Hunton Retail Law Resource

The FTC has just announced a release of updated “Health Products Compliance Guidance” to help advertisers ensure that claims about the benefits and safety of health-related products are truthful, not misleading, and supported by science.

Last tackled in 1998 and styled as a Dietary Supplements Advertising guide for dietary supplements, the new guidance document covers a broad spectrum of products including foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests and health apps, and other health-related products. The FTC staff indicates the new materials take into account several decades worth of law enforcement and seeks to debunk certain “urban myths” about FTC enforcement in this area. Among the many items discussed, FTC staff emphasizes that:

• Adequate Substantiation:
  • As a general matter, to meet the competent and reliable scientific standard, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing.
  • Animal studies have only limited value in predicting the effect of a product in humans.
  • While in vitro studies may help identify a possible mechanism of action, they similarly are of limited value to predict benefits for humans.
  • Anecdotal evidence (including surveys of consumer experiences) is never sufficient to substantiate claims about the effects of a health product.
  • Public health recommendations and advisories are not equivalent to a finding that there is a causal link between the recommended course of action and the health benefit.

• Study Design: The design, implementation, and results of each piece of research are important to assessing the adequacy of a marketer’s substantiation.

• P-hacking: Post hoc analysis that departs from the originally stated study protocol (e.g., an analysis that looks at various smaller subgroups of the study population) does not generally provide reliable evidence to substantiate a claim.

• Claims Construction: Claims must accurately reflect what the research shows.

• Traditional/Homeopathic Medicine:
  • Claims for products based on traditional use are subject to the same requirement of substantiation in the form of competent and reliable scientific evidence as any other product.
  • A claim that suggests a health-related benefit for which there isn’t competent and reliable scientific evidence must clearly communicate the lack of scientific evidence.

Advertisers should familiarize themselves with the FTC’s new guidance, including the examples, which are drawn directly from the agency’s cases.