NAD Recommends Novartis Discontinue Claim that Benefiber ‘Helps Maintain Regularity,’ Company to Appeal

New York, NY – Sept. 3, 2015 – The National Advertising Division has recommended that Novartis Consumer Health, Inc., discontinue the claim, made in television and print ads, that its dietary supplement product Benefiber “Helps Maintain Regularity.” The advertiser has said it will appeal NAD’s finding to the National Advertising Review Board (NARB).

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 claim was challenged by the Procter & Gamble Co., maker of Metamucil, a competing dietary supplement and laxative product.

Both parties have claimed that their respective products help promote regularity. The challenger, however, argued that wheat dextrin – the fiber contained in Benefiber – has not been clinically proven to promote regularity and, given the product’s mechanism of action, would not be expected to do so.

The advertiser disagreed with the challenger’s argument that its claims are not supported by published studies on the digestive effects of dietary fiber intake. The advertiser noted that some of the studies it cited as part of evidence examined slightly different types of fiber – polydextrose, soluble corn fiber, and other dextrins – that it argued shared analogous physiological, clinical, and safety characteristics to wheat dextrin. As a result, the advertiser argued, studies addressing the regularity benefits of such fibers may properly be extrapolated to wheat dextrin.

The issue in this case, NAD noted, was not whether the advertiser’s product provided the overall benefit of taking a fiber supplement, but whether wheat dextrin, the specific fiber in the advertiser’s product, provided the claimed benefit – regularity.

To support its health-related “helps maintain regularity” claim, NAD noted, the advertiser must demonstrate through competent and reliable scientific evidence that the product, used at the dosage indicated, provides a consumer relevant benefit with respect to “regularity.”

Following its review, NAD found that many of the studies presented in support of the advertiser’s claim were focused on testing the ability of humans to tolerate large doses of wheat dextrin without discomfort or negative side effects. Certain other studies examined the role of the fiber in Japanese diets or looked at the effect of fiber supplementation on gut bacteria.

None of the studies, NAD noted, showed that supplementation of a healthy American adult population with 9 grams per day of wheat dextrin or an equivalent fiber provides any measurable improvement along any of the various markers that would indicate an improvement in “regularity.”  As a result, NAD recommended that the advertiser discontinue the claim at issue.

Novartis, in its advertiser’s statement, said the company “respectfully disagrees with the NAD’s conclusions on the scientific issues, and will appeal to the NARB to request that the claim at issue be allowed based on the scientific evidence.  Notwithstanding our disagreement, Novartis appreciates the opportunity to participate in the NAD self-regulatory process.”