Imagine a breakthrough dietary supplement that solves all your problems—you’ll lose weight, feel calm and relaxed, reduce bloating, sleep better, wake up happier and have more energy. Sound too good to be true? Maybe. But what if studies show that the ingredients in the supplement each support those claims—would that be false advertising?

On Aug. 13, the National Advertising Division (NAD) issued a decision that provides useful new guidance or, in the advertiser’s words, “novel critiques” for substantiating health product claims. BBB National Programs, NAD Division is a self-regulatory body that ensures that advertising claims are truthful and fair. Proceedings before the NAD are akin to other alternative dispute resolution processes, and participation in the self-regulatory process is voluntary. According to the NAD, its case decisions represent the single largest body of advertising law in the country. If one opts out of the NAD process or refuses to comply with the NAD’s recommendations, the NAD will refer the matter to a regulatory agency, typically the Federal Trade Commission. Alternatively, the advertiser could face a challenge to its advertising in federal or state court.

The NAD’s recent decision concerned Happy Mammoth’s dietary supplement HORMONE HARMONY, which contains a proprietary blend of ingredients claimed to ease symptoms associated with menopause. Happy Mammoth voluntarily discontinued several advertising claims in response to the NAD proceeding, but attempted to defend its claims that the supplement:

• “Relieves symptoms of menopause”

• “Relieves hot flashes”

• “Improve[s] sleep quality”

• “Reduces bloating [and] gas.”

In reviewing such claims, the NAD evaluates whether the advertiser can properly substantiate its claims with evidence, such as scientific studies or reliable research. An advertiser must have a reasonable basis (i.e., substantiation) for its claims prior to running an ad. While Happy Mammoth cited numerous studies and articles to substantiate its claims, all the studies and articles concerned the individual ingredients contained in the supplement, not the supplement itself. The NAD clarified that evidence regarding individual ingredients cannot support a claim that the product provides a claimed benefit.

Happy Mammoth indicated a willingness to qualify its claims by tying the ingredients to the health claims, for example, stating “this supplement contains ashwagandha which improves sleep quality.” The NAD agreed that such qualified statements would be acceptable, but only if substantiated by competent and reliable scientific evidence. Happy Mammoth produced several studies on the ingredients in its Hormone Harmony supplement. However, the NAD found none of them adequately substantiated Happy Mammoth’s claims, even if such claims were limited to the ingredients.

One of the studies cited by Happy Mammoth concerned ashwagandha as an aid for sleep. The study was conducted on both men and women from age 18-60. Happy Mammoth’s product, however, was marketed to women experiencing menopause. Happy Mammoth also relied upon a study to support the claim that rosemary extract reduces bloating, but the NAD noted that the study was conducted on mice rather than humans.

The NAD found that other studies relied upon by Happy Mammoth had “relatively small” population sizes (e.g., 50-100 participants), were conducted for “relatively short” periods of time (e.g., eight weeks), or varied in the formulation, dosage or method of administration of the ingredient (even when Happy Mammoth’s supplement had more of the ingredient than the dose in the study). The NAD also criticized the fact that there was no evidence as to “what affect the other ingredients in the product have” on the symptoms or the efficacy of an ingredient.

The NAD further noted that while many of the studies reported statistically significant improvements in the relevant symptom, they also contained limiting statements. For example, studies included statements that fennel can “probably” be a suitable alternative for treating menopausal symptoms or that “further clinical trials” were recommended. The NAD also cautioned against relying on monographs issued by foreign regulators and held that “review articles” that provided background information were not competent and reliable evidence to substantiate a product or ingredient claim.

Ultimately, the NAD issued a decision recommending that Happy Mammoth discontinue its challenged claims but noted that Happy Mammoth could make some alternative ingredient efficacy claims “supported by the limited findings” of the studies or claims that “describe the traditional or historic use of” certain ingredients to support sleep or reduce bloating. So, what can advertisers do to avoid these pitfalls?

1. Limit the claim to the product or specific ingredient studied. If the studies are not on the product itself, be sure to qualify that the claim is about a specific ingredient rather than the product as a whole.

2. Match your evidence to your product. Try to obtain evidence on the same formulation, dosage, method of administration, and target population as that of your product.

Obtain additional evidence to explain the impact of any gaps or inconsistencies between the focus of the studies used for substantiation and your actual product or ingredients.

3. Rely on conclusive studies. Be certain that the studies relied upon are not only statistically significant, but generally accepted as reliable and accurate scientific evidence. Avoid relying on evidence that does not specify the exact symptom improved, relies on self-reporting, or includes soft statements that a product “may” cause or “probably” causes a desired result, or that further research is needed. NIE

Jonathan Hyman is a trademark and brand protection partner at Knobbe Martens and co-chair of the firm’s Advertising, Media and Entertainment practice group. Kate McMorrow is a senior associate at Knobbe Martens with extensive experience litigating and counseling clients on trademark, false advertising, unfair competition, patent and other IP matters. Zoe Vikstrom is an associate at Knobbe Martens whose practice focuses on domestic and international trademark prosecution and enforcement.