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The American Herbal Products Association (AHPA) has requested that FDA clarify its policy on products combining over-the-counter drugs and dietary supplement ingredients. To read the letter from AHPA to FDA, click here.

According to this article in Natural Products Insider, 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 this 2000 letter from FDA in which the agency “strongly” recommended companies not to market such products, given possible health and policy issues.

To read the AHPA press release on this, click here.


Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.