Regulatory Focus™ > News Articles > FTC Asks FDA to Reevaluate Framework for Homeopathic Products

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Posted 24 August 2015 | By Michael Mezher 

FTC Asks FDA to Reevaluate Framework for Homeopathic Products

The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient.

Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications."


In March 2015, FDA announced a public hearing to evaluate its regulatory framework for homeopathic products for the first time since releasing its Compliance Policy Guide Conditions Under Which Homeopathic Drugs May be Marketed in 1988.

FDA said it was motivated by the growing market for homeopathic products, which it estimates as a nearly $3 billion industry and by safety concerns related to homeopathic products. The agency said that it has received some adverse event reports regarding homeopathic products and said that the 2012 American Association of Poison Control Center Annual Report contained more than 10,000 cases referencing homeopathic products.

FTC Comments

In a statement released Friday, FTC announced that its staff believes FDA should revise or repeal its current regulations for homeopathic products.

The issue, as FTC sees it, has to do with how over-the-counter homeopathic drugs are labeled and sold. Currently, FDA does not approve homeopathic drugs for safety or efficacy as long as they meet certain conditions, such as being sold "for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment," and are labeled for their intended use.

However, FDA does not require scientific or clinical data to back homeopathic products’ indications for use, which FTC says "may harm consumers and confuse advertisers."

FTC also says it has had issues with advertisers mistakenly thinking they "do not have to comply with FTC advertising substantiation requirements" if they meet the requirements in FDA's compliance policy guide.

Lastly, FTC says its research has shown that "most consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, or the level of scientific evidence needed to support health claims for homeopathic products."


FTC Announcement, Comments and Exhibits


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