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June 22, 2007

FDA Rule Still Won’t Ensure That Dietary Supplements Are Safe or Effective

Statement by Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen

A final rule issued today by the Food and Drug Administration (FDA) not only is 13 years late but will not do anything to ensure that dietary supplements are safe or effective – a critical necessity.

Congress mandated in 1994 that the agency issue a rule governing the manufacturing practices of dietary supplements. It is baffling that the FDA has taken until 2007 to finalize it. Large businesses have a year to comply; small businesses have another three years to comply, meaning that 16 years will have passed between the time that Congress told the FDA to write the rule and the time it takes effect for all businesses.

In the meantime, because of the absence of good manufacturing practice regulations, dozens of dietary supplements have been purposely and illegally laced with prescription drugs in an attempt to make them effective.

Even with these new manufacturing practices, there will be no assurance that dietary supplements work or are safe. Because of the same 1994 law, the FDA has no authority to require testing for safety or efficacy of any dietary supplement. We saw with the ephedra-related deaths the dangers that dietary supplements pose. Congress should address this enormous deficiency in the law.

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