S.3546 the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the AER bill) has been added to the Senate calendar, and staff expect it to be considered this week. What is unknown is whether it will be a roll call vote (recorded) or under unanimous consent*. Recorded is preferable and is expected.
There is still time to halt this bill if you make your voice heard today and encourage others to contact Congress as well.
If S. 3564 becomes law, it will amend the federal Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over the counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration. [Ed. note: There will be no such requirement for prescription drugs, however, and all reporting of prescription drug side effects will remain voluntary.]
While S.3546 was created and introduced by supporters of dietary supplements (Senators Hatch and Harkin), this is not a bill that should become law.
First, we believe that this bill is a step towards treating dietary supplements more like pharmaceuticals and not like food. Second, we believe that this bill will ultimately have a negative impact on the dietary supplement industry and the consumer. Third and most importantly, a person experiencing an adverse event (especially one that is serious) from a drug (prescription or OTC), food, or supplement, should work with their healthcare professional to determine the cause.
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