by Anna Soref
In response to mass manufacturer Bayer’s new Aspirin with Heart Advantage, which the company is touting as an “analgesic phytosterol supplement,” the American Herbal Products Association has requested that the Food and Drug Administration clarify its policy on over-the-counter drug and dietary supplements combinations. In the past, the agency has recommended that companies refrain from marketing products that combine both OTC drug and dietary supplements ingredients.
In May 2000, the FDA warned that adding supplements to a drug product could affect the safety and efficacy of the drug component. In addition, the FDA noted that consumers may be confused about the degree of scrutiny the agency 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 FDA for safety and effectiveness, the agency said.
“Against this background, AHPA is asking for prompt clarification from FDA to avoid confusion among the public and regulated industries as to the agency’s policy,” said AHPA President Michael McGuffin.
Natural Foods Merchandiser volume XXVIII/number 7/p. 10