Mr. James Ascher, Sr.
President and Chief Executive Officer
B.F. Ascher & Company, Inc.
15501 West 109th Street
Lenexa, Kansas 66219-1381
Dear Mr. Ascher:
The purpose of this letter is to advise you that the Food and Drug Administration (FDA) has serious concerns about the marketing of your Melagesic PM product and any other product that combines a dietary supplement and a drug.
These types of 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 both drug and dietary supplement ingredients (except for products marketed under an approved new drug application). 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 |
This document was issued on May 30, 2000.
For more recent information on Dietary Supplements
See
http://www.cfsan.fda.gov/~dms/supplmnt.html
Hypertext updated by bap/dms/kwg/ear 2001-NOV-26