Looking for advice on substantiating your company’s advertising claims? The FTC staff has just released a new Health Product Compliance Guide publication that deserves your attention. You might be wondering if the post reflects major changes to the FTC’s 1998 guidelines. As we will explain, the answer to this question is both yes and no. So turn off your phone, pour yourself 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 have regularly consulted the FTC’s 1998 pamphlet, Dietary Supplements: An Advertising Guide for the Industry, the new publication is intended to take its place. For the most part, the legal foundations remain unchanged, but there are key revisions that we hope to deliver.
The rationale compliance guidelines in the new publication aren’t just for companies that sell dietary supplements. One big change is the title, which aims to make clear that the guidelines apply across the board to all health claims.
The new publication builds on key compliance points conveyed by FTC actions taken since 1998. When it comes to ad substantiation, a lot has happened since 1998—including more than 200 FTC enforcement actions challenging false or deceptive health claims. We’ve incorporated the lessons from these cases into numerous new examples—revisions designed to add practical gloss to long-standing compliance foundations. In addition, the new publication reflects updates from other FTC guidance documents—for example, Guidance on Approvals and Recommendations and Policy Statement on the Administration of Homeopathic Medicines.
The new publication aims to correct the misunderstandings and “urban myths” that have been circulating about the FTC’s substantiation standards. FTC staff have always encouraged open lines of communication with businesses that have questions about the substantiation of health claims. However, we occasionally hear from industry representatives who have misread the original publication, selectively misquoted it, or repeated a misinterpretation of certain cases. One of the goals of the revised Health Product Compliance Guide is to correct these misconceptions.
Readers will note that the core content of the manual is largely unchanged. Like its predecessor, it sets out the regulatory framework for the FTC’s authority over health-related product advertisements, describes how the FTC and the FDA coordinate their enforcement activities, and explains the FTC’s process for identifying of express and implied claims communicated by advertising and assessing whether there is adequate scientific support for those claims. The revised guidance also reiterates a central theme from the 1998 publication: that the alleged evidence that the company offers in support must be related to the specific product and to the advertising claims. Additionally, the Health Product Compliance Guide clarifies that it offers practical perspectives from FTC staff, but does not have the force or effect of FTC law.
There’s no substitute for reading the post cover to cover, but here are some revisions and expansions that deserve special attention:
- The range of products discussed. Underscoring the publication’s broad applicability, 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 statements. 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 claims with high-quality, randomized, controlled human clinical trials (RCTs).
- Testing methodology. Drawing on POM Wonderful decision, the revised guidelines dive deeper into the key elements of qualitative research. Some basic principles have been carried over from the 1998 publication regarding the use of control groups, randomization, double-blinding, and the requirement that results be both statistically significant between the treatment and control groups and clinically relevant to consumers. One notable point elaborated on: a special 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 as a whole.
There is much more, of course, including discussions of the use of user testimonials and expert endorsements, DSHEA disclaimers, claims of traditional use, claims of FDA approval, and third-party literature. For the legally inclined, the publication includes notes to FTC cases and other key resources, but is written in a precise style intended for business executives and advertising professionals—not just lawyers and academics.