New enforcement policy in regard to homeopathic drugs in U.S.A

On November 15th, 2016, the Federal Trade Commission (FTC) in the USA, 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.

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 and in violation of the FTC Act.

Companies will now be required to have “[…] competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions,” FTC stated.

However, FTC also recognizes that marketing claims may include explanatory information to prevent claims from being misleading 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 has indicated that they “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.”

Contact us for more information about this new policy and for any help needed to comply with their requirements.

Homeopathic granules scattered around a glass bottle and a medicinal herb on a wooden table