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.

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The policy statement notes that any such disclosures should stand out and be in close proximity to the product’s efficacy message and might need to be incorporated into that message. It also warns marketers not to undercut a disclosure with additional positive statements or consumer endorsements reinforcing a product’s efficacy. The statement warns that the FTC will carefully scrutinize the net impression of OTC homeopathic marketing claims and that if an ad conveys more substantiation than a marketer has, it will violate the FTC Act.