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Court Gives FDA Greater Latitude In Declaring Dietary Supplements 'Unapproved Drugs'

Date: Jun 01, 2001


The U.S. Court of Appeals for the 10th Circuit has ruled that the Food and Drug Administration (FDA) has the authority to declare a dietary supplement to be an unapproved drug when the active ingredient in the supplement is the same as one used in an approved drug product.

Under the Dietary Supplement Health and Education Act, Congress included a provision to exclude from the term, dietary supplement, "an article that is approved as a new drug." Congress included this provision to prevent a product that is the equivalent of a new drug from being sold as a dietary supplement. However, the provision is ambiguous: Does the term "article" refer to a finished drug product or the active ingredient used in the product?

One company tried to sell a dietary supplement with an active ingredient derived from red yeast rice called mevinolin, which is intended to promote healthy cholesterol levels. Mevinolin is chemically identical to the active ingredient, lovastatin, which is found in the prescription drug Mevacor.

There is no question that the dietary supplement is not identical to Mevacor; all they share in common is the chemical identity of the active ingredient, lovastatin. Although the U.S. District Court found that the term "article" should refer only to finished products, the U.S. Court of Appeals disagreed finding sufficient basis for FDA's determination that the term encompasses both active ingredients as well as finished drug products.

What this means is that greater consideration must be given to the nature of the active ingredients being used in products labeled as dietary supplements. If FDA finds a nexus between the active ingredient in a dietary supplement with an approved drug product, along with similar health claims, FDA is likely to take issue with the marketing of the product.

Used with permission. Copyright FOOD & DRUG PACKAGING, June, 2001.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.