Editor’s note: This column reflects the views of the authors.
In late December 2022, without prior notice or opportunity for public comment or input, the Federal Trade Commission (“FTC”) released a so-called “update” to its previous 1998 guidance document, “Dietary Supplements: An Advertising Guide for the Industry.”
The “Health Products Compliance Guidance” (hereinafter “Guidelines”) has ballooned to 34 pages. The document provides 52 examples, accompanied by several pages of endnotes with citations to case law and prior FTC settlements, to suggest activities and practices that may fall under FTC scrutiny.
Despite its increased heft, the Guidelines do not announce any new policy changes or initiatives by FTC. Rather, they are, for the most part, a rehash of increasingly hardline litigation positions taken by the agency in recent years regarding dietary supplement advertising.
What is new, however, is FTC’s application of the Guidelines beyond dietary supplements to an array of other products, including, but not limited to, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests and health-related apps. Set forth below are some of the key features of the Guidelines, which impact their authority and usefulness to the dietary supplement industry.
Uncertain authority of FTC Guidelines
The Guidelines’ overarching flaw is set forth in the opening paragraphs, which note they are distilled from more than 200 settlements and/or litigations brought by FTC and, as a guidance document, do not have the force of law. Practitioners of FTC/advertising law often lament that FTC regulates via consent decree rather than clear rulemaking with public comment and input.
The Guidelines make the latter observation abundantly clear. It is a tall order to expect lawyers who work in the dietary supplement space to be on top of FTC’s many litigation results, let alone business executives in the dietary supplement industry, yet that is what FTC expects with publication of the Guidelines.
The Guidelines’ status as a guidance document creates difficulties for lawyers and business executives alike. The administration of former President Donald Trump went to great lengths to scale back the force and effect of agency guidance documents. In Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” Trump stressed, among other things, guidance documents were to be “non-binding both in law and in practice.”
Similarly, a pair of U.S. Department of Justice memoranda from 2017 and 2018 sought to limit the force and effect of executive agency documents. See DOJ Memorandum, Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases, Jan. 25, 2018; Attorney General Memorandum, Prohibition on Improper Guidance Documents, Nov. 16, 2017.
In a sharp policy reversal, on his very first day in office, President Joe Biden rescinded Executive Order 13891 and several others. Attorney General Merrick Garland followed suit and revoked prior DOJ memoranda that limited the use of guidance documents. See Attorney General Memorandum, Issuance and Use of Guidance Documents by the Department of Justice, July 1, 2021.
It thus remains to be seen what weight federal courts will afford the Guidelines in litigation with FTC. Suffice to say, the Guidelines can be viewed as an accurate predictor of the position(s) FTC will take in litigation—whether in administrative or federal court—concerning the appropriateness of dietary supplement advertising. Accordingly, business executives who work in the dietary supplement industry should heed the guidance in the Guidelines carefully.
Randomized controlled human clinical trials
What has been the subject of extensive litigation between FTC and numerous dietary supplement companies for years is whether “competent and reliable scientific evidence” requires human clinical research, i.e., randomized controlled human clinical trials (“RCTs”). The Guidelines carry over the definition of “competent and reliable scientific evidence” from the 1998 guidance, which focuses on scientific evidence evaluated by experts to substantiate advertising claims. The Guidelines state, “As a general matter, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing…” Thus, in FTC’s view, “competent and reliable scientific evidence” means RCTs.
In footnote 31 to the Guidelines, FTC disingenuously claims courts have “consistently applied an RCT standard” in evaluating advertising claims. It buttresses this assertion through a strained reading of a federal district court decision that decided just the opposite, United States v. Bayer Corp., No. CV 07-01 (JLL) 2015 WL 5822595 (D.N.J. Sept. 24, 2015), and by ignoring other court decisions, e.g., FTC v. Enforma Nat’l Prods., Inc., 362 F.3d 1204, 1217 (9th Cir. 2004); FTC v. Garden of Life, 845 F. Supp. 2d 1328, 1335 (S.D. Fla. 2012), affirmed in part and vacated in part, 516 F. App’x 852 (11th Cir. 2013), which have held “competent and reliable scientific evidence” does not require RCTs.
More troubling for dietary supplement makers is FTC’s suggestion that, in most instances, at least two RCTs will be required to substantiate a health-related claim for a dietary supplement. As to what RCTs should contain, the Guidelines set forth on pages 17-18 the elements FTC will be looking for when evaluating RCTs, and its attempts to align those requirements with those for FDA-approved drugs. Requiring RCTs used for drugs to substantiate health-related claims for dietary supplements will drive-up costs for dietary supplement companies, and RCTs are beyond the resources available to many of these companies.
Key ingredient testing
Assuming, for the moment, that “competent and reliable scientific evidence” requires RCTs, another hot-button issue for dietary supplement advertisers was whether one could rely on RCTs of key or active ingredients, or whether the RCTs had to be for the specific product itself. Here, the Guidelines do not clearly articulate the agency’s position on this issue, which will likely cause confusion as companies endeavor to follow the Guidelines.
Indeed, the Guidelines provide conflicting examples that render this question difficult to resolve. In some of the numerous examples set forth in the Guidelines, it appears that key ingredient testing can be sufficient substantiation. See examples 24 and 32. In other examples, the agency seems to take the position that only RCTs of the exact product will do. See examples 36 and 37.
It seems that, for the agency, relying on key ingredient testing will be a very fact-specific evaluation, and one that dietary supplement companies should be aware of moving forward.
Disclosure of negative information
The Guidelines stress a dietary supplement marketer has an affirmative obligation to disclose negative information about a product, or any information that might contradict or limit an advertising claim related to the product. In imposing this requirement, FTC takes the position that the average consumer is especially gullible/ignorant and that, even if only a minority of consumers are potentially misled, the disclosures must be made. What is not clear from the Guidelines is what level of “seriousness” potential negative information must reach for the affirmative disclosure obligation to kick in.
For instance, example 10 in the Guidelines states: “An energy drink contains an ingredient that, when consumed daily over an extended period, can (emphasis added) result in a significant increase in blood pressure. Even absent any representation about the product’s safety, the marketer should disclose this potentially serious risk.”
The glaring omission from this example is the meaning of “can.” If the purported increase in blood pressure occurs in 1 in 100,000 users of the energy drink, is there still a disclosure obligation? What if the purported increase in blood pressure occurs in 1 in 1,000,000 users? Moreover, is a “significant increase in blood pressure” a safety risk at all?
Health care practitioners will likely agree that a statistically “significant increase in blood pressure” is not necessarily a clinically significant increase. Indeed, the Guidelines themselves recognize this concept when discussing the quality of RCTs by noting, “Some results that are statistically significant may be too small to provide real consequences for consumer health.”
It seems that—as it does with substantiation requirements—FTC is attempting to impose on dietary supplements regulatory requirements that are more appropriate for FDA-approved drugs meant to treat disease. This ignores business realities. Unlike a patentable molecule which can be turned into a lucrative drug product, dietary supplements, which include natural ingredients, cannot obtain the same legal protections and profitability. The literal application of the Guidelines to many dietary supplement products would result in an inability to successfully market them and perhaps their ultimate removal from commerce.
The revised Guidelines make clear that FTC will continue to take an aggressive approach when scrutinizing the advertising of dietary supplement products. Dietary supplement companies should carefully marshal as much scientific evidence as they can to support advertising claims.
In addition to having advertising drafts reviewed by counsel, it makes sense to have a scientific expert review ads and the underlying data that has been gathered to support claims before publication. The more rigorous the underlying scientific data, the greater the likelihood that it will pass muster with FTC.
Jack Wenik is a member of Epstein Becker Green in Health Care and Life Sciences and Litigation practices who focuses on guiding dietary supplement companies and health care providers to reduce the risks of litigation by the government. He has advised clients dealing with cases from fines to corporate integrity agreements, and Medicare/Medicaid exclusion. Jack is a regular speaker and commentator to the media on dietary supplement and drug topics.
Elena M. Quattrone is highly experienced at counseling clients on state and federal enforcement issues and health care regulatory matters and responding to government-issued subpoenas and civil investigatory demands. She also conducts internal investigations and defends clients in white-collar criminal matters. Elena has a deep bench of regulatory experience and a Master’s degree in Public Health.
Theodora McCormick is an accomplished commercial litigator who represents businesses in disputes with their competitors, business partners, suppliers and customers. She also specializes in representing dietary supplement companies, assisting them with growing their business while minimizing risk, whether regulatory, competitive or from consumers.