This is Part III of a three-part series in which I dissect the FTC’s Health Products Compliance Guidance of 2022. Some content is fairly technical (thank you, FTC), but hopefully, I convey the larger concepts.
Part I: Scope of new FTC regulations of Health Advertising
In Advertising Law in 2023: Health Claims Analyzed, we discussed how this new guidance covers more health-related products, including:
- foods
- dietary supplements
- over-the-counter (OTC) drugs
- homeopathic products
- health equipment
- diagnostic tests
- health-related apps
We also examined regulatory agencies, types of advertising claims, disclaimers, and disclosures, also known as “qualifying information.”
Part II: A Look at the Scientific Standard (Randomized Controlled Clinical Testing)
In Proving Health-Advertising Claims with Science: A 2023 Legal Guide, we examined the science of “Competent and Reliable Scientific Evidence” under FTC. We looked deeply into scientific studies, including the “gold standard”: Randomized, Controlled Human Clinical Testing (“RCT”).
Part III: The Totality of Evidence (this blog)
In sum, marketers, consumers, and regulators should consider the following:
- All scientific studies should not be considered in isolation.
- All relevant well-conducted research should be considered
- Any research that does not support the sought effect should be considered.
- Inconsistencies in evidence should be examined for a sound explanation.
- The totality of the evidence will impact the evidence required to substantiate a claim.
- A qualified claim can still be deceptive if a more substantial body of evidence contradicts it.
Examples of “substantiation” (“proof” or lack thereof)
Lack of Substantiation (not good enough proof for the health claims)
- Relying on a lower-quality 50-person trial while disregarding a 100-person trial to establish that juice high in antioxidants treats erectile dysfunction (Example 29, FTC, Health Products Compliance Guidelines).
- Selecting a six-week double-blind study instead of a less-favorable 12-week double-blind study to show that a supplement “substantially” reduces body fat. (Example 30, FTC, Health Products Compliance Guidance).
- Using the first of three studies, and a post hoc analysis, to show that a fruit drink reduces arterial plaque over a placebo. (Example 31, FTC, Health Products Compliance Guidance).
- Using only epidemiologic evidence to show a relationship between a nutrient and lower cholesterol levels because other food components or combinations may attribute to the relationship. (Example 33, FTC, Health Products Compliance Guidance).
- Relying on studies of unhealthy humans to infer the same results on healthy humans. For example, a tea advertiser may not assume that a tea’s alertness effects on brains with impaired blood circulation would work similarly on healthy brains. (Example 34, FTC, Health Products Compliance Guidance).
- An ad for brain-training software showed a man trying to remember where he left his keys. However, the study used for the product was memory tasks, for example, the short-term mental manipulation of information, such as numbers. The two types of memories are different. “Forgetting where one left one’s keys is an example of a different type of memory failure, unrelated to working memory, the type of memory tested.” (Example 35, FTC, Health Products Compliance Guidance).
- To test a probiotic drink’s effect on Chron’s disease, relying on two independent well-controlled studies on Japanese subjects but of a different probiotic strain delivered in another form (time-released capsule). The Japanese studies will not substantiate the ad claims on Americans whose diets and lifestyles are likely to vary. (Example 36, FTC, Health Products Compliance Guidance).
- Relying on well-conducted clinical studies of individual, active ingredients of an energy drink to show safety is likely inadequate since the product’s active ingredients interacting together, which may produce different results. (Example 37, FTC, Health Products Compliance Guidance).
- Relying on tests extracting botanicals but differently than used in the advertised product to support the immune systems. The different extraction method produces a different chemical profile, which can significantly alter the outcome. (Example 38, FTC, Health Products Compliance Guidance).
Sufficient substantiation (enough proof for a health claim)
- Sponsoring a 12-week study involving 100 subjects over 65 and a well-controlled double-blind study (accepted for a medical journal); Active ingredient supported in Europe in a similar formulation to produce statistically significant results. An independent expert vouched for the totality of the evidence to substantiate the advertiser’s claims. (Example 32, FTC, Health Products Compliance Guidelines).
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Tips for analyzing studies used for advertising
1) Compare and contrast the dosages and formulations of ingredients used in the product versus those used in the studies.
- Examples:
- 100 mg of DHA that “promoted healthy brain and eye development in children” are deceptive for a supplement containing only 100 mcg of DHA). NBTY, Inc., 151 FTC 201, 205 (2011) (settled by consent order).
- Studies that involved the anti-cancer benefits of vegetables did not support claims for tablets containing the equivalent of 1/16 servings of vegetables. Gen. Nutr., Inc., 113 FTC 146, 175 (1986) (initial FTC decision).
2) Ensure the ingredient or combination of ingredients used in the study mirrors those used in the product.
- Examples:
- Undisputed expert testimony established that a different dose or combination of active ingredients would fail to substantiate an efficacy claim. Nat’l Urological Grp., Inc., 645 F. Supp. 2d at 1202.
- Federal court accepted an “expert requirement” that RCTs for diabetes supplements should appear on the exact dosage and formulation rather than on individual ingredients because “there may be interactions between the ingredients that affect their physiological actions.” FTC v. Wellness Support Network, Inc., No. 3:10-cv-04879 (N.D. Cal. Feb. 19, 2014) (order granted the FTC summary judgment).
3) Ensure the advertised product is administered in the same matter as the product used in the study.
4) Analyze whether the outcomes tested in the study relate to the specific benefits advertised.
- Example:
- Actual weight loss—not a change in metabolism—fairly ascertains whether a product causes weight loss. Nat’l Urological Grp., Inc.,2017 US Dist. LEXIS 182256 at *105-106.
5) Ensure that the study population used in the study represents the characteristics of the people targeted by the ad.
- Example:
- As to whether POM pomegranate juice treated prostate cancer, the trial must compare men with the disease at various stages to healthy men showing no signs of prostate cancer. POM Wonderful LLC, 155 FTC at 38.
Consumer Testimonials and Expert Endorsements: Advertising Hurdles
Here is the FTC guidance on endorsements and testimonials updated in 2022.
In any medium of advertising (TV, print, internet, social media, etc.), advertisers may not make unsubstantiated express or implied claims. Scientific evidence must back up any claim that the product will work for the public similarly. Id. § 255.2(a); see also Daniel Chapter One Initial Decision, 148 FTC at 993; FTC v. Bronson Partners, LLC, 564 F. Supp. 2d 119, 125 (D. Conn. 2008), aff'd, 654 F.3d 359 (2d Cir. 2011).
Examples of testimonials or endorsements that fail substantiation requirements:
- Smartphone app testimonials, or reviews, by consumers whose insomnia allegedly disappeared after using the app. Testimonials are not "competent and reliable scientific evidence" of a medical-treatment claim for insomnia.
- Marketers may not hire bloggers to endorse claims who lack competent and reliable scientific evidence to rely upon. Marketers may be held liable for the endorsers' claims. Any such blog must also use a "clear and conspicuous disclosure" of the endorsement relationship to expose potential bias.
- Testimonials that over-dramatize a product's effects may be deceptive.
- Using "Doctors" who are not licensed to practice medicine, did not read the available scientific literature about the active ingredient in a supplement, and did not test the product.
- A book’s paid promotional reference to a specific would require a clear and conspicuous disclosure of the connection between the manufacturer and the book’s author.
What is the difference between a testimonial and an endorsement?
An endorsement and a testimonial are both forms of personal recommendation or support, but there is a subtle difference between the two:
Endorsement: An endorsement is a public statement or approval from a person or entity to promote a product, service, or brand. It is typically a formal and often paid agreement between the endorser and the endorsed entity. Endorsements can involve various forms of media, such as advertisements, social media posts, or product placements. They are often used for marketing purposes to leverage the reputation or influence of the endorser to promote a product or brand.
Testimonial: A testimonial is a personal statement or recommendation provided by a customer, client, or user of a product or service. Testimonials are based on the individual's personal experience and satisfaction with the product or service. Unlike endorsements, testimonials are typically unpaid and voluntary. They can be in the form of written statements, reviews, ratings, or verbal endorsements. Businesses often use testimonials as social proof to build trust and credibility among potential customers.
Additional issues in substantiating health claims:
- Traditional Use: Health-related products with a history of traditional use (historical medicinal application) must have claims substantiated by reliable scientific evidence under FTC law. Advertisers who reference a product's historic use must ensure the product matches its use in terms of ingredients, formulation, strength, dose, and administration. They should clearly communicate the lack of scientific evidence for any health-related benefits. Using consumer endorsements or other positive elements in the ad can be misleading if they suggest the product is effective without proper scientific backing.
- DSHEA Disclaimer: The Dietary Supplement Health and Education Act (DSHEA) requires a two-part disclaimer on product labels for dietary supplements, stating the product has not been evaluated by the FDA and isn't intended to diagnose, treat, cure, or prevent any disease. Including this disclaimer in an advertisement does not absolve it from being deceptive if it contains unfounded health-related claims.
- FDA Approval Mischaracterizations: Advertisers should avoid implying that a product or claim has been approved by the FDA based on DSHEA notification and disclaimer compliance.
- Third-Party Literature: Marketers may be held responsible for claims suggested by third-party literature referenced in their advertisements. Independent, non-commercial literature isn't regulated by the FTC, but deceptive use of such materials in product marketing is prohibited.
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