Marketing companies take notice: on December 20, 2022, the Federal Trade Commission’s (“FTC’s” or “Agency’s”) Bureau of Consumer Protection released a 40-page, comprehensive Health Products Compliance Guidance (the “Guide”). The new Guide is considered to be a significant update to the earlier 1998 version, Dietary Supplements: An Advertising Guide for Industry.The FTC Health-related advertising guide is comprehensive and restrictive in coverage, containing many illustrative examples of what constitutes prohibited marketing conduct. As many readers know, the FTC is tasked with preventing “unfair or deceptive acts or practices” in interstate commerce. Accordingly, the Agency tirelessly pursues advertising companies that operate in a way that may deceive consumers. The new Guide was released to help ensure that marketing claims concerning the purported benefits and safety of health-related products are both accurate and substantiated, so that consumers can make informed decisions prior to purchase.
General Principles Underlying the new FTC Health-Related Advertising Guide
As a practical matter, the new FTC Health-Related Advertising Guide identifies two “common-sense” principles that comprise the core of the FTC’s health product marketing regulations:
1. Advertising must be truthful and not misleading; and
2. Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication, to consumers acting reasonably.
But just what does compliance now look like following the release of the new Guide? Companies are now tasked with examining their business practices under a microscope, to ensure that their marketing claims do not run afoul of the law.
FTC Health-Related Advertising Guide Compliance
Compliance just a got a lot more complicated with the release of the new FTC Health-Related Advertising Guide. Significantly, the Guide comprehensively covers the following compliance factors that businesses must consider before publishing health product marketing (online or offline) in interstate commerce:
- What are the express and implied claims suggested by the ad?
- Prominent disclosure of qualifying information
- Clear and conspicuous disclosure of material terms
- The amount and type of evidence necessary to substantiate claims
- The relevance of the evidence to the specific product and claim
- Claims based on consumer testimonials and expert endorsements
- Claims based on traditional use
- Use of the DSHEA disclaimer in advertising
- Mischaracterizations of Food and Drug Administration (“FDA”) approval
- Reliance on third-party literature for substantiation
Each Guide section referenced above outlines items to consider and examples of associated acceptable and non-acceptable marketing practices.
How Can Businesses Comply with the New FTC Health-Related Advertising Guidelines?
As a general matter, marketers of health-related products, including dietary supplements, should be aware of FTC and FDA marketing requirements. Specifically, advertising claims must be: 1) truthful; 2) not misleading; and 3) substantiated (emphasis added). In that vein, according to the FTC press release, “the new Guide includes a much more detailed discussion of the amount and type of evidence needed to substantiate health-related claims, with more emphasis on the fact that the FTC, as a general rule, expects high quality randomized, controlled human clinical trials.” Accordingly, marketing companies must now step up their efforts to secure the necessary studies and substantiating evidence prior to advertising a product to the public. Absent such measures, companies face the prospect of incurring the wrath of the FTC — resulting in bad press, liability, and hefty penalties.
Given this significant risk, it is best to obtain guidance from experienced marketing attorneys before launching any health-related product marketing campaigns. If you are interested in learning more about this topic or need to review your advertising practices and procedures, please email us at info@kleinmoynihan.com, or call us at (212) 246-0900.
The material contained herein is provided for information purposes only and is not legal advice, nor is it a substitute for obtaining legal advice from an attorney. Each situation is unique, and you should not act or rely on any information contained herein without seeking the advice of an experienced attorney.
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