New York, NY – July 13, 2016 – The Electronic Retailing Self-Regulation Program (ERSP) has recommended that Capillus, LLC modify or discontinue claims for Capillus, a laser therapy hair cap.

ERSP is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The marketer’s advertising came to the attention of ERSP pursuant to an anonymous consumer challenge.

ERSP reviewed online advertising claims for Capillus, including:

•  “…the first FDA-cleared laser therapy cap for hair regrowth.”
• “Capillus82 features 82 medical grade lasers designed to provide optimal hair follicle stimulation— more than any other laser comb or dome device in its class.”
• “It’s never been more affordable to enjoy safe, proven, and effective hair loss treatment in the comfort of your own home”
• “There are scientific studies that show its effectiveness in treating male and female pattern hair loss.”
• “Capillus laser devices are proudly manufactured in the United States of America” and “Hand-Made in the USA.”
• “Physician-recommended. Around the world, physicians agree that Capillus laser caps are among the most effective LLLT products for hair loss treatment.”

As support for the claim “…the first FDA-cleared laser therapy cap for hair regrowth,” the marketer submitted its FDA 510(k) clearance. In reviewing the submission and evaluating other similar devices, ERSP determined that the marketer provided a reasonable basis for the “first FDA-cleared laser therapy cap” claim. However, ERSP recommended that the marketer discontinue claims that the Capillus82 has more lasers than any other device in its class.

Regarding the establishment claims at issue, ERSP determined that the net impression conveyed by the advertising was that the Capillus82 device, not just the Capillus technology, was “proven,” and “effective” to treat hair loss. After reviewing the evidence in the case record, ERSP recommended that the marketer discontinue any express or implied claims that the Capillus82 product is “proven” and “effective” at regrowing hair or treating hair loss.  Similarly, ERSP recommended that the claim “[t]here are scientific studies that show its effectiveness in treating male and female pattern hair loss” be modified or discontinued in its current context.

ERSP also recommended that the marketer include clear and conspicuous disclosures throughout the website regarding the FDA’s indications for use, the length of time to realize product-specific results, the need to use the product indefinitely to achieve continued results, and material differences between the tested and advertised devices, where appropriate.

In its review of the “manufactured in the USA” claim, ERSP found that the advertised products have a significant amount of U.S. processing and the marketer may make a properly qualified Made in USA claim. However, ERSP determined that the marketer’s current “Hand-made in the USA” and “manufactured in the United States of America” claims are improperly qualified as they imply more U.S. product content than actually exists. As such ERSP recommended that Capillus’ Made in USA claims be discontinued unless the marketer makes proper qualifications concerning the imported parts.

Finally, ERSP recommended that the physician recommended claims be discontinued, as well as claims that using the Capillus82 device will result in definite treatment benefits.

The company, in its marketer’s statement, said, “We will take ERSP’s recommendation into consideration as we review our advertising and our website content to ensure consistency with the appropriate legal standards and clearance rules promulgated by the FDA including, but not limited to, FDA’s position on the use of terms such as ‘proven’ and ‘safe and effective.’ Capillus supports the ERSP review process and is committed to providing consumers with safe and affordable technology. We also strive to ensure that our advertising materials accurately market our FDA-cleared low level laser therapy devices to our consumers.”