The FDA is about to declare dietary supplements to be drugs, says Bill Sardi.
... Unlike drugs which must be approved for safety and efficacy before entering the market, dietary supplements marketed before 1994 are presumed to be safe. FDA must demonstrate that a product presents a significant or unreasonable risk to the public to get it off the market. But that may change.
An ominous sign of things to come – the FDA just classified a form of vitamin B6 (pyridoxine) as a new drug (Pyridorin, Biostratum).
Despite recent outbreaks of foodborne disease (Salmonella in peanuts) and approval of deadly or problematic drugs (recently Vioxx, Seroquel, many others) compared against few if any reported deaths in the newly implemented Adverse Event Reporting for dietary supplements, the Federal government is aiming its regulatory muscle at vitamin, mineral and herbal pills. Read more
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