The American Herbal Products Association (AHPA) requested that FDA clarify its policy on over-the-counter (OTC) drug and dietary supplement combination products to avoid confusion among companies and consumers.
The group’s action follows the recent launch of Bayer Healthcare’s new “analgesic phytosterol supplement,” Bayer Aspirin With Heart Advantage, which contains 81 mg of aspirin and 400 mg of phytosterols, bearing both OTC drug and dietary supplement labeling and claims.
In a May 29 letter to the FDA assistant commissioner for policy, AHPA cited two past warning letters issued to companies marketing OTC drug/dietary supplement hybrid products without first filing new drug applications. The association also references a letter from May 30, 2000 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.”
AHPA also urges FDA to provide additional information specifically addressing the reporting of adverse events associated with combination drug/dietary supplement products.
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06-02-2008, 03:00 PM
AHPA Seeks Clarification on Marketing of OTC Drug/Supplement Products
I guess we'll just see what happens.
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