Washington Report:
Alternative Medicines and Treatments

©Copyright 1998 by Emalee Murphy, Esq., McKenna & Cuneo, LLP, Washington, DC, USA
(Explore Issue: Volume 8, Number 4)

This issue marks the beginning of a feature column for Explore!: a regular report on legal/regulatory and related developments of interest to practitioners and others involved with the field of alternative medicine and treatment. The last few years have seen spectacular growth in the recognition and use of homeopathic and herbal treatments. The value of the US homeopathic market is estimated by Nicholas Hall Reports at just under $200 Million and herbal products are reported to have generated $225 Million in 1996, a 15% increase over 1995 sales. As you know, this trend has not gone unnoticed by Congress Regulators of supplements, herbals, and homeopathic products command a much higher profile than previously. This is likely to continue as the market grows and as scientific research sheds increasing light on the merits of non-traditional approaches to health maintenance. This first column outlines a few of the more recent events from both inside and beyond the Beltway.

The FDA Modernization Act of 1997

On November 21, 1997, President Clinton signed into law the Food and Drug Administration Modernization Act of 1997 (Pub. Law 105-115). The new law contains a number of important reforms affecting the alternative medicine community. first, the Act establishes a new mechanism for the approval of health claims for foods and dietary supplements, by which a manufacturer may make a health claim if a scientific body of the Federal Government with responsibility for public health protection publishes an authoritative statement providing basis for the claim. The manufacturer must notify FDA at least 120 days prior to making the claim, and FDA may by regulation prohibit or modify the claim. Second, the Modernization Act expands FDA inspection authority to OTC manufacturing facilities and records, although it clarifies that records from self audits should not be required in the normal course of inspection. Third, the Act contains national uniformity provisions prohibiting states from establishing or continuing any regulatory requirement relating to the labeling of cosmetics or OTC drugs different from or additional to those established by FDA. However, as with similar language covering medical devices, the scope of preemption granted under this provision likely will be construed narrowly by FDA and the courts.

Intended Use of Drugs and Supplements

FDA's tobacco rulemaking and tobacco litigation are expanding the scope of intended use in ways that may expose dietary supplement manufacturers to FDA action even for unpromoted health benefits. In a recent case, Coyne Beahm, Inc. v. FDA, 966 F. Supp 1374 (M.D.N.C. 1997), a U.S. District Court held that the intended use of a product may be established by evidence of foreseeable use, actual consumer use, and internal manufacturer memoranda, in addition to the labeled use. Although the case has been appealed, FDA is already working to implement this decision with regard to drugs and medical devices, which form the basis for regulation of tobacco products. The impact of the decision on dietary supplements remains unclear, but it could significantly alter the manner in which firms should view potential new uses for their products.

Dietary Supplement Commission

The President's Commission on Dietary Supplement Labels issued its final report on November 24, 1997. Among its major recommendations were the retention of a high standard of evidence for health claims, the completion of research into the attitudes of health and nutritional professional toward supplements, and research into whether consumers actually want and can use the information currently required by FDA regulations. The Commission rejected suggestions that summaries of evidence substantiating structure and function claims and safety be submitted with FDA notification letters. The report did call upon manufacturers to increase efforts to make such information available to consumers. FDA has until February 22, 1998 to propose regulations implementing any recommended changes deemed necessary by the agency.

In addition to the Dietary Supplement Commission's recommendations, the Federal Trade Commission's Division of Advertising Practices continues to consider whether it should issue additional guidance to the dietary supplement industry with regard to permissible advertising. The FTC has entered into two recent consent agreements based upon allegations that the firms involved made health and other claims without scientific substantiation. The FTC is considering whether to issue a formal policy statement, informal guidance (possibly including examples of "safe harbors"), or even less formal industry educational materials.

Regulation of Botanicals

The Dietary Supplement Commission also recommended as a priority for the FDA the establishment of an OTC review panel for botanicals intended for therapeutic and preventative use, as well as the study of possible alternative approval means for regulating therapeutic claims of botanicals not meeting OTC review requirements. While botanical products are generally considered safe, the relation of nutritional claims to therapeutic claims is an area of concern for the Commission. Consumer groups had argued that botanical products making therapeutic claims should be regulated as OTC or prescription drugs, as many of the most widely used drugs are of similar botanical origin. However, the Commission stopped short of recommending that botanicals be removed from the definition of dietary supplements under DSHEA, stating that a dedicated review panel would merely facilitate the review of appropriate OTC claims. In a related matter, FDA has yet to release guidance, which had been expected in the fall, regarding clinical studies of botanical ingredients being developed for prescription or OTC drug use. It is clear, however, that FDA as well as certain segments of the industry, actively support drug status for botanicals making therapeutic claims. Such a development would be certain to narrow the scope of permissible claims for remaining herbal supplement products.

Homeopathic Drugs

At this time, there is no effort underway at FDA to review or change the manner in which the agency regulates homeopathic drugs. FDA's focus in this area continues to be centered in action against manufacturers and distributors that promote OTC homeopathic products for treatment of serious disease conditions more suitable to prescription status, and educating the homeopathic industry about current agency requirements. However, the U.S. market for homeopathic drugs is expected to experience double digit growth rates over at least the next 5 years. Such growth very well could increase the level of scrutiny given the industry by FDA as could any well-publicized adverse reaction attributable to a homeopathic product.

FDA Cosmetics Division to Join CDER?

Speculation continues that decreasing resources and increasing responsibilities could lead FDA to move the Office of Cosmetics and Colors out of its Center for Food Safety and Nutrition, where it currently resides, and into the Center for Drug Evaluation and Research. Proponents of such a move argue that the increasing number of cosmetic products are incorporating ingredients for which exaggerated, non-cosmetic claims are being made. Discussion at a recent meeting of the Cosmetic Ingredient Review (CIR) Expert Panel over the use of wild yam extract and its possible promotion as an alternative to estrogen replacement therapy, as well as claims related to possible benefits from topical antioxidants, are evidence of this view. Proponents of the move believe that review under the auspices of CDER would ensure appropriate agency expertise is used in the most efficient manner. CIR is an industry-supported program established to review the safety of substances used in cosmetics and toiletries. CIR reports are published in the Journal of the American College of Toxicology.

Patient Access to Alternative Medicines

The Access to Medical Treatment Act (HR 746, S 578) continues to attract support in Congress. The bill would permit an individual to be treated by a health care practitioner with any medical treatment that the individual desires, including a treatment that is not approved by the FDA, if the practitioner agrees to treat the patient and the administration of the treatment does not violate licensing laws. The bill explicitly states that although it allows for the manufacturer and distribution of products for use solely under the provisions of this legislation, it does not allow manufacturers to make advertising claims relating to unapproved products unless such claims are otherwise permitted under the Food, Drug, and Cosmetic Act. A similar bill died in committee in the last Congress, but the sponsors of the legislation hope increased support will allow it to move forward in 1998.

Did you know?

Under provisions of the FDA Modernization Act, non-US drug and device manufacturers will be required to register the name and address of their establishments and the name of the U.S. agent for the establishment with FDA beginning in February 1998. It is unclear at this time whether FDA intends to publish any guidance for non-U.S. firms or whether submission of a new or amended establishment registration form will suffice.

The U.S. Federal Trade Commission (FTC) and FDA, in conjunction with other federal and state health agencies in the U.S., Canada and Mexico, as well as state attorneys general and non-profit organizations, participated in a "North American Health Claim Surf Day" last September. the purpose of the Surf Day was to identify Web sites and news groups making product-related therapeutic claims. As a result of this event, the FTC contacted over 400 Internet advertisers by e-mail regarding advertised health claims for products and informed advertisers of the FTC's substantiation requirements for health claims. The FTC plans to visit targeted sites to determine if changes have been made and if not, the agency says it may:

1. bring legal action to halt the ads,
2. seek an order imposing restrictions on such ads, or
3. seek financial compensation for consumers deceived by the ads.

In a letter to Advanced Plant Pharmaceuticals, a New York dietary supplement firms, the FDA prohibited the company from marketing a new dietary ingredient made from pokeweed, on the basis that pokeweed is a well-characterized poisonous plant. As required by the Dietary Supplement and Health Education Act (DSHEA), APP notified FDA within 75 days of marketing the pokeweed-containing supplement, but according to FDA failed to include information regarding the quantity of pokeweed in the product or the conditions of the product's use. FDA therefore held that the firm failed to establish the safety of the supplement and concluded that its introduction into interstate commerce was forbidden under DSHEA.

 

According to the Wall Street Journal (Dec. 3, 1997), Cholestin importer Pharmanex might have avoided FDA regulatory action against its Chinese medicine cholesterol lowering product, Cholestin if it had not carefully researched and publicized the elements of the herb responsible for its beneficial effects. When Pharmanex research identified lovastatin as the active element in Cholestin, FDA concluded that the actual intent of Pharmanex was to produce lovastatin, a substance already marketed in the U.S. for the same purpose as a drug,, rather than a dietary supplement.

The January 1998 Techgazette reports that pfisteria, the microorganism responsible for significant fish kills in Maryland last year, remains an enigma. Pfisteria, first discovered in the sediment of the Choptank River in 1993, is "an ancient, opportunistic dinoflagellate" that survives by changing its shape. According to researchers, Pfisteria can assume between 21 and 24 different shapes and appearances, from a "slimy, crawly" organism to knot-like appearances and life forms that are resistant to drying. One or more of these forms produces a toxin dangerous to fish. Scientists were looking for the organism when they should have been looking for traces of the toxins produced during four of pfisteria's lifeforms. This apparent example of "pleomorphism" is currently under investigation at North Carolina State University, the National Marine fisheries Lab in Charleston, SC and the and the National Institute of Environmental Health Science in Research Triangle Park, NC.

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.

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