CANADIAN SUNSCREEN POLICY RECLASSIFYING IMPLIED PROTECTION CLAIMS

CANADIAN SUNSCREEN POLICY RECLASSIFYING IMPLIED PROTECTION CLAIMS as drug claims was issued in final form in June by the Canadian Department of Health and Welfare's Nonprescription Drugs Branch. The policy is essentially unchanged from its draft form with regard to the implied protection claims and specifies that products making sunscreen claims -- including: "screens or blocks or filters out some of the sun's rays"; "allows you to stay out in the sun X times longer"; "with sunscreen"; and "Sunscreen 8 (or other number)" -- will be considered drugs and must undergo Canada's drug approval process prior to marketing. Established in the early 1980s, Canada's labeling policy for sunscreens has maintained that sun protection claims and references to SPFs were drug claims. However, certain implied protection claims have been allowed as cosmetic claims under the previous policy. The new policy statement explains that because consumer understanding of the use of sunscreen products and the sun protection factor (SPF) system has increased, "implied claims to the sun protection factor or reference to the presence of sun protectants without at the same time expressing the degree of protection they offer, may lead to consumer confusion and increased risk." Sunscreen products are expected to be in compliance with the final policy by April 1, 1994, with the exception of makeup product lines in which the individual products, such as lipsticks, differ from each other only with respect to color. Such products will be given until April 1, 1995 to comply. A draft version of the policy was released in January 1992. The policy decrees that sunscreen-containing products will continue to be regarded as cosmetics as long as they make "no reference, either direct (other than in a complete ingredient declaration without emphasis) or implied, to the presence of sunscreens and/or sunblocks or to protection from the sun's rays." Claims that will be allowed on cosmetic products are "restricted to those related to moisturizing or improving the appearance," the bureau stated. Such claims may include: "gives a bronze (suntanned) color (appearance) (in the case of dihydroxyacetone which imparts a color to the skin)"; "prevents (protects against) the drying effects of the sun"; and "soothes (moisturizes) the skin after (exposure to the sun)." The final policy contains a provision not included in the draft that stipulates that certain cosmetics, such as shampoos, conditioners and nail products, may continue to refer to the presence of sunscreens "provided that they refer unequivocally to the function of preserving the cosmetic attributes of hair or nail colors," the bureau stated. Separately, Canada's Bureau of Nonprescription Drugs has recommended that seven color additives currently approved for use in cosmetics be added by amendment to the government's list of permitted colors for external use drugs. The colors are: annatto; bismuth oxychloride; D&C Orange No. 5; guanine; manganese violet; mica and zinc oxide. The recommendation will become effective after approval by the bureau's legal department, the Minister of Health and Welfare and Canada's Privy Council. Five additional color additives are under consideration for inclusion in the external use drug list. Also currently approved for cosmetics use, these additional color additives include: D&C Red No. 31; pigment metal 1; pigment blue 29; pigment green 17 and pigment blue 27. According to the bureau, there are currently insufficient data to prove the safety of the ingredients for drug use.