FDA Cosmetics Definition Hampering Harmonization Efforts - L'Oreal Exec
This article was originally published in The Rose Sheet
Executive Summary
FDA cosmetics regulations are "primitive" and out of date, thus hindering international harmonization of a cosmetics definition, L'Oreal R&D Director Claude Bouillon maintained at the Colipa-sponsored Mutual Understanding meeting in St. Julian's, Malta April 11.
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Cosmetics working group
FDA convenes internal working group to investigate cosmetics thought to be on the periphery of OTC drugs, such as those that have an effect on the structure and function of the body, the agency said. "We need to develop a little bit more conversation in terms of what we'd like to see in the marketplace, how we get there, what is appropriate for the consumer to see and that sort of thing," OTC Drugs Division Acting Director Debra Bowen, MD, recently announced. The working group is still in the "formative" stage; members now identifying the project agenda. FDA said it will invite public discussion on the group's findings. The move is one step in FDA's commitment to create a better link between the cosmetics program and the Center for Drug Evaluation & Research, as announced by the agency earlier this year ("The Rose Sheet" April 6, p. 1)
Japan cosmetics deregulation
Japanese Ministry of Health and Welfare final report on cosmetics regulatory system calls for creation of a negative list similar to that used in the U.S. and EU, to replace the current category-by-category approval process. UV absorbents, coal tar colors and preservatives would be placed on a positive list and thus would still need approval prior to marketing. Ingredients will appear on labeling in descending order in Japanese characters, however the ministry will further study a move to the International Nomenclature for Cosmetics Ingredients system. The government will also continue to study the possibility of regulating Japan's "quasi-drugs" (antiperspirants, medicated shampoos and hair dyes). The deregulation will fully implemented by 2001. The ministry spoke of a re-evaluation of Japan's cosmetics regulatory process at an international conference in 1996 ("The Rose Sheet" April 22, 1996, p. 2)
International harmonization: CTFA/COLIPA to adopt EU cosmetics definition.
INTERNATIONAL HARMONIZATION: CTFA/COLIPA TO ADOPT EU COSMETICS DEFINITION, which includes sunscreens and colors, as the standard the two groups will use in efforts to reconcile disparate regulatory requirements, Cosmetic, Toiletry and Fragrance Association President Edward Kavanaugh said at the Global Cosmetic Regulatory Harmonization meeting, sponsored by the Italian cosmetics trade association UNIPRO and the European Cosmetic Toiletry and Perfumery Association (COLIPA), in Florence, Italy April 22-23. The establishment of a universal cosmetics definition represents a milestone for COLIPA and CTFA, Kavanaugh explained. The new standard gives CTFA and COLIPA a unified harmonization ideal it can present to governments interested in pursuing the process, he added.