The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims.
The policy was informed by an FTC workshop held last year to examine how such drugs are marketed to consumers. The FTC also released its staff report on the workshop, which summarizes the panel presentations and related public comments in addition to describing consumer research commissioned by the FTC.
“Companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions,” FTC said.
The use of homeopathy, dating back to the 1700s, is based on the theory, according to the FTC, that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people.
However, many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance and as FTC says, homeopathic theories are not accepted by most modern medical experts.
The problem FTC seeks to address is that for the vast majority of OTC homeopathic drugs, “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.
However, FTC also says it recognizes that marketing claims may include explanatory information to prevent claims from being misleading.
Accordingly, the commission says 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.
The policy statement notes that any such disclosures should stand out and be near the product’s efficacy message.
A disclosure should also not be undercut by additional positive statements or consumer endorsements reinforcing a product’s efficacy, FTC says, noting it “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.”