FDA faces barrage of criticism over plans to assess safety of supplementsBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e583 (Published 25 January 2012) Cite this as: BMJ 2012;344:e583
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DSHEA provides an appropriate legal framework to protect consumers.
FDA has the authority to protect consumers by inspecting facilities as well as testing and removing harmful products from the market. The legal framework set forth by DSHEA and the other 20+ laws/regulations applicable to dietary supplements in the US provide FDA with the authority it needs to prosecute and remove products such as Zotrex from the market. Dr. Cohen is correct, the dietary supplement market has expanded since the passage of DSHEA; however FDA funding has not increased in the same increment to give the agency adequate resources to enforce the many laws/regulations which pertain to dietary supplements. The downfall to the draft NDI guidance is that it puts a burden on innovation for reputable companies who already invest millions of dollars annually in safety research to substantiate their brands without leveling the playing field for companies like NovaCare, LLC. Because FDA draft guidance documents are meant to provide a roadmap for law abiding companies to be in compliance with regulations, those who already disregard existing regulations will continue to undermine consumers until Congress gives FDA the resources it needs to adequately enforce current regulations.
Competing interests: Both authors work for the Council for Responsible Nutrition.