ERSP Recommends Theradome Modify, Discontinue Certain Claims for Hair-Loss Laser

The Electronic Retailing Self-Regulation Program (ERSP) has recommended that  Theradome, Inc., modify or discontinue certain advertising claims for Theradome, a product designed to treat hair loss through the use of a low-level laser.

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 through an anonymous competitive challenge.

ERSP reviewed online advertising claims for Theradome, including:

• “The first and only FDA cleared clinical strength laser treatment that has proven triple action”
• “Proven to grow hair in 98 percent of users”
• “In our clinical studies ALL participants benefited from the Theradome™ and experienced one or more of the following: 1) Thicker and more manageable hair, 2) Reduced hair loss, and 3) New hair growth after three to four months. We know it works, that's why we guarantee that you'll see great results.”
• ”100% Proven. 100% Easy. 100% Safe.”
• “The world’s most powerful in-home solution to treat hair loss."

As support for the performance and establishment claims at issue, the marketer submitted testing on low-level laser therapy (LLLT), the main technology behind Theradome. The marketer also provided ERSP with materials concerning its 510(k) premarket notification, which established its equivalence to a predicate device.

Following its review of the evidence in the case record, ERSP did not object to some general performance claims, but determined that the marketer did not provide adequate support for claims that Theradome will help consumers “… experience thicker and longer hair, a healthier scalp with reduced scalp itching and inflammation. Plus those with curly hair will see enhanced curl retention. After 52 treatments (20 minutes per treatment), the hairs on the top of the head and the vertex will start filling in. After 100 treatments (20 minutes per treatment), fuller and thicker hair will result with continued use.”

ERSP recommended that the marketer clearly and conspicuously disclose that Theradome is specifically intended for “females with female pattern hair loss on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin Types I to IV” as it is necessary information for consumers.

ERSP found insufficient evidence to demonstrate that the FDA had “approved” the product “to increase the diameter of hair up to 200%” – a message that ERSP determined could by reasonably understood by consumers – and recommended the marketer discontinue this claim.

Further, ERSP found that studies presented by the advertiser did not meet general standards of competent and reliable evidence and found that the marketer did not support the comparative claims at issue.

The company, in its marketer’s statement, said, “We will continue to make appropriate modifications to advertising for Theradome LH80 PRO in accordance with ERSP's recommendations … Theradome Inc. is committed to ensuring that its advertising is truthful, accurate, and substantiated. We value and support industry self-regulation and welcome the ERSP's decision regarding advertising for the Theradome LH80 PRO medical device.”