On December 20, 2022, the Federal Trade Commission (FTC) published “Health Products Compliance Guidance” for advertising and marketing health claims. The guidance document replaces “Dietary Supplements: An Advertising Guide for Industry”, originally issued in 1998.
The document maintains much of the same scope as the original 1998 version such as the FTC’s role in claim review in marketing and advertising for dietary supplements which contrasts with the FDA’s role in the review of dietary supplement labels. However, as the title “Health Products Compliance Guidance” suggests, this new guidance document adds new categories of health products beyond dietary supplements such as foods, OTC drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps.
Those familiar with the FDA claims review process should note that there is no need for premarket approval for a health claim, and no notification needed for a structure/function claim. The FTC applies the same approach to evaluating health-related claims regardless of whether the claim is, under FDA law, a “health” claim, a “structure/function”, or a “drug” claim. There are two types of claims under the FTC definition: an express claim, and an implied claim. Express claims are claims made directly in an advertisement about the product itself, while implied claims are made indirectly or by inference. While that definition has not changed, the guidance around “competent and reliable scientific evidence” to substantiate these claims has. The FTC holds competent and reliable scientific evidence from randomized, controlled human clinical testing as its gold standard for claims substantiation. In addition, sample size, duration, and outcome measures also factor into their definition of “competent and reliable scientific evidence”. Furthermore, a claim that meets the FDA “significant scientific agreement” standard is presumed to be substantiated under FTC law. However, advertisers should note that the FTC will act against labeling claims if these claims are considered deceptive in the eyes of the FTC.
Advertisers should also consider the “totality of evidence” when referencing scientific studies to substantiate claims. In other words, the scientific literature should support your claim, and not be inconclusive or contradictory. In cases where evidence is inconclusive, advertisers can choose to use a “qualified claim”, clearly and unambiguously disclosing qualifying information to prevent deception.
Other notable points of difference include:
The overall theme of the guidance document is that advertisers should take as many stops as possible when using claims not to deceive the consumer. Advertisers of all health-related products, including foods, OTC drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps must also back their claims with conclusive substantiating evidence regardless of whether they choose to use an express claim or an implied claim.
This article provides a supplemental review of “Health Products Compliance Guidance” and is not a substitute for reading the full guidance document. Please access the full guidance document here.
If you are a marketer or an advertiser of a health-related product and are unsure whether your advertising is FTC-compliant, get in touch with us today.