BBB National Programs Archive

NAD Refers Claims Made For Zeltiq’s ‘CoolSculpting Cryolipolysis’ Process to FTC, FDA For Further Review

New York, NY – Oct. 5, 2016 – The National Advertising Division has referred advertising claims made by Zeltiq Aesthetics, Inc.,  for the company’s “CoolScupting Cryolipolysis Body Contouring System” to the Federal Trade Commission (FTC) for further review after the company said it would not abide by certain of NAD’s recommendations.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

According to the advertiser, CoolSculpting is the only medical device cleared by the U.S. Food and Drug Administration (FDA) that works by applying precisely controlled cooling to a treatment site to target the fat cells underneath the skin, a process which is called Cryolipolysis.

According to the advertiser, the treated fat cells crystalize and break down and those dead cells are naturally eliminated from the body within the weeks and months following the treatment.  The advertiser maintained that the effectiveness of CoolSculpting procedure has been verified by more than 60 peer-reviewed abstracts and papers.  The advertiser also referred to the studies its submitted to the FDA in support of its applications for medical clearance.

As part of its ongoing monitoring program, NAD inquired about express and implied claims made by the company in print advertising, including:

  • “See a Slimmer You.”
  • “Eliminate Fat With The World’s #1 non-Invasive Fat Removal Treatment.”
  • “CoolSculpting is an FDA-cleared procedure that uses controlled cooling to eliminate fat without surgery or downtime. And with up to 95% customer satisfaction, you’ll love the results of CoolSculpting every time you look in the mirror.”

Following its review of the evidence in the record, NAD the claim “See a slimmer you” and “CoolSculpting is an FDA-cleared procedure that uses controlled cooling to eliminate fat without surgery” were supported.   However, NAD recommended that the advertiser clearly and conspicuously disclose that CoolSculpting is “intended for use in patients with small and discrete fat bulges, is not recommended for use on obese patients or patients with excess skin laxity, that results become visible over the course of 2-3 months, and in conjunction with the ‘after’ photographs, indicate the number of sessions the subject underwent as well as the number of weeks after the procedure the photograph was taken.”

In its advertiser’s statement, the company said that it would comply with most, but not all, of the NAD’s recommendations.

The company contended that its current advertising addresses NAD’s recommendation regarding “discrete, localized fat bulges.” Further, the company said, it would not “add statements about ‘excess skin laxity’ given that this limitation is at odds with the current FDA-cleared indications for use and supporting studies conducted in the years after the 2009 article that NAD cites.”

NAD’s procedures provide that an advertiser’s statement shall state whether the advertiser agrees to comply with NAD’s recommendations. In this case, the advertiser informed NAD that it would not implement certain of NAD’s recommendations. NAD, as a result, referred the advertising at issue to the FTC and FDA for further review.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.