The National Advertising Division has recommended Boehringer Ingelheim, maker of the anti-flatulence product “DulcoGas Maximum Strength,” discontinue “maximum strength” claims. The labeling claim was challenged by Novartis Consumer Health, Inc.
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 challenger in this case argued that the “maximum strength” claim refers to the strength of the tablet itself, while the advertiser contended that the claim refers to the cumulative dose of four 125 mg. tablets over the course of a day.
Following its examination of the single claim at issue, NAD determined that consumers could take away the message that one dose of DulcoGas provides at least as much simethicone – the active ingredient – as any other antiflatulence product on the market or that 125 mgs is the maximum amount of simethicone permitted by the relevant regulatory body. Neither of these messages is substantiated.
Each DulcoGas tablet contains 125 mg. of simethicone, less than the amount of simethicone in other tablets on the market and less than the maximum daily dose of 500 mg set by the Food and Drug Administration in a 1974 Antiflatulent Monograph.
NAD noted in its decision that the advertiser’s evidence did not support theory that gas sufferers necessarily take antiflatulence products four times per day. Further, NAD was not persuaded by the advertiser’s argument that other competing products also used the “maximum strength” designation to describe tablets containing 125 mg of simethicone.
Following its review, NAD recommended that the advertiser discontinue this claim.
Boehringer Ingelheim, said in its advertiser’s statement that it would follow NAD’s recommendation, but was disappointed at NAD’s findings.
“The specific amount of active ingredient was clearly spelled out in immediate proximity to the “Maximum Strength” claim. NAD’s decision effectively prohibits the use of this term to specify even inter-brand differences in strengths that have been used in a variety of OTC products for many years. While again disappointed in the decision. Boehringer Ingelheim hopes at minimum that NAD will be consistent in its enforcement of this new guidance to ensure there is a level playing field in the OTC industry,” the company said.