AHPA requests FDA policy on OTC/supplement combos

6/4/2008

SILVER SPRING, Md. The American Herbal Products Association earlier this week challenged the launch of Bayer Consumer Care’s Bayer Aspirin with Heart Advantage, an aspirin product combined with 400 mg of the dietary supplement phytosterols, in a letter to the Food and Drug Administration that requested the agency clarify its policy on over-the-counter drug/dietary supplement combination products.

The association referenced a May 30, 2000 letter in which FDA “strongly recommends” firms refrain from marketing similar type products due to “a number of significant health and policy issues.” Bayer Aspirin With Heart Advantage bears both OTC drug and dietary supplement labeling and claims, the APHA charged, and would seem to run contrary to FDA’s 2000 letter.

“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,” stated AHPA president Michael McGuffin. “If FDA has not changed its policy, we assume the agency should evaluate Bayer’s product in the same manner it evaluated the OTC drug-dietary supplement combinations cited in these previous warning letters. If, on the other hand, there is a new policy, it appears as if the marketplace may now be open to other OTC drug-dietary supplement products.”

In its letter, AHPA also urges FDA to provide additional information, especially information addressing the reporting of adverse events associated with combination drug-dietary supplement products.

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