November 16, 2016

Homeopathic Hot Potato: FTC Publishes Enforcement Policy Statement on Marketing of OTC Homeopathic Products

4 min

On November 15, 2016, the Federal Trade Commission (FTC) decided once again to force itself into the U.S. Food and Drug Administration’s (FDA) ill-fitting shoes by effectively establishing safety and efficacy standards for over-the-counter (OTC) homeopathic drugs. In particular, the FTC is taking the position that claims related to homeopathic drugs, like other health-related claims, must be substantiated by competent and reliable scientific evidence. From the FTC’s perspective, reliance on “traditional homeopathic theories” does not constitute competent and reliable scientific evidence, and simply disclosing the fact that the claim is based on homeopathy is insufficient to protect the claim from being deceptive. Instead, the FTC has decided to rewrite the Federal Food, Drug, and Cosmetic Act (FDCA) to require that competent and reliable scientific evidence, consisting of studies using current scientific methods (likely randomized, controlled clinical trials), are required to substantiate claims unless the marketer clearly 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 FTC cautions that merely perfunctory disclaimers are insufficient.

In other words, the FTC has decided to reject and tar a whole healing modality because, in the FTC’s opinion, that healing modality lacks the necessary scientific rigor to substantiate its claims. This approach ignores the fact that the FDA is the agency tasked with evaluating the effectiveness of drugs, ignores the key tenets of homeopathy, and attempts to hold a centuries-old body of medicine to allopathic standards that are not appropriate to measure its effectiveness. This is yet another example of the FTC asserting itself into areas of food and drug law where it simply has no regulatory authority. And this is despite the fact that millions of Americans believe in the power of homeopathy to treat health-related conditions such as colds and pain.

Unfortunately, the FTC’s latest policy statement does not come as much of a surprise, as we’ve watched the FTC pressure the FDA to take a harder stance against homeopathic drugs over the past few years. From an FDA perspective, OTC homeopathic drugs are permitted by the FDCA but have been regulated within an imperfect construct—drugs by definition, yet without safety and efficacy standards established or confirmed by the Agency itself. Rather, homeopathic drugs have generally been considered safe if developed in accordance with the Homeopathic Pharmacopeia of the United States (HPUS) and have generally been considered effective based on homeopathic provings and Materia Medica. And while the FDA has questioned the efficacy of these products, it has declined to directly assess efficacy under the Drug Efficacy Study Implementation (DESI) project and later as part of the OTC drug review process, perhaps, in part, based on a recognition that allopathic standards are not appropriate to measure the efficacy of homeopathic medicines.

The FDA and the FTC have recently held several public meetings on how to best address the homeopathic drug market under existing regulatory schemes. To date, the FDA has not adopted the FTC’s recommendations on how to overhaul the regulatory framework for homeopathic medicines. That doesn’t mean the FDA is ignoring homeopathic products entirely, but perhaps is dividing responsibility. While the FDA recently warned consumers of the safety risk associated with homeopathic products, the FTC has now taken it upon itself to create a new efficacy standard for OTC homeopathic drugs—requiring well-designed clinical trials prior to marketing—despite the fact that no such requirement exists in the FDCA and despite the fact that the Agency tasked with evaluating the efficacy of drugs (the FDA) has not set such a requirement.

As pressure looms over regulatory agencies to maintain their influence over the next few months, we can expect that the FTC will not waste time in pursuing enforcement actions against OTC homeopathic drugs consistent with its new policy. The FTC Enforcement Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs is available here.