Letter about the Regulatory Status of Products that Combine an Over-the-Counter Drug with a Dietary Supplement

May 30, 2000

Kathleen M. Sanzo, Esq.
Phoebe Mounts, Ph.D., J.D.
Morgan Lewis & Bockius
1800 M Street, N.W.
Washington, D.C. 20036-5869

Dear Ms. Sanzo and Dr. Mounts:

This is in response to your letter of February 16, 2000 to the Food and Drug Administration (FDA) concerning the regulatory status of a product that combines an over-the-counter drug with a dietary supplement. The purpose of this letter is to advise you that FDA has serious concerns about the marketing of any such combination product.

These combination products raise a number of significant public health and policy issues. For example, the addition of a new ingredient to a legally marketed drug product could affect the safety and efficacy of the drug component. In addition, consumers may be confused about the degree of scrutiny FDA gives such combination products. Consumers may believe that both components have been subjected to the more stringent drug regulatory requirements when, in fact, only the drug component may have been reviewed by the agency for safety and effectiveness. Moreover, it is uncertain under what circumstances the disclaimer required by the Dietary Supplement Health and Education Act (DSHEA) (codified in 21 U.S.C. 403(r)(6)(C)) could appear on a combination product without furthering consumer confusion.

The agency must determine under what conditions these combination products can be marketed in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by DSHEA. More specifically, the agency must determine what regulatory standards are appropriate, including, but not limited to, what safety and effectiveness standards will apply and how such products will be labeled. The number of inquiries we have received on this subject has made resolution of these issues a priority at the agency. We will be providing additional information as we develop our policy in this area.

Until the agency has carefully considered these issues, however, FDA strongly recommends that firms refrain from marketing products that combine or co-package drug and dietary supplement ingredients. As you suggested in your letter, the agency would, of course, be prepared to review new drug applications (NDAs) for such products, in accordance with all applicable sections of the FD&C Act, including the various provisions of section 505, as appropriate. The amount of data and information required to support such applications will necessarily vary, depending on, among other variables, the ingredients involved and the claims being made for the specific combination product at issue.

Please be advised that in this interim period, we intend to take appropriate measures including, if necessary, regulatory action with respect to any such product that violates the FD&C Act or the agency's implementing regulations.

If you have any questions on this matter or wish to discuss it further with us, please contact Sharon Lindan Mayl at (301) 827-3360.

Sincerely yours,

Margaret M. Dotzel
Associate Commissioner for Policy

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