Weighed down by the advertiser’s performance claims, the National Advertising Division (NAD) recommended that Weighting Comforts modify or discontinue the express claims for its weighted blankets.

The self-regulatory body requested that Weighting Comforts substantiate claims, including “Our weighted blankets help you sleep better and reduce anxiety” and “In a recent study, 63% reported lower anxiety after use.” Several other challenged claims and consumer testimonials were permanently discontinued by Weighting Comforts as part of the inquiry.

As a preliminary argument, the advertiser told the NAD that the sleep improvement and anxiety reduction claims related only to “general wellness” and did not constitute health claims that required scientific substantiation. The NAD disagreed.

“Anxiety is a mental health disorder and anxiety symptoms can be measured,” according to the decision. “Reducing anxiety is a health-related efficacy claim requiring support in the form of competent and reliable scientific evidence such as human clinical trials that are methodologically sound and statistically significant to the 95 percent confidence level with results that translate into meaningful benefits for consumers that relate directly to the advertised performance benefits.”

Similarly, since sleep improvements can be measured and related to consumer health, the claim must be supported by competent and reliable scientific evidence, the NAD said.

In support of the challenged claims, Weighting Comforts provided four studies, two of which were on weighted blankets, as well as positive consumer reviews. Although the NAD determined that a Swedish study designed to determine whether a weighted blanket could have a positive impact on adults with chronic insomnia was sufficiently reliable, it also found that the study was not a good fit to support the challenged claim.

“The study concluded that ‘a weighted blanket may aid in reducing insomnia through increased tactile and proprioceptive inputs, may provide an innovative, non-pharmacological approach and complementary tool to improve sleep quality,’” the NAD said. “However, the claim at issue—our weighted blankets help you sleep better—does not reflect the qualified nature of the study’s conclusion.”

Instead, the self-regulatory body recommended the claim be modified to state that the weighted blankets “may improve sleep quality.”

The other two studies—one assessing the impact of massage therapy on cortisol, serotonin and dopamine, and a second on the impact of serotonin and melatonin on the digestive physiology of mice—did not test weighted blankets, and the NAD found them irrelevant to support the challenged claims.

As for the anxiety reduction claims, the NAD found “significant flaws” in the final study as, among other problems with the study, its subjects had low to no anxiety and underwent only a brief, five-minute test session with the blankets. “Taken together, NAD determined that these were fatal flaws which rendered the study insufficiently reliable to support the challenged anxiety reduction claims.”

The inclusion of positive consumer reviews provided no support for the claim, the NAD added, as advertisers may not make claims through consumer testimonials that it could not otherwise substantiate if made directly by the advertisers, and such reviews do not constitute evidence as to the efficacy of the product.

In the absence of competent and reliable scientific evidence demonstrating that the advertiser’s weighted blankets reduce anxiety, the NAD recommended that the anxiety claim be discontinued, although “nothing in the record prevents the advertiser from touting that its blankets provide users a sense of security.”

To read the NAD’s press release about the decision, click here.

Why it matters: The decision provides insight on a range of issues, from the evidence needed to substantiate health claims to appropriate study methodology, including whether a study conducted outside the United States can be applied to claims made to the U.S. population, a discussion of proper control and the importance of a study’s consumer relevance to the challenged claims.