FTC sets enforcement policy for homeopathic drug labeling claims

Efficacy and safety claims made on over the counter (OTC) homeopathic drug labeling must be substantiated by reliable scientific evidence, according to an enforcement policy statement on the marketing of OTC homeopathic drugs released by the Federal Trade Commission (FTC). The policy statement notes that qualified efficacy and safety claims must clearly indicate: (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. The policy statement indicates that the FTC will enforce OTC homeopathic drug labeling no differently than it does any other health products.


The homeopathic theory is premised on the belief that disease can be treated by small doses of substances, which, in larger doses, produce in healthy individuals, symptoms similar to the disease. However, homeopathic products are often diluted so that the “therapeutic” substance is below a detectable level. Homeopathic theory states the more a substance is diluted, the more potent it becomes. The theory is not accepted by most modern medical experts. As a result, marketing claims for homeopathic remedies have a tendency to be misleading, in violation of federal law.


Section 5 of the Federal Trade Commission Act (FTC Act) (15 U.S.C. § 45(a)(2)), which applies to both advertising and labeling, prohibits unfair or deceptive acts or practices in or affecting commerce, such as the deceptive advertising or labeling of OTC drugs. Due to the significant expansion of the homeopathic industry over the last few decades—growth from a multimillion-dollar market to a more than billion-dollar market—the FTC held a workshop in 2015 to better comprehend the homeopathic marketplace. The workshop was focused on assisting the agency with understanding its legal authority with respect to the advertising and marketing of OTC homeopathic drugs.


The policy statement notes that disclosures regarding the absence of scientific evidence should be prominent and in close proximity to any statement about the product’s efficacy. Depending upon the strength of the efficacy statement, the FTC indicated that the disclosure might need to be incorporated into the efficacy message, itself. Additionally, the policy statement warns marketers of homeopathic drugs not to make statements which undercut those disclosures because the FTC will scrutinize the “net impression” of OTC homeopathic marketing claims when determining whether a marketer has violated the FTC Act.