NAD Tells Capillus to End Some Hair Cap Claims

Capillus, a manufacturer of products designed to address hair loss, has been told to stop making certain claims about their products.

This recommendation came in September 2017 from the National Advertising Division (NAD) of the Better Business Bureau, an agency charged with monitoring advertising and ensuring that marketing claims are truthful and accurate.

According to the NAD, claims made about the Capillus82 Laser Growth Cap were not supported by clinical studies, even though it had been approved by the FDA.

Capillus, which continues to manufacture, sell and distribute the Capillus82 and similar, higher-end models, continues to make claims on the company product page on Amazon.com that triggered the NAD inquiry and subsequent recommendation that said claims be discontinued. Meanwhile, the company has left itself open to false advertising claims from customers who have spent anywhere from $800 to $3,000 on a product that may not live up to the manufacturer’s assertions.

About the Capillus Products

The Capillus82, 202 and 272Pro are essentially baseball caps, lined on the inside with laser-emitting diodes, the difference being in the number of diodes. The company website claims that their “laser therapy caps” employ the use of “safe, low-level lasers,” which are supposed to “energize hair follicles and spur new, natural hair growth.” The products are marketed to both men and women.

The Capillus82 now comes with a one-year manufacturer warranty; the warranty periods are longer for the higher-priced models.

How are Capillus Laser Caps Supposed to Work?

According to Capillus, the low-level laser therapy technology of their caps is meant to affect hair follicles on a cellular level, “energizing hair follicles and spurring new, natural hair growth.” Caps come with a certain number of laser diodes (a higher number of diodes is associated with a higher price tag) and is powered by a lithium-ion battery pack.

FDA Approved?

Capillus claims that its products have been cleared by the FDA. While this is technically true, approval of the device was not based on any clinical studies of the product itself, but rather a “predicate” device that was already on the market, known as the HairMax Laser Comb.

The company’s initial application for approval of the Pro272 model was made through the FDA’s 510(k) Premarket Notification process, which requires no clinical testing. Instead, the applicant need only demonstrate that the new device is “substantially equivalent” to a previous, or “predicate” device that has already been FDA-approved for public sale. This is considered by many to be a poor FDA approval process, as failed metal hips and artificial knees were also approved through this program.

There was also a question about the study in which Capillus claims that their product was “clinically proven” to regrow hair. The study, which involved the HairMax Laser Comb and was sponsored by the manufacturer, was titled, “A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy.” No male subjects participated; furthermore, some of the women in the study’s control group and were treated with a placebo also experienced some hair regrowth.

Physician Recommended?

The NAD also took issue with Capillus’s “physician recommended” claim for the Capillus82. This was based on testimonials from specialists in hair restoration.

However, as it turns out, 60 percent of those testimonials were based on experience with the Capillus272Pro, the original model. The remaining 20 percent had been speaking about the benefits of laser therapy for hair loss in general. There were no testimonials from physicians who actually recommended and used the Capillus82 model in treating their own patients.

Consumer Complaints About Capillus

Consumers have also had a lot to say about the Capillus devices. In fact, a large chunk of its product reviews on Amazon and on other review sites give it only one star, as consumers complain that the product is a scam, that it’s ineffective and far too expensive for what it actually does. There is very little evidence to support the idea that low-level laser devices like the Capillus caps are as effective as they claim to be.

The False Claims Act

The False Claims Act allows consumers to pursue litigation against companies that made claims about their products that turn out to be misleading, exaggerated, untrue, or even unsafe. Under the False Claims Act, consumers may be able to file lawsuits for a number of false claims: that the caps are “physician recommended,” that they are “highly effective,” or even that they have “no known side effects.”

Consumers may have been influenced into purchasing these laser devices by false claims—and since these devices are quite costly in the first place, this can be an expensive problem when you’re not getting a product with the capabilities you’ve been promised.

Did Capillus Fail to Work For You?

Some people swear by Capillus products, but nearly half of those who have purchased and used the laser hair growth products say it was a waste of money. If you are among the latter and were drawn in by false advertising, you may have a legal claim against Capillus.

Join a Free Capillus82 Class Action Lawsuit Investigation

If you or a loved one purchased the Capillus82 Laser Growth Cap and it did not help prevent hair loss or help your hair regrow, you may qualify to join this Capillus82 lawsuit investigation.

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This article is not legal advice. It is presented 
for informational purposes only.