FTC asks FDA to require scientific proof for homeopathic remedy labels

A significant percentage of consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, or the level of scientific evidence supporting homeopathic claims, according to the Federal Trade Commission (FTC). However, when given additional information, consumers look more critically at homeopathic treatments and have a better basis on which to evaluate them in comparison to other remedies. Therefore, the FTC is urging the FDA to reconsider its 1988 Compliance Policy Guide (CPG) on over-the-counter (OTC) homeopathic drugs and remove conflicts between FTC and FDA regulations.

Homeopathic drugs

Homeopathy is based on the view that disease symptoms can be cured by small doses of substances that produce similar symptoms when provided in large doses to healthy people. The CPG defines a homeopathic drug as one that is “labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.”

Agency authority

Anything that meets the definition of a “drug” under the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.)—including homeopathic drugs—are subject to FDA regulation. The FTC Act (15 U.S.C. §§41-77) gives the FTC authority over unfair or deceptive advertising and labeling, as well as the dissemination of false advertisements, which includes advertisements for food, drugs, devices, services, and cosmetics. According to the FTC, there is considerable overlap between the two agencies’ jurisdiction; pursuant to a 1971 Memorandum of Understanding, the FDA focuses on product labeling and the FTC focuses on product advertising.

Safe and effective

In general, the FDC Act prohibits the sale of drugs in the United States until the drug is recognized among qualified experts to be safe and effective. Under the CPG, however, the FDA permits the sale of OTC homeopathic products without demonstrating their efficacy. Further, OTC homeopathic drugs are allowed to include claims about treating specific conditions as long as the conditions are “self-limiting” and not chronic. The labeling of homeopathic drugs is required to display an indication for use.

The FTC Act requires competent and reliable scientific evidence to substantiate all health claims.

Because the CPG does not require proof of effectiveness, some homeopathic drug advertisers incorrectly assume that the FTC does not require competent and reliable scientific evidence to support the advertisers’ efficacy claims. The FTC notes that it has been reluctant to pursue cases against OTC homeopathic products because the its traditional remedies, such as requiring that health claims be supported by competent and reliable scientific evidence, could create a potential conflict with FDA policy under the CPG.

Recommended action

To avoid conflicts between the two agencies, as well as to prevent confusion among advertisers and consumers, the FTC asked the FDA to do one of three things:

  • withdraw the CPG and subject homeopathic drugs to the same regulatory requirements as other drug products;
  • eliminate the CPG’s requirement that an indication appear on the labeling; or
  • require that any indication appearing on the labeling be supported by competent and reliable scientific evidence.