Center for Inquiry to FDA: Label Homeopathic Drugs as Untested and Unproven

August 20, 2015

In comments filed with the FDA this week, the Center for Inquiry (CFI) urged the Food and Drug Administration (FDA) to subject homeopathic drugs to the same testing requirements as conventional drugs. Failing that, CFI urged the FDA to at least require homeopathic products to be clearly labeled as untested and unproven.

You can read our comments in full here 

Homeopathy is a centuries-old pseudoscience, developed before the discovery of disease-causing pathogens, based on the false beliefs that “like cures like” and that the more an ingredient is diluted the more potent it is, due to water’s “memory” of the diluted ingredient. Yet, for historical reasons relating to the passage of the original Food, Drug, and Cosmetic Act in 1938 (which had a homeopathic practitioner as a key sponsor), homeopathic products can be marketed even though they are not subject to the rigorous testing for safety and effectiveness that conventional drugs must undergo. Indeed, consumers spend $3 billion a year on homeopathic drugs, yet most remain unaware that the FDA has not evaluated these products for safety and effectiveness.

In March, the FDA announced it was reconsidering its position on homeopathic drugs. The Center for Inquiry had previously petitioned the FDA to address the inadequate regulation of homeopathic products, and was invited by the FDA to deliver testimony at public hearings on the subject in April. You can read our testimony here

Following the hearings, the FDA announced it would also accept public comments on the issue. CFI has now submitted comments, which conclude:

In summary, homeopathy is unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. To ensure the protection of the American public, we believe the FDA should rely on its well-established regulatory system to require homeopathic products to meet the same safety and efficacy standards as conventional drugs. That said, we recognize there are practical and political barriers to mandating this requirement.

However, no such obstacles prevent the FDA from mandating that homeopathic products carry truthful, informative labeling. We propose that the FDA require homeopathic products to carry a prominent warning that they have not been evaluated by the FDA for safety or effectiveness. In addition, the product’s labeling should disclose the product’s active ingredients in plain English, using standard scientific measurements.

The FDA has a proud tradition of protecting the American public and of enabling them to make informed choices. Although, arguably, at one time the FDA could largely ignore homeopathic products given their relatively small market, that time has passed. The FDA needs to exercise its authority by subjecting homeopathic products to meaningful regulation.  

You can read our comments in full here