AHPA requested that the FDA clarify its policy on over-the-counter drug-dietary supplement combination products following the recent launch of Bayer Healthcare’s new “analgesic phytosterol supplement,” Bayer Aspirin With Heart Advantage. The Bayer product includes 81 mg of aspirin and 400 mg of phytosterols, and bears both OTC drug and dietary supplement labeling and claims.

AHPA cites two past warning letters issued to companies marketing OTC drug-dietary supplement combination products without first filing new drug applications. Additionally, the association references a May 30, 2000 letter in which FDA “strongly recommends” firms refrain from marketing these products due to “a number of significant health and policy issues.”

“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. “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.