FTC Revises and Expands 25-Year Healthcare Product Advertising Compliance Guide – Healthcare

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On December 20, 2022, the FTC announced the release of its Healthcare Product Compliance Guidean update of his 1998 guide, Dietary supplements: an advertising guide for the industry. Like the 1998 version, the revised guidance conveys the government’s thoughts on ensuring health-related product claims are “true, not misleading and supported by science”. It reflects legal developments from more than 200 cases since the 1998 guide, including 23 illustrative examples. While the guide does not have the force and effect of law, it remains an important tool for companies engaged in health-related advertising. Notable changes include:

  • Wider application: The guidance now explicitly applies to the marketing of “any health-related product”, including “food, over-the-counter (OTC) medicines, homeopathic products, health equipment, diagnostic tests and health-related apps”.
  • Standard “Clear and visible disclosure”.: When disclosure of qualifying information is necessary to prevent an ad from being misleading, advertisers must present the information “clearly and prominently.” According to the updated guidance, the disclosure should be easily visible and easily understood by ordinary consumers and should not be diluted by, or inconsistent with, anything else in the ad. Where a claim is made visually, audibly, or both, disclosure should be as well. According to the FTC, the “ultimate test” of effective disclosure is consumers’ net impression of an ad: if even a significant minority of consumers are misled, disclosure isn’t enough.
  • Standard “Competent and reliable scientific evidence”.: Updated guidance suggests that “competent and reliable scientific evidence” should be in the form of randomized controlled human clinical trials, and that the FTC will review the entirety of the evidence when evaluating an advertiser’s substantiation.
  • Consumer testimonials or expert endorsements: New guidance advises that advertisers are responsible for misleading endorsements and should not make claims through consumer testimonials or expert endorsements that would be deceptive or could not be substantiated if the advertiser made the claim directly. The updated guidance provides examples of such use and reiterates that advertisers must have appropriate scientific evidence in place to support both explicit and implicit claims that a product is effective and will work as advertised.

The content of this article is intended to provide general guidance on the subject. Specialist advice should be sought regarding the specific circumstances.

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