Washington Report:
Rough Going for FDA in the Courts

©Copyright 1999 by Emalee Murphy, Esq., McKenna & Cuneo, LLP, Washington, DC, USA
(Explore Issue: Volume 9, Number 2)

If you have not noticed, FDA is having a streak of bad luck in the courts. On January 15 of this year, the U.S. Court of Appeals for the DC Circuit found that FDA rules barring certain health claims are invalid under the First Amendment. In a landmark ruling, the court ordered FDA to change its health claim rules for dietary supplements and to define the "significant scientific agreement" standard applied to these products. In doing so, the court suggests that the First Amendment may override FDA regulatory efforts to restrict food and dietary supplement labeling.

Specifically, the Circuit Court ordered FDA to reconsider the following claims:

1. "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer."
2. "Consumption of fiber may reduce the risk of colorectal cancer."
3. "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."
4. "0.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."

FDA rejected these claims originally because the evidence in support of them was inconclusive and as a result they failed to meet the "significant scientific agreement" standard for health claim acceptance. The Circuit Court, however, found this position "almost frivolous" and concluded the government failed to justify its restrictions on commercial speech. This may not let marketers off the hook entirely, since the Court suggested that FDA could address some of its concerns by requiring disclaimer statements.

FDA was similarly disappointed in the February 16, 1999 ruling by the U.S. District Court for the District of Utah. The court agreed with Pharmanex, Inc. that its product Cholestin, which is produced from red rice yeast, is a dietary supplement and not a new drug, as alleged by FDA. The ruling, which FDA may appeal, confirms that "articles approved as new drugs" in DSHEA (Dietary Supplement Health and Education Act), refers to finished drug products and not to unrefined dietary supplement components, such as red rice yeast.

As the Senate Committee on Labor and Human Resources explained at the time, "a substance that has been marketed as a dietary ingredient in a dietary supplement, or otherwise as a food, does not lose its status as a food just because FDA approves the substance for use as an active ingredient in a new drug, certifies a finished product containing the substance as an antibiotic or licenses a finished product containing the substance as a biologic. ...For example, if ever FDA should eventually approve Vitamin C as a drug to treat cancer, Vitamin C properly would also continue to be available as a dietary supplement (food) product, so long as it is promoted as a dietary supplement without disease prevention S. Rep. No. 103-410, at 20-21 (1994) (cited by the Utah District Court in Pharmanex v. Shalala, et al..)

Finally, also on February 16, 1999, D.C. federal court Judge Royce Lamberth declared the new legislative provisions on dissemination of "off-label" claims (claims not approved by FDA for drugs and devices) in reference books and journal articles to be unconstitutional. Judge Lamberth reasoned that the policies underlying the provisions are the same as the FDA policies previously declared unconstitutional by the court in Washington Legal Foundation v. Friedman. In that decision, the US Court of Appeals for the District of Columbia ruled that two FDA Guidances published prior to the FDA Modernization Act (FDAMA) in 1996, violated the First Amendment by placing overly restrictive limits on dissemination of off-label information about approved drugs. Judge Lamberth also clarified that the ruling only applies to information about unapproved uses of already approved drugs, and not to information about unapproved products.

FDA sought to keep the ruling on the 1996 Guidances from also applying to FDAMA. Judge Lamberth's February 16 clarification cleared the way for review of the future constitutionality of the FDA's final regulations implementing FDAMA provision on "Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices" which appeared in the November 30, 1998 Federal Register.

Changes to the FDC Act, changes in the practice of medicine, and changes in consumer demand for alternative and complementary treatment options have resulted in a more hospitable marketplace for nontraditional medicine. However, the balance between FDA control and industry responsibility has swung more than a few times and is likely to swing again in FDA's direction. This could happen quickly if there is a widely publicized and serious safety problem related to alternative medicines and supplements. So although FDA appears to be losing FDA's tendency to expand given its jurisdiction and authority, and with a new Commissioner and a change in Congress, the situation is fluid.

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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