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FDA Has Duty to Crack Down on Homeopathic Fake Medicine, Says Center for Inquiry

The Food and Drug Administration (FDA) must take a much firmer stance on the manufacturing and marketing of homeopathic health products, said the Center for Inquiry (CFI) in comments submitted to the FDA March 26, urging the agency to take seriously its duty to inform and protect American consumers from wasteful and dangerous fake medicine. CFI called for the agency to expand the scope of its Draft Guidance for Drug Products Labeled as Homeopathic1 to fulfill its responsibility to the American people and ensure that these pseudoscientific products are properly tested and labeled.

“Homeopathy is a sham. About this, there is no doubt whatsoever. Every piece of credible scientific research has demonstrated that it has no effect of any kind other than as a placebo,” said Nick Little, CFI’s vice president and general counsel. “Nonetheless, this modern-day snake oil exists in a shadow legal status, where it can be sold without being subject to the same testing and labeling requirements that real, science-based medicine must follow. It is a recipe for waste, fraud, and tragedy.”

The FDA’s draft guidelines suggested a risk-based approach, focusing on the regulation of homeopathic products when the ingredients or method of administration pose particular dangers, the condition it claims to treat is particularly serious, the target population is particularly vulnerable (such as children or the elderly), or when the product is revealed to be tainted. However, the draft also recommended the withdrawal of the existing Compliance Policy Guide regarding homeopathy.

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Skeptical Inquirer
July/August 2018

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