A panel of the National Advertising Review Board has recommended that Novartis Consumer Health, Inc., now a GSK Consumer Healthcare Company, discontinue the claim, made in television and print ads, that its dietary supplement product Benefiber “Helps Maintain Regularity.”

NARB is the appellate unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

The claim was initially challenged before the National Advertising Division (NAD) by the Procter & Gamble Co., maker of Metamucil, a competing dietary supplement and laxative product.

In the underlying case, P&G argued that wheat dextrin—the fiber contained in Benefiber—had not been clinically proven to promote regularity and, given the product’s mechanism of action, would not be expected to do so.

NAD, following its review, recommended the advertiser discontinue the challenged claim.

In its appeal, Novartis/GSK argued that it had provided sufficient support for the
challenged claim through clinical studies and expert opinion.

The panel noted in its decision that Novartis/GSK primarily relied on two Japanese studies discussed in a book on dietary fiber and health. The actual studies were not submitted to NAD, and the panel agreed with NAD that short descriptions of study results did not provide sufficient information to determine whether the studies were competent and reliable scientific evidence. The panel noted there was insufficient detail as to the overall study results with respect to regularity since findings that related to regularity were cited only for selected subgroups.

The record included a number of other studies, including some offered by P&G that tested wheat dextrin in dosages that approximated the recommended dosage for Benefiber.

The panel noted that while evidence in the record “clearly establishes the importance of fiber in the human diet,” different types of fibers have different effects on the human digestive system. The panel observed that studies that tested wheat dextrin or functionally equivalent fibers at dosages similar to the recommended dose for Benefiber did not demonstrate a meaningful impact on regularity.

The panel recommended that Novartis/GSK discontinue the challenged claim. The panel noted that its decision does not preclude Novartis/GSK from truthfully advertising the importance of fiber in the human diet and/or other digestive health benefits provided by Benefiber.

In its advertiser’s statement, Novartis/GSK said it respectfully disagrees with the NARB Panel’s affirmance of the NAD decision that the claim “Benefiber helps maintain regularity” is not substantiated. GSK specifically objects to the Panel’s refusal to accept the full translations of two confirmatory studies referred to in the record, such that it’s decision was not fully informed. Nevertheless GSK respects the self-regulatory process and will discontinue the advertising.”