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SUNSCREEN TFM SPF UPPER LIMIT OF 30

Executive Summary

SUNSCREEN TFM SPF UPPER LIMIT OF 30 will be set for product labeling, FDA OTC Drug Evaluation Division microbiologist Jeanne Rippere told a Society of Cosmetic Chemists annual scientific seminar May 2 in Chicago. Rippere explained that the agency would set the sun protection factor (SPF) limit at 30 in the tentative final monograph "because I don't think we're convinced that there's any benefit to be gained by values higher than that." Rippere remarked that the limit would be 30 because "the maximum number of MEDs [minimal erythemal dose] a person can get during the day is probably 24 or 25"; the MED is the standard measure for determining SPFs. However, the FDAer pointed out that "the agency believes that SPF values above 15 could provide more protection for extremely sun-sensitive people and . . . children." Rippere added that products with SPFs of 15 or over are also helpful "to accommodate weather conditions that cannot be factored into the SPF testing itself." Rippere predicted that "maybe the [TFM] will be out later this year." The most recent quarterly regulatory agenda update from FDA estimated the proposed rule on OTC sunscreens products would be published in September. However, the length of the document, now 500 pages, and the multiplicity of issues involved may well delay the TFM publication further. In the spring of 1990, OTC Drug Evaluation Director William Gilbertson was optimistically predicting a November or December 1990 publication ("The Pink Sheet" April 9, 1990, T&G-13). Commenting on anti-aging claims, Rippere said: "Using the word 'anti-aging' alone probably will not be permitted without some qualifier." The issue of anti-aging claims "is the one part of the [tentative final] monograph that is not done yet," she remarked. Rippere said that, unlike anti-aging claims, the issue of possible nitrosamine contamination in the sunscreen ingredient Padimate O would not further delay publication because that matter will be deferred until later: the agency plans to publish a decision on the Category I ingredient separately. Questions about the safety of sunscreens containing the active ingredient Padimate O prompted FDA to reopen the sunscreen monograph in July 1989 ("The Pink Sheet" Aug. 7, 1989, T&G-7). Another area that "may still be up in the air" when the sunscreen TFM is published, Rippere said, is that of ingredients marketed in Europe but currently not in the U.S. She noted that FDA has received three citizen petitions and one comment asking the agency to reopen the sunscreen rulemaking to admit safety and effectiveness data for ingredients marketed in Europe. Among the petitioners are E. Merck, Givaudan, Haarman & Reimer and L'Oreal. Ingredients used in Europe that have been submitted for FDA consideration, Rippere reported, include: Peg 25 PABA, Isoamyl-P- methoxycinnamate, Givaudan's Parsol 1789, Haarman & Reimer's Neo Heliopan Type E 100, L'Oreal's Mexoryl SO and Mexoryl SE, and E. Merck's Eusolex 6300, which was included in the original OTC sunscreens panel review but was labeled as Category II due to a lack of U.S. marketing as a drug. Rippere stated that FDA "is looking at its policy," since "foreign safety and effectiveness [data] have been accepted for several years now" in drug approval registrations. She remarked that some ingredients may resemble current Category I ingredients closely enough to alleviate agency hesitation at labeling the European counterparts safe and effective for use in the U.S. For example, Peg 25 PABA "is very closely related to amino benzoic acid," she said, adding that the mechanism, action and adverse events "should be similar enough" for FDA to approve the ingredient. The FDAer also noted that the sunscreen TFM would distinguish between "beach" and "non-beach" sunscreens. Fitting into the latter category of "everyday products" would be items such as moisturizers, lip conditioners and makeups that contain sunscreen, Rippere said. Addressing industry requests that non-beach sunscreen products not be considered drugs by FDA, Rippere remarked that "the agency realizes there is a developing market for products for everyday use.... The agency also believes that the inclusion of sunscreens in everyday products . . . is beneficial to consumers, but such products cannot be regulated as cosmetics."
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