FTC Issues New Health Products Compliance Guidance

The FTC just published an updated Health Products Compliance Guidance, which replaces its 1998 brochure, Dietary Supplements: An Advertising Guide for Industry. As the title indicates, the updated guidance covers all health products within the FTC’s jurisdiction, not just dietary supplements. This short summary hits some of the highlights, although the reader is encouraged to review the original document and its many examples.

The guidance reaffirms that, as a general rule, “claims about the health benefits or safety of foods, dietary supplements, drugs, and other health-related products require substantiation in the form of competent and reliable scientific evidence.” 

Disclosure size and placement

In a section that is certain to attract attention, the FTC provides guidance regarding the appropriate size and placement of necessary disclosures. It says that “advertisers should present the information clearly and conspicuously, so it is difficult to miss (i.e., easily noticeable) and easily understandable by ordinary consumers.” When the claim is oral, the disclosure should be oral.

A visual disclosure “should stand out and, based on its size, contrast, location, the length of time it appears, and other characteristics, it should be easily noticed, read, and understood.” Giving the back of the hand to speed-reading announcers, the FTC reminds us that an audible disclosure “should be delivered in a volume, speed, and cadence so that it can be easily heard and understood.” In social media, the internet, and other interactive media, the disclosure should be unavoidable; “disclosures made through hyperlinks are avoidable” and therefore should not be used for important information. Of course, a disclosure “should not be contradicted or mitigated by, or inconsistent with, anything else in the ad.” 

Use of terms like “helps”

Providing guidance that will disappoint some supplement makers, the FTC expressly discourages the use of “[v]ague qualifying terms,” such as that a product “may have” the claimed benefit or “helps” achieve the claimed benefit. “Similarly, consumers are likely to interpret modifiers such as ‘promising,’ ‘preliminary,’ ‘initial,’ or ‘pilot’ as positive product attributes, rather than as substantial disclaimers about the state of the science behind a claim, particularly when the study is positively touted in the ad.” 

Substantiation

The most detailed part of the guidance deals with the FTC’s standards for substantiation of health product claims. In general, the FTC requires “competent and reliable scientific evidence,” which means “tests, analyses, research, or studies that (1) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and (2) are generally accepted in the profession to yield accurate and reliable results.” In addition, the FTC requires that the research must be “sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.” “As a general matter, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing [“randomized clinical trials” or “RCTs”] to meet the competent and reliable scientific standard” because this level of support is “generally the type of substantiation that experts would require for health benefit claims.”

The FTC frowns on relying solely on epidemiological or observational studies because “they don’t prove a causal link," even though they “can show an association between a product or ingredient.” To prove causation, the FTC says, human RCTs are generally required. The FTC leaves the door open a crack for epidemiological evidence where RCTs are infeasible.

The FTC sets out a number of criteria for what it considers to be good science. These include a randomized study design, with test and control cells, double-blinding, and statistically significant results. None of this should be news to FTC practitioners.

Can you trot out an expert that believes RCTs are unnecessary for the type of health claim being made? Yes, but be prepared for the FTC to disagree and to offer up contradictory testimony.

Homeopathy

The FTC reiterates its longstanding concerns regarding homeopathic or botanical products. “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.” In other words, there is no homeopathic exemption. A manufacturer may be able to make a claim regarding longstanding traditional use, but if there is no supporting data, it should qualify the claim to indicate the lack of any clinical evidence for such traditional use.

Conclusion

Publication of the new guidance signals that the FTC may be getting ready to commence a new wave of investigations into health products. If your business sells health products of any kind, now is the time to ensure that the advertising meets these updated FTC guidelines. Consider that, because the guidance is no longer limited to supplements, the Commission may have its eye on a broader array of products marketed as providing health benefits.