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SUNSCREEN TFM: UVA PROTECTANT LIST HAS "SERIOUS ERRORS," CTFA MAINTAINS

This article was originally published in The Tan Sheet

Executive Summary

SUNSCREEN TFM: UVA PROTECTANT LIST HAS "SERIOUS ERRORS," CTFA MAINTAINS in an Aug. 27 submission to FDA. The Cosmetic, Toiletry and Fragrance Association told the agency that its members "are currently undertaking laboratory evaluations of various sunscreen active ingredients listed in the TFM as providing UVA protection, and already we have determined that the list contains a number of serious errors." The filing requests a 180-day extension of the comment period, to May 12, 1994, for the OTC tentative final monograph on sunscreens, maintaining that the number and breadth of issues raised by the TFM merit an extension. The TFM lists dioxybenzone, lawsone with dihydroxyacetone, octocrylene, octyl methoxycinnamate, red petrolatum, sulisobenzone and titanium dioxide as examples of sunscreen active ingredients that absorb UVA radiation. The TFM was published May 12 ("The Tan Sheet" May 17, pp. 10-19) and comments are currently due by Nov. 8. CTFA is generating data to show that the minimum concentration limits for combinations of sunscreen active ingredients should be lower than what the TFM proposes. The TFM allows for a range of concentration limits for Category I ingredients in order to give companies more flexibility in formulating products. The document does, however, propose minimum concentrations of the ingredients in combination products to ensure that each ingredient contributes to the product. CTFA notes that it is generating data in response to new SPF testing requirements proposed in the TFM. In one area, the association will attempt to determine if the minimal erythema dose (MED) differs between 16 and 24 hours after UV exposure, since the TFM proposed to change the time interval for reading MEDs from 16- 24 hours after exposure to 22-24 hours. In addition, CTFA is studying whether SPFs generated by the TFM-proposed use of seven exposure sites, two of which are smaller, half dose increments centered around the expected SPF, differ from SPFs generated by past methods. The previous FDA sunscreen panel report method used five sites at equal 25% increments around the expected SPF. Noting that the TFM proposes a new statistical procedure and a series of seven exposures in order to provide more precise SPF values, CTFA said it is collecting data on the extent to which an individual's MED varies from day to day. The association also will assess the appropriateness of using a 25% increment for the unprotected MED exposure with different increments for protected sites. CTFA is coordinating other tests to determine the minimum size of the irradiation spot that can be accurately evaluated. The TFM stipulates a minimum of 1 cm. Finally, CTFA said it is studying the TFM in the context of proposed regulatory requirements for sunscreens in Europe, Australia and Japan in an effort to determine if international harmonization of testing requirements is possible. CTFA asserts that "it is impossible, in the six-month comment period called for in the TFM, to understand fully how these new proposals will affect the industry." CTFA added: "Although we recognize that the TFM provides additional time to submit new data to FDA, in numerous instances CTFA members will be required to conduct additional testing to understand the impact of the TFM's proposals, and then they must reanalyze tests conducted several years ago in order to provide meaningful comment with respect to those proposals." The Nonprescription Drugs Manufacturers Association said it worked with CTFA on the petition for an extension and, therefore, would not be filing a separate request.
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