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FDA Plans Tougher Policing of Homeopathic Drugs

Statement of CSPI President Dr. Peter G. Lurie

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The tougher, risk-based stance announced today by the Food and Drug Administration is a shot across the bow for an industry that is now worth $3 billion a year and growing rapidly. Without enhanced FDA oversight, homeopathy risks joining other lightly regulated categories such as compounding, dietary supplements, and laboratory-developed tests. In these cases, products that were unsafe and/or ineffective have eluded agency action for years—with sometimes fatal consequences.

The serial dilution theory of homeopathy assures that these products are both safe and ineffective, unless they are contaminated or divert patients from treatments that work. In other words, homeopathic products are essentially placebos, and aren’t worth consumers’ money. But it is good news that the FDA is putting the industry on notice that swifter and more decisive action can be expected when problems arise with homeopathic products in the future.

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Contact Jeff Cronin (jcronin[at]cspinet.org) or Ariana Stone (astone[at]cspinet.org).