NAD Refers Claims for Aubio’s Cold Sore Treatment Gel to FDA, FTC for Further Review Following GSK Challenge

New York, NY – Aug. 23, 2018 – The National Advertising Division has referred to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) advertising claims made by Aubio Life Sciences for its Cold Sore Treatment Gel that communicate the product provides relief at the “first sign” of a cold sore or during the “tingling” phase of an outbreak.

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 were challenged before NAD by GlaxoSmithKline Consumer Healthcare, L.P., the manufacturer of Abreva, a competing over-the-counter product. Abreva is marketed pursuant to a Food and Drug Administration (FDA) New Drug Application.

During the course of NAD’s review, the Aubio agreed to permanently discontinue a number of the challenged claims, including express and implied claims that the product has a healing effect on cold sores; significantly shortens the lifecycle of a cold sore by as much as half the healing time; works better or faster than its competitors generally and Abreva specifically; is “Dermatologist” recommended; is an antiviral medication or performs equivalently to an antiviral medication; has been clinically proven; has a 100% recommendation rate amongst users based on its ability to heal cold sores quickly; and is all-natural.

Relying on the advertiser’s representation, NAD did not review the claims on their merits.  The voluntarily discontinued claims will be treated, for compliance purposes, as though NAD recommended their discontinuance and the advertiser agreed to comply.

Turning to the remaining challenged claims, NAD determined that Aubio’s use of the claim, “Apply at the first sign of a cold sore” conveyed to consumers that they would experience a benefit from application of the product while a cold sore if forming.

NAD noted in its decision that the parties disagreed about whether claims of relief during the formulation of a cold sore are authorized by the FDA in its External Analgesic Tenative Final Monograph (TFM). The advertiser argued that the TFM properly allows claims regarding the “itching, burning or tingling” associated with the cold sore at any stage, including during its development.

“In an NAD proceeding, the advertiser has the initial burden of presenting a reasonable basis for its claims.  In this case, the advertiser did not provide any independent competent and reliable evidence supporting the efficacy of its product and instead solely relied upon the fact that the product was formulated according to the specifications set out in the External Analgesic TFM and its interpretation of the monographed indications,” the decision states.

In this case, NAD noted, it is not clear whether FDA intended the indication to encompass pain or itching preceding the development of a cold sore or fever blister, or only once the cold sore has erupted.  Further, the advertiser did not provide evidence demonstrating that the FDA panel that developed the External Analgesic TFM considered evidence of efficacy for the covered active ingredients on pain and itching during the cold sore development process.

NAD determined that the advertiser had not reasonably shown that its claims were covered by the External Analgesic TFM, to the extent that it intends to use the phrase “first sign of a cold sore” to mean pain or itching during the tingling phase and prior to the existence of an actual cold sore or fever blister.

NAD recommended that the advertiser discontinue claims that state, expressly or impliedly, that the product provides a benefit prior to the formation of a cold sore, including claims that the product provides relief at the “first sign” of a cold sore or during the “tingling” phase.

Nothing in its decision, NAD said, prevents Aubio from instructing consumers to start using the product at the first sign of the indications approved pursuant to the External Analgesic TFM.

Aubio, in its advertiser’s statement, said the company “appreciates the opportunity to participate in the NAD Self-regulatory process but will not comply with NAD’s recommendation. … Aubio disagrees with the conclusion of the NAD on the sole remaining claim and maintains that the challenged claim is authorized according to the FDA monograph, with which the company intends to comply.”

As a result of the advertiser’s decision and pursuant to the policies and procedures that govern advertising industry self-regulation, the claims at issue will be referred to the FDA and FTC for possible enforcement action.

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.