Taking a stance on marketing claims for over-the-counter homeopathic drugs, the Federal Trade Commission published an Enforcement Policy Statement explaining that the agency intends to hold the products to the same standard as other OTC products making similar claims.

The "Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs"—based on a workshop held by the agency last fall and triggered by the burgeoning mainstream marketing of OTC homeopathic products alongside other OTC drugs—applies only to OTC products intended solely for self-limiting disease conditions amenable to self-diagnosis of symptoms and treatment, the agency said.

Generally speaking, advertisers must have "at least the advertised level of substantiation" for their products, the agency noted, and for health, safety, or efficacy claims, the Commission "has generally required that advertisers possess 'competent and reliable scientific evidence,' defined as 'tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results.' In general, for health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms, the substantiation required has been well-designed human clinical testing."

But for "the vast majority" of OTC homeopathic drugs, the substantiation for efficacy is based solely on traditional homeopathic theories, without valid studies using current scientific methods, the FTC explained. "Accordingly, marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis, are likely misleading, and in violation of Sections 5 and 12 of the FTC Act."

However, the Commission has "long recognized" that marketing claims may include additional explanatory information in order to prevent the claims from being misleading.

"Accordingly, the promotion of an OTC homeopathic product for an indication that is not substantiated by competent and reliable scientific evidence may not be deceptive if that promotion effectively communicates to consumers 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," according to the Policy Statement.

Perfunctory disclaimers are unlikely to successfully communicate the information necessary to make OTC homeopathic product claims non-misleading, the FTC cautioned. Disclosures should "stand out," be in close proximity to the efficacy message and, in some cases, may actually need to be incorporated into the efficacy message.

Marketers should be careful not to undercut qualifications with additional positive statements or consumer endorsements, the agency said, and it is possible that the disclosures may be insufficient given the "inherent contradiction" in asserting the effectiveness of a product and also disclosing there is no scientific evidence for such an assertion.

The FTC frowned upon certain disclosures as insufficient. For example, that a product's efficacy "has not been evaluated by the Food and Drug Administration," that a product is based on traditional homeopathic theories, and that a product's efficacy is not supported by scientific evidence.

"The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted," the FTC wrote. "If, despite a marketer's disclosures, an ad conveys more substantiation than the marketer has, the marketer will be in violation of the FTC Act."

To read the Enforcement Policy Statement, click here.

Why it matters: Historically, the FTC has rarely challenged misleading claims for products that were homeopathic or purportedly homeopathic, the agency wrote. But that position appears to be changing. Given the growing OTC homeopathic market and the Commission's new Enforcement Policy Statement, the makers of such products should brace themselves for heightened regulatory scrutiny.