New York, NY – May 9, 2018 – The National Advertising Division has recommended that Carma Laboratories, Inc., discontinue certain challenged advertising claims for the company’s Carmex Cold Sore Treatment, including claims that the product works “immediately,” treats symptoms on contact or heals cold sores.

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

The claims at issue, made in television advertising, website advertising, social media advertising and on product packaging were challenged by GlaxoSmithKline Consumer Healthcare L.P., maker of Abreva, and included:

• “Less sore. More smile.”
• “Carmex Cold Sore Treatment helps minimize the appearance of sores while it helps promote healing.”
• “Carmex Cold Sore Treatment works on contact to provide immediate results.”

Both the challenger and the advertiser offer products targeted at cold sore sufferers, but with different active ingredients and different indications.  GSKCH’s Abreva, formulated with docosanol cream, is marketed pursuant to a Food and Drug Administration (FDA) New Drug Application.  Abreva is the only over-the-counter cold sore treatment approved by the FDA to shorten cold sore healing time and duration of symptoms.

Carmex Cold Sore Treatment, formulated with benzocaine white petrolatum, is indicated for “temporary relief of pain associated with cold sores/fever blisters” and/or to “help prevent and protect dry, chapped lips.”

Cold sore blisters are usually caused by a strain of the Herpes simplex virus 1. The blisters will typically heal over 8-12 days without treatment.

The challenger argued that there is an important distinction between products that promise to speed or promote the healing process, shortening the cold sore cycle, and those that merely offer temporary relief of symptoms. The advertiser argued that its advertising does not convey a message that the product speeds healing or shortens the duration of symptoms, that it prevents future outbreaks, that it is FDA-approved, or that it works on the HSV-1 virus.

Generally, NAD noted in its decision, the competent and reliable scientific evidence required to support health-related claims is a human clinical trial, methodologically sound and statistically significant to the 95 percent, confidence level with results that translate into meaningful benefits for consumers that relate directly to the performance attributes promised by advertising.

The advertiser did not submit any clinical studies demonstrating the efficacy of Carmex Cold Sore Treatment in healing cold sores, or any other form of clinical proof supporting any of the promote benefits of Carmex Cold Sore Treatment.

As NAD noted, claims, demonstrations, dramatizations, and side-by-side depictions that convey a cold sore “healing” message require clinical proof to be substantiated.

Following its review of the evidence in the record, NAD recommended that the advertiser discontinue the claim that Carmex Cold Sore Treatment “helps promote healing” of cold sores.  NAD also recommended that the advertiser discontinue the claim that Carmex Cold Sore Treatment “minimizes” the appearance of cold sores.

NAD determined that the advertiser had a reasonable basis to advertise that the product treats pain, itch, and dryness, but recommended that the advertiser modify its claim that the product treats “scabbing” to indicate that the product can “soften scabs.”

NAD further recommended that the advertiser discontinue claims that Carmex Cold Sore Treatment treats cracking, redness, or irritation or that the product treats any symptom “on contact.”

NAD recommended that the advertiser discontinue its commercial and website video, determining that it reasonably conveys the unsupported message that Carmex Cold Sore Treatment speeds cold sore healing time.  NAD also determined that “Less Sore. More Smile.” was not puffery and recommended that the advertiser discontinue using the tagline.  Finally, NAD recommended that the advertiser discontinue the claim that the product treats the “worst” symptoms of a cold sore outbreak.

NAD noted in its decision that the advertiser agreed to permanently discontinue certain claims in digital advertising that GSK contended were express or implied claims with a reasonable takeaway that Carmex Cold Sore Treatment speeds healing, shortens symptom duration, prevents cold sores, or stops progression of the virus. The advertiser also agreed to discontinue its use of testimonials and reviews on its website, retailer websites, and via social media, that make unsupported claims about Carmex Cold Sore treatment and modify any paid reviews to disclose the existence of a material connection between the reviewer and Carma Labs.  The advertiser also agreed to permanently discontinue the claim that Carmex Cold Sore Treatment was “improved.”

The voluntarily discontinued and modified claims will be treated, for compliance purposes, as though NAD recommended their discontinuance or modification and the advertiser agreed to comply.

Carmex, in its advertiser’s statement, said the company “agrees to comply with NAD’s recommendations. Carma appreciates NAD’s recognition of the truth and accuracy of its express claims that Carma’s Cold Sore Treatment treats pain and itch, relieves dryness, and softens scabs.  Regarding the other claims at issue, Carma did not intend any consumers to be – nor does it believe that a reasonable consumer was – misled, misinformed, or otherwise deceived.  Nonetheless, Carma respects the self-regulatory process and intends to follow NAD’s recommendations in future advertising and packaging for its Cold Sore Treatment.”

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.