GenDerm will reuse Pentrax shampoo coal tar concentration claim following NAD review.

GENDERM PENTRAX SHAMPOO COAL TAR CONCENTRATION CLAIMS will be altered to become "more consistent with the coal tar specifications articulated in the FDA final monograph" for over-the-counter use of drug products for dandruff, psoriasis and seborrheic dermatitis, the company resolved in the December NAD Case Reports. The National Advertising Division of the Council of Better Business Bureaus reviewed GenDerm's Internet and print ads for Pentrax Extra Strength Shampoo at the request of Neutrogena, which makes a competing product, Neutrogena T/Gel. NAD recommended that GenDerm modify its advertising.

GenDerm's web site stated: "According to a recent survey of dermatologists, most would use Pentrax. The survey, held during the recent 54th Annual Meeting of the American Academy of Dermatology in Washington, D.C., asked dermatologists which tar shampoo they prefer. An overwhelming majority indicated they trust Pentrax over Neutrogena T/Gel Extra Strength. Many also say they would use Pentrax for themselves or recommend it to family members more than any other tar shampoo" and "Compared with Neutrogena T/Gel Extra Strength, Pentrax is four times as potent." A hang-tag attached to the product packaging claimed "four times the dandruff fighting medicine in Neutrogena T/Gel."

After GenDerm informed NAD that it would discontinue the dermatologists' preference and "four times as potent" claims, the BBB division decided to limit its review to the "four times the dandruff fighting medicine in Neutrogena T/Gel" claim.

GenDerm asserted that the claim in question "is factually true based upon the coal tar content in the product," the report says. The firm stated the claim is "consistent with the label disclosures mandated in the FDA final monograph," which states that "information concerning coal tar equivalent concentrations is useful and would allow consumers to be able to evaluate the comparative strengths of coal tar-containing products," and "coal tar content is the only `apples to apples' comparison relevant when comparing two coal tar-containing preparations," according to the report.

Neutrogena argued that the monograph "only requires that coal tar products include on the label of the product the concentration of coal tar, but does not permit a manufacturer to make an unsupported comparative claim of `four times the dandruff fighting medicine' claim," the report says. NAD's opinion on the issue dovetailed with Neutrogena's; the BBB division concluded it "agrees with the challenger that the FDA monograph does not expressly permit a manufacturer to make a `dandruff fighting medicine' comparison of respective coal-tar concentrations -- particularly if the claim would connote a performance advantage."

"Stating the active ingredient content of a product is quite different from claiming a `cause and effect' with regard to the ingredient's overall efficacy (i.e., because the shampoo has more of the active ingredient, coal tar, the product will `fight dandruff' better)," NAD said. "If this were true, then any product with a higher level of active ingredients could always claim that it outperforms any other competitive products with a lower active ingredient content. Absent proof that the product performs better at fighting dandruff, the presence of a larger amount of the active ingredient, coal tar, is insufficient support for this claim."

NAD determined that the claim could be "reasonably interpreted by consumers to mean that Pentrax shampoo outperforms T/Gel in treating dandruff," and "the advertiser did not submit any data to support such an interpretation." Therefore, NAD recommended that GenDerm modify the claim "to be more consistent with the coal tar concentration specifications articulated in the FDA final monograph for over-the-counter use of drug products for dandruff, psoriasis, and seborrheic dermatitis."

"GenDerm is pleased that the NAD agreed with our position by acknowledging that the labeling provisions in the FDA's final monograph were created to allow consumers `to compare `apples to apples' when comparing two coal tar containing preparations' and `evaluate the comparative strengths of coal tar-containing products,'" the company commented in the report. "Because coal tar is the only active ingredient in both Pentrax and Neutrogena T/Gel, GenDerm respectfully disagrees with the NAD position that the term `dandruff fighting medicine' is misleading to the consumer," but the firm will modify its advertising, GenDerm noted.