TINA.org zooms in on the fine print in ad for “heart chews.”
Taking the lid off company's claims that laser hats are "FDA cleared" and "clinically proven" to regrow hair.
UPDATE 9/15/17: NAD has recommended that Capillus discontinue several of the claims that served as the basis of the following ad alert, including that one of its laser hats, the Capillus 82, is “clinically proven to regrow hair.” NAD said Capillus had not conducted any clinical studies on the product to back up the claim, which also led NAD to recommend that Capillus stop claiming that there are “no known adverse side-effects” associated with using the cap. Capillus agreed to implement the changes immediately. Our original ad alert follows.
Capillus claims that its laser hats — which we can only hope precede laser cats — are “FDA cleared” and “clinically proven” to regrow hair. Pop on one of these bad boys for 30 minutes every other day and let the device and its “low level laser therapy” do its thing. Unlike laser combs, Capillus laser hats “require no effort from the user,” the company notes in this recent print ad.
Interestingly, though, it’s another company’s laser comb that helped Capillus get FDA clearance in the first place. The company’s first application to the agency in January 2015 for “clearance” or permission to market its Capillus 272 Pro hat listed the HairMax LaserComb as the sole reference device. As part of the application, Capillus had to prove that the Capillus 272 Pro, which costs $3,000, is “substantially equivalent” to products in its class already legally on the market and it chose the HairMax LaserComb. (See our ad alert on the laser comb here).
That first application also included the study for which Capillus claims that the laser hats are “clinically proven” to regrow hair. But as the title of the company-sponsored study reveals, “A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy,” the test subjects consisted entirely of women. Also, Capillus noted in its FDA clearance application that some members of the placebo group were also shown to regrow hair.
Lastly, while Capillus touts a “satisfaction guarantee,” the guarantee has some strings attached to it. Namely, customers have to wait 180 days after delivery before they can return the product and then have to send it back before an additional 30 days go by. On top of that, there’s a 25 percent restocking fee of the purchase price. That leaves customers who bought the Capillus 272 Pro $750 out of pocket and those who purchased the $799 Capillus 82 advertised in the print ad with a $200 loss.
Find more of our coverage on hair loss here.