The Federal Trade Commission ("FTC")'s revised Health Products Compliance Guidance expands its reach to explicitly cover all health-related products while providing important updates on claim substantiation and consumer standards.
On December 20, 2022, the FTC announced the release of its Health Products Compliance Guidance, an update to its 1998 guidance, Dietary Supplements: An Advertising Guide for Industry. Like the 1998 version, the revised guide relays the government's thoughts on ensuring health-related product claims are "truthful, not misleading, and supported by science." It reflects legal developments drawn from more than 200 cases since the 1998 guidance, including 23 illustrative examples. While the guidance does not have the force and effect of law, it remains an important tool for companies engaging in health-related advertising. Notable changes include:
- Broader Application: The guidance now explicitly applies to marketing of "any health-related product," including "foods, over-the-counter (OTC) drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps."
- "Clear and Conspicuous Disclosure" Standard: When the disclosure of qualifying information is necessary to prevent an ad from being deceptive, advertisers should present the information "clearly and conspicuously." According to the updated guidance, the disclosure should be easily noticeable and easily understandable by ordinary consumers, and should not be mitigated by, or inconsistent with, anything else in the ad. Where a claim is made visually, audibly, or both, the disclosure should be, too. According to the FTC, the "ultimate test" of an effective disclosure is consumers' net impression of an ad—if even a significant minority of consumers are misled, the disclosure is not sufficient.
- "Competent and Reliable Scientific Evidence" Standard: The updated guidance suggests that "competent and reliable scientific evidence" should be in the form of randomized, controlled human clinical testing, and that the FTC will review a totality of the evidence when evaluating an advertiser's substantiation.
- Consumer Testimonials or Expert Endorsements: The new guidance advises that advertisers are liable for misleading endorsements and that they 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 on such use and reiterates that advertisers must have appropriate scientific evidence to back up both express and implied claims that a product is effective and will work as advertised.