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International Programs and Activities Office of International Programs International Visitor's Program Industry Requests and FDA Responses Color Additives Animal Testing & Cosmetics Rulemaking History for OTC Sunscreen Drug Products International Harmonization; Policy on Standards; Notice--Federal Register, vol. 60
FDA's involvement in international activities has grown in recent years, accelerated by the globalization of the market, a desire on the part of the regulated industries to facilitate or streamline the flow of products, and the importance of ensuring that consumer health is protected. In line with the agency's policies, the Office of Cosmetics and Colors (OCAC) likewise has directed increasing efforts toward issues related to the international cosmetic market.
Among the ways in which OCAC works with other regulatory agencies and the regulated industry to facilitate international trade are--
- Participating in workshops and meetings to help government officials and members of industry in other countries understand U.S. laws and regulations.
- Developing lines of communication to government agencies in other countries to help them understand the differences between their regulatory approach and ours.
- Responding to industry requests regarding the harmonization of ingredient nomenclature.
- Exploring areas where U.S. requirements match those of other countries so that harmonization can be accomplished without compromising FDA's public health priorities and commitments.
This last item is of particular importance. Although "harmonization" is a term widely used to describe efforts at streamlining international trade, neither the international activities of FDA in general nor of OCAC in particular are to be understood as "harmonizing down" the agency's mission to protect public health in the United States.
The following are key international issues under consideration at OCAC, within the framework of U.S. legal and regulatory requirements:
Harmonization of Ingredient Nomenclature. As the European Union (E.U.) has worked toward agreement on ingredient terms to ease marketing across the borders in countries representing nine different languages, the cosmetic industry has requested that FDA allow similar changes in ingredient labeling for cosmetics marketed in the U.S. OCAC has considered these requests on a case-by-case basis, in line with its legal responsibilities under the Fair Packaging and Labeling Act (FPLA) to promulgate regulations "necessary to prevent the deception of consumers or to facilitate value comparisons."
Color Additives. OCAC has received several requests regarding possible steps for harmonizing ingredient labeling for color additives. This is a complicated issue, due to factors such as the requirements that only colors approved for use in the United States by FDA are allowed to be added to cosmetics and that, for some of these "approved" colors, only those specifically tested and certified in FDA laboratories may be used. Although the lists of approved colors in the United States and other countries share some common ingredients, there are also differences that complicate formulation of products for the different markets. The cosmetic industry in the U.S. and the E.U. has expressed interest in exploring ways in which the different lists are more alike.
Animal Testing and the Development of Alternatives. Although U.S. law does not prescribe the methods used by cosmetic firms to test their ingredients or finished products for safety, regulations require a product to bear a warning statement if the safety of the product or its ingredients is not substantiated. That leads to the question of what constitutes "adequate substantiation of safety," a question that becomes especially important in light of a pending E.U. ban on animal testing.
Ultraviolet (UV) Filters (Sunscreens). Sunscreens pose a special challenge in international harmonization because they are considered drugs under U.S. law and cosmetics according to the E.U. However, there has been interest in exploring the approval processes in different countries for sunscreen active ingredients and sharing information about test procedures for measuring Sun Protection Factor (SPF).