Canada Reclassifies Antiperspirants As Cosmetics; Labeling Changes Needed
This article was originally published in The Tan Sheet
Executive Summary
Aluminum-based antiperspirants are no longer considered drugs in Canada under new regulations
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Aluminum-based antiperspirants are no longer considered drugs in Canada under new regulations. The switch follows stakeholder consultation and a review of aluminum-based antiperspirants in light of Health Canada's September 2008 Guidance on the Classification of Products at the Cosmetic-Drug Interface. According to Canada's health authority, antiperspirants qualify as cosmetics due to their mechanism of function and the way they are used and perceived by consumers. The active ingredient in a typical antiperspirant -aluminum or zirconium salts - forms a gel when mixed with sweat. The gel temporarily impedes sweat gland ducts and reduces the amount of sweat secreted, according to Health Canada's product assessment criteria. Previously "it was maintained that because antiperspirants interfere with the natural passage of sweat from the sweat glands," they fit the definition of a drug. However, Health Canada has decided that the products' mode of action is "mechanical in nature" and does not serve to substantially correct or modify an organic function of the body. "Any physiological effect of the aluminum and/or zirconium is minor, transient and secondary to its primary cosmetic purpose of decreasing odor and unsightly sweat marks," the agency says. Consumers generally use antiperspirants for aesthetic reasons and not for the prevention or treatment of any disease. The products "behave in the marketplace in every way as cosmetics," Health Canada concludes. From Drug/Natural Health Product To Cosmetic The move for antiperspirants means the products will no longer be eligible for a Canadian drug identification number under the country's food and drug regulations or a product license number under its natural health products regulations. Manufacturers and importers will need to create new labels for their products in recognition of their new status. Under cosmetics rules, claims that can be used to market an antiperspirant include, "Reduces (or provides protection against) underarm perspiration," "Protects against wetness" and "24-hour antiperspirant effect." Marketers will not be able to say their product "stops or prevents perspiration," "helps check, halt or stop underarm wetness, dampness or perspiration," or "helps keep you dry." Antiperspirants designed to reduce hyperhydrosis, or overproduction of sweat, and products that claim to protect for more than 24 hours will remain classified as drugs, Health Canada states. The agency notes that Europe, Australia and New Zealand regulate antiperspirants as cosmetics, while FDA classifies the products as OTC drugs. Steps Manufacturers Must Take To help manufacturers and importers of antiperspirants make the switch, Health Canada has released a consultation document on which it is accepting comments through Aug. 31. According to the transition plan, firms will have to remove drug identification or natural product numbers from products, list ingredients by International Nomenclature of Cosmetic Ingredients names and scrub away any reference to "medicinal ingredients." U.S.-style "drug facts" labeling is no longer acceptable, Health Canada says. A warning should appear on the label instructing consumers to "discontinue use if rash or irritation occurs. Do not use on broken skin." For aerosol products, a statement should appear telling users to "keep away from face to avoid inhalation and spraying in the eyes. Keep out of reach of children." Firms have six months to create and implement new cosmetic labels and one year to allow for the depletion of old stock at retail. Medicated skin care products and diaper rash creams also were reviewed as products with both cosmetic and drug characteristics; Health Canada reaffirmed their classification as drugs. - Molly Laas ( 1 [email protected] ) |