FTC Updates Health Claims Substantiation Guidance

By Alvin J. Lorman, AAHP Legal Counsel

The Federal Trade Commission last month released a lengthy guidance document on the substantiation it expects for health claims, Health Products Compliance Guidance. While the press release accompanying the guidance says it applies to homeopathic products as well as most other health products, the new guidance is, in fact, an updated version of FTC’s diet supplement guidance. There is nothing specific about homeopathic products in the guidance. The new guidance confirms FTC’s prior advice that claims appropriately qualified by disclaimers can meet the requirements of the law. Of the 52 product-specific examples in the guidance, not one mentions homeopathy. And, as the new guidance notes, guidance documents represent FTC’s position on the law, not the law itself.

Nonetheless, it is useful to take a quick look at the new guidance. FTC notes that the FTC Act requires “Advertising must be truthful and not misleading” and “Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication, to consumers acting reasonably.” The new guidance provides an excellent review of how FTC approaches both the analysis of what claims an ad makes as well as how to substantiate those claims. As to products that rely on “traditional use,” the prominence of the disclaimer will be key in any FTC review of its adequacy. FTC explained that:

“Under FTC law, claims for products based on traditional use are subject to the same requirement of substantiation in the form of competent and reliable scientific evidence as any other product. At the same time, FTC law does not prohibit advertising that is sufficiently qualified to be truthful and not misleading. Advertising that merely describes the traditional or historic use of a product and that is carefully qualified to avoid any misleading implications about the product’s efficacy or health benefits may be permissible. An advertiser who wants to describe a product’s historical or traditional use should take the following steps to avoid communicating a misleading message about the product’s efficacy or about the scientific basis for any health benefit:

The advertiser should clearly identify the historical or traditional use and make sure that its product is consistent with that use — for example, that it contains the same ingredients and formulation, the same strength or dose, the same form of administration, and the same indications for use. If there is a significant difference between the traditional use of the product and the marketed product, a “traditional use” claim isn’t appropriate.

A claim that suggests a health-related benefit for which there isn’t competent and reliable scientific evidence must clearly communicate the lack of scientific evidence. To avoid any deceptive implication, a disclosure that there is no scientific basis for the traditional use should stand out and be in close proximity to the claim. To be effective, it may actually need to be incorporated into the claim.

As with all claims, marketers shouldn’t undercut a disclosure about the lack of science with additional positive statements, consumer endorsements, images, or other elements of the ad suggesting the product is effective.

Given the inherent difficulty of discussing the traditional use of a product while also effectively communicating that there is no scientific basis for its efficacy, an advertiser should consider conducting a copy test or other consumer research to confirm that consumers understand the limited nature of the claim. The FTC will look closely at how consumers perceive a traditional use claim and whether they assume the claim means the product is effective and backed by more evidence than the marketers have. An ad that, despite a disclosure, conveys more substantiation than a marketer has, is deceptive.”