting, or holding food is a food additive that requires premarket review and approval before it can be used in food. In a warning letter to Pharmline, Inc. dated May 25, 2010, the Food Our Office of Food Additive Safety is currently reviewing a food ad- and Drug Administration raised three important issues for ditive petition for the use of irradiation on dietary ingredients and dietary supplement ingredient suppliers. http://www.fda.gov/ICECI/ dietary supplements. Until that review process is completed and we . EnforcementActions/WarningLetters/ucm217574.htm have authorized this use of irradiation through a final rule codified First, FDA warned that the company had received gamma radia- in part 179, irradiation of dietary ingredients and dietary supple- tion-treated spirulina powder and had also sent spirulina powder ments as a means to reduce or eliminate microbial loads is not per- out to a contract facility to be irradiated. FDA pointed out that “a mitted. However, you may use an irradiated component (such as a food is adulterated if it has been intentionally subject to radiation, spice that is used to flavor a dietary supplement) when the irradia- unless the use of the radiation was in conformity with a regulation tion of that component is allowed under § 179.26.”

National and International PRODUCTS LIABILITY INSURANCE PROGRAM for Manufacturers & Distributors of Herbal & Health Food Supplements

Now you can take advantage of a casualty insurance program that is endorsed by the American Herbal Products Association (AHPA) and is available to AHPA Members. The program offers Commercial General Liability Insurance, which includes:  Products Liability  Vendors Legal Liability  Premises Liability  Employment Benefits Liability Excess Liability with limits to $50,000,000 with extensions over underlying coverages. The program is designed specifically for your industry and your unique needs. We work with manufacturers, importers, exporters, distributors, wholesalers, and multi-level marketers on a continuing basis. The result is a program for AHPA Members that thoroughly protects, yet still remains affordable. More than 150 companies nationally are now insured in the AHPA program. You can access the AHPA Program through your agent/broker by having them contact Richard M. Griffin, or you can call Dick direct: GRIFCON Enterprises, Inc. AHPA Insurance Program Manager at 916-434-8874 for details. www.dickgriffin.com • [email protected]

August 2010 • Page 13 Note that the food additive petition referred to above is apparently practice to put minimal labeling on the outer containers and to pro- still under review by FDA, and that AHPA has filed comments to vide ingredient information and certificates of analysis for their oppose FDA approval of the petition (see AHPA Report, January ingredients. 2008, page 13). While this is the first warning letter to warn against Third, the FDA’s warning letter to Pharmline appears to recognize the use of irradiation for certain food or dietary ingredients, it is not that as a dietary ingredient manufacturer, the company is not sub- new news. ject to the cGMPs for dietary supplements and instead is subject to Second, FDA warned that the company’s “Saw Palmetto Extract the cGMPs for foods, i.e., 21 CFR Part 110. In its letter, FDA states 30% product is misbranded under section 403(i)(2) of the Act [21 “In addition, if you are manufacturing a dietary supplement, in- U.S.C. 343(i)(2)] because it is fabricated from two or more ingredi- cluding a dietary supplement that you manufacture but that is pack- ents, but the label fails to bear the common or usual name of each aged or labeled by another person, you are subject to 21 CFR Part ingredient, as required by 21 CFR 101.4(a)(1).” FDA noted that 111, Current Good Manufacturing Practice in Manufacturing, the product contains “dicalcium phosphate dihydrate, sorbitol, Packaging, Labeling, or Holding Operations for Dietary maltodextrin, and calcium silicate, but these ingredients are not de- Supplements.” These are important distinctions between the cGMPs clared on the label of the product.” for dietary supplements and foods.  The short story is this – a food ingredient, or an ingredient intended for use in the manufacture of a dietary supplement, is a food. Safe Cosmetics Act Introduced in U.S. House Accordingly, such ingredients or blends must be labeled as food, at By Stacy L. Ehrlich, Kleinfeld, Kaplan and Becker, LLP least with respect to common and usual name, ingredient labeling in descending order, net quantity of contents, and name and place of On July 21, 2010, Reps. Jan Schakowsky (D-IL), Ed Markey (D- business of the manufacturer and distributor. There is a provision in MA) and Tammy Baldwin (D-WI), introduced in the House of the FDA’s regulation exempting foods for processing, labeling or re- Representatives H.R. 5786, the Safe Cosmetics Act of 2010. If en- packing at other establishments: 21 CFR 101.100(d). Ingredient acted, this would significantly increase FDA’s regulatory authority suppliers might consider using this provision to continue the general over cosmetics.

SPECIAL LOW PRICE for MEMBERS You Manufacture Herbal Extracts? Then Your Company Needs AHPA’s Guidance Documents for the Manufacture and Sale of Botanical Extracts, the Standardization of Botanical Products, and Manual for Alcohol Tax Drawbacks

developed by the American Herbal Products Association’s Botanical Extracts Committee A collection of five documents that set forth guidelines for procedures and issues encountered in the manufacture, sale and labeling of herbal extracts: • Guidance for the Manufacture and Sale of Bulk Botanical Extracts • Guidance for the Retail Labeling of Dietary Supplements Containing Soft or Powdered Botanical Extracts • Use of Marker Compounds in Manufacturing Labeling Botanically Derived Dietary Supplement • The White Paper on Standardization of Botanical Products describes the many factors that contribute to the proper standardization of a botanical product. This document is intended to foster a heightened awareness of the complexities associated with standardization and to facilitate informed discussions between raw material suppliers, product manufacturers, practitioners, clinicians, regulators and consumers. • The Manual for Alcohol Tax Drawbacks assist manufacturers to understand and conform to the Federal Regulations that govern the drawback of prepaid excise tax on alcohol used in the production of non-beverage products.

Special Member Price: $49.99 U Non-Member Price: $79.00 To order, call: 301-588-1171 or buy online at: http://www.ahpa.org/bookstore.htm

August 2010 • Page 14 The proposed legislation includes the following provisions:  FDA Order to Cease Distribution: Gives FDA the authority to issue an order requiring a company to immediately cease distrib-  FDA Registration: Requires domestic and foreign establishments uting a cosmetic if it may cause serious adverse health conse- that manufacture, package, or distribute cosmetics to register an- quences to humans, is misbranded, or was manufactured, nually (including the number of workers, gross receipts of sales, packaged or distributed by an unregistered facility. and the name and address of companies that supply the establishment with any ingredient) and list products with FDA.  FDA Recall Authority: Gives FDA the authority to require a cosmetic product recall if the product presents an imminent threat of  User Fees: Establishes cosmetic user fees based on an establish- serious adverse health consequences or death to humans. ment’s gross receipts or sales, applicable only to companies with annual gross receipts or sales of more than $1 million.  Nanomaterials: Gives FDA the authority to require that cosmetics containing nanomaterials be labeled with information regard-  Ingredient Disclosure: Requires, within one year after the date of ing such ingredients. enactment, identification of all ingredients on cosmetic labels in descending order of predominance, including contaminants pres-  Adverse Event Reporting: Requires the submission of reports con- ent at levels above technically feasible detection limits, fragrances, taining information received concerning any serious adverse event flavors and preservatives, declared individually. Fragrances, fla- associated with the use of a cosmetic within 15 days of receipt. vors, and colorants will not be considered confidential business information. In addition, Internet vendors of cosmetics would be  Alternative Testing Methods: Requires FDA to publish a list of required to display the ingredient list on their websites. “alternative testing methods” that do not involve the use of animals or use fewer animals to test a chemical substance and that  Data Submission to FDA: Requires manufacturers and distribu- must be used in ingredient testing where practicable. tors of cosmetics and ingredients to submit electronically, not later than one year after enactment, “all reasonably available Companies that sell cosmetic products may wish to maintain atten- information in the possession or control of the manufacturer or tion on the progress, if any, of this legislation. There is no related bill  distributor that has not previously been submitted to [FDA] re- in the Senate. garding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels,” including function and uses, exposure and fate information, and tests of finished cosmetics. This information (except for confidential information) will be published in a public database. This space could be yours  FDA Regulation on Safety of Ingredients: Requires FDA to issue ADVERTISE IN THE AHPA REPORT regulations not later than two years after enactment identifying ingredients as “prohibited,” “restricted,” or “safe without limits” for use in cosmetics. Within 18 months of enactment, FDA must develop a “priority assessment list of not less than 300 ingredi- • easy ents” that cannot be included on the above-referenced lists “because of a lack of authoritative information on the safety of the • cost effective ingredient” and must conduct safety determinations for these ingredients. FDA must add at least 100 ingredients to the priority • targeted audience assessment list each year. Within 24 months of placement on this list, FDA must issue, by regulation, a safety determination for the ingredient. FDA is also required to consider petitions on ingredi- Non- ent safety. Members Members

 CEO Certification: Requires, within 18 months of enactment, Half Page $200 $300 each cosmetic manufacturer/marketer to submit to FDA a statement signed by the CEO that, based on available information af- Quarter Page $100 $150 ter a good faith inquiry, “the cosmetic and its ingredients meet the safety standard” or “there is insufficient data to determine whether the cosmetic and its ingredients meet the safety standard.” contact: [email protected]

August 2010 • Page 15 Communications Update

March 29, 2010 – Guidelines on Good Field Collection Practices for AHPA Media Scan: medicinal plants issued Pharmabiz.com Notable “Herbal Headlines” March 24, 2010 – Green tea extract might not be so good for you after all The Chronicle Herald These “herbal headlines” – and headlines of interest to the herbal March 22, 2010 – What health care reform means for your business industry – have been selected from the past few weeks of media CNN.com activity. March 22, 2010 – House passes health-care reform bill without Republican votes Washington Post July 22, 2010 – Phytopharm hints at solid future for hoodia March 19, 2010 – U.S. Plans Spot Tests of Organic Products Nutraingredients.com New York Times July 22, 2010 – Heart Trouble? 30 Herbal Remedies to Avoid March 14, 2010 – FDA targets processing of spices in bid to make Health.com supply safer Washington Post July 16, 2010 – Reed’s, Inc. Announces Fred Meyer to Carry ‘Reed’s March 4, 2010 – FDA Criminal Division to Increase Prosecutions Rx’ Remedy for Nausea Reed’s, Inc. Wall Street Journal July 7, 2010 – Nunavik herbal teas now a national delight Nunatsiaq March 2, 2010 – Can a Caffeine-Packed Plant Give a Boost? Wall Online Street Journal June 29, 2010 – Special Report: Supplements for athletes stir serious Feb. 23, 2010 – Acupuncture Benefit Seen in PregnancyReuters debate Times Herald Record Feb. 16, 2010 – “Natural” Cleaners: “Green”? Effective? CBS News June 29, 2010 – Kerala sees red over herbal ‘Viagra’ Arab News Feb. 12, 2010 – ‘Biggest Loser’ trainer Jillian Michaels sued over June 24, 2010 – Whole Foods Cracks Down On Organic Claims ‘bogus’ diet pill claims The Money Times Forbes May 26, 2010 – Herbals making deceptive health claims, GAO finds Feb. 11, 2010 – Fake doctor sentenced to 9 months in OC jail Mercury Salt Lake Tribune News May, 26, 2010 – Study Finds Supplements Contain Contaminants Feb. 11, 2010 – Poisonings point to holes in supplement oversight New York Times Reuters May 14, 2010 – State ginseng crop crippled after May snowstorm Feb. 11, 2010 – Vegetable tests show pesticides: Guangdong residents Journal Sentinel say they are concerned about quality China Daily May 8, 2010 – Which Dietary Supplements Are Best for You? Feb. 6, 2010 – Chemnutra Owners Sentenced for Melamine-Tainted CBS News Pet Food Consumer Affairs April 30, 2010 – China launches ginseng genome program Feb. 3, 2010 – Fewer Than 1% of U.S. Farms Are Organic, USDA People’s Daily Says Wall Street Journal April 29, 2010 – Alternative Health Guru Sues Company Over His Feb. 1, 2010 – Santa Cruz prosecutor finds no Hoodia in diet pill; Own Product ABC News company says ‘so sue us’, prosecutor complies Santa Cruz Sentinel March 30, 2010 – FDA pressured to combat rising ‘food fraud’ Feb, 1, 2010 – Herbal remedies, heart drugs a dangerous combo Washington Post CNN 

August 2010 • Page 16 Calendar of Botanical Events

Many more listings are online at www.ahpa.org. Plant and Natural Product Research as well as the 7th Tannin Conference offered as presymposium to be held in Berlin, AHPA on the Road Germany. The International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research  AHPA Chief Science Officer Steven Dentali attends the will be to promote dialogue and the exchange of medical American Society of Pharmacognosy annual meeting in practices and resources of modern and traditional nations. St. Petersburg Beach, Fla. July 10-14. Website: http://www.ctw-congress.de Website: http://www.asp2010.com/  Aug. 30-Sept. 3: II International Symposium on the  AHPA’s Dentali attends a U.S. Pharmacopeia nomenclature Genus Lilium, Pescia, (Tuscany) Italy. meeting in Rockville, Md. July 27-28. Learn more at http:// E-Mail: [email protected]. www.usp.org/meetings/workshops/nomenclatureWorkshop.html. Website: www.symplitaly2010.com.

 Sept. 12-15: ABIC 2010: Bridging Biology & Business,  August 3-4: GMP TRAINING CLASS FOR DIETARY Saskatoon, Canada, ABIC 2010 features a stellar line-up of SUPPLEMENTS, DBA Analytical, Ann Harbor, MI. presenters in three streams: Energy, Health and Sustainability, Attend an extensive 2-day training course on 21 CFR 111, with 66 expert speakers and four keynote presentations. ABIC the Current Good Manufacturing Practices (cGMPs) in 2010 also includes a tradeshow, an international poster Manufacturing, Packaging, Labeling, or Holding Operations competition and a public forum. A gala and other networking for Dietary Supplements. The course, hosted by DBA Analyti- events round out the social aspects of this premier conference. cal, will feature Dr. Norm Howe, DBA Analytical and NSF Website: International consultant, as trainer. This course is geared to http://www.abic.ca/abic2010/ those individuals involved in the dietary supplement industry.  Sept. 20: Prop. 65 Conference, City Club of San Francisco, Website: http://www.nsf.org/media/enews/1006_dba-a_gmp_ San Francisco, California. This year’s panels are geared to help training.html you catch up on the latest developments, hear the experts discuss the critical issues, and find out where Prop. 65 is heading.  August 19: NBJ Webcast: U.S. Nutrition Industry Overview. Website: https://www.prop65clearinghouse.com/Register.html Website: http://nutritionbusinessjournal.com/calendar/2010- nutrition-business-webseminar/index.html  Sept. 20-25: 11th Congress of the International Society of Ethnopharmacology (ISE 2010), Albacete, Spain. This  Aug. 21-23: 2nd International Conference of Natural joint conference will certainly be one of the most exciting and Products and Traditional Medicine (ICNPTM’ 2010) prestigious international events in the field of medicinal plant Theme: Traditional Medicine and Human Health, Xi’an, sciences. Spain is a fascinating country that is full of vitality, China. ICNPTM 2010 will showcase original natural cultural diversity and culinary delights. We trust that the products and traditional medicine research through keynote dynamic and magical spirit of the small city of Albacete and plenary presentations, oral and poster presentations, (Castilla-La Mancha) will provide a very stimulating milieu for and parallel sessions. Website: http://www.icnptm.com/ scientific exchange amongst ethnopharmacologists, ethnobiolo-  Aug. 22-27: 28th International Horticulture Congress gists and ethnobotanists from all over the world. We are certain (IHC), Lisbon, Portugal. Participants will find events to that this event will offer exciting opportunities for exchanging suit specific interests among the 8 colloquia, 18 symposia, the latest scientific news and for networking with colleagues. 14 seminars, workshops and thematic sessions. Website: http://www.ise2010.org/ Website: http://www.ihc2010.org.  Sept. 24-25: 2010 Smithsonian Botanical Symposium:  Aug. 22-24: AAIM National Conference, Orlando, FL. Food For Thought: 21st Century Perspectives on Plants Website: http://www.aaimedicine.com/conference/ and People, Washington, DC. The Smithsonian Botanical Symposium, hosted by the Departments of Botany and  Aug. 29-Sept. 2: 58th International Congress and Annual Anthropology, will examine the 21st century transformation Meeting of the Society for Medicinal Plant and Natural of the study of interactions between plants and people. Product Research, Berlin, Germany. The 58th International The invited speakers will cover a wide range of topics: from Congress and Annual Meeting of the Society for Medicinal the role molecular biology now has in elucidating crop

August 2010 • Page 17 domestication to the ways in which peoples across myriad needed to transform their lives and practices. ecosystems interact with specific plants and landscapes. Website: http://www.cmbm.org/holistic_medicine_ Website: http://botany.si.edu/sbs/ PROFESSIONAL_TRAINING_EDUCATION/mind_ body_medicine_description.php  Sept. 26-29: PSE Symposium: TERPENES Application, Activity & Analysis, Istanbul, Turkey. The aim of this  Oct. 3-8: The VIII International Ethnobotany Symposium, symposium is to bring together worldwide eminent scientists Lisbon, Portugal. and industry involved in chemistry, biochemistry, biology, Website: http://www.ff.ul.pt/eventos/VIII_INTERNATIONAL_ pharmacology, biosynthesis and analysis as well as applications ETHNOBOTANY_SYMPOSIUM.pdf of terpenes. The meeting will consist of plenary lectures, short lectures, poster sessions and social activities to catalyse vigorous  Oct. 17-21: 8th Annual International Restorative Medicine scientific discussions at various levels and platforms. Conference: Practical Skills in Endocrinology, Medical Herbalism and Nutrition, Moab, UT. The term ‘Restorative  Sept. 29: CRN’s The Workshop, Hyatt Regency Lost Pines Medicine’ was coined to describe the use of bioidentical Resort, Austin, Texas. The Council for Responsible Nutrition hormones, botanical medicines, and nutritional supplements to each year brings together top scientific experts on nutrition and assist the body’s innate mechanisms in returning to healthy dietary supplements for a full day of focused discussion in an equilibrium. The goal of Restorative Medicine is to help intimate setting. Website: http://www.crnusa.org/TheWorkshop/ patients regain and maintain optimal health after treatment has ended. Our conferences are geared towards providing you with  Sept. 29-Oct. 2: CRN’s The Conference, Hyatt Regency Lost practical information and effective protocols that can be Pines Resort, Austin, Texas. Join the Council for Responsible directly applied in practice. The Restorative Medicine Confer- Nutrition for the premier event that brings together top ence draws a diverse group of health care professionals to learn industry professionals for three days of the most relevant together in a relaxed and friendly environment. sessions on business, legislative, regulatory and scientific Website: http://www.restorativemedicine.com/conference/moab issues—and plenty of networking opportunities. Website: http://www.crnusa.org/TheConference/

 Oct. 1-2: First International Ayurveda Congress,

Klagenfurt, Austria. The Austrian Association for Ayurveda The 8th Annual International O

O and the Carinthian Chamber of Commerce cordially invites RESTORATIVEI MEDICINE CONFERENCE you to participate in the first International Ayurveda Congress &0(&5(',76 I in Austria. The target audience for this congress is all Ayurvedic MOAB, UTAH October 17-21, 2010 experts who are at the cutting edge of research in this field and PRACTICAL CLINICAL SKILLS I wish to share their experiences with colleagues. This Ayurveda IN ENDOCRINOLOGY AND CHRONICN DISEASE Congress in Klagenfurt is of great significance. For the first time ever, European medical practitioners and Ayurvedic practitioners from all over the world will meet to discuss the Medical Herbalism Meet the Faculty:

O possibilities of reciprocal enrichment for these two spheres. O

In particular, the congress will explore the benefits that could Jill Stansbury ND Eugene Zampierone ND arise for European medicine through the integration of Chair of the Botanical Senior-Most Faculty of Medicine Department Botanical Medicine at Ayurvedic knowledge. at NCNM in Portland, University of Bridgeport Oregon. Naturopathic Medical Website: www.ayurveda-austria.com School.

 Oct. 2-6: Mind-Body Medicine, Hyatt Regency, Crystal City, Va., Learn the scientific basis for mind-body medicine and Michael Friedman ND 7Song Author of the medical Director of the Northeast experience the depth and power of our unique small group textbook, Fundamentals School of Botanical of Naturopathic Medicine and the Clinic approach. Explore and learn to use a range of the most Endocrinology. Director of Holistic effective tools for self-care and stress management, including: Medicine. meditation, guided imagery, biofeedback & autogenic training, breathing & movement, and self expression through words and drawings.This is the Center’s core program. We have been RESTORATIVE teaching it around the world since 1994. It has provided MEDICINE www.RestorativeMedicine.com thousands of professionals with the tools and experiences

August 2010 • Page 18  Oct. 20-22: SupplySide West, Venetian & Sands Expo, This conference will constitute a global platform open to all Las Vegas. SupplySide is the world’s largest trade show and researchers of any nationality, who would like to present their conference for healthy and innovative ingredients. Thousands relevant studies as well as to establish new collaborations of decision makers from the global food, beverage, dietary between participants all around the world. Leading researchers supplement and cosmeceutical industries converge to learn, from various institutes, universities and industries from all network, source and create. Your next big idea is just a show over the country and abroad will participate in the conference. away. Website: www.supplysideshow.com It will provide an excellent platform for all the researchers/ industrialist/business group to interact and discuss various  Oct. 21: NBJ Webcast: Consumer Research breakthroughs, bottlenecks and recent developments in the Website: http://nutritionbusinessjournal.com/calendar/2010- area of aromatic and medicinal plants. nutrition-business-webseminar/index.html Website: http://www.asianherbalshow.com/prog.htm  Oct. 21-22: The 2010 AICR Annual Research  Nov 26-29: 3rd International Conference on Advancement Conference on Food, Nutrition, Physical Activity in Science and Technology (iCAST) 2010, Kuantan, & Cancer, Capital Hilton Hotel, Washington, DC. Malaysia. For thousands of years, knowledge, skills and Who Should Attend: Basic scientists, clinical investigators, practices based on the concepts, beliefs and experiences epidemiologists, dietitians, nutritionists, policy makers a indigenous to cultural origin have been used to maintain nd other health professionals interested in food, nutrition, health, as well as to prevent or treat physical and mental physical activity and weight management in relation to cancer. illnesses. The use of garlic oil to prevent infectious diseases, Website: www.aicr.org/conference honey to empower body defense mechanism or practicing yoga  Nov 3-4: The 2nd International Symposium on Medicinal to control anxiety and psychological stress are just a few of Plants, Their Cultivation and Aspects of Uses, Petra, Jordan. those traditions that mankind has inherited through ages from The symposium will focus on new developments in all aspects different parts of the world. Furthermore, customarily ‘drying’ related to medicinal plants. Website: http://ismp.bau.edu.jo has been applied for food preservation for hundreds of years without knowing the effect of water activity. Along with the  Nov 16-18: Health Ingredients Europe, Madrid, Spain. tremendous advancement in science and technology observed With demand for natural and organic foods growing exponen- in the last few decades, these traditional practices of health tially, food manufactures are increasingly shifting towards and disease, have never been in oblivion. In recent decades, natural alternatives. Natural ingredients delivers you potential traditional practices in health and disease have re-emerged with customers from every sector of the food & beverage industry. increasing popularity by integrating these traditional practices Website: http://hieurope.ingredientsnetwork.com/home with the new knowledge in biomedical science and biotechnol-  Nov 18: NBJ Webcast: Raw Material & Ingredient Supply ogy. Thus, this conference is aimed to have lively exchange of Website: http://nutritionbusinessjournal.com/calendar/2010- ideas and networking opportunities among the participants nutrition-business-webseminar/index.html from all around the globe on the integration of this new knowledge with the tradition  Nov. 18: Natural Health Research Institute (NHRI) 5th Website: http://www.iiu.edu.my/icast/2010 Annual Scientific Symposium “Natural Products – Cost- Effectiveness & Safety of Dietary Supplements”, Hilton  Dec 6-8: Middle East Natural & Organic Product Expo Chicago, Bloomingdale, Illinois. NHRI is an independent, 2010, Dubai, U.A.E. The overwhelming response from the non-profit organization that supports science-based research trade community in the region showed at MENOPE 2009 is a on natural health and wellness. 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August 2010 • Page 19 Botanical Science Update

excipients, dietary supplements, biologics, and food ingredients by Steven Dentali, Ph.D. challenges with respective breakout sessions for productive discussions. MEETINGS ATTENDED Roger Williams, M.D., USP’s CEO, led off by saying that it was USP Nomenclature Workshop and fitting that the first workshop of the current cycle deal with nomen- Expert Committee Meetings clature. To illustrate the fact that names identify things Dr. Williams displayed his original birth certificate replete with his infant foot- I reported on the United States Pharmacopeia (USP) 2010 prints that could serve to identify him uniquely, presumably though Convention in last month’s AHPA Report (July 2010, Volume 25, matching his modern footprint with the one(s) recorded on the Number 7, pp. 15-18). More recently USP announced the new birth certificate. Council of Experts (COE), composed of the Chairs of the Expert Committees, with Roger Williams, MD as Chair, that were elected The first speaker of the session on drug substance nomenclature on April 23 by the Convention. The COE subsequently elected overview and initiatives was Gail Karet, Ph.D., Program Senior Expert Committee Members that included my appointment to the Scientist for USAN (United States Adopted Names). USAN is an Nomenclature, Safety and Labeling Expert Committee (DSL-EC). organized US effort to coin nonproprietary names for drugs and re- The complete list of the chairs of the twenty 2005-2010 expert lated agents and is cosponsored by the American Medical Association committees and the individuals to serve on them is available at (AMA), the American Pharmacists Association (APhA), and USP. http://www.usp.org/pdf/EN/aboutUSP/governance/2005_ The USAN Council membership has one member from each of 2010ExpCommList.pdf. these 3 organizations, a liaison from FDA, and a member at-large. Established in the 1960s, USAN recognized that USAN are “estab- The DSL-EC held their first meeting on July 29, 2010. This was lished” names in the US. preceded by a public workshop, the first in the series of the 2010- 2015 Convention cycle, on Compendium Nomenclature – Overview USAN are nonproprietary names assigned to drugs sold in the US. and Challenges, held on July 27-28 at USP headquarters in Rockville, They are used in regulatory filings, are published online (see http:// MD. USP held an earlier nomenclature meeting on December 21, www.ama-assn.org/go/usan), and are reported to public databases. 2005 in order to gain an understanding of the activities of naming They are the names accepted for US approved generic drugs as they organizations and to identify ways for inter-organizational efforts to are assigned to the active ingredient in pharmaceutical products. provide nomenclature consistency. Organizations involved in that Different pharmaceutical trade names may employ the same USAN effort included the United States Adopted Names (USAN), the generic name that cannot be patented. USAN are needed for pack- International Nonproprietary Names (INN), FDA, USP, and the aging, labeling, and advertizing for prescription drugs that are mar- National Library of Medicine. keted with FDA approved trade names. Although the workshops, and the DSL-EC, necessarily focus on is- The goals of the USAN program include the selection of simple, in- sues of drug nomenclature, the committee is also charged with no- formative, and unique nonproprietary names for drugs, establishing menclature issues regarding naming of dietary supplement a logical nomenclature classification system based on pharmacologi- monographs that appear in the USP-NF and the DSC (Dietary cal and/or chemical relationships, and the formulation of nomencla- Supplement Compendium). My involvement with the DSL-EC is ture rules for selecting nonproprietary names. They do not name needed in order to help assure that these herbal issues are appropri- drugs and dietary supplements for human uses that are not yet in ately dealt with. Currently the FCC (Food Chemicals Codex) nam- clinical trials. ing of materials does not fall under the responsibilities of the DSL Since USAN only have domestic applications, the organization though I suggested that proposed new FCC names of botanical and works with the International Nonproprietary Names (INNs) pro- botanically derived items be shared with the DSL-EC and the vided by the World Health Organization (WHO). Professor Witold Dietary Supplements Monographs Expert Committee. Wieniawski of the INN Programme of the WHO explained that the The workshop was designed to provide background to the work of INN system includes over 82,000 names and has attained global the DSL-EC and to obtain helpful feedback. The first day examined relevance. Started by the WHO in the 1950s about 120-150 new existing nomenclature for the naming of drug substances and how INNs are added each year. New INNs are proposed by manufactur- drug substances and drug products are defined. A regulatory over- ers in an application that includes the chemical name, structure, ac- view, pharmacopoeial and international nomenclature overview, tivity, and a $9,000 fee. and the USP nomenclature and initiatives overview were covered. The Applications can be submitted directly to the INN Secretariat at the second day examined nomenclature challenges from compendial, WHO headquarters in Geneva, Switzerland or indirectly through

August 2010 • Page 20 national entities such as USAN. Proposed new INNs are posted on- The session on defining medicinal products and substances included line on the WHO Drug Information website (see http://www.who. an overview of the regulations of established names for drugs, with int/medicines/publications/druginformation/en/) for a 4 month com- the clarification that “drug” refers to both a drug substance and a ment period after which time they become permanent recommend- drug product. The established name for a drug substance comes ed INNs. They are intended for global use and no longer use the from USAN while USP designates drug products via USP mono- letters h and y, and avoid the use of the letter k. INNs and trade- graph titles. The creep of proprietary names into standard dosage marks co-exist as designations of pharmaceuticals. forms was noted for drugs and dietary supplements. The next speaker, Haruhiro Okuda, Ph.D. of the National Institute A presentation by the European Medicines Agency (EMA) on the of Health Sciences in Japan explained Japanese Accepted Names International Standardization of Identification of Medicinal Product (JAN). The JAN committee is composed of 6 organic chemists, (ISO IDMP) comprised an overview while other presenters covered 3 biologics experts, a biochemist , a pharmacologist, an information routes of administration, medicinal products, and pharmaceutical technology expert, and a patent expert who is a reviewer from the products. Following that were sessions on FDA and nomenclature Japanese Patent Office. 127 chemicals and 32 biologics were named with presentations from the Center from Drug Evaluation & from 2005-2010. Of these 14 didn’t have an INN as of May 2, 2010. Research (CDER), the CDER Office of Biotechnology Products, If a drug substance has an INN then it is translated into Japanese. If and the Center for Food Safety and Applied Nutrition (CFSAN). an INN does not exist for the material then it is named according to Diane Schmit described the CFSAN Thesaurus that currently con- INN nomenclature rules and if INN later selects a name different tains over 180,000 terms representing 65,000 preferred terms of than the JAN, the JAN is altered to the new INN. JAN names are which 75% are chemical substances and natural products. An elec- incorporated into the Japanese Pharmacopoeia and are available in tronic text file derived from the thesaurus containing approximately the JAN database (see ) http://jpdb.nihs.go.jp/jan/index.aspx 57,000 terms, the CFSAN Technical Lexicon, is available at http:// William Heller, Ph.D., the Executive Director of USP from 1970- www.fda.gov/Food/ScienceResearch/ucm181420.htm. From the web- 1990, spoke about the importance of pronunciation and meaning site: “This is an electronic text file derived from the CFSAN and pointed out the lack of consistency in pronouncing names with Thesaurus, which installs into most word processors or email clients the same stems. A phonetic Pronunciation Guide that had been pre- in a few minutes. It contains a comprehensive list of approximately viously developed has not been consistently used. fifteen thousand technical and scientific terms commonly used in

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This revised edition, published in 2000, lists 2,048 separate species, including 25 fungi and 23 seaweeds, by their Standardized Common Names and Latin binomials, and includes Indian Ayurvedic names for more than 300 plants and Chinese (pinyin) names for 500 herbs. Also, 639 botanical synonyms are included; older botanical names no longer accepted can be cross-referenced. AHPA published the first edition in 1992 to reduce confusion by establishing “standardized” common names. It was recognized and codified when FDA adopted the original edition in 1997: the common names may be used instead of Latin binomials to identify herbal ingredients in dietary supplements.

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August 2010 • Page 21 the Center for Food Safety and Applied Nutrition in correspon- Haruhiro Okuda, Ph.D. provided a Japanese Pharmacopoeia (JP) dence and regulatory documents. Once installed, spell-checkers will perspective. He discussed the organization of the nomenclature not flag correctly spelled technical terms as misspellings. In addi- committee and gave examples where JP names were the same as tion, misspelled technical terms will be flagged, and the correct USP, but different than INN (acetaminophen, not paracetamol), spelling offered as suggested spellings by the spell-checking tools of and where USP and INN were consistent (epinephrine) and the JP the word processor.” name differed (adrenaline). The JP name database is available in Claude Coune, Ph.D., with the EDQM (European Directorate for English at http://jpdb.nihs.go.jp/jp/index.aspx. the Quality of Medicines & HealthCare), spoke as a representative Thomas Reinders, Pharm.D., reviewed the charge of the of the European Pharmacopoeia (Ph. Eur.) explaining that in general Nomenclature, Safety and Labeling Expert Committee of which he ingredients are named but finished product forms are not. He pointed is chair. It is anticipated that the committee will approve 300 new out that INN nomenclature is mandatory in Europe and while individ- USP monograph titles a year, therefore 1,500 are expected by the ual country nomenclatures are still around, they must match the INN. end of the current cycle. The decision making responsibilities of the Some rare exceptions exist such as adrenaline being a recognized committee will extend to excipients, biologics, supplements, but not name for epinephrine due to the strength of its historical position. food ingredients. Other areas of committee focus include the devel- Dr. Coune also explained that herbal monographs employ common opment of a nomenclature guideline, web posting of approved titles, names and the plant part used, which is consistent with US labeling the pronunciation guide project, and development of an educational requirements. However where there is no common name a Latin ti- program. Safety topics will be considered as they arise. tle is derived from the scientific name formed by the genus (geni- Day two began with USP representatives discussing compendial no- tive) and or/ species names, followed by the name of the organ used. menclature challenges from regulatory and scientific overviews. It A more common name may also be used. Belladonnae folium and was explained that a drug is deemed misbranded unless its label Chamomillae romanae floswere given as respective examples. During bears the established name to the exclusion of any other nonpropri- the question and answer period I suggested that this use of pharma- etary name. Statutory roots for this requirement are found under copoeial Latin was not as clear as common name use, particularly both the food and drug provisions of the FD&C Act. A dietary sup- for identification of plant parts. plement will be deemed misbranded under the food misbranding

August 2010 • Page 22 provisions of the Food, Drug and Cosmetic Act if it is “covered by is unique to dietary supplements. A representative from Brazil of- the specifications of an official compendium” (e.g. USP-NF), is rep- fered to supply a copy of their dictionary for this purpose. After the resented as conforming to USP-NF, and fails to conform. Europeans said that the nomenclature for extracts has already been worked out I mentioned that AHPA has also done this some time Joy Joseph spoke on dietary supplement nomenclature challenges. ago. When another workshop attendee asked if there was a trade as- She talked about different dosage forms and potential nomenclature sociation that could help with botanical nomenclature issues I again challenges when industry apparently invents new terms. The inten- raised my hand. tion for the NSL-EC with is to develop a systematic approach to naming dietary supplement (DS) raw materials and dosage forms. As mentioned earlier the NSL-EC will not be defining food names. Ms. Joseph stated that it was important to know specifics about ex- FCC monograph titles are approved by the Food Ingredients Expert tracts in order to know how to name them. Committee (FIEC) that also approves synonyms. Concerns are to minimize the number of ingredients, to avoid “chemicals” and to The issue of different names for USP drug and dietary supplements move away from the hot list such as salt, high fructose corn syrup, was touched upon. For example sinecatechins is the name for the sugar, and allergens. Lycopene extract from tomato and approved approved topical drug that contains a powdered green tea extract; synonyms was brought up with. this latter name is a supplement ingredient. “Elm” is a USP drug name while “slippery elm” appears in the DSC as a dietary supple- I suggested that the FIEC should confer with the people responsible ment ingredient. A trend to identify a material category or grade was for DSC content when names were applied to botanically derived mentioned so that pharmaceutical grade material would be differen- ingredients, that it was not be a good idea to continue with the tiated from supplement grade material, for example. Of course this practice of separate USP groups creating names for herbal ingredi- presumes that there is a difference. ents without conferring with one another ahead of time. I pointed out the arbitrary, from a scientific point of view, approach of the The dietary supplement break out session discussion considered the separation of botanical ingredients into drug, supplement, and food question if one should start with the botanical name or with the categories, and the need for a consistent USP approach to their con- name of active compounds. The concept of different potencies based sideration.  on growing regions and other factors contributing to natural varia- tion was also raised as was the question if the drug model of naming ingredient, route of administration, and dosage form could be LITERATURE CITATIONS applied to supplements. It was correctly pointed out that the oral route of administration was the only one applicable to dietary Further research on topical aloe vera for burns supplements. and wound healing Another opinion said that the focus should be on the supplement Hosseinimehr SJ, Khorasani G, Azadbakht M, Zamani P, and not the ingredient because of the variety of preparations that Ghasemi M, Ahmadi A. Effect of aloe cream versus silver can be made from the same plant. Someone asked what a Latin bi- sulfadiazine for healing burn wounds in rats. Acta nominal is. An FDA representative mentioned the difficulty in cor- Dermatovenerol Croat. 2010;18(1):2-7. relating entries in the DSC with the Homeopathic Pharmacopoeia Eshghi F, Hosseinimehr SJ, Rahmani N, Khademloo M, of the United States (HPUS). For example an HPUS monograph Norozi MS, Hojati O. Effects of Aloe vera cream on post- may have the same title as USP but be describing different materials. hemorrhoidectomy pain and wound healing: results of a It was suggested to include the plant part in the naming scheme of randomized, blind, placebo-control study. J Altern botanicals. Complement Med. 2010 Jun;16(6):647-50. Someone asked how you name a substance that may have come The first citation above complements earlier research by this group from one of many different species. The immediate correct consen- as reported in a previous AHPA Report (October 2009, Volume 24, sus was that the source is immaterial and that the name should be Number 10, p. 21). The earlier paper compared the effects of aloe the name of the purified compound that should also be the desig- vera versus silver sulfadiazine (SSD) cream products in a random- nated monograph title. It was suggested that some information be ized controlled study on 30 patients with second degree burns. This placed into the labeling component of a monograph instead of the newly reported study provides additional proof of principle whereby title of the monograph. The existence of a wide variety of extracts the aloe vera product was compared to SSD in wound healing from available on the market was mentioned. second degree burns in an animal model. The preparation of aloe vera cream employing a 200:1 aloe inner leaf fillet to powder mate- The European representatives pointed out that these labeling issues rial was again described. have already been sorted out on an international level. The form of extract is included in European definitions and the process that The results are consistent to what was found in humans; that is the made them. The question was raised if a dictionary was needed that aloe vera cream product showed significantly better wound healing

August 2010 • Page 23 than the antimicrobial SSD treatment. Notably no bacteria were Aloe vera food and supplement ingredient reviews found in the biopsy of the aloe vera treated skin unlike the skin Rodríguez Rodríguez E, Darias Martín J, Díaz Romero C. treated with the cream base only. Curiously the authors apparently Aloe vera as a functional ingredient in foods. Crit Rev Food seem to have written “saffron” in a few places in their article when Sci Nutr. 2010 Apr;50(4):305-26. they meant aloe! Rodriguez S, Dentali S, Powell D. (2010). Aloe vera. In The second citation is yet another paper by this research group, this Coates PM, Blackman M Encyclopedia of Dietary Supplements time for the use of aloe vera cream in wound healing and pain re- (2nd ed., pp. 7-14). London: Informa Healthcare. duction following hemorrhoid surgery. The same product was employed in a randomized study following 49 patients for 4 weeks after The first citation above, a 22 page review of aloe vera as a functional surgery. The aloe vera cream treated patients had significantly lower food ingredient, covers the major papers of the last 30 years on the pain scores from 12 hours post surgery through two weeks. All of chemical composition of aloe vera exudate and inner leaf gel, me- the aloe vera cream treated patients had complete skin covering the dicinal uses and applications, biologically active compounds and surgical wound at two weeks compared to only one of the patients therapeutic properties, and quality control and legal issues. It begins receiving the placebo cream. The rest of the placebo group was split by addressing the confusion that often arises between aloe vera leaf half and half between fresh wounds with inflammations and wounds exudates and gel, pointing out that while different parts of the leaf with granulated tissue. can yield different types of polysaccharides it is appropriate to draw a clear distinction between the anthraquinone rich yellow leaf exu- The reported consumption of 500-mg acetaminophen tablets (for date and the carbohydrate rich inner leaf gel. pain) was also significantly lower for the aloe vera cream treated group at two weeks (18 tablets for 24 patients) compared to the pla- The wound healing and anti-inflammatory properties of topically cebo group who reported consuming 53 tablets among 25 patients. applied aloe vera are discussed as well as its immunologic, antioxi- The authors suggested that the beneficial effects of topical aloe vera dant, gastrointestinal, and other beneficial effects. Attention is given on wound healing may be due to antimicrobial and anti-inflamma- to factors that may influence the quality of aloe vera leaf juice and tory effects, and the promotion of collagen production. that authenticity testing and determination of aloin content are important considerations. The advisability of seeing products marked

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August 2010 • Page 24 with the logotype of the International Aloe Science Council (IASC) in treatment of acute heart attack. This research looked into the was mentioned as was the problem with adulteration of commercial mechanisms by which hawthorn (Crataegus oxycantha) berry extract materials, most commonly with maltodextrin. may be helpful for in the management of acute heart attacks. Issues regarding contamination of aloe vera gel derived materials Ethanol extracts of hawthorn berry are reported to be traditionally with aloin from the leaf rind were also covered and the maximum used as cardiotonics in India, China, and many European countries. threshold for aloin content in food products for human consump- They contain oligomeric proanthocyanidins (OPCs) that display tion set by the European Council of 0.1 mg/l (0.1 ppm) was men- antioxidant activity. Studies have shown hawthorn extracts to be ef- tioned. While aloe vera concentrates may exceed this limit by a fective in quenching free radicals and human patients have shown considerable margin it was pointed out that their addition to food improvement in heart function when treated with hawthorn after products or beverages is generally below a 1% concentration. This heart attack. Additionally, a meta-analysis of randomized clinical results in products that are well below the European regulatory limit trials using hawthorn indicated that it was beneficial in the treat- that was established with food flavoring applications in mind. ment of chronic heart failure. The last of the aloe vera references presented here is a chapter in the While it seems clear that what is essentially a hawthorn tincture is second edition of the Office of Dietary SupplementsEncyclopedia of heart-helpful, how beneficial effects are exerted are not well known. Dietary Supplements that was the subject of a July 15, 2010 AHPA This study subjected isolated rat hearts to ischemia (no blood flow) Update (see http://www.ahpa.org/Default.aspx?tabid=69&aId=602& followed by reperfusion (the return of blood flow) and examined zId=1). This resource clearly delineates aloe vera juice materials molecular and functional markers. They found improvements in (differentiating between filtered aloe vera juice and purified whole cardiac function from hawthorn berry extract treatment on both lev- leaf aloe vera juice) and aloin-rich materials based on the different els. The preparation employed was made from crushed dried berries industrial processes employed to create them. A more detailed de- extracted with 50% ethanol for 48 hours at 4 degrees centigrade. scription of this text can be found on page 4 of this issue of the The authors inexplicably created an extract from hawthorn seeds and AHPA Report, in the article titled, “AHPA Staff Contribute to ODS analyzed it for catechins content, which accounted for less than 6% Publication on Dietary Supplement Ingredients.” of the seed extract. The work up of the seed material was quite extensive and its connection to the berry extract was not made clear. I Hawthorn for heart health? suspect there wasn’t any. It would have been advisable to better char- Swaminathan JK, Khan M, Mohan IK, Selvendiran K, acterize the berry extract beyond the process used to make it. No men- Niranjali Devaraj S, Rivera BK, Kuppusamy P. tion was made of the source of the berries; the taxonomy of hawthorn Cardioprotective properties of Crataegus oxycantha extract is extremely problematic due to ready hybridization between species. against ischemia-reperfusion injury. Phytomedicine. 2010 In spite of its shortcomings this study adds weight to the authors’ Aug;17(10):744-52. conclusion that patients suffering from a heart attack may benefit Heart attacks are deadly along the same lines of “it’s not the fall that from the administration of hawthorn extracts when blood flow is kills you, it’s the landing,” in that damage to heart muscle from reestablished to the heart muscles that were deprived of it during heart attacks is not caused by a lack of blood supply, but by the reac- the attack. It’s great that they have advanced the mechanisms of tive oxygen species generated when blood flow resumes. These oxi- action that may provide a beneficial effect and I hope they do a better dizing agents are what cause heart muscle damage and dysfunction. job at characterizing their starting material and resultant extract Antioxidants that can attenuate their effect may prove worthwhile next time. 

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August 2010 • Page 25