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CHESE-POND's PURSUING "PROTECTIVE BARRIER" CLAIM FOR VASELINE

Executive Summary

CHESE-POND's PURSUING "PROTECTIVE BARRIER" CLAIM FOR VASELINE petroleum jelly in an April 11 filing with the Federal Trade Commission requesting relief from a 1963 consent order. That FTC action prohibited use of the protective barrier claim and several other therapeutic advertising claims for the product. Chese-Pond's is maintaining that the order should be eased, or set aside completely, based in part on conclusions reached by FDA and its OTC panels that support use of most of the claims. Of the twelve claims which were banned, Chese-Pond's seeks the use of seven based on FDA OTC advisory panel recommendations and in some cases on OTC tentative final monographs. For the remaining five, Chese-Pond's said, "there is no reason, after 22 years, for the commission to believe that Chesebrough would be any less faithful to its duty to have a reasonable basis than its competitors not subject to any commission order." Since the consent order was issued, FDA's OTC panels have "specifically concluded that petrolatum is effective for the key uses currently covered by the proscriptions of the order," Chese-Pond's stated. "Any such claims now made by Chesebrough thus would be supported by a reasonable basis." The two "most clinically and commercially important" claims which are included in OTC tentative final monographs are that Vaseline provides a protective barrier to skin and is a benefit in the treatment of diaper rash, the company said. In the original order, FTC prohibited the company from attributing the barrier properties -- "unless limited to the water repellent effects of a continuous film of the product" -- or that Vaseline helps treat diaper rash -- "unless expressly limited to diaper rash characterized by dry, scaly skin." To support the "barrier" claim, Chese-Pond's pointed to FDA's Skin Protectant and Ophthalmic Tentative Final Monographs (published Feb. 15, 1983 and June 28, 1983, respectively), which conclude that petrolatum does provide a protective barrier to skin without limitation to its water repellent effect. The skin protectant monograph also expressly supports the "diaper rash" claim, the company said. In addition, Chese-Pond's pointed out that while FDA has not issued a tentative final monograph on anorectal products, the OTC advisory panel on hemorrhoidal products has concluded that petrolatum offers "significant protection against diaper wetness that causes diaper rash." Further, Chesebrough stated, the advisory panels "nowhere confined their conclusions to diaper rash characterized by dry, scaly skin." Chese-Pond's argued that the five other claims now permissable based on FDA advisory panel recommendations are: (1) that the product can help in the treatment of burns, scratches or abrasions, (2) that it is a benefit in the treatment of scabbed skin, (3) that it will have [an] effect on itching, (4) that it prevents the escape of tissue fluids from the skin and (5) that it will soothe and soften skin better than competitors' products having substantially similar properties. Chese-Pond's maintained the claims for the treatment burns, scrapes, scratches or abrasions and the treatment of scabbed skin are also supported by the Skin Protectant Tentative Final Monograph. The other banned claims -- which Chese-Pond's has promised not to use without adequate substantiation -- are that "the product is of value in preventing infection" "the product will prevent or be of any benefit in the treatment of cradle cap" "the product is of any benefit in the treatment of cuts or open wounds," and that Vaseline "is a substitute for a first aid kit or is 'The First Aid Kit in a Jar' (unless that slogan is used in direct connection with or in close proximity to illustrations or descriptions of the unprohibited first aid uses of the product)." FTC has already said it will accept ad claims which have been included in FDA tentative final monographs, Chese-Pond's pointed out. The firm cited a November 1984 decision in a case involving Thompson Medical, in which the commission stated: ". . . advertisers of drug products subject to the joint jurisdiction of the FTC and FDA will benefit from greater regulatory certainty if they can act with reasonable assurance that the two agencies will accept the same evidence to demonstrate the safety and efficacy of a particular ingredient." The FTC concluded: "Thus, we state that advertisers who comply with the FDA's requirement of well-controlled clinical tests to demonstrate efficacy have adequate substantiation to make such claims in their advertisements." FTC also said that an FDA finding of effectiveness would amount to an "automatic modification" of an order prohibiting advertising for the claim involved, Chese-Pond's noted.
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