New York, NY – Oct. 10, 2019 – The National Advertising Division has recommended that Bayer Healthcare LLC discontinue the claims “Proven Better on Pain than Tylenol Extra Strength” and “Proven Better on Pain than Tylenol,” following a challenge by Johnson & Johnson Consumer Inc., maker of Tylenol products. The advertiser has said it will appeal NAD’s findings to the National Advertising Review Board.

NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBB NP’s self-regulatory and dispute resolution programs.

The challenged claims appeared in television, print, and online advertising for Aleve.  The active ingredients in Aleve and Tylenol are naproxen sodium and acetaminophen, respectively.  Aleve and Tylenol have different dosing regimens, but both products are labeled for the same indications of use: (1) temporary relief of minor aches and pains due to minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, or the common cold; and (2) temporary reduction of fever.

NAD noted that the advertiser’s “Proven Better on Pain” claims are establishment claims that convey a broad and unqualified message about the superior efficacy of its product as a pain reliever. NAD determined that one reasonable consumer takeaway is that Aleve has been proven to provide higher quality pain relief than Tylenol Extra Strength.  Further, NAD concluded that the message of superiority is not limited to a particular type or intensity of pain, but rather all types of pain that might be treated by an OTC analgesic.

In support of its claim that Aleve is “Proven Better on Pain than Tylenol Extra Strength,” the advertiser provided the results of three dental pain studies and one dysmenorrhea study.  In support of the broader claim that Aleve is “Proven Better on Pain than Tylenol,” the advertiser provided an additional dental pain study and a menstrual pain study. 

NAD noted that in order to substantiate the broad claim that Aleve is “Proven Better on Pain than Tylenol,” the advertiser must be able to support its product’s claimed superiority against the entire Tylenol line, including Tylenol Extra Strength, Johnson & Johnson’s best-selling product.  With regard to the four studies that evaluated Aleve’s efficacy in comparison to Tylenol Extra Strength, NAD noted that these bore many well-known indicia of reliability, such as being randomized, double-blind and/or placebo controlled.  However, after careful review, NAD determined that the studies did not comprise a good fit for the advertiser’s establishment claim. 

NAD found it problematic that the Kiersch study (which was the only published, peer reviewed study submitted by the advertiser), and every other study offered by the advertiser, tested a single dose of each product over 12 hours.  However, a single dose of Tylenol Extra Strength does not, and is not intended to, last 12 hours.  Further, NAD noted that the “Proven Better on Pain” claim conveys a broad message of superiority across the board and is not limited to consumers experiencing pain on the higher end of the over-the-counter spectrum or consumers experiencing pain that lasts for more than a specific amount of time. While the Kiersch researchers reported that Aleve “was significantly superior to placebo and acetaminophen in hours 2 through 12” in mean pain relief scores and pain intensity differences, they also limited the conclusions drawn from the data based on the fact that acetaminophen is mostly commonly used for treatment of pain at the lower end of the intensity continuum.  Therefore, NAD determined that the positive results of the Kiersch study could not support a claim that consumers experiencing milder pain, or pain of a shorter duration than 4-6 hours would experience the claimed benefit.  NAD also had concerns about the inconsistency in the results of the four studies on a variety of pain metrics and endpoints.

NAD concluded that the evidence provided by the advertiser did not provide a reasonable basis for its strong health-related claim and recommended that the advertiser discontinue the claims “Proven Better on Pain than Tylenol Extra Strength” and “Proven Better on Pain than Tylenol.”

In its advertiser’s statement, Bayer stated that it will appeal to the NARB because it believes it “relied on robust and methodologically sound clinical testing in support of its claims” and is “highly disappointed with and strongly disagrees with NAD’s decision, which misapprehends the scientific evidence.”  Further, “while Bayer appreciates the NAD’s consideration of its advertising and the opportunity to participate in the self-regulatory review process, Bayer looks forward to addressing these issues before the NARB.”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.