New York, NY – Jan. 16, 2013 – The National Advertising Division has referred to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) advertising claims made by Hisamitsu America, Inc., manufacturer of Salonpas Brand Pain Relief products. The claims at issue were challenged by Pfizer Consumer Healthcare, a competing manufacturer of ThermaCare over-the-counter heat wraps.

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

NAD had requested substantiation for advertising claims that included:

•  “Salonpas is the strongest labeled pain reliever available without a prescription.”
•  “It’s proven to relieve mild to tougher, moderate pain. Something no other OTC pain reliever can claim.”
•  “The only OTC pain reliever labeled to relieve mild to tougher, moderate pain.”
•  “Salonpas is the only FDA-approved topical pain reliever that provides up to 12 full hours of serious relief.”
•  “Salonpas is the #1 brand of patches in the world.”
•  “SALONPAS is the largest brand of pain relief patches in the U.S.”

The company, in response to NAD’s inquiry, declined to participate in the self-regulatory process. The advertiser maintained that the challenged claims were submitted as part of its New Drug Application (NDA) for use on the OTC drug product label which the FDA subsequently approved.

The advertiser argued that its claims truthfully conveyed information that was consistent with its NDA. The advertiser maintained that its products are unique in the OTC external analgesic drug marketplace in the degree of FDA scrutiny and evaluation they have undergone and that it should be free to communicate this information to consumers. Further, the advertiser said that it has made no reference to, or impugned the safety, effectiveness or quality of, competing products, including Pfizer’s ThermaCare products.

NAD, in its decision, noted that the FDA’s approval of the advertiser’s NDA does not preclude NAD review of competitive advertising claims.

Given that the advertiser elected not to participate in a self-regulatory examination, NAD has referred the claims at issue to the FDA and the FTC for further review.