Getting to the truth of the matter

7 tips for substantiating establishment claims

“Clinically proven…” “Laboratory tested.” “45% More Effective!” Claims like these sell product. They also carry with them the assertion that the advertising claim has been “established” or proven by competent and reliable testing. Establishment claims can be express (e.g., “Studies show…”) or implied (e.g., use of a caduceus or images of actors in lab coats). In all cases, however, they require that a company have the form of substantiation alluded to by the claim and that the touted performance benefit be both statistically and clinically meaningful. The risks for the unprepared advertiser are substantial, and include Lanham Act litigation, competitor-initiated challenges at the National Advertising Division (NAD), regulatory inquiries, consumer class actions, and adverse publicity.

A review of recent advertising cases reveals that most establishment claims that are found to be unsubstantiated are rejected because, although the advertiser had the study referenced by the claim, the advertiser failed to prove that its statistically significant study results were material enough to be meaningful. The elements required to establish that “statistically significant” testing results are “meaningful” can vary based on the product and claim. There are, however, preliminary steps that can be taken to help an establishment claim survive scrutiny, including the following:

  • Use industry standards testing protocols, where available. When assessing the validity of a study used to substantiate an establishment claim, the courts, Federal Trade Commission (FTC) and the NAD generally defer to industry standards, especially those developed by reputable benchmark organizations (e.g., ASTM International or USP). Standard protocols exist for virtually everything, from measuring the shear strength of adhesives to evaluating the strength of cleansers in spray bottles. If a company chooses to deviate from an industry standard protocol, or to use a novel study design, the company should be prepared to explain why the deviations from the standard protocol are reasonable.
  • Cross-check the sample size with applicable industry and regulatory standards. Authoritative bodies also review the number of participants in a study to ensure it is reasonable to extrapolate the results to the larger population. The appropriate “N” for a study varies by type of product and type of claim. For example, sample sizes for cosmetics and cleansers generally are permitted to be significantly smaller than the sample sizes used to test drug products. And parity claims typically require larger sample sizes than superiority claims. Special attention should be paid to the sample size of a study to ensure it is consistent with the industry (and, where available, regulatory) standards for the claim and product category.
  • Confirm the use of controls. Ensure that the protocol includes an adequate control to help confirm that the benefit experienced by the subjects can be attributed to the product, as opposed to placebo. Where possible, blinding and randomization also should be used to mitigate the risk of subject or investigator bias. Studies have been found to be inadequate to substantiate establishment claims where the study design failed to control for placebo effect, subject bias, or investigator bias.
  • Bridge any differences between the tested and final product formulations. At times, advertisers will develop product claims using testing on individual product ingredients (or a similar product formulation) in lieu of testing on the actual product in commerce. When doing so, it is important to confirm that there is competent and reliable scientific evidence that the product in commerce will perform in the same manner as the ingredients (or combination of ingredients) tested in the underlying study. Upon a challenge, the advertiser will have the burden to confirm that the tested ingredient(s)’ effectiveness is not compromised by the existence of other ingredients in the product. In the absence of bridging evidence, advertising law standards require that product claims either be based on testing of the actual product or limited to the actual ingredient(s) tested (e.g., “x ingredient is proven to…” instead of “x product is proven to…”).
  • Narrowly tailor the final claim to the underlying protocol and results. Ensure that the final claim lines up with the testing, and that the form and regularity of product use conveyed by the final claim correlate with the study protocol upon which the claim is based. For example, a single-day study should not be used to make claims about prolonged product performance. Similarly, a study that solely measures product efficacy after repeated product use should not be used to make claims regarding product efficacy after a single application. 
  • Review the publicly available scientific data regarding product efficacy. A study will be found to be insufficient to substantiate an establishment claim if it contradicts the larger body of evidence regarding the efficacy of a product. Before featuring an establishment claim, companies should compare their study results to other publicly available information regarding product efficacy and, where the two diverge, be prepared to explain why its testing results are more persuasive than contradictory data.
  • When using in vitro studies, document why the statistically significant difference is material. Proving materiality can be difficult when attempting to tout differences that are based on in vitro studies or benefits that are not immediately perceptible to humans. In these instances, it is helpful to establish a relationship between the new data and either other studies previously endorsed by regulatory bodies or published, peer-reviewed scientific literature by independent parties, to help confirm that the differences established by the new study are material for consumers. It is also helpful to correlate the study with a mechanism of action of the product that can be more easily understood.

Advertising that a product claim has been proven by well-designed tests is a highly effective way to sell product. But touting a test result will attract the attention of not only consumers, but also competitors and regulators. Attention to the underlying testing will help ensure that advertisers realize the benefit of this compelling form of advertising without incurring substantial and unnecessary risks.

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John E. Villafranco

John E. Villafranco is a partner in the advertising and marketing practice at Kelley Drye & Warren LLP in Washington, D.C. Mr. Villafranco can be...

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Raqiyyah R. Pippins

Raqiyyah R. Pippins is an associate in the food and drug and advertising practices at Kelley Drye & Warren LLP in Washington, D.C. Ms. Pippins...

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