Adverse Event Reporting bill designed to discredit nutritional supplements, say opponents: NewsTarget.com

The Adverse Event Reporting bill -- also known as S. 3546 and its House companion bill HR. 6168 -- is proposed to amend the Federal Food, Drug, and Cosmetic Act to create a reporting system for nutritional supplements and over-the-counter medicines, but whether its passing would be a victory or not has split supplement advocates down the middle.

Under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, any severe adverse reaction -- including hospitalization, incapacitation or death resulting from overdose, abuse or failure of the drug to perform as expected -- reported to the manufacturer in connection with a person using nutritional supplements or over-the-counter medicines must be passed on to the Secretary of Health and Human Services within 15 days.

Currently, doctors, hospitals and other health care providers are required by law to report a severe adverse reaction to a drug or medical device to the FDA through the Medwatch program. Supporters of the bill within the supplement community claim that consumers and health care providers already voluntarily report adverse reactions to dietary supplements to the FDA through Medwatch and the Center for Food Safety and Applied Nutrition Adverse Event Reporting system. Supplement makers have also been reporting adverse reactions of their products for a long time. This bill, they claim, is an opportunity to show how much smaller the supplement-related number of adverse reactions is compared to drugs, and bring down dishonest supplement makers at the same time.

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Adverse Event Reporting bill designed to discredit nutritional supplements, say opponents

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