On February 16, 1999, a federal district court set aside and held unlawful the U.S. Food and Drug Administration's ("FDA") determination that Cholestin. is a drug rather than a dietary supplement under the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act ("DSHEA"). See Pharmanex, Inc. v. Shalala, No. 97 CIV. 0262K, 1999 U.S. Dist. LEXIS 1659 (S.D. Utah February 16, 1999). On April 23, 1999, the FDA (through the Department of Justice) filed a Notice of Appeal with the district court declaring its intention to appeal the court's decision. The 10th Circuit Court of Appeals will hear the case, with the Government's brief due July 6, 1999, and Pharmanex's response 30 days later. This alert will briefly describe the district court's decision, which focused on the statutory definition of dietary supplement.
The Product
Cholestin is a capsule consisting solely of milled red yeast rice, a traditional food that has been eaten in China for centuries and in the U.S. for decades. Cholestin contains a range of HMGCoA reductase inhibitors. These inhibitors reduce serum cholesterol levels in humans by inhibiting HMG-CoA reductase, a naturally-occurring enzyme that facilitates the formation of cholesterol. One of the Cholestin inhibitors, mevinolin, is chemically indistinguishable from lovastatin, the active ingredient in the prescription drug Mevacor., a cholesterol-lowering drug marketed by Merck & Co., Inc. Pharmanex began marketing Cholestin in the U.S. in November, 1996. The company promoted Cholestin for its ability to help maintain healthy cholesterol levels.
The Statutory Definition
The Pharmanex decision turned on the DSHEA definition of dietary supplement. Specifically, part of the DSHEA definition explicitly excludes from consideration as a dietary supplement "an article that is approved as a new drug under section 505 [of the Act] ... which was not before such approval ... marketed as a dietary supplement or as a food ..." 21 U.S.C. ' 321(ff)(3)(B) (emphasis added).
FDA's Position
FDA sought to prevent the sale of Cholestin as a dietary supplement on the grounds that the biologically active ingredient in the product was an FDA-approved active ingredient in Mevacor, and that the ingredient was not sold as a dietary supplement or food prior to the drug approval. The FDA thus maintained that Cholestin was precluded from consideration as a dietary supplement under the exclusionary provision of dietary supplement definition.
The District Court's Decision
The district court rejected the Agency's interpretation of the statute and held that the term "article that is approved as a new drug," refers to a finished drug product (a combination of ingredients, both active and inactive) and not to the drug's active ingredient(s) alone. Thus, the court concluded
that because neither Cholestin nor lovastatin has been approved by FDA as a finished drug product, Pharmanex was not precluded from selling Cholestin as a dietary supplement.
Implications of Decision
It appears from FDA's recent actions, including the position it took in the Pharmanex case, that the FDA is attempting to narrow the universe of permitted dietary supplements. On one front, the Agency appears to be trying to force some dietary supplements into the category of traditional foods; for example, the Agency's well-publicized efforts to require plant sterol-containing spreads to be marketed as traditional foods rather than dietary supplements in conventional food form. On another front, the Agency is seeking to restrict the scope of claims for dietary supplements so that claims that appear to be permitted under DSHEA may render the products unapproved new drugs rather than dietary supplements. It is important to note that the Agency has greater regulatory authority over traditional foods and drugs than over dietary supplements. The 10th Circuit Court of Appeals' decision in the Pharmanex case is likely to affect the way the FDA formulates its strategy for regulating dietary supplements in the future.