FTC Issues Updated Guidance on Health Product Claims – Healthcare

On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Product Compliance Guide (the “Health Product Guide”). This is the first update in nearly 25 years to the Federal Trade Commission’s guidelines regarding advertising claims for dietary supplements, foods, over-the-counter drugs and other health-related products. The update is based on over 200 new cases since the publication of the last guide to illustrate potentially false and misleading claims and their proper substantiation. Major updates and changes include:

  • 23 new examples of expanding the guidelines to cover foods, over-the-counter drugs, devices and other health-related products;
  • Clarifying the FTC’s coordination with the FDA regarding health product claims;
  • Detailed guidance on the FTC’s standards for proper “clear and conspicuous” disclosure of claim qualifications; and
  • An extended discussion of the required “competent and reliable scientific evidence” and testing methodology needed to substantiate health claims.


The FTC and FDA have jurisdiction over the marketing of dietary supplements, foods, over-the-counter drugs, devices, and other health-related products. The agencies signed a memorandum of understanding that clarifies that the FDA has primary responsibility for labeling claims (“including packaging, product inserts, and other promotional materials available at the point of sale”), and the FTC has primary responsibility for advertising claims (“traditional TV, radio, print and internet ads, but also more widely… [a] variety of marketing techniques and promotional methods”). But as explained in the Health Products Guide, agencies may regulate the same type of claim differently for the same type of product. For example, while the FDA evaluates a claim differently depending on whether the product is a supplement, food, or drug, the FTC treats all health product claims equally. The FTC also does not pre-approve health claims like the FDA and does not require notification of structure/function claims like the FDA. And while the FTC places great respect to the claims that the FDA has approved, the FDA’s assessment is not positive as to whether a claim may be deceptive according to the FTC.


The Health Products Guide outlines the FTC’s two-step process for evaluating the truthfulness and accuracy of advertisements for dietary supplements, foods, over-the-counter drugs, and other health-related products. The first step is to “identify all claims that advertising materials communicate to reasonable consumers.” Second, “the FTC evaluates the scientific evidence on which the company relies to determine whether there is adequate support for these claims.” The examples in the Health Products Guide help illustrate how the FTC applies these standards to claims and advertising.

Step One: Identify and interpret claims and advertisements

In identifying and interpreting advertising claims, the FTC focuses on the consumer’s understanding of the ad, not the marketer’s intent, because the target audience may have special attributes that make it more susceptible to certain claims. For example, “terminally ill users may be particularly susceptible to exaggerated claims of cure.” The Health Products Guide explains that deceptive advertising can arise from either: (1) direct or implied claims about the product’s benefits, safety, or other characteristics, or (2) omissions of information that “are material in light of the claims in an advertisement or in terms of how users would normally use the product[,]” such as stating that a certain vitamin can cause fatigue.

Where disclosure of material information is necessary to prevent false or misleading advertising, the disclosure must be “clear and obvious.” In other words, simply including qualifying information is not enough, and to prevent deceptive advertising, advertisers must ensure that the written disclosure is “easily seen, read and understood” and that the audio disclosure is “delivered at a volume, speed and cadence so that it may be easily heard and understood.” Ultimately, whether a disclosure is sufficiently clear and obvious depends on whether it has an effective effect on a reasonable consumer.

Step Two: Assessing the Justification of the Claim

The FTC’s updated guidance dives deep into its second step in evaluating the truth of an ad: whether a health product claim is properly substantiated by “competent and reliable scientific evidence.” When evaluating whether an advertiser has reasonable grounds to bring a claim, the FTC considers five factors.

Under this framework, the FTC generally requires randomized, controlled human clinical trials for most health benefit claims because such trials are necessary to prove a causal relationship, but there may be some exceptions where experts in the field accept alternative evidence and human clinical trials are not feasible. The Health Products Guide explains that to serve as an adequate rationale, a reliable, high-quality clinical trial must generally include randomization, a control group, double-blinding, statistically significant results, and clinically relevant results, among other characteristics.

But the body of evidence must be considered in the context of the available scientific evidence in the applicable field and the actual claim being made. An individual study supporting a claim is not enough to make the claim true if surrounding evidence in the field contradicts the study.


The Health Products Guide also discusses five separate issues with health product advertising that may attract the attention of the FTC.

  1. The Federal Trade Commission (FTC) cautions against claims based on consumer testimonials or expert endorsements unless those claims can be proven, as the advertiser bears ultimate responsibility for the misleading use of an endorsement.
  2. Claims based on traditional use, such as an advertisement showing that a herbal tea mixture has been used to aid digestion for hundreds of years, are not
  3. Mere use of the DSHEA disclaimer stating that the product has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent disease will not cure an otherwise deceptive advertisement or claim.
  4. Advertisers must be careful “not to mischaracterize the extent to which a product or claims have been reviewed, cleared, or approved by the FDA.”
  5. The FTC will evaluate whether a reference to third-party literature may constitute an implied and deceptive claim on a case-by-case basis.

Advertisers of health-related products should be especially careful about the claims they make. Both the FTC and the FDA have jurisdiction in this area, and both agencies have increased their enforcement efforts in recent years against advertisers of health-related products for false and misleading claims. And as the FTC’s updated Health Products Guide indicates, advertising of health-related products must be nuanced, carefully considered, and reviewed to avoid potential pitfalls that could lead to regulatory enforcement and litigation.

Kai Mindick, a former attorney in our Austin office, contributed to this post.

Due to the general nature of this update, the information provided here may not be applicable in all situations and no action should be taken without specific legal advice based on specific situations.

© Morrison & Foerster LLP. All rights reserved

Leave a Comment

Your email address will not be published. Required fields are marked *