On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The update draws on the over 200 new cases since the last guidance was published to illustrate potentially false and misleading claims and proper claim substantiation. Key updates and changes include:
- 23 new examples to broaden the guidance to cover foods, over-the-counter drugs, devices, and other health-related products;
- Clarification of FTC’s coordination with the Food and Drug Administration (FDA) regarding health product claims;
- Detailed guidance on FTC’s standards for proper “clear and conspicuous” disclosure of claim qualifications; and
- Expanded discussion on the required “competent and reliable scientific evidence” and testing methodology required to substantiate health-related claims.
I. FTC AND FDA – JURISDICTION AND COOPERATION
FTC and FDA both have jurisdiction over marketing of dietary supplements, foods, non-prescription drugs, devices, and other health-related products. The agencies signed a memorandum of understanding that clarifies FDA has primary responsibility for labeling claims (“including the package, product inserts, and other promotional materials available at point of sale”) and FTC has primary responsibility for advertising claims (“traditional TV, radio, print, and internet ads, but also more broadly to [a] variety of marketing techniques and promotion methods”). But as explained in the Health Products Guidance, the agencies may regulate the same type of claims for the same type of product differently. For example, while FDA evaluates a claim differently depending on whether the product is a supplement, food, or drug, FTC treats all health product claims the same. Unlike FDA, FTC does not pre-approve health claims or require notification for structure/function claims. And while FTC gives great deference to claims that FDA has endorsed, an FDA assessment is not dispositive of whether a claim may be deceptive according to FTC.
II. FTC’S EVALUATION OF HEALTH-RELATED PRODUCT ADVERTISING
The Health Products Guidance outlines FTC’s two-step process for evaluating the truthfulness and accuracy of advertising of dietary supplements, foods, over-the-counter drugs, and other health-related products. The first step of the process is to “identify all claims the advertising materials communicate to reasonable consumers.” The second step is “FTC assesses the scientific evidence upon which the company relies to determine whether there is adequate support for those claims.” Examples throughout the Health Products Guidance help illustrate how FTC applies these standards to claims and advertising.
Step One: Identifying and Interpreting Claims and Advertisements
When identifying and interpreting advertising claims, FTC focuses on the consumer’s understanding of an advertisement rather than the marketer’s intent because the intended audience may have special attributes that render them more susceptible to certain claims. For example, “terminally ill consumers might be particularly susceptible to exaggerated cure claims.” The Health Products Guidance explains that deceptive advertising may arise from either: (1) direct or implied claims about the benefits, safety, or other characteristics of the product, or (2) omitted information that “is material in light of the claims in the ad or with respect to how consumers would customarily use the product,” such as not indicating that a vitamin may cause fatigue.
When disclosure of material information is necessary to prevent advertising from being false or misleading, the disclosure must be “clear and conspicuous.” In other words, mere inclusion of qualifying information is insufficient, and to prevent an ad from being deceptive, advertisers should ensure that a written disclosure is “easily noticed, read, and understood” and that an audible disclosure is “delivered in a volume, speed, and cadence so that it can be easily heard and understood.” Ultimately, whether a disclosure is sufficiently clear and conspicuous depends on whether it has an effective impact on a reasonable consumer.
Step Two: Evaluating Claim Substantiation
FTC’s updated guidance dives deep on its second step in evaluating an advertisement’s truthfulness: whether a health product claim is properly substantiated with “competent and reliable scientific evidence.” When evaluating whether the advertiser has a reasonable basis to make a claim, FTC considers the following five factors.
Under this framework, FTC generally requires randomized, controlled human clinical trials for most health benefit claims because they are needed to prove a causal link, but may make some exceptions where experts in the field accept alternative substantiation and human clinical trials are not feasible. The Health Product Guidance explains that to serve as adequate substantiation, a reliable, quality clinical trial should generally include randomization, a control group, double blinding, statistically significant results, and clinically meaningful results, among other characteristics.
But the totality of the 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 a claim truthful if the surrounding evidence in the field runs contrary to the study.
III. OTHER ADVERTISING ISSUES
The Health Product Guidance also discusses five distinct health product advertising issues that may draw FTC scrutiny.
- Consumer testimonials or expert endorsements.FTC cautions against claims based on consumer testimonials or expert endorsements, unless those claims can be substantiated, as the advertiser is ultimately responsible for the misleading use of an endorsement.
- Traditional use claims. Claims based on traditional use, such as an advertisement that indicates an herbal tea mixture has been used to aid digestion for hundreds of years, are not per se acceptable, and will be considered misleading if such claims are not substantiated.
- DSHEA disclaimers. Mere use of the Dietary Supplement Health and Education Act (DSHEA) disclaimer stating that the product has not been evaluated by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease will not cure an otherwise deceptive advertisement or claim.
- FDA oversight.Advertisers should be mindful “not to mischaracterize the extent to which a product or claim[GJL1] has been reviewed, authorized, or approved by the FDA.”
- Third-party literature. FTC will evaluate whether reference to third-party literature may constitute an implied and deceptive claim on a case-by-case basis.
Advertisers of health-related products must be especially diligent about what claims they are making. Both FTC and FDA have jurisdiction over this area and both agencies have increased enforcement efforts in recent years for false and misleading claims. And as FTC’s updated Health Products Guidance demonstrates, advertising for health-related products must be nuanced and thoughtfully considered to avoid potential pitfalls that could lead to regulatory enforcement and litigation.
Kai Mindick, a former law clerk in our Austin office, contributed to the writing of this post.