Adverse Event Report Labeling for Supplements — the Controversy Continues

October 28, 2008
Category: Uncategorized

In 2006, AAHF took a stand against the proposed Dietary Supplement and Non-Prescription Drug Consumer Protection legislation, now law, because we felt the bill was not in the public’s best interest. The Food, Drug, and Cosmetic Act had already been amended to require reporting of serious adverse events for both over-the-counter and dietary supplements to the FDA. AAHF’s position pointed out that this new legislation would make the FDA one step closer toward treating dietary supplements more like pharmaceuticals.

An eye-opening article in a recent Pulse of Health Freedom showed that from 1998 through 2005, there were an average of 856 adverse events reported per year for dietary supplements, versus 467,809 reported for prescription drugs.
According to a pre-publication article in the Federal Register (subsequently withdrawn, pending re-release), the FDA proposes collecting adverse event reporting information for dietary supplements. The Natural Products Association is closely monitoring the situation, which raises concerns that the FDA guidance would impose a financial burden on the dietary supplement industry, and that the guidance would depart from the longstanding provisions of the Federal Food, Drug, and Cosmetic Act.
AAHF is working to see that the FDA serves the rights and needs of practitioners and consumers alike. It is time for reform the FDA, and you can help. Our dietary supplements have been scientifically proven to aid in the prevention and treatment of disease. It is important to ensure that dietary supplements remain available to practitioners and consumers alike.

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