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,
For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at firstname.lastname@example.org.