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Changes in Homeopathic Drugs Lead FDA to Change Policy

Attention, homeopathic drug packagers: The Food and Drug Administration has a new attitude toward you.

Eric Greenberg
Eric Greenberg

From a distance, FDA’s October announcements look like a collection of obscure policy actions that only a regulator would love, but taken together, they add up to a distinct plan to crack down on some homeopathic drug products that raise health concerns. FDA doesn’t think its past policies toward this special category of drugs are sufficient to protect the public health.

The core principle of homeopathy is that diluted forms of substances that cause bad symptoms or illnesses can be used to treat people with those symptoms or illnesses. Homeopathy has for decades been recognized by the law as an alternative form of medicine. In fact, ever since 1938, the Federal Food, Drug and Cosmetic Act’s very definition of what a “drug” is has explicitly included a clause saying that any product whose active ingredients are listed in the Homeopathic Pharmacopeia of the United States would be considered a drug on that basis alone. 

FDA says that lately there have been newer examples of homeopathic products that pose significant risks. The FDA points to, for example, 99 cases of belladonna toxicity possibly related to teething products in 2016, and over 130 reported cases of loss of the sense of smell potentially related to an intranasal zinc product.

FDA emphasizes the point that that homeopathic drugs products are “subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements.”  

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