TAILIEUCHUNG - NOMINATION OF CHEMICAL/ AGENT/SCIENTIFIC ISSUE FOR TESTING....

The terms “cosmetic tattooing” or “permanent makeup” (. micropigmentation) refer to mechanical application of pigmented materials to the area of the eye, lips and face for the purpose of changing the color or appearance of that facial feature. This is a rapidly growing business in the United States becoming mainstream in many sociological circles. The inks and methods used for application of permanent makeup are similar to those used for general body tattooing; however, many manufacturers of inks make the distinction between inks that should or should not be used in the area of the eyes | January, 2005 NOMINATION OF CHEMICAL/AGENT/SCIENTIFIC ISSUE FOR TESTING CONSIDERATION BY THE NATIONAL TOXICOLOGY PROGRAM NOMINATING CENTER/OFFICE/BRANCH: Linda M. Katz, ., .; Director, Office of Cosmetics and Colors; Center for Food Safety and Applied Nutrition; FDA CHEMICAL/AGENT NAME: Permanent makeup inks. CAS NUMBER: Not applicable. Permanent makeup inks consist of a variety of pigments suspended in a vehicle. SOURCE OF DRUG/COMPOUND: The terms “cosmetic tattooing” or “permanent makeup” (. micropigmentation) refer to mechanical application of pigmented materials to the area of the eye, lips and face for the purpose of changing the color or appearance of that facial feature. This is a rapidly growing business in the United States becoming mainstream in many sociological circles. The inks and methods used for application of permanent makeup are similar to those used for general body tattooing; however, many manufacturers of inks make the distinction between inks that should or should not be used in the area of the eyes. The inks used for permanent makeup are widely available in the US. These inks are generally a complex mixture of pigments suspended in a vehicle/diluent which also contains multiple components. While recipes exist for “home-made” tattoo inks and tattooing devices are available on the internet (, 2004a,b; Tattoo FAQS, 2004), permanent makeup is typically applied by a professional. The application of permanent makeup (and tattoos) is regulated as a commercial business in most states, requiring licensing and/or registration by most state health departments. In the United States, regulation of the composition of permanent makeup inks is under the authority of the Food & Drug Administration (FDA). The FDA has considered intradermal permanent makeup to be cosmetics because they are applied to the body for the purpose of altering appearance or promoting attractiveness (FDA, 1994). No pigments are approved by the FDA for use in .

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