March 6, 2023
In December 2022, the Federal Trade Commission released an update to a 1998 set of guidelines for advertising and promotion of health products, but while the 1998 guidance was understood to cover primarily dietary supplements, the 2022 update mentions other products, such as medical devices.
The FTC highlighted the fact that the 2022 update is not just for companies that sell dietary supplements, but now applies across the board to all health-related claims. The guidance states that the two principles for FTC regulation are that advertising must be truthful and not misleading, and that an advertiser must take steps to ensure that it possesses adequate substantiation of the claims in the advertisement.
The definition of advertisement includes not just conventional ads, but also statements or depictions on packages and labels, as well as material such as booklets or brochures. Any information disseminated through intermediaries such as healthcare practitioners also falls under the definition of advertising. FTC enforcement has been undertaken against those who have disseminated the information on the part of the sponsor of the advertising as well, including advertising agencies and export endorsers.
The FTC said that it shares jurisdiction with the FDA over the marketing of dietary supplements, drugs and devices, a point of collaboration that is memorialized in the FDA-FTC Liaison Agreement. While the FDA focuses primarily on labeling and the FTC on advertising, the guidance states that this agreement does not limit the FTC from taking enforcement action in connection with claims made in product labels.
While the FTC will defer to the FDA’s understanding of whether a health claim is backed by substantial evidence under the FDA significant scientific agreement standard, any advertising or other communication that falls short of the FDA standard may be deemed deceptive. An exception may be attained with the use of qualifying language that can be understood by a reasonable consumer. The FTC begins its analysis of the claims made to a reasonable consumer with identification of express and implied claims. Any statements that may indirectly hint at a benefit that cannot be supported by substantial evidence may be construed as deceptive.
The FTC’s focus in evaluating advertising claims will not be on the intent of the advertisement, but on the consumer’s understanding of the content of the advertisement. When an advertisement can be interpreted in more than one way, the advertiser is responsible for providing substantiation for each interpretation. The advertiser should also be aware of the net impact of the advertisement, not just on specific statements found therein.
Advertisers must take into consideration whether an advertisement includes a structure/function claim that explicitly or implicitly suggests that the product is beneficial for treatment of a disease. Any such implications, direct or indirect, must be substantiated. Any important information that is omitted about the benefits of the product, or about any significant safety risks, may also cause the FTC to act.
The standard for substantiation of health claims is examined in detail in the guidance, including the statement that as a general matter, substantiation of those claims will need to be in the form of randomized, controlled human clinical testing. Among the factors of interest for the FTC are the study enrollment size, the duration of follow-up, and the outcomes measured by the study. A single randomized, controlled trial may not be sufficient to alleviate any FTC concerns about the level of substantiation, even in instances in which medical professional societies have recommended the use of the product.
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