Intended for healthcare professionals


FDA faces barrage of criticism over plans to assess safety of supplements

BMJ 2012; 344 doi: (Published 25 January 2012) Cite this as: BMJ 2012;344:e583
  1. Keith Epstein
  1. 1Washington, DC

A plan by the US Food and Drug Administration to assess the safety of nutritional supplements is facing criticism for being not enough to protect the public from harm.

The latest complaint arises in an article in the New England Journal of Medicine (doi:10.1056/NEJMp1113325) in which Pieter Cohen, an assistant professor at Harvard Medical Schools, warns, “If the FDA succumbs to industry pressure, the public health consequences will be significant.”

While applauding the agency for acting “before a public health crisis forces it to do so,” Professor Cohen cautions against the FDA’s intended reliance on documented history of an ingredient’s use instead of experimental data. By insisting on scientific evidence to demonstrate the expectation of safety, the FDA would not only improve the safety of new supplements but also create a database of evidence to guide regulators and consumers, he writes.

A report from the Institute of Medicine in 2004 noted that “even widespread …

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