FDA Policy/General

FTC Enforcement Policy on OTC Homeopathic Drug Claims

The Federal Trade Commission (FTC) has announced a new “Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs.” The policy statement was developed based on a 2015 FTC workshop that examined how such drugs are marketed to consumers.

According to the policy statement, FTC plans to hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims — companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions. It also describes the type of scientific evidence that the agency requires for such product claims.

For the vast majority of OTC homeopathic drugs, the policy statement notes, “the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.” As such, the marketing claims for these products are likely misleading, in violation of the FTC Act. However, the policy statement also notes that “the FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. Accordingly, it recognizes that an OTC homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

FTC also released its staff report on the 2015 workshop, which summarizes the panel presentations and related public comments in addition to describing consumer research commissioned by the FTC.

Annual homeopathic and herbal remedy sales in the U.S. were estimated at about $6.5 billion in 2012.

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