Washington Report: The FDA, A Union Employer

©Copyright 1999 by Emalee Murphy, Esq., McKenna & Cuneo, LLP, Washington, DC, USA
(Explore Issue: Volume 9, Number 4 and 5)

Did you know that Food and Drug Administration (FDA) employees are covered by a union contract? The exceptions are supervisors and administrative employees who work on personnel matters, Public Health Service officers, confidential employees and employees of the Offices of Criminal Investigations and of Internal Affairs.

Under a new contract ratified by the FDA chapters of the National Treasury Employees Union this month, employees in the normal chain of "concurrence" for product approval decisions will be permitted to document any professional disagreements they may have with a decision. The ability to document disagreements has apparently not previously been formally available to FDA product reviewers.

The issue arose from scientific disputes in the Center for Drug Evaluation & Research and from suggestions that in at least one instance involving the diabetes drug Rezulin, that FDA superiors okayed products despite reviewers' recommendation against approval.

Other parts of the contract take note of FDA's plans to lower projected staffing in some areas. According to reports, the union will monitor increases in uncompensated work that results from credit time that exceeds the 24 hours that employees are able to carry over from one pay period to the next. Also reportedly in the new contract is an attempt to remove differing implementation within the agency of alternative work schedules. For anyone who has been unable to reach a key employee within the normal work hours of 8 a.m. to 4:30 p.m. Monday through Friday due to an alternative work schedule, it will be heartening to know that alternative schedules will only be granted if they do not result in diminished productivity, reduced services to the public, or increased cost to the government.

As to what FDA has been doing within those work hours recently, at least in the area of herbals and supplements.

Desperately Defining "Disease"

The definition of disease continues to be a central issue in the FDA's attempts to craft a new regulatory framework for dietary supplements. The Consumer Healthcare Products Association (CHPA) has proposed that FDA adopt the following definition of "disease" to use in the regulation of dietary supplement claims:

A disease is any adverse deviation from, or impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by one or more signs or systems that are not characteristic of a natural state or process.

A natural state or process is a life change or physiological manifestation expected in the normal course of life progression.

An exemption for conditions that are "characteristic of a natural state or process" -- such as pregnancy and age-related conditions such as menopause -- is also supported by the Grocery Manufacturers of America (GMA).

The American Medical Association (AMA) has recommended a similar definition, but the AMA's proposal would not exempt natural states. The American College of Obstetricians specifically raised concern about claims dealing with "natural states" such as pregnancy, asserting that consumers should not be delayed from seeking medical care when natural states such as menopause become serious and cause adverse health effects. In addition, the AMA and ACO -- along with the American Cancer Society -- urged the FDA not to lower its standards for structure/function claims. The groups argued that consumers are not aware that there are different standards for drug and dietary supplement claims, and that the FDA must be vigilant in preventing implied disease claims on supplement labels.

The Pharmaceutical Research and Manufacturers of America (PhRMA) also weighed in on the issue at a public meeting held on August 4. PhRMA stated that FDA must be free to evaluate the overall context to determine whether there is an implied disease claim. According to the drug industry, the statutory disclaimer stating that the product is not intended to treat disease should not allow disease claims to masquerade as claims of nutritional value.

There is some feeling that FDA and other interested parties, having lost the battle to define dietary supplements in such a way as to minimize their use by consumers, is attempting to limit supplement use by moving the borderline between food and drugs through an expansive definition of "disease"!

In the meantime, the classification and regulatory control of supplements, vitamins, and botanicals are also on the agenda in Europe.

EC to Fight Germany Over Vitamin Restrictions

For example, on July 8, the European Commission announced that it would take Germany before the European Court of Justice over the country's restriction on imports of vitamin-enriched food supplements. The Commission is objecting to the criteria used by Germany to determine whether a supplement is a food or a medicine. Food products are classified as medicines in Germany if they contain more than three times the recommended daily intake of a vitamin. The Commission believes that specifying a limit for each vitamin based upon the risk from excessive consumption would provide a less restrictive means of protecting the public health of Germany's citizens. The Commission is also objecting to the six to nine month timeframe that it currently takes for Germany to make the classification determination.

United Kingdom to Establish Appeals Panel for Classification Decisions

The UK Medicines Control Agency will set up an independent review panel to consider appeals of its classification decisions for borderline substances. The new regulations establishing the

FDA Receives Comments on Possible Codex Vitamin & Mineral Guidelines

In response to an FDA request issued on April 9, 1999, public comments have been submitted to the agency on potential guidelines for vitamin and mineral supplements issued by the international Codex Alimentarius Commission. Mead Johnson Nutritionals, a division of Bristol-Myers Squibb Co., argued to FDA that such an effort would involve lengthy negotiations with little chance of success, given the wide disparity in how countries regulate the supplements. Mead Johnson also asserts that any international guidelines developed should not establish a positive list of approved nutrients, that maximum dosage levels should be based upon sound scientific data and analysis, and that supplement labels should be permitted to make scientifically substantiated structure/function claims.

WHO Releases Monographs for 28 Medicinal Plants

The World Health Organization's Monographs on Selected Medicinal Plants, Vol. 1 is now available from the WHO and the American Botanical Council (cost: US$82.50). The publication includes monographs covering many of the most popular herbals, including gingko biloba, echinacea, ginseng, and chamomile. Each monograph includes pharmacopoeial summaries for quality assurance, botanical features, distribution, identity tests, purity requirements, chemical assays, and active or major chemical constituents. The second volume -- which will include monographs for 30 additional plants, including eucalyptus and St. John's wort -- should be available in late 1999 or early 2000.

Botanical Methods Validation Program Extended for Two Additional Years

In a related event, the Institute of Nutraceutical Advancement (INA) has announced that it will extend its Methods Validation Program (MVP) for another two years to peer review and publish additional methods to analyze the most popular botanical ingredients. The NVP is funded by 30 companies in the natural products industry. To date, it has validated analytical methods to test for:

• · ginsenosides in Panax and American ginseng root and extract
• · phenolics in echinacea
• · ginkgoflavinol glycosides in Ginkgo biloba
• · ginkgoterpenoids in Ginkgo biloba
• · kavalactones in kava and
• · fatty acids in saw palmetto.

The validation of additional methods for sterols in saw palmetto and pseudo herpericins in St. John's wort are expected soon. The next phase of the program will include the development of methods for black cohosh, ephedra and garlic. Once validated, the methods are available on the INA's website at: http://www.nutraceuticalinstitute.com

INA also announced that the Consumer Healthcare Products Association (CHPA) has joined the MVP advisory committee. CHPA (which as you may know, recently changed its name from the Nonprescription Drug Manufacturers Association) joins the other organizations holding open seats on the board -- the American Botanical Council, the American Herbal Pharmacopoeia, the American Herbal Products Association, AOAC International, the Council for Responsible Nutrition, the Herb Research Foundation, and the National Nutritional Foods Association.

ConsumerLab.com to Provide Independent Testing Information on Dietary Supplements to Health Profesionals

ConsumerLab.com is a new website that will offer consumers and health professionals information from independent testing of herbals and dietary supplements. The results from the initial round of tests, which will evaluate the top 25 brands containing ginkgo biloba, should be available in November 1999. Products will be evaluated with blind tests conducted by two laboratories, using methods validated by the U.S. Pharmacopoeia, the American Organization of Associated Chemists and other sources. Company revenues will come from the sale of product review reports, advertisements on the web site, licensing fees and fees derived from manufacturers authorized to use the Consumer Lab certification seal. The corporate leadership includes a former natural products chemist at the FDA. Mark Bluementhal, Executive Director of the American Botanical Council, will serve as an advisor. Additional information from the laboratory's website.

Lawsuit Names Trainer, Health Club, And Dietary Supplement Manufacturers For Lack of Warnings On Drug Interactions

The need to better assess the effects of dietary supplement safety and effects and to make this information available to health professionals and the public, is well illustrated by the following report: The estate of a New York woman who died from a hypertensive stroke after allegedly taking nutritional supplements filed a $40 million negligence and strict liability suit in New York Supreme Court on June 28. The suit names the personal trainer who recommended the products, a health club, and five nutritional supplement manufacturers and distributors as defendants. The complaint alleges that Anne Marie Capati, 37 years old, signed a contract with defendant Crunch Fitness International to provide her with workout facilities and a personal trainer, August Casseus. Casseus wrote out a list of products for Capati to take and went with her to purchase them. The complaint listed these products as: EFA's, Lean Body Shake, Thermadrene, Whey Fuel, and Yohimbe.

On October 1, 1998, Capati went to the Crunch Facility for her morning workout with Casseus. She had been taking the supplements he recommended for several months. During her workout, she told Casseus that she felt ill. A few minutes later, she suffered a hypertensive stroke and died later that day.

FAC Recommends That Herbal & Botanical Ingredients Undergo Multiple Testing

The FDA's Food Advisory Committee Working Group on Ingredient Identity Testing, Records, and Retention said in a June 25 draft report that herbal and botanical products should undergo multiple tests to confirm the identity of their dietary ingredients. The report recommends that different macroscopic, organoleptic, microscopic, and chemical techniques should be used to identify an uncut wildcrafted or cultivated plant and an identifiable whole plant part.

Aloe, Ginseng, Kava, Milk Thistle Recommended For Toxicology Testing

The National Toxicology Program Interagency Committee for Chemical Evaluation and Coordination (ICCEC) has recommended toxicity testing for the botanicals aloe vera, ginseng, kava kava and milk thistle. Nomination of the four plant substances for study was announced July 27 by the National Institute of Environmental Health Sciences. Scientific information and public comments will be accepted through September 7. Reasons listed for the nominations included "wide-spread use as a dietary supplement" and "inadequate toxicity information." Another justification for the recommendation to evaluate kava kava is "reported human toxicity," while the basis for milk thistle study is "reported hepatoprotective and anticarcinogenic action." Other common dietary supplement ingredients that could be tested in the near future include St. John's wort and ginkgo biloba.

All in all, the supplement industry, because many of the ingredients are now known to be effective contributors to healthy states, its success as a result in the marketplace, and the subsequent interest by the drug industry in these products and market, is being steadily drawn toward the kind of tighter controls probably not initially envisioned at the passage of DSHEA (the legislation amending the federal Food, Drug, and Cosmetic Act to redefine supplements as a separate food category outside of the food additive definition). It will take considerable vigilance and effort to keep supplements on the food side of FDA's structure while assuring that products are safe and that their nutritional content is accurately stated in labeling. Good manufacturing practices are next on FDA's agenda and in the fast-moving supplement marketing world, a company that can claim a GMP-compliant production facility may have a considerable advantage.

About the Author

Emalee Murphy, whose experience in FDA-regulated industries spans over 20 years, provides regulatory and enforcement counseling for clients in the drug (prescription and OTC), medical device, dietary supplement, cosmetic, food, and food additive industries, with particular emphasis on market entry issues and strategies for new products and new companies. She is experienced in FDA import and export issues and provides assistance to companies involved in FDA compliance, import detention, and enforcement matters. Ms. Murphy is a member of the Food and Drug Department of McKenna & Cuneo, LLP and practices in the firm's Washington, DC office. She has written and spoken on a variety of FDA related issues, most recently on the international aspects of dietary supplement regulation.

We would like to pay a special tribute to Emalee Murphy for the tremendous work she has accomplished with the FDA and biological medicine.

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