NAD Finds Salonpas Duration Claim Supported; Recommends Hisamitsu America Discontinue Comparative Pain Relief, Onset of Action, Range of Motion Claims
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New York, NY – March 10, 2021 – The National Advertising Division (NAD) of BBB National Programs determined that Hisamitsu America, Inc. supported its duration claims that Salonpas Pain Relief Patch Large “works for up to 12 hours” and “provides relief for up to 12 hours.” NAD also determined that Hisamitsu provided a reasonable basis for the challenged claims comparing the Salonpas patch’s regulatory pathway to competitor products. However, NAD has recommended that Hisamitsu discontinue the following parity and product performance claims:
- The parity claim “All OTC pain relievers, including Voltaren, have one thing in common. None are proven stronger or more effective against pain than Salonpas Pain Relief Patch Large.”
- Severity of pain claims that characterize the Salonpas patch as the “only pain reliever labeled to relieve mild to tougher, moderate pain” and “the strongest labeled OTC topical pain reliever.”
- The claim “Salonpas demonstrated . . . improved range of motion.”
Further, NAD recommended that Hisamitsu modify its onset of action claims to avoid the misleading message that arthritic consumers specifically will receive pain relief within one hour of application and clinically meaningful pain relief in the first day, as well as the misleading implied message that the Salonpas patch has been shown to provide meaningful relief of arthritis pain faster than Voltaren.
The claims, which appeared in television and online advertising, were challenged by GlaxoSmithKline Consumer Healthcare, L.P. (GSK), maker of Voltaren Topical Gel.
The advertiser’s Salonpas patch is a topical patch imbued with medicine and is currently marketed under an FDA approved New Drug Application. While NAD seeks to harmonize its own efforts and recommendations with those of the applicable regulatory framework, NAD determined that the challenged advertising either expressly or impliedly communicates messages to consumers about benefits of the Salonpas patch that go beyond the indications cleared by the FDA.
To support its claim that “All OTC pain relievers, including Voltaren, have one thing in common. None are proven stronger or more effective against pain than Salonpas Pain Relief Patch Large,” NAD determined that the advertiser should have evidence that the compared products perform equally well, or at parity. Hisamitsu provided no evidence that its product is as strong or efficacious as Voltaren for the treatment of arthritic pain. In the absence of such evidence, NAD recommended that the claim be discontinued.
NAD determined that the challenged claims that characterize the Salonpas patch as the “only pain reliever labeled to relieve mild to tougher, moderate pain” and “the strongest labeled OTC topical pain reliever,” reasonably communicate that the product provides stronger relief than any other available product, including Voltaren. NAD noted that the FDA approval of the Salonpas patch evaluated only the efficacy of the Salonpas patch for the specific indications on the label (i.e., “mild to moderate” pain), but did not evaluate the comparative efficacy to Voltaren, which was approved as an effective treatment for arthritis pain, without qualification. In the absence of any competent and reliable scientific evidence demonstrating that its product is stronger than competing products, NAD recommended that the advertiser discontinue such claims.
The challenged advertising, which NAD determined is targeted to people who suffer from the pain associated with arthritis, contains several express performance claims regarding Salonpas’ onset of action, including “For Salonpas Pain Relief Patch LARGE, pain relief generally occurs within 1 hour of application” and “Salonpas demonstrated the clinically meaningful pain relief in the first day.” While Hisamitsu presented a reliable and well-conducted study in support of these claims, NAD found that a study on the onset of pain relief for muscle strain patients does not demonstrate the onset of pain relief for a consumer suffering from arthritis might experience. Therefore, NAD determined that the advertiser failed to provide a reasonable basis for these claims and recommended modification to avoid the misleading message that arthritic consumers specifically will receive pain relief within one hour of application and clinically meaningful pain relief in the first day.
NAD further recommended that the advertiser discontinue the claim “Salonpas demonstrated . . . improved range of motion” because the study relied on by the advertiser did not investigate changes to range of motion, only pain relief.
Regarding the advertiser’s duration claims that the Salonpas patch “works for up to 12 hours” and “provides relief for up to 12 hours,” NAD concluded that FDA approval supports a duration for up to 12 hours. Therefore, NAD determined that Hisamitsu provided a reasonable basis for these claims.
Further, NAD determined that references in the challenged advertising to the Salonpas patch’s one hour onset of action and Voltaren’s label disclosure that the product “may take up to 7 days to help achieve relief,” convey the implied message that Salonpas works faster than Voltaren for people suffering from arthritis pain. NAD concluded that this comparative onset of action claim is unsupported and recommended that the advertising be modified to avoid the misleading implied message that Salonpas patch has been shown to provide meaningful relief of arthritis pain faster than Voltaren.
NAD determined that the advertiser provided a reasonable basis for claims comparing the Salonpas patch’s regulatory pathway to competitor products. NAD found that claims describing the New Drug Applications for Salonpas and Voltaren do not convey the message that FDA specifically reviewed arthritis clinical studies its reviews for the Salonpas patch, Voltaren, or any of the other products mentioned in the challenged claim. Further, there was nothing in the record that suggests FDA’s review of the data submitted by Hisamitsu was any less rigorous than otherwise would be expected.
Finally, during the proceeding, the advertiser voluntarily permanently discontinued claims that it was the “only FDA-approved OTC topical pain reliever,” therefore NAD did not review these claims on the merits.
In its advertiser statement, Hisamitsu stated that it “will comply with NAD’s recommendations.” The advertiser further stated that it “has complied with the decision by modifying or discontinuing the questioned advertising,” but stated its belief that its advertising was “truthful and accurate."
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About the National Advertising Division: The National Advertising Division (NAD), a division of BBB National Programs, provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
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