Safe and effective over-the-counter (OTC) medicines—easily available to consumers without a prescription—play a vital and cost-effective role in the nation’s healthcare system. The marketing of these drugs is subject to strict oversight by the U.S. Federal Trade Commission (FTC) which has a long history of enforcement against improper OTC drug advertising.
The FTC regulates the advertising of OTC drugs (as well as foods, dietary supplements, devices, and cosmetics) under the Federal Trade Commission Act. Advertising includes product labels, brochures, website content and magazine and television advertisements. Usually, the FTC focuses on whether the claims being made for a product are truthful, not misleading and supported by “competent and reliable scientific evidence.”
In 2010, the FTC announced that it would be working closely with the FDA to enforce laws dealing with unsubstantiated claims for dietary supplement products.1 More recently, the Department of Health and Human Services released a report finding that substantiation documents for a subset of marketed dietary supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.2
The National Advertising Division (NAD) of the Council of Better Business Bureaus also maintains a vigorous advertising oversight program that frequently adjudicates challenges to OTC drug advertising and in particular, those advertisements related to dietary supplement dieting or weight loss claims. The NAD has no legal authority to act against unsubstantiated or false advertising. However, decisions issued by the NAD become public and can be forwarded to the FTC and/or FDA if the advertiser does not voluntarily comply.
1"Deceptive Marketing of Dietary Supplements: FTC Enforcement Activities" (May 2012)
2Office of Inspector General Report—"Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements" (October 2012)