Making health claims?  And who isn’t?  If you are, you should be sure to read the FTC’s new Health Products Compliance Guidance.  Or at least this blog post!

The new Guidance updates and replaces the FTC’s previous guidance on dietary supplements from 1998, but this new guidance applies far beyond dietary supplements: it applies to all health claims, whether for a supplement, drug, food, health app, or other health-related product.  As noted in the introduction, the document “provides guidance from FTC staff on how to ensure that claims about the benefits and safety of health-related products are truthful, not misleading, and supported by science.”

The Guidance starts by reiterating some basic – and very important -- principles:

1. What proof is needed: As a general rule, claims – whether express or implied (as determined by likely takeaway by the intended consumer audience, not by marketer intent) --  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. 
2. What materials are covered: Advertising subject to truth-in-advertising requirements includes statements or depictions on packaging and labeling; promotional materials such as brochures or booklets; online and digital content; social media and influencer marketing content; statements in press releases, press interviews, or other media appearances; statements and materials at trade shows, conferences, and seminars; and statements made through healthcare practitioners or other intermediaries.
3. Who is liable: the marketers themselves, as well as individual owners and corporate officers of the marketer, ad agencies, distributors, retailers, catalog companies, infomercial producers, and expert endorsers, basically all “parties who participate directly in marketing and promotion, or who have authority to control those practices, have an obligation to make sure that claims are presented truthfully and to check the adequacy of the support for those claims.”
4. What’s the risk: the FTC can mandate that an advertiser cease making deceptive claims, can mandate disclosures and corrective advertising, can ban a company or individual from engaging in certain marketing activities altogether, and can seek financial remedies, including, in some instances, consumer refunds or civil penalties.

The Guidance provides a number of examples to illustrate when implied claims may be communicated, and how disclosures should be made to effectively communicate qualifying information.  Noting that claims based on limited and still-emerging science can be particularly difficult to qualify, the Guidance states that consumers are likely to interpret terms such as “promising,” “preliminary,” “initial,” or “pilot” as “positive product attributes, rather than as substantial disclaimers…”

And then there’s the crux of the Guidance: the substantiation needed to support a health-related claim, i.e., what constitutes competent and reliable scientific evidence.  The Guidance reiterates the standards articulated in various FTC enforcement actions: as a general matter, “substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing to meet the competent and reliable scientific standard. In evaluating the reliability of such testing, the FTC will consider several parameters, such as sample size, duration, and outcome measures, that will vary depending on the exact nature of the hypothesis being tested and accepted norms in the relevant field.”  And, overall, quality is more important than quantity: a bunch of lousy studies do not substantiation make. Also, epidemiological, animal, in vitro and anecdotal evidence and public health advisories may all be useful, but they are not likely to be sufficient to substantiate a health benefit claim.

So how does an advertiser ensure that its research is good research?  The Guidance points to basic principles accepted by the scientific community:

1. The use of an “appropriately designed control (ideally a control using a placebo or sham treatment) helps to isolate the effects of these other variables from the effect of the treatment.”
2. The use of “appropriate randomization or, in the alternative, careful matching criteria, to prevent selection bias and to assure that demographic characteristics and other variables are similar in the control group and the treatment group,” such as gender, age and health status.
3. Double-blinding: both the participants and the researchers should be blinded as who is in the test group and who is in the control group to prevent bias.
4. Statistically significant results.  The Guidance warns against “p-hacking,” i.e., the use of a post-hoc analysis of the data to find some positive result from a study that otherwise failed to show any treatment effect.
5. Clinically meaningful results. Even if the results are statistically significant, they should also be significant enough to provide real consequences for consumer health in order to support a health claim.

In addition to these basic principles, the Guidance lays out detailed factors it evaluates when assessing the quality of research purported to support a health claim, like the use of a clear and detailed protocol, and a rigorous and unbiased peer review process. The Guidance also reminds us that the FTC will look at the totality of evidence when evaluating support for a claim and advertisers should too: they “should consider all relevant well-conducted research relating to the claimed benefit and shouldn’t focus only on research that supports an effect, while discounting research that doesn’t.” The FTC will also consider whether the studies’ findings, even if the studies are well-conducted and robust, actually match the particular claims at issue.

In addition, the Guidance addresses a number of issues that commonly arise in the context of health-related advertising, such as endorsements, claims based on traditional use, the use of the DSHEA disclaimer and others.

Finally, a reminder about FTC guidance, straight from the Guidance itself: “This document is intended as business guidance only. It interprets and explains FTC advertising law pursuant to the FTC Act and as set out in case law, and Commission policy statements. The guide, however, doesn’t have the force or effect of law. The principles and examples are intended to help advertisers comply with the basic tenets of FTC law. They don’t provide a safe harbor from potential liability; whether a particular advertising claim is deceptive or otherwise violates the FTC Act will depend on the facts of the specific case.”  All that said, advertisers violate the guidance at their peril.