New York, NY – Sept. 12, 2017  – The National Advertising Division has recommended that Capillus, Inc., the maker of a laser therapy device designed to prevent hair loss and regrow hair, discontinue claims that the product is “clinically proven” and “physician recommended.”

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

As part of its routine monitoring program, NAD requested Capillus provide substantiation for claims made in print advertising for the Capillus 82, a low-level laser therapy medical device.  The following claims formed the basis for NAD’s inquiry:

• “Clinically proven to regrow hair.”
• “Capillus laser therapy caps prevent progression of hair loss and regrow thinning hair in a dignified manner.”
• “The physician-recommended cap that’s clinically proven to regrow hair.”
• “Wear our cap for 30 minutes, every other day.”
• “Made in the USA, the Capillus 82 is FDA-Cleared and has no known adverse side-effects so you can use it with confidence.”
• “Unlike laser comb devices, Capillus lasers require no effort from the user – making it a preferred choice of doctors worldwide.”
• “At $799, the Capillus is the best value you can get for the amount of lasers (comb devices are priced at more than 4X as much per laser).”

NAD noted in its decision that the advertiser did not conduct any clinical studies on Capillus 82, but referred instead to studies conducted on different devices which demonstrated the efficacy of those devices in regrowing hair in subjects with androgenetic alopecia, or male- and female-pattern baldness.  While the advertiser established to the satisfaction of the Food and Drug Administration that the Capillus 82 is substantially equivalent to other devices cleared by the FDA to promote hair growth, the cited studies are not a good fit to support the challenged claims that Capillus 82 is clinically proven to regrow hair or prevent the progression of hair loss.

NAD recommended that the advertiser discontinue the claims that Capillus 82 is “clinically proven to regrow hair” and “Capillus laser therapy caps prevent progression of hair loss and regrow thinning hair in a dignified manner.”   NAD noted, however, that nothing in the decision prevents Capillus from making claims that are consistent with its FDA clearance for indications of use – to treat male- and female-pattern baldness in men and women with specific patterns of hair loss and skin types.

In support of its “physician recommended” claim, the advertiser relied on testimonials from  five hair restoration experts.  NAD noted that three out of the five testimonials addressed the  Capillus 272, a predecessor laser therapy product, and two referred to the general benefits of laser therapy in treating thinning hair.  NAD noted that testimonials are not sufficiently reliable to support a doctor recommended claim. In the absence of reliable survey evidence demonstrating that physicians recommend Capillus 82 as part of their practice, NAD recommended that the advertiser discontinue the claim “[t]he physician-recommended cap that’s clinically proven to regrow hair.”

NAD has typically found that a claim that a product has no side effects requires a study on the actual product. In this case, the challenged claim stated that the product has “no known side effects.” However, NAD determined that even a claim that a product has “no known” side effects should be supported by studies on the actual product. NAD further determined that the absence of any adverse events being reported to the FDA is not sufficient to support the claim and recommended the claim be discontinued. However, NAD said nothing in the decision prevents the advertiser from claiming that no adverse events have been reported to the FDA in connection with Capillus 82.

NAD noted that the lasers in the Capillus 82 are manufactured outside of the U.S., and recommended the advertiser discontinue its “Made in the USA” claim.

As to the claim “Unlike laser comb devices, Capillus lasers require no effort from the user – making it a preferred choice of doctors worldwide,” NAD determined that the “Unlike laser comb devices, Capillus lasers require no effort” portion of the claim was supported because the device requires no additional effort beyond turning the device on and placing it on the head.  However, NAD recommended that the “preferred choice of doctors worldwide” portion of the claim was not supported and that it be discontinued.  NAD also found the claim “Wear our cap for 30 minutes, every other day” was supported because it comports with the product’s use instructions.

Finally, NAD recommended that the advertiser discontinue the claim “At $799, the Capillus is the best value you can get for the amount of lasers (comb devices are priced as much as 4x the amount per laser.)” because there was no evidence demonstrating that additional lasers are more effective in regrowing hair and impeding hair loss than laser comb devices with fewer lasers (and which are significantly less expensive than Capillus 82).

Capillus, in its advertiser’s statement, said the company “agrees to comply with NAD’s recommendations, and our advertising will reflect these changes immediately.”

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.