Health Products and Dietary Supplements Compliance Lawyer
In December 2022, the Federal Trade Commission issued new Health Products Compliance Guidance on health-related product marketing claims to replace the dietary supplements advertising guide. The new guidance document reinforces the FTC’s high-prioritization of policing the advertising of health-related products.
What is the Difference Between the Former Guidance and the New Health Products Compliance Guidance?
The 1998 Dietary Supplements Guidance focused on dietary supplements. The new FTC Health Products Guidance applies to both express and implied claims made in the marketing of any health-related product, including, but not limited to, foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps.
The new Guidance is a guide for the digital advertising industry and reflects FTC cases and recent product innovations.
How Can an FTC Health Products and Supplements Compliance Attorney Help Advertisers Substantiate Claims?
Notably, the new Guidance discusses what kind of evidence is required in order to lawfully substantiate express and implied health-related claims.
Digital advertisers should not be fooled.
Despite much of the FTC’s guidance about substantiating claims remains largely unchanged, there are numerous notable changes. An experienced FTC health product and nutraceutical compliance lawyer can help marketers advertise safely while maintaining business objectives.
What is the “Competent and Reliable Scientific Evidence” Claim Substantiation Standard?
Generally speaking, health benefits must be substantiated by “competent and reliable scientific evidence.”
According to the Federal Trade Commission, “competent and reliable scientific evidence” means “tests, analyses, research, or studies that (i) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and (ii) are generally accepted in the profession to yield accurate and reliable results.”
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.”
Benefits must be show to be clinically relevant. The FTC continues to note that any statistically significant results must translate to a benefit that is clinically meaningful for consumers. Some results that are statistically significant may be too small to provide real consequences for consumer health. In evaluating the quality of a study, FTC will examine whether the study is of sufficient duration to show that the benefit will persist.
Are Randomized, Controlled Human Clinical Trials (RCTs) Necessary?
It is the FTC’s position that RCTs are the most reliable form of evidence and are generally the type of substantiation that experts would require for health benefit claims.
Although there is no requirement for a specific number of RCTs, the replication of research in an independently-conducted study adds to the weight of the evidence, says the FTC. The Guides also provide that replication in a second study by independent researchers reduces the chance that the results of a single RCT may be influenced by unanticipated, undetected, systematic biases that may occur despite the best intentions of sponsors and investigators.
The Guides state that an additional, independently conducted study to corroborate findings provides much greater confidence in the validity of the initial results. The Guides discuss that the quality of the research is more important than the quantity. For that reason, numerous flawed and inadequate studies are unlikely to add up to competent and reliable scientific evidence sufficient to substantiate a claim.
Notably, the Guides discuss that epidemiological or observational studies can be valuable to show an association between a product or ingredient, but they do not prove a causal link. Methodologically sound human clinical testing is necessary to prove causation, although there may be limited situations where such testing may not be feasible, the Guides state.
In the field of nutrition, for example, the Guides reiterate that it may take decades to determine whether there is a relationship between eating a particular food or nutrient and the risk of developing a disease. The FTC will accept high-quality epidemiologic evidence to substantiate a claim in those limited cases where: i) it is considered an acceptable substitute for RCTs by experts in the field; ii 2) RCTs are not otherwise feasible.
“Experts in the Field” as Arbiters of Evidence Needed
FTC enumerates a number of factors to determine the amount and type of substantiation required, including the type of product, the type of claim, the benefits of a truthful claim, the consequences of a false claim, and the amount of substantiation that experts in the field believe is reasonable.
The FTC gives significant weight to accepted norms in the relevant fields of research and consults with experts in those fields. For example the FTC states that research supporting a claim about heart benefits would need to meet accepted norms of research in the field of cardiology. The agency also states that research that has not been through a rigorous peer-review process will be subject to greater scrutiny
What About Animal and In Vitro Studies?
The Guides discuss that animal and in vitro studies may provide useful supporting or background information, but, without confirmation by human RCTs, they are not sufficient to substantiate health-related claims.
In the eyes of the Federal Trade Commission, animal studies have only limited value in predicting the effect of a product in humans, making it difficult to extrapolate results in animal research to benefits for humans. In vitro studies look at a product’s effect on isolated cells or tissues and may help identify a possible mechanism of action, but similarly are of limited value to predict benefits for humans, the Guides states.
What About Anecdotal Evidence and Public Health Recommendations?
Anecdotal evidence about the individual experiences of consumers, including surveys of consumer experiences, are never sufficient to substantiate claims about the effects of a health product, according to the FTC. “Even if consumer experiences are genuine, they may be attributable to a placebo effect or other factors unrelated to the product. For the same reason, a healthcare practitioner’s observation about the effect of a health product on patients is anecdotal and does not provide evidence of a causal relationship. Individual experiences are not a substitute for scientific research.”
Finally, the Guides discuss that advertisers should not rely on public health recommendations, such as advisories from a medical organization, as substantiation. “Public health recommendations and advisories reflect a judgment based on the best currently available evidence. They are not equivalent to a finding that there is a causal link between the recommended course of action and the health benefit.”
For that reason, public health recommendations alone are not considered sufficient to support a claim.
The FTC recommends that marketers instead evaluate the strength of the scientific evidence underlying those recommendations and the relevance of that evidence to the marketed product and advertised claims.
A claim that suggests a health-related benefit in the absence of competent and reliable scientific evidence must clearly communicate the lack of scientific evidence. The disclosure should stand out and be in close proximity to the claim. Maybe better, incorporated into the representation.
How Can an FTC Health Products and Supplements Lawyer Help Advertisers Assess the Need for Limitations or Qualifying Language?
The Guides also discuss that, to avoid being deceptive, an advertiser should "clearly and conspicuously" disclose any significant limitations or qualification on a claimed benefit.
Qualifying information – information that explains or limits the applicability of an ad claim – should be sufficiently simple and clear that consumers not only notice it, but also understand its significance. This can be a particular challenge when explaining complicated scientific concepts to a general audience. For example, it may be difficult to adequately qualify a claim based on limited and still-emerging science to make clear to consumers the uncertain and limited nature of the support for the claim. An advertiser should make sure consumers understand both the extent of scientific support and the existence of any significant contrary evidence.
Vague qualifying terms are inadequate. For example, it is not enough to say that the 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. Thus, consumers may interpret an ad to mean that a product will prevent or reduce the risk of a disease, even if the ad includes language indicating that the science supporting the effect is limited in some way.
Additionally, advertisers should disclose negative scientific data showing risk, including, for example, negative long-term effects of consuming a product over an extended period. A product that may be utilized by consumers with a particular health condition should make a disclosure that the product is not intended to treat that health condition.
For example, FTC stated that an advertisement for nasal strips to reduce the sound of snoring should disclose that the nasal strips are not intended to treat sleep apnea. This example is noteworthy because the FTC reached this conclusion without express or implied claims related to sleep apnea or any finding that a reasonable consumer would otherwise expect any product intended to treat snoring to also treat sleep apnea.
New Standard for Disclosure of Qualifying Information
When the disclosure of qualifying information is necessary to prevent an ad from being deceptive, advertisers should present the information clearly and conspicuously, so it is difficult to miss (i.e., easily noticeable) and easily understandable by ordinary consumers. If the claim requiring a disclosure is made both visually and audibly, the disclosure should 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 a simultaneous visual and audible disclosure is more likely to be clear and conspicuous.
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. 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. A disclosure should not be contradicted or mitigated by, or inconsistent with, anything else in the ad. When an endorsement targets a specific audience, such as older adults or children, the effectiveness of the disclosure will be judged from the perspective of members of that group.
The ultimate test of whether a disclosure is effective is the net impression that consumers take from an ad with the disclosure. If a significant minority of reasonable consumers take a misleading claim from an advertisement despite a disclosure, the disclosure is not considered sufficient by the FTC. As a general rule, if it is not possible to make an effective disclosure, the claim should be modified so that a disclosure is not necessary – or the claim should not be made.
Studies on Ingredients v. Finished Products
This issue has been an FTC favorite over the years, one which digital advertisers may not be aware.
Simply stated, the FTC states that a “clinically tested ingredient” claim on a product not only implies that the ingredient has a benefit but also that the product containing the ingredient confers that benefit. However, the product may contain other ingredients. Advertisers should therefore consult with a qualified expert in the relevant field to determine whether experts in that field would generally require a clinical test of the product itself, rather than just a an ingredient or a handful of ingredients, to confirm the benefit.
Studies on individual ingredients may not be sufficient to substantiate a safety claim about a combination product containing two or more active ingredients because the ingredients together may create an "additive" or "synergistic" effect (i.e., impact the body differently than they might, individually). Advertisers are responsible for having competent and reliable scientific evidence, in-hand, prior to disseminating and promotional materials, and - according to the FTC - must have studies on the product if that is what experts in the field would generally require to substantiate the claim.
Prohibition Against “P-Hacking”
Post hoc analysis of data (i.e., analysis that departs from the original study protocol, such as looking at various smaller subgroups of the study population) is addressed in the new Guidance. The FTC cautions against “p-hacking” or data mining in an attempt to find some positive result to report from a study that otherwise failed to show any treatment effect. Post hoc analysis does not generally provide reliable evidence to substantiate a claim.
Consumer Testimonials and Expert Endorsements
The new Guidance discusses that advertisers should not make express or implied claims through consumer testimonials or expert endorsements that would be deceptive or could not be substantiated if the advertiser made them directly.
The advertiser itself must have competent and reliable scientific evidence that the product will be as effective for purchasers as it was for the endorser. Testimonials should include clear and conspicuous disclosures about the typical results consumers can expect, and disclosing “results are not typical” will not cure deception. Furthermore, when using experts, advertisers must ensure the individual has appropriate qualifications and has tested the product, as well as prominently disclose any material connections between the endorser and the advertiser.
The Guidance also discusses the FTC and Food and Drug Administration share jurisdiction over the marketing of health-related products, including dietary supplements, foods, drugs, and devices. Both agencies have authority to take action against marketers making deceptive labeling claims.
The Guidance highlights the following distinctions between FDA and FTC requirements for marketers to keep in mind:
- Unlike the FDA, the FTC does not distinguish between types of health-related products or claims
- The FTC’s approach to advertising of health-related products is the same whether the claim is a structure/function or drug claim, or whether the product is a food, supplement, or drug
- The Dietary Supplement Health and Education Act of 1994 ("DSHEA") requiring a two-part disclaimer on dietary supplement product labels stating that the product has not been evaluated by FDA and is not intended to diagnose, treat, cure, or prevent any disease, “has no effect on the FTC Act.”
- The DSHEA disclaimer is not required in other forms of advertising
- The FTC makes clear that inclusion of a DSHEA disclaimer also will not cure otherwise deceptive advertisement
- Unlike the FDA, the FTC does not pre-approve health claims
- The FTC presumes that health claims that meet FDA’s “significant scientific agreement” standard are substantiated
- Advertisers should be careful not to mischaracterize the extent of FDA approval, review, or authorization of a claim or product, including the science supporting a particular claim (e.g., compliance with the DSHEA notification and disclaimer provisions does not constitute FDA authorization, and advertisers should not imply that the FDA has specifically approved any claim on that basis
- Unlike the FDA, the FTC does not require notification for structure/function claims. The FTC only requires that the marketer have prior substantiation that the claims are truthful and not misleading
The New Guidance does not have the force or effect of law. However, it does illustrate that health-related claims remain a key area of focus for the FTC and should serve as a reminder that marketers operating in the health-related space should consult with a qualified FTC defense lawyer prior to going to market. Health-related marketers should work with counsel to deliberately evaluate all health-related advertising representations and claim substantiation practices to ensure they are scientifically defensible, clinically significant, and relevant to the specific product and advertising claim. The sufficiency of disclaimers should also be carefully evaluated to ensure that they align with applicable legal regulations and guidance.
The FTC actively enforces the advertising of health-related products. Contact an experienced Health Products Compliance Guidance lawyer to discuss to compliance how to avoid a regulatory investigation or lawsuit, or if you are already the subject thereof.
Table of Contents
- What is the Difference Between the Former Guidance and the New Health Products Compliance Guidance?
- How Can an FTC Health Products and Supplements Compliance Attorney Help Advertisers Substantiate Claims?
- What is the “Competent and Reliable Scientific Evidence” Claim Substantiation Standard?
- Are Randomized, Controlled Human Clinical Trials (RCTs) Necessary?
- “Experts in the Field” as Arbiters of Evidence Needed
- What About Animal and In Vitro Studies?
- What About Anecdotal Evidence and Public Health Recommendations?
- How Can an FTC Health Products and Supplements Lawyer Help Advertisers Assess the Need for Limitations or Qualifying Language?
- New Standard for Disclosure of Qualifying Information
- Studies on Ingredients v. Finished Products
- Prohibition Against “P-Hacking”
- Consumer Testimonials and Expert Endorsements
- What is the Interplay Between FTC and FDA Regulation of Health-Related Claims?