Advertising Law in 2023: Health Claims Analyzed

By Jesse Langel, Esq., LL.M.

| February 11, 2023

What is the Health Products Compliance Guide of 2022?

The Federal Trade Commission (FTC) has provided an overhaul to its 1998 Guidance called Dietary Supplements: An Advertising Guide for Industry. This 2022 guidance aids the FTC and advertisers to comply with rules about advertising the benefits and safety of health to ensure that each claim is truthful, not misleading, and supported by science.

The Health Products Compliance Guide (Dec. 2022) is considered “business guidance”—not law so it lacks the force of law. Compliance with this guidance does not serve as a “safe harbor” from potential liability, like compliance with federal regulations would likely be.

The Guide incorporates the following legal matter:

FTC advertising law under the FTC Act
Case law
Commission policy statements

Since 1998, the FTC has adjudicated over 200 cases involving false or misleading advertising claims about the benefits or safety of health-related products including the following:

foods
dietary supplements
over-the-counter (OTC) drugs
homeopathic products
health equipment
diagnostic tests
health-related apps

This updated 2022 FTC Guideline conveys the wisdom and expertise drawn from analyzing advertising claims in all of those cases. The FTC has identified a myriad of express and implied claims, and has analyzed the scientific support for those claims. Although many cases involved dietary supplements, the same scientific issues would apply to the marketing of all health-related products. The Guide is displayed on the FTC website.

What is Advertising?

Advertising refers to marketing techniques and promotion methods designed to increase consumer interest and consumer demand.

Advertising includes statements or depictions relating to

packaging and labeling
promotional materials such as brochures or booklets
the internet and other digital content
social media and influencer marketing
press releases, press interviews, or other media appearances
trade shows, conferences, and seminars
communications made indirectly through healthcare practitioners or other intermediaries.

Examples of Implied Claims in Health Products

A website that sells a weight-loss product shows images of doctors, molecular structures, and medical textbooks. These images produce a “net impression” of medical and scientific legitimacy to support the conclusion that the product has been clinically proven to be effective for weight loss.
A magazine ad shows a child drinking a nutritional drink that surrounds the child with a protective halo that is immunizing the child from another sneezing child close by. This ad implies that the drink will prevent the child from catching a cold.
An ad for a dietary supplement claims that 90% of cardiologists take the product. This ad makes an express claim of “90% of cardiologists...” that must be substantiated. The ad also implies that the product benefits the heart or circulatory system.
An ad for infant formula claims to reduce symptoms of colic. The ad includes an unrelated chart showing the general sleep patterns of colicky babies over the first year of life. This ad falsely implies a connection between the formula and babies’ sleep patterns. For that implied-disease claim, the maker would need credible scientific evidence.
An herbal supplement, “Cold Away” claims to boost the immune system and maintain a “healthy nose and throat.” These represent improper cold-prevention claims for an unapproved drug.

When to Disclose "Qualifying Information" for Confusing or Dangerous Health Claims

The federal FTC Act (15 USC § 55(a)(1)) deems an ad misleading if it fails to reveal facts that consumers ought to know about such a product. The specific language of that statute is as follows:

False Advertisement (FTC Act)

(1) The term “false advertisement” means an advertisement, other than labeling, which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the commodity to which the advertisement relates under the conditions prescribed in said advertisement, or under such conditions as are customary or usual. No advertisement of a drug shall be deemed to be false if it is disseminated only to members of the medical profession, contains no false representation of a material fact, and includes, or is accompanied in each instance by truthful disclosure of, the formula showing quantitatively each ingredient of such drug.

If without needed “qualifying information,” the ad would be misleading, it must be disclosed. Limitations on promised health benefits must be disclosed, as must hidden safety risks.

For example, Snore Formula, Inc., 136 F.T.C. 214, 296 (2003) required, by consent order, that snoring treatment claims be accompanied by a disclosure about the dangers of sleep apnea, along with the suggestion to consult a physician when appropriate.

In another case, a consent order compelled the makers of St. John’s Wort to disclose potentially dangerous drug interactions even when no safety claims are made. Formor, Inc., 132 F.T.C. 72, 101-02 (2001).

In an exercise-equipment case, a marketer was required to disclose the risk of injury from the exercise device’s spring snapping or breaking. Consumer Direct, Inc., 113 F.T.C. 923, 925-26 (1990) (consent order).

What is “Qualifying Information” for the Purposes of Clarifying A Health Product’s Claims?

“Qualifying information” is information that explains or limits the applicability of an ad claim. It should be not only clear and noticeable but also understandable, which may be challenging in areas of scientific uncertainty. For example, in Nestlé HealthCare Nutr., Inc., (2011), the FTC stated that “experience and research show that it is very difficult to adequately qualify a disease risk-reduction claim in advertising to indicate that the science supporting the claimed effect is limited.” At issue in Nestle were ads promoting “BOOST Kid Essentials," a children’s nutritional drink that also delivers probiotics using an attached straw. The FTC challenged that BOOST Kid Essentials can prove that it “prevents upper respiratory tract infections in children; strengthens the immune system, thereby providing protection against cold and flu viruses; and reduces absences from daycare or school due to illness.” Nestle entered into a consent order agreeing to refrain from making such claims per the Nutrition Labeling and Education Act of 1990 (NLEA). In order to make such health claims, as in all cases, Nestle would have needed it authorized by the FDA upon a finding of “significant scientific agreement” among experts. The idea of using “qualifying information” was raised in Nestle to clarify the limited scientific support for the ad claims. But even with the qualifying information, if the “net impression” of the ad claims communicated disease reduction, then the product would need approval as a drug.

Marketers are responsible to ensure that consumers understand the extent and scope of scientific support in health-related claims. Contradictory or confusing disclaimers, especially in light of significant contrary evidence, would run afoul of their legal obligations.

Qualifying disclaimers may not contradict the underlying advertising claim. Nor may disclaimers be buried in the “terms and conditions” contained elsewhere.

Marketers’ sly use of vague qualifying terms such as “may,” “promising,” “preliminary,” “initial,” or “pilot” is likely to be misinterpreted by consumers as positive product attributes versus necessary scientific disclaimers. Such “disclaimers” are often disguised as positive spins rather than as substantive disclaimers. As we saw in the Pom Wonderful case, a concurring FTC Commissioner found that certain POM ads warranted extrinsic evidence to determine the impact of such qualifiers on “establishment claims.” An establishment claim is a claim that "contains an express or implied statement regarding the amount of support the advertiser has for the product claim." Nat'l Council Against Health Fraud, Inc. v. King Bio Pharms., 133 Cal. Rptr. 2d 207 (Cal. Ct. App. 2003). Examples of establishment claims include “clinically proven,” “laboratory tested,” and “45% More Effective!” "scientifically tested," and "proven effective."

Reasonable consumers may interpret such establishment claims 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.

Examples of Health-Supplement Ads that Need "Qualifying Information" to Address Potential Misleadingness

A mineral supplement claims to remedy fatigue by restoring a mineral deficiency that only afflicts 2% of the population. The ad should “qualify” its benefit claim by pointing out that only 2% of people actually suffer from that deficiency.
A weight-loss supplement posted results of a placebo-controlled, double-blind clinical study to show that the group that its product resulted in an average weight loss of 12 pounds over eight weeks. But the test subjects also controlled calories and exercised vigorously. Any ad that touts that study needs that qualifying information about the behaviors of the test group.
An herbal pain remedy advertises “no side effects of the over-the-counter pain relievers.” The herbal remedy, however, produces nausea in consumers who take it regularly. This ad implies to reasonable consumers that the herbal remedy produces no side effects and can be construed as deceptive. The nausea side effect is considered “qualifying information” that should be disclosed.
An energy drink when regularly consumed steadily increases blood pressure. Even absent any representations about the drink’s safety, a marketer should disclose this risk.
A botanical supplement marketed as a “natural” sleep aid but which has active compounds that interfere with other prescription medications often used by those who have sleep problems. This potential interaction should be disclosed.
A magazine ad for nasal strips that reduces the symptoms of snoring but not its cause, for example, sleep apnea. Consumers may be misled into believing that such nasal strips remediate the underlying medical condition that is causing the snoring. Therefore, a legible disclaimer that is as clear and conspicuous as the “snoring” claims are needed to allay reasonable confusion as to what the product actually does.

The Need for “Clear and Conspicuous Disclosures” of Qualifying Language on Dietary Supplements

After we’ve established the need to clarify a potentially misleading ad using qualifying language, what is the acceptable formatting? The language must be easily noticeable and understandable by ordinary consumers. It should stand out to a degree in contrast to the underlying ad claim(s).

A general rule is that the qualifying language should be provided in the same medium as the underlying advertising claim(s). For example, if an ad claim is made both visually and audibly, then the qualifying language should also be made visually and audibly.

An audible disclosure should be delivered in 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 easily accessible and not rendered through a hyperlink.

No disclosure of qualifying language may be contradicted, mitigated by, or inconsistent with, any other impressions made in the ad.

The interpretation of express and implied ad claims is gauged by the targeted members of that advertising campaign. For example, the reasonable child or the reasonable elderly person will be a standpoint for how an ad is perceived, which includes the effectiveness of any disclosure.

Whether a disclosure is effective will depend on the “net impression” of the ad with the disclosure. If a “significant minority” of consumers is still misled despite the disclosure, then the disclosure is not sufficient. Generally, the FTC has found that a “significant minority” may range from 10% to 22%. ECM Biofilms, Inc., 160 F.T.C. 652, 667-68 (citing Firestone Tire & Rubber Co. v. FTC, 481 F.2d 246, 249 (6th Cir. 1973); Telebrands Corp., 140 F.T.C. at 325), aff’d ECM Biofilms, Inc. v. FTC, 851 F.3d 599, 611 (6th Cir. 2017) (“We have previously expressed unwillingness ‘to overturn the deception findings of the Commission’ where an ad misleads ‘15% (or 10%) of the buying public.’”).

If a misleading ad claim cannot be remedied by an effective disclosure, then the ad should be modified to avoid misleadingness or the ad should be removed.

Examples Where Disclosures Not “Clear and Conspicuous” to Cure Misleading Ad Claims

A magazine ad for nasal strips that reduces the symptoms of snoring but not its cause, for example, sleep apnea. Consumers may be misled into believing that such nasal strips remediate the underlying medical condition that is causing the snoring. Therefore, a legible disclaimer that is as clear and conspicuous as the “snoring” claims are needed to allay reasonable confusion as to what the product actually does.
An herbal supplement uses two studies that suggest that it helps to maintain healthy cholesterol levels. The studies have considerable limits, and a better study would be warranted. The company’s attempt at a qualifying disclaimer declares, “promising, preliminary scientific studies show that our product may be effective in reducing cholesterol.” The words “promising,” “preliminary,” and “may” most likely fail to convey the limitations of the science behind the studies used.
An internet article claims that certain light “therapy” can remove acne with two minutes of daily treatment. Below the claim, in the same print size, color, and style, the ad disclaims, “this statement is not intended for the treatment of any disease or medical condition.” But the disclaimer contradicts the advertising claims and is therefore unacceptable.
A weight-loss advertisement is cloaked in medical images and medical terminology, such as “medical innovation” and “research facilities.” A disclaimer appears in the terms and conditions section of the website that states: “no clinical study has been performed on the product.” The disclaimer is not “clear and conspicuous,” and also fails to cure the medical misimpressions caused by the images and terminology.

Does the FTC Regulate False Advertising of Health Products?

Yes. Chief among the FTC’s missions is to ensure that marketers convey accurate information about the benefits and safety of dietary supplements and health products. Spanning across many industries, the FTC’s “Policy Statement” on Deception links to guidance relating to all health products. For example, the website houses separate guidelines for false weight-loss claims, eyeglass prescriptions, and Lasik promotions.

The FTC regulates the “substantiation” (evidentiary support) of advertising claims.

The FTC polices the marketplace to ensure that advertising claims are 1) truthful and not misleading, and 2) substantiated by "competent and reliable scientific evidence."

The FTC requires sellers to possess adequate substantiation of all express and implied ad claims before the products are disseminated. Adequate substantiation depends on the nature of the product and the nature of the advertising claims.

Who is liable for False Advertising under FTC Law?

Anyone participating in marketing and promotion is potentially liable under FTC law. That includes anybody who has the authority and the obligation to ensure the truthfulness of claims.

The FTC may take legal action against product marketers, owners, corporate officers, marketing agencies, distributors, retailers, catalog companies, infomercial producers, expert endorsers, and others engaged in deceptive marketing and promotion.

Examples of FTC cases for false advertising:

FTC v. LeadClick Media, LLC, 838 F.3d 158, 167-73 (2d Cir. 2016) (affiliate advertising network);
POM Wonderful, LLC,155 F.T.C. at 82-84 (individual officer);
FTC v. Fitness Brands, Inc., No. 1:12-cv-23065-CMA (S.D. Fla. Aug. 23, 2012) (stipulated final judgment) (infomercial host);
Dreher, 150 F.T.C. 560 (2010) (consent order) (expert endorser);
Campbell Mithun LLC,133 F.T.C. 702 (2002) (consent order) (ad agency);and
Tru-Vantage Int’l, LLC, 133 F.T.C. 299 (2002) (consent order) (infomercial producer).

What Legal Remedies May the FTC Seek for False Advertising?

I wrote in this blog about the FTC’s power to regulate false advertising:

The FTC requires advertisers to prepare substantiation of their ad claims prior to dissemination. Upon request, advertisers must produce documentary evidence of that substantiation. The FTC will then decide whether, in fact, it substantiates the claims. If it does not, litigation may ensue. Or the advertiser may agree to a "Consent Order" that compels corrective advertising, restitution, [refunds], [civil penalties], and/or clearance by the FTC of future ads.

Corrective advertising compels companies to cure any “lingering deception” in the marketplace. In Novartis Corp. v. FTC, 223 F.3d 783, 787-88 (D.C. Cir. 2000), the federal appeals court held that corrective advertising is appropriate to stop reinforcing a “false belief about a product that is likely to linger).”

In extreme cases, the FTC has secured outright bans on a company’s marketing activity. For example, in FTC v. Kevin Trudeau, No. 1:03-cv-03904 (N.D. Ill. Aug. 7, 2008), the court imposed a three-year ban on Trudeau from participating in any infomercial for any product). Mr. Trudeau sold a book called The Weight Loss Cure “They” Don’t Want You To Know About. The court found that Trudeau was ‘"not a credible witness."’ The judge noted several "undeniably false" statements in his infomercials, finding that, contrary to Trudeau's claims:

the diet protocol could not be done "easily" and "at home" because the protocol described requires colonics, which must be done at the office of a licensed practitioner, as well as injection of human growth hormone;
dieters could not "complete" or "finish" Trudeau's four-phase program because Trudeau's book states that "Phase 4 is for the rest of your life";
dieters could not eat "anything" they want, because Trudeau's book prescribes that dieters following Phase 4 must eat "only 100% organic food," and no "brand name" food, "fast food," or "food served by regional or national chain restaurants"; and
the diet protocol did not require "no exercise," because Trudeau's book states that three of the diet's four phases, including Phase 4, require walking one hour outside every day.”

Here is an FTC press release that discusses this Trudeau weight-loss case.

Any advertising claim that falsely advertises attributes about the safety, efficacy, or benefits of a product is subject to FTC investigation and enforcement.

How Does the FTC Coordinate with the FDA on False Advertising?

The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing of food, dietary supplements, drugs, devices, and other health-related, consumer products.

Both Federal agencies share a Memorandum of Understanding also referred to as the “FDA-FTC Liaison Agreement” that governs the basic division of responsibilities between them.

The FDA primarily governs labeling, including the package, product inserts, and other promotional materials available at the point of sale. The FTC primarily governs all other forms of advertising. Some forms of marketing, like a website that sells health supplements, may fall under the jurisdiction of both the FDA and the FTC. But such dual jurisdiction does not preclude the FTC’s authority to remedy false or deceptive advertising.

As to Regulating Health Claims, How does the FTC differ from the FDA?

All health products, including dietary supplements, must use advertising that is truthful and not misleading. But there are key differences in the agencies’ legal frameworks that affect their approaches to enforcement. Advertisers would be well served to know both agencies’ customs and practices.

The FTC is not bound by scientific distinctions set forth in the Dietary Supplement Health and Education Act of 1994 (DSHEA). In DSHEA, for example, supplement manufacturers have a right to advertise using basic nutrient-health claims (e.g., “promotes heart health”) without FDA pre-approval. These types of advertising claims are called “structure-function” claims. The FDA follows basic steps when evaluating structure-function claims versus health claims, disease claims, or drug claims. The FTC, however, operates under its general deception standard using a “net impression” standard unimpaired by the FDA’s scientific distinctions. In Daniel Chapter One, 148 F.T.C. 832, 1086 (2009), the court found “no authority that the DSHEA amendment to the FDCA regarding “structure/function” claims is binding on the Commission.” This case was affirmed by the D.C. Court of Appeals in 2010.

Does the FTC Pre-Approve Health Claims Like the FDA?

No. Only the FDA evaluates and pre-approves health claims for food, supplements, and health products. But the FTC does give significant deference to FDA determinations on issues of health-claim substantiation. A product with a health claim must be backed up by “significant scientific agreement” in order to be approved and sold. As to the FTC’s approach to investigating food advertising, see Enforcement Policy Statement on Food Advertising. For health claims that do not meet the FDA’s “significant scientific agreement” standard would be deceptive unless “limitations or uncertainty in the supporting science are clearly communicated with the qualifying language that is noticed and understood by consumers.” Id.

Must Advertisers Also Notify the FTC of Structure-Function Claims?

No. Supplement makers using structure-function claims or other nutrition claims must notify the FDA only within 30 days of marketing. The FTC does not require the same notice. But the FTC still requires and may seek the production of, substantiation that the claims are truthful and not misleading. Both agencies may adhere to the same methods to assess the quality and adequacy of the science that allegedly substantiates the advertising claims. Both agencies look for “competent and reliable scientific evidence” about the benefits and safety of dietary supplements, food, and other health-related products. For more guidance about health-claim substantiation, see Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Food and Drug Admin. (Jan. 2009).

**Does the FTC Examine Express and Implied Advertising Claims?**

Yes. All claims, which include implied claims as interpreted by reasonable consumers, are examined. Once all claims are identified, the FTC will match them against the available scientific evidence to determine the adequacy of the substantiation of the claims at issue.

First, advertisers must ensure that their express claims are accurate. But some ads, taken in context with the entire product, may convey implied messages for which advertisers are equally responsible to ensure accuracy. See, Novartis Corp., 223 F.3d at 787 (ad claim that back pain remedies were of superior efficacy were material and “played a substantial role in creating or reinforcing in the public’s mind a false belief about the product”; no requirement of actual deceit necessary); Kraft, Inc., 114 F.T.C. 40, 121-22 (1991), aff’d, 970 F.2d 311 (7th Cir. 1992)(FTC would rely on its own reasoned analysis rather than extrinsic evidence to determine what claims, including implied ones were conveyed in the challenged advertisement; Kraft was accused of misrepresenting the amount of calcium contained in its processed cheese slices relative to the calcium content in five ounces of milk, and in imitation cheese slices).

Advertisers may not imply indirect health benefits that they may assert directly.

From Whose Viewpoint is Questionable Advertising Examined?

The reasonable consumer’s viewpoint. Similar to New York law, misleadingness is gauged by a “reasonable person acting reasonably under the circumstances.” The reasonable consumer’s understanding controls—not the marketer’s intent.

The FTC will consider the “net impression” communicated by an ad within its whole context, which can include the product’s text, name, charges, graphs, or other images. For example, in FTC v. Roca Labs, Inc. (M.D. Fla. 2018), relating to an “Anti-Cravings” weight-loss product with the complimentary website, gastric bypass.me, the court had no problem inferring deception from that and other ad elements such as the use of white lab coats, medical terminology, third party reviews called “success videos,” before and after photos, and testimonials without disclosing pay. The court ordered a permanent injunction and disgorgement. Similarly, in F.T.C. v. Direct Mktg. Concepts, Inc., 624 F.3d 1, 8–9 (1st Cir. 2010), the court used the reasonable-consumer standard when ruling against infomercials declaring that “coral-derived calcium supplements cure cancer, multiple sclerosis, and other degenerative diseases by rendering acidic bodies more alkaline, and they are 100% absorbed by the human body.” Nor were the “specific health claims not cured by general disclaimers,” held the court.

Advertisers are responsible for substantiating with competent and reliable scientific evidence all reasonable interpretations of their advertising.

The “intended audience” is the vantage point from which the court gauges the reasonable consumer. Different audiences may be particularly susceptible to exaggerated claims. For example, cancer patients are likely to be more vulnerable to claims that a product can cure cancer. Fairness dictates that those audience members act as reasonable consumers when receiving an advertisement’s messag.

For express claims, the deception may be proven by the claims themselves. For implied claims, extrinsic evidence, such as consumer surveys and copy tests, may be necessary to prove the consumer’s reasonable interpretation of an ad.

Worth noting is that the FTC as a regulatory body can rely on its common sense and expertise to determine what messages are being clearly conveyed. See, e.g., POM Wonderful LLC, 155 F.T.C. at 13, 66. Even if an advertisement clearly implies a claim, a court may not require the FTC to produce extrinsic evidence of a reasonable consumer’s interpretation of the implied claim. See, e.g., F.T.C. v. Natl. Urological Group, Inc., 645 F. Supp. 2d 1167, 1189 (N.D. Ga. 2008), aff'd, 356 Fed. Appx. 358 (11th Cir. 2009)(unpublished)(“When assessing the meaning and representations conveyed by an advertisement, the court must look to the advertisement's overall net impression rather than the literal truth or falsity of the words in the advertisement.”).

As to the FTC’s burden on misleadingness, the court held:

To demonstrate that a claim is likely to mislead a reasonable customer, the FTC may proceed under a 'falsity theory,' a “reasonable basis theory,” or both. QT, Inc., 448 F.Supp.2d at 957–58.
If the FTC proceeds under a falsity theory, it “must demonstrate either that the express or implied message conveyed by the ad is false.” FTC v. Natural Solutions, Inc., C.A. (C.D.Cal. Aug. 7, 2007).
If the FTC proceeds under a 'reasonable basis' theory, it must demonstrate that the advertiser lacked a reasonable basis—or adequate substantiation—for asserting that the message was true. Id.
As discussed in the defendant's motion for summary judgment, in the case of health-related claims or claims concerning the efficacy or safety of dietary supplements, this reasonable basis must, at a minimum, consist of competent and reliable scientific evidence." QT, Inc., 448 F.Supp.2d at 961.

Click below for more examples of structure-function claims.

To be continued...