By: Vanessa K. Fulton, Stacy L. Ehrlich, and Suzan Onel
On December 20, 2022, the Federal Trade Commission (FTC) released its “Health Products Compliance Guidance,” which significantly revises FTC’s 1998 “Dietary Supplements: An Advertising Guide for Industry.” While there are many changes from the 1998 Guidance, most of these changes reflect the positions the Commission has taken in health-related matters (and other guidance documents) in recent years. As a result, the 2022 Guidance does not necessarily reflect a major change in FTC policy, but it reflects a visible effort to expand its guidance beyond dietary supplements and compile FTC’s current positions regarding advertising for health-related products.
Some of the key changes to FTC’s Guidance include the following:
- expanded scope of the guidance;
- revised disclosure guidelines and recommendations;
- stricter substantiation standard (which is arguably at odds with case law);
- expanded discussion on evaluating the quality of evidence; and
- added discussion of the mischaracterization of FDA approval.
We discuss these changes further below. Generally, the 2022 Guidance reflects FTC’s shift away from the “flexible” substantiation standard in the 1998 guidance towards a stricter, higher substantiation standard. Indeed, the revised guidance removes the word “flexible” completely.
Expanding the Scope of the Guidance
As evidenced by the title of the 2022 Guidance, “Health Products Compliance Guidance,” the revised guidance expands the scope of the guidance to cover all health-related products, not just dietary supplements.
Additionally, the revised guidance changes the language throughout the guidance to apply to “marketers” as opposed to “advertisers,” reflecting FTC’s current position as to who can be accountable for false or misleading claims. FTC states: “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, [including] individual owners and corporate officers of the marketer, … ad agencies, distributors, retailers, catalog companies, infomercial producers, expert endorsers, and others…”
Clear and Conspicuous Disclosures
The 2022 Guidance changes the 1998 Guidance’s “clear and prominent” standard for disclosures to a “clear and conspicuous” standard and provides more detail on what qualifies as a “clear and conspicuous” disclosure. Specifically:
- If a claim is made both visually and audibly, the disclosure should also be made both visually and audibly.
- If the claim is made just visually or just audibly, the disclosure should at least appear the same way the claim is made, but including the disclosure both visually and audibly is more likely to be clear and conspicuous.
- For visual disclosures, the 2022 Guidance also adds the “length of time it appears” as a relevant factor in determining whether the disclosure is “clear and conspicuous.”
- The 2022 Guidance also adds discussion on disclosures in the context of social media, the internet, and other interactive media, stating that disclosures in these contexts should be “unavoidable,” and that “hyperlinks are avoidable.” In other words, a hyperlink to a disclosure is unlikely to be considered “clear and conspicuous.”
- The 2022 Guidance also adds that whether a disclosure is “clear and conspicuous” will be judged from the perspective of the target audience (such as children or elderly, for example).
In the context of qualifying a claim that is based on emerging science, the 2022 Guidance also makes several changes to either strengthen previous statements or remove language that previously left open the possibility that certain disclosures would be adequate.
- The 1998 Guidance left open the possibility that an advertiser could carefully craft a qualified claim in certain circumstances, while the 2022 Guidance instead uses stronger language to emphasize that it is “very difficult to adequately qualify a claim based on emerging science.”
- The 1998 Guidance said that “[v]ague qualifying terms are unlikely to be adequate,” but the 2022 Guidance now states, “Vague qualifying terms are inadequate.”
- The 1998 Guidance suggested that, “[a] disclosure that clearly describes the limitations of the research, in language consumers can easily understand, and states directly and unambiguously that additional research is necessary to confirm the preliminary results is more likely to be effective.” The 2022 Guidance removes this statement, and instead states that consumers are likely to interpret modifiers such as “promising,” “preliminary,” “initial,” or “pilot” as positive product attributes rather than substantial disclaimers about the state of the science behind a claim.
As with the 1998 Guidance, the 2022 Guidance cites the “competent and reliable scientific evidence” standard. However, in discussing this standard, the 2022 Guidance reflects FTC’s shift away from the “flexible” substantiation standard in the 1998 Guidance towards a stricter, higher substantiation standard. Indeed, as noted above, the revised guidance removes the word “flexible” completely. The 2022 Guidance does, however, identify the same five factors as relevant to determining the “amount and type of substantiation required”: (1) type of product; (2) type of claim; (3) benefits of a truthful claim, and the cost or feasibility of developing substantiation for the claim; (4) the consequences of a false claim; and (5) the amount of substantiation that experts in the field believe is reasonable. The identification of these same five factors suggests that there may still be some amount of subjectivity in the substantiation needed to support a claim.
Regarding what constitutes “competent and reliable scientific evidence,” the 2022 Guidance re-states the following definition from the 1998 Guidance: “tests, analysis, 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.” The 2022 Guidance, however, adds an additional requirement after this definition: 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.” This added language reflects FTC’s position that the marketer cannot simply “cherry pick” supporting evidence and ignore negative evidence.
Perhaps the most controversial aspect of the 2022 Guidance is the statement that, “[a]s 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.” Although the 2022 Guidance does not completely foreclose the possibility that substantiation in a form other than a human, randomized, controlled clinical trial (RCT) will be sufficient, the revisions indicate that this is, at best, a narrow exception.
This strong statement that human RCTs are required for adequate substantiation in most cases is not necessarily consistent with current case law. For example, in United States v. Bayer Corp., when evaluating the “competent and reliable scientific evidence” standard for a dietary supplement claim, the U.S. District Court for the District of New Jersey expressly stated that “[r]andomized clinical trials are not required.” However, a later case out of the U.S. District Court for the Middle District Court of Florida, Fed. Trade Comm’n v. Roca Labs, attempted to distinguish Bayer, noting that Bayer involved a challenge to a consent decree that required the challenger to establish a violation by clear and convincing evidence. The court in Roca Labs went on to say that “the FTC is not precluded from requiring RCTs or challenging claims for lack of an RCT, and the absence of the RCT is just one piece of evidence demonstrating the lack of competent and reliable evidence of the truth of the claims or their reasonableness.”
The 2022 Guidance relies largely on the Roca Labs decision to support the position that RCTs are required for adequate substantiation, attempting to distinguish Bayer for the same reasons as Roca Labs (i.e., on procedural grounds as an enforcement action related to non-compliance with a consent order). However, there are two issues with this approach: (1) it ignores the fact that in Bayer the court was evaluating the same “competent and reliable evidence” standard, including the same definition of “competent and reliable” as the 1998 Guidance; and (2) Roca Labs does not necessarily support the position that RCTs are required for adequate substantiation for every health-related claim.
The 2022 Guidance additionally states that epidemiological or observational studies are generally insufficient by themselves to substantiate health claims because they do not provide a causal link. FTC will accept only “high-quality” epidemiological evidence to substantiate a claim in limited cases where: (1) it is considered an acceptable substitute for RCTs by experts in the field; and (2) RCTs are not otherwise feasible.
The 2022 Guidance likewise makes clear that animal and in vitro studies are generally insufficient by themselves to substantiate health claims. In contrast, the 1998 Guidance was more permissive, saying that animal and in vitro studies “will be examined, particularly where they are widely considered to be acceptable substitutes for human research or where human research is infeasible.”
Finally, the 2022 Guidance advises that advertisers should not rely on public health recommendations, such as advisories from a medical organization, as substantiation because they are not equivalent to a finding that there is a causal link between the recommended course of action and the health benefit. The 2022 Guidance adds an example for this point, regarding an online brain training program that “tout[s] the recommendation by a well-recognized medical institution that individuals should engage in regular mental stimulation to improve memory and help stave off dementia.” The example states that “[t]he recommendation is accurately reported, but it doesn’t provide substantiation for any express or implied claim that the marketer’s brain training program will provide memory benefits.”
Quality of the Evidence
Along with emphasizing that the quality of evidence is more important than the quantity of evidence, the 2022 Guidance also goes into much more detail on what FTC looks at in evaluating the quality of the evidence. While most of these factors (except for those identified below as new) were included in the 1998 Guidance, they were only mentioned briefly with little to no discussion on each.
- Sample size, duration, and outcome measures. These are identified in the general “Substantiating Claims” section as opposed to the specific “The Quality of The Evidence” section, but they are identified as parameters FTC considers in evaluating the reliability of RCTs.
- Control group, randomization, and double blinding. The 1998 Guidance briefly mentions a “carefully controlled” study “with blinding of subjects and researchers” as “likely to yield more reliable results.” The 2022 Guidance goes into much more detail on each of these parameters, explaining why each parameter is relevant in evaluating the reliability of RCTs.
- Statistically significant results. The 1998 Guidance mentions the importance of statistically significant results to show any measured effects are not merely the result of placebo or chance. The 2022 Guidance goes further, explaining that studies that use multiple outcomes should report both positive and negative outcomes, and include a statistical adjustment to account for the increased likelihood that, for multiple outcomes, a positive outcome is not due to chance.
- Post hoc analysis. The 2022 Guidance indicates that post hoc analysis (one that departs from the original study protocol) generally will not provide reliable evidence to substantiate a claim.
- Clinically meaningful results. Both the 1998 Guidance and the 2022 Guidance discuss the importance that results translate to a meaningful benefit to consumers.
After identifying these factors, the 2022 Guidance goes on to identify “other factors” that FTC evaluates “in assessing the quality of a study and whether the study meets accepted standards in the relevant field of research to yield accurate and reliable results.” Most of these factors are newly added in the 2022 Guidance, except for study duration, other aspects of the research results, the nature and quality of the research, and publication in a reputable journal.
- Clear and detailed protocol. Research should begin with a clear and detailed protocol that describes the research question, methodology, and primary and secondary outcome measures (preferably independently validated measures). The protocol should also clearly state inclusion and exclusion criteria for subjects.
- Submission of protocol to an Institutional Review Board (IRB). FTC indicates that submission of the protocol to an IRB for review and registration is “generally accepted as a necessary step to ensure that the research is ethical, and the safety of the subjects is protected.”
- Registering a clinical trial in a public database. Clinical trials that are registered in a public database helps promote transparency and helps ensure the study follows the protocol and that all data (both favorable and unfavorable) are reported.
- Relevant population. The inclusion and exclusion criteria for subjects should be relevant to the population for which the product is marketed.
- Dropout rates and noncompliance should be carefully assessed. These can impact the validity of the study findings.
- Study duration. A study should be of sufficient duration to support the claim, particularly claims that the treatment effect will persist. If product safety may be a concern, the study should be of sufficient size and duration to detect potential side effects.
- Other aspects of research results. For example, evidence of a dose-response relationship (i.e., the larger the dose the greater the effect) or a recognized biological or chemical mechanism to explain the effect adds weight to study results.
- Nature and quality of written report. The 1998 Guidance also included this factor, noting that FTC cannot evaluate the quality of a study from an abstract or informal summary. The 2022 Guidance includes this same language, but goes further to state that the FTC “will evaluate research based in part on how closely it adheres to the protocol and how well the report explains any deviations.”
- Publication in a reputable journal. The 2022 Guidance uses stronger language to convey the importance of publication in a reputable journal, noting that the “rigor of peer review varies widely from journal to journal, with some journals accepting studies based on little more than payment of a publication fee.”
The 2022 Guidance also adds another factor to consider when evaluating the relevance of the evidence to the specific product and claim: how well the outcomes tested in the study relate to the specific benefits advertised. In other words, the study’s endpoints must mirror the claimed benefit (e.g., a study examining metabolic endpoints cannot assess whether weight loss will also occur).
Mischaracterization of FDA approval
The 2022 Guidance explains that an advertiser should be careful not to mischaracterize the extent to which a product or claim has been approved by FDA or mischaracterize or overstate FDA’s assessment of the science supporting a particular claim.
The 2022 Guidance includes two examples for this point:
- The first example involves a nutritional shake manufacturer that, in response to a petition, receives a letter from FDA indicating FDA will exercise enforcement discretion with respect to a certain qualified health claim. In the example, the marketer of the nutritional shake includes a prominent banner in all advertisements that states, “Meets FDA Qualified Health Claim.” FTC explains that, by using a technical regulatory term unfamiliar to most consumers, the advertisement likely deceptively communicates both FDA approval of the product for a particular health benefit and a high level of supporting evidence.
- The second example involves a medical device that receives clearance from FDA to sell the product as a Class II medical device for the intended purpose of stimulating and strengthening healthy muscle. In the example, the marketer includes the words “FDA Approved” alongside claims that the product can help with dramatic weight loss. FTC explains that the use of “FDA Approved” next to the dramatic weight loss claims is deceptive because it gives the impression that the product is FDA approved for weight loss.
The discussion above summarizes some of the key changes from the 1998 Guidance to the 2022 Guidance. There are other notable changes (as well as minor ones) to harmonize the 1998 Guidance with FTC’s current positions. For example, the 2022 Guidance revises the section on consumer testimonials and expert endorsements to reflect FTC’s position as outlined in the FTC’s Guides Concerning Use of Endorsements and Testimonials in Advertising and revises the section on claims based on traditional use to reflect the position expressed in FTC’s 2016 Policy Statement on Marketing Claims for OTC Homeopathic Drugs. The 2022 Guidance also explicitly states that claims based on traditional use are subject to the same competent and reliable scientific evidence standard. Additionally, like the 1998 Guidance, the 2022 Guidance includes many examples. While 17 of these examples are identical to those in the 1998 Guidance, the 2022 Guidance also includes 11 examples from the 1998 Guidance with modifications, as well as 22 examples that did not appear in the 1998 Guidance.
Because the 2022 Guidance reflects a comprehensive compilation of FTC’s current positions regarding advertising for health-related products and provides examples that offer useful insight into FTC’s current thinking, we recommend that all marketers familiarize themselves with the 2022 Guidance.
KKB attorneys would be pleased to answer any questions about the 2022 Guidance or discuss how it may apply to your promotional materials.
 The 1998 Guidance used the word “flexible” four times to describe the substantiation standard. See, e.g., Dietary Supplements: An Advertising Guide for Industry, at 3 (““The FTC’s substantiation standard is a flexible one that depends on many factors.”).
 The 2022 Guidance’s discussion on disclosures in the context of social media is slightly different than the FTC’s discussion in its March 2013 “.com Disclosures: How to Make Effective Disclosures in Digital Advertising” guidance. For example, the March 2013 guidance expressly contemplates the use of a hyperlink to lead to a disclosure.
 2022 Guidance, at 12. See also Lesley Fair, What’s new – and what isn’t – in the FTC’s just-published Health Products Compliance Guidance (Dec. 20, 2022) (“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).”).
 United States v. Bayer Corp., No. CV 07-01(JLL), 2015 WL 5822595, at *3 (D.N.J. Sept. 24, 2015).
 Fed. Trade Comm’n v. Roca Labs, Inc., 345 F. Supp. 3d 1375, 1387 (M.D. Fla. 2018).
 Bayer Corp., 2015 WL 5822595, at *3 (D.N.J. Sept. 24, 2015) (“The FTC Guidance [Dietary Supplements: An Advertising Guide for Industry] and Consent Decree therefore use the same definition of “competent and reliable scientific evidence.”).