ERSP Reviews Advertising For “Hairmax Laser Comb” Recommends Marketer Include Additional Disclosures

New York, NY – April 3, 2010 – The Electronic Retailing Self-Regulation Program (ERSP) has determined that Lexington International, marketer of the HairMax Laser Comb, can support claims that the product has been cleared by the Food and Drug Administration (FDA), but recommended the marketer include additional disclosures and modify a claim related to onset of action.

The marketer’s advertising came to ERSP’s attention pursuant to its ongoing monitoring program.

ERSP, the electronic direct-response industry’s self-regulatory forum, is administered by the Council of Better Business Bureaus (CBBB) with policy oversight by the National Advertising Review Council (NARC).

ERSP examined claims in broadcast and online advertising that included:

  • “First and Only FDA Cleared Medical Device Clinically Proven to Grow Hair.”
    • “In fact, the HairMax LaserComb is so effective that it is the only medical laser device proven to work and FDA 510(K) cleared for marketing for the promotion of hair growth.”; ”FDA Cleared for the promotion of hair growth”; ”HairMax Lasercomb’s FDA 501(K) clearance as a medical device for marketing was based primarily on proof of efficacy”
  • “Clinically Proven to Treat Hair Loss and Promote Hair Growth”
  • ”…in as little as 12 weeks you will start to see results”
  • Accuracy of the “before and after” depictions of product users

 

Following its review of the evidence, ERSP determined that the marketer provided a reasonable basis for the claim that the product is the only laser therapy device that has been both the subject of a clinical study and cleared by the Food and Drug Administration (FDA) for the promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classification of IIa to V.

 

ERSP recommended, however, that Lexington International more clearly and conspicuously disclose throughout its Website that FDA clearance is limited to “males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V.”

 

ERSP determined that the marketer could support the claim that the product is “clinically proven” to promote hair growth, and the claim that the product’s 510(K) clearance as a medical device for marketing “…was based primarily on proof of efficacy.”

 

ERSP found that the subjective testing data provided by the marketer did not adequately support the claim “… in as little as 12 weeks you will start to see results.” ERSP recommended that, if the marketer intends to rely on the subjective responses of test subjects, that it clearly state such results are, for example, based upon the “reports” of product users or test subjects.

 

Finally, ERSP determined that the marketer has substantiated the accuracy of “before and after” depictions in the advertising.

 

The company, in its marketer’s statement, said it is “is pleased to have been able to participate in this process and to receive suggestions as to how to more effectively communicate information on the HairMax LaserComb to consumers.” The marketer added “we will modify our statements in the future.”