AHPA Seeks FDA Clarification on OTC/Supplement Combos

WASHINGTON—The American Herbal Products Association (AHPA) sent a letter to Jeffrey E. Shuren, FDA’s assistant commissioner for policy, asking the agency to clarify its policy on products combining over-the-counter drugs and dietary supplement ingredients. AHPA sent the inquiry following the launch of an “analgesic phytosterol supplement”, Bayer Aspirin with Heart Advantage, by Bayer Healthcare; the product combines 81 mg of aspirin and 400 mg of sterols, and carries both OTC drug and dietary supplement labeling and claims.

In its May 29 letter, AHPA cited two past warning letters from FDA issued to companies marketing OTC-supplement combination products without first filing new drug applications. AHPA also referenced a 2000 letter from FDA in which the agency “strongly” recommended companies not to market such products, given possible 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 Michael McGuffin, president of AHPA. “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.”