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Looking for advice on substantiating your company’s advertising claims? FTC staff just issued a new Health Products Compliance Guidance publication that merits your careful attention. You may be wondering if the publication reflects major changes to the FTC’s 1998 guidance. As we’ll explain, the answer to that question is yes – and no. So turn off your phone, pour a cup of cocoa, and spend some time with what may be one of the most important documents you’ll read in 2022. 

If you’ve routinely consulted the FTC’s 1998 brochure, Dietary Supplements: An Advertising Guide for Industry, the new publication is designed to take its place. For the most part, the legal fundamentals remain unchanged, but there are key revisions we hope to convey.

The new publication’s substantiation compliance guidance isn’t just for companies that sell dietary supplements. One major change is the title, which is meant to make it clear that the guidance applies across the board to all health-related claims.

The new publication draws upon key compliance points conveyed by FTC actions brought since 1998. When it comes to ad substantiation, a lot has happened since 1998 – including more than 200 FTC law enforcement actions challenging false or deceptive health claims. We’ve incorporated the lessons of those cases in numerous new examples – revisions designed to add a practical gloss on long-standing compliance fundamentals. In addition, the new publication reflects updates from other FTC guidance documents – for example, guidelines on endorsements and testimonials and the enforcement policy statement on homeopathic drugs.

The new publication aims to correct misunderstandings and “urban myths” that have circulated about FTC substantiation standards. FTC staff has always encouraged open lines of communication with businesses that have questions about substantiating health claims. However, every now and then we hear from industry representatives who have misread the original publication, selectively misquoted it, or repeated misinterpretations of certain cases. One goal of the revised Health Products Compliance Guidance is to correct those misperceptions.

Readers will notice that the basic content of the guide is largely unchanged. Like its predecessor, it sets out the regulatory framework for the FTC’s authority over ads for health-related products, describes how the FTC and FDA coordinate their enforcement activities, and explains the FTC’s process for identifying the express and implied claims communicated by an ad and assessing whether there is adequate scientific support for those claims. The revised guide also repeats a central theme from the 1998 publication: that the purported evidence a company proffers as substantiation must be relevant to the specific product and to the advertising claims. In addition, the Health Products Compliance Guidance makes clear that it offers practical perspectives from FTC staff, but that it doesn’t have the force or effect of FTC law.

There’s no substitution for reading the publication from cover to cover, but here are some revisions and expansions worthy of special mention:

• The breadth of products discussed. Underscoring the broad applicability of the publication, you’ll see new examples related to foods, over-the-counter drugs, devices, and other health-related products.
• The “clear and conspicuous” standard and qualified claims. You’ll find more detailed guidance on the FTC’s “clear and conspicuous” standard, including the challenges companies face in adequately communicating qualified claims to consumers. (And just to be clear, in FTC parlance a “qualified claim” is one with limitations or caveats.)
• The “competent and reliable scientific evidence” standard. This section has been expanded to emphasize the general rule that the FTC expects companies to support health-related claims with high quality, randomized, controlled human clinical trials (RCTs).
• Testing methodology. Drawing on the POM Wonderful decision, the revised guidance takes a deeper dive into the key elements of quality research. Some fundamentals have been carried over from the 1998 publication regarding the use of control groups, randomization, double blinding, and the requirement that results must be both statistically significant between the treatment and control group and clinically meaningful to consumers. One noteworthy point spelled out in more detail: a specific caution against “p-hacking” – the practice of selectively relying on an analysis of a small subset of data  after failing to find a treatment effect in the study population at large.

There’s much more, of course, including discussions about the use of consumer testimonials and expert endorsements, the DSHEA disclaimer, traditional use claims, FDA approval claims, and third-party literature. For the legally inclined, the publication includes endnotes to FTC cases and other key resources, but it’s written in a to-the-point style designed for business executives and advertising professionals – not just attorneys and scientists.