The bill -- S.3546, or the Adverse Event Reporting Bill -- would require consumers of nutritional supplements and over-the-counter (OTC) drugs to report "serious" adverse events to the U.S. Food and Drug Administration. Critics of the bill say it is a step toward classifying nutritional supplements more as drugs than foods, and that it will leave important medical decisions in the hands of consumers with no medical training to determine the cause of side effects.
"Consumers who take five prescription drugs and one vitamin will inevitably blame the vitamin for their drug side effects," said Mike Adams, a consumer health advocate and author of The Seven Laws of Nutrition. "Consumers have been lied to by drug companies and the FDA. They've been told that drugs are safe and that herbs are dangerous, when in reality, the opposite is true," he added. "This AER legislation is clearly designed to discredit vitamins and herbs in an effort to eliminate Big Pharma's competition."
The Nutritional Health Alliance (NHA) -- a healthcare rights protection group -- writes, "Under AER (Adverse Events Reporting), dietary supplements can be associated with adverse events like heart attacks and strokes -- even if supplements had nothing to do with, and did not cause, these events. In our frustrating age of frivolous lawsuits, the result is predictable: Joe Smith suffers a stroke and sues the manufacturer of the vitamin C he takes every day. The floodgates open wide and the entire nutritional supplement industry is buried under groundless lawsuits."
Natural health advocates are also concerned that Sen. Durbin's bill only requires reporting of adverse side effects for nutritional supplements and OTC drugs -- not prescription pharmaceuticals, for which adverse event reporting is entirely voluntary. "Isn't it interesting," Adams notes, "that prescription drugs would be exempted from this side effect reporting requirement? This is an egregious double standard that clearly favors drug companies who just happen to control powerful lobbying groups that strongly influence our nation's legislators."
The NHA and CHF are urging voters to contact their Congressional representatives and ask them to vote against S.3546.
###