From The November 2000 Issue of Nutrition Science News

FDA Urges Caution on "Combination" Products

Washington, D.C.—The U.S. Food and Drug Administration (FDA) has begun issuing warning letters to manufacturers marketing hybrid products containing both drugs and supplements.

One such product contains 500 mg aceta-minophen, a top-selling analgesic, with 1.5 mg melatonin, a well-known natural sleep enhancer. It is being marketed to promote natural, restful sleep while relieving pain.

In letters sent to companies, FDA expressed concern that the addition of a new ingredient to a legally marketed drug could affect the safety and efficacy of the drug component. FDA is also concerned about consumer confusion because FDA scrutiny of these combination products is less than that for drugs that do not contain supplements.

Manufacturers are urged to hold off marketing such products until FDA can issue a ruling.