Document mmYemrMG7BnkXqog55g3nK8Od

FILE NAM E: Talc (TALC) DATE: 2016 DOC#: TALC138 DOCUMENT DESCRIPTION: FDA Info on Talc Ingredients > Talc U.S. Food and Drug Administration Protecting and Promoting Your Health 5/28/16, 12:12 PM Talc Talc is an ingredient used in many cosmetics, from baby powder to blush. From time to time, FDA has received questions about its safety and whether talc contains harmful contaminants, such as asbestos. FDA's authority over cosmetic safety Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. Cosmetic companies have a legal responsibility for the safety and labeling of their products and ingredients, but the law does not require them to share their safety information with FDA. FDA monitors for potential safety problems with cosmetic products on the market and takes action when needed to protect public health. Before we can take such action against a cosmetic, we need sound scientific data to show that it is harmful under its intended use. Talc: What it is and how it is used in cosmetics Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc Is a hydrous magnesium silicate with a chemical formula of Mg3Si40io(OH)2. Talc has many uses in cosmetics and other personal care products; in food, such as rice and chewing gum; and in the manufacture of tablets. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product. Asbestos: What it is, why it's a concern, and how to prevent its occurrence in cosmetics Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen. For this reason, FDA considers it unacceptable for cosmetic talc to be contaminated with asbestos. Published scientific literature going back to the 1960s has suggested a possible association between the use of powders containing talc and the incidence of ovarian cancer. However, these studies have not conclusively demonstrated such a link, or if such a link existed, what risk factors might be involved. Nevertheless, questions about the potential contamination of talc with asbestos have been raised since the 1970s. To prevent contamination of talc with asbestos, it is essential to select talc mining sites carefully and take steps to purify the ore sufficiently. How FDA followed up on the latest reports http://www.fda.gov/Cosmetics/Produotslngredients/lngredients/ucm293184.htm Page 1 of 7 Ingredients > Talc 5/28/16, 12:12 PM Because safety questions about the possible presence of asbestos in talc are raised periodically, FDA decided to conduct an exploratory survey of currently marketed cosmetic-grade raw material talc, as well as some cosmetic products containing talc. Because FDA's cosmetic laboratories do not have the equipment needed to perform the analyses, we searched for a qualified outside laboratory to do the work. We contracted with AMA Analytical Services, Inc. (AMA) of Lanham, MD to conduct this laboratory survey, based on demonstrated experience with asbestos analysis in complex matrices, appropriate facilities, equipment, personnel, analytical strategy, and budget criteria. The study ran from September 28, 2009 to September 27, 2010. back to top How the survey was conducted The first step was to identify cosmetic talc suppliers and talc-containing cosmetic products. We found seven talc suppliers identified in the 2008 edition of the International Cosmetic Ingredient Dictionary and Handbook and two more by searching online. The contract laboratory contacted each supplier to request samples of its talc. Of the nine suppliers identified, four complied with the request. We found talc-containing cosmetic products to analyze by visiting various retail outlets in the Washington, D.C. metropolitan area. The samples identified for testing included low, medium, and high priced products, along with some from "niche" markets, in order to cover as broad a product range as possible. A total of thirty-four cosmetic products containing talc were selected, including eye shadow, blush, foundation, face powder, and body powder. All cosmetic products were purchased from retail stores in the Washington, D.C. metropolitan area. The contract laboratory analyzed the samples using polarized light microscopy (PLM) and transmission electron microscopy (TEM) methods published by the New York State Department of Health, Environmental Laboratory Approval Program. Each sample was analyzed three times using both methods. The results of FDA's survey and what they mean The survey found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc. The results were limited, however, by the fact that only four talc suppliers submitted samples and by the number of products tested. For these reasons, while FDA finds these results informative, they do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination. As always, when potential public health concerns are raised, we will continue to monitor for new information and take appropriate actions to protect the public health. The tables below list details for each of the cosmetic-grade raw material talc samples and cosmetic products containing talc that were analyzed in this survey. Limits of detection are shown below the table for each group of samples. Note: "NAD" means "no asbestos detected." back to top Cosmetic-grade raw material talc S u p p lie r Product Identity L o t# % Asbestos by PLM Rio Tin to M in e ra ls /L u ze n a c A m erica Im perial 2 0 0 U S P H10018 NAD Rio Tin to M in e ra ls /L u ze n a c A m erica Im perial 2 5 0 U S P H10018 NAD Rio T in to M in e ra ls /L u ze n a c A m erica Im perial 4 0 0 U S P H 06049-43 NAD http://www.fda.gov/Cosmetics/Productslngredients/lngredients/ucm293184.htm % Asbestos by TEM NAD NAD NAD Page 2 of 7 Ingredients > Talc 5/28/16, 12:12 PM Rio Tinto M in e ra ls /L u ze n a c A m erica Rio T in to M in erals/L u zen ac A m erica Rio Tin to M in erals/L u zen ac A m erica Rio T in to M in erals/L u zen ac A m erica O lym pic H U S P Suprem e H U SP Lot 2 Supra H USP Suprafino H U S P H04018 NAD H09219-7S NAD H10018 NAD H 6309-78 NAD NAD NAD NAD NAD PLM average limit of quantitation and limit of detection = 0.23% 0.01 TEM average limit of detection = 0.0000021 % 1.26567E-09 TEM average limit of detection = 0.021 ppm 0.001 TEM average limit of quantitation = 0.46% 0.01 Supplier Presperse Presperse Presperse Presperse Presperse Presperse Product Identity Micro Ace P-2 Micro Ace P-4 Rose Talc Talc NK-48 TalClear BH TalClear LH Lot # 33070516 37080823 2008-09 017 0306 070608 070529 % Asbestos by PLM NAD NAD NAD NAD NAD NAD % Asbestos by TEM NAD NAD NAD NAD NAD NAD PLM average limit of quantitation and limit of detection = 0.22% 0.01 TEM average limit of detection = 0.0000021 % 3.0099E-09 TEM average limit of detection = 0.021 ppm 0.003 TEM average limit of quantitation = 0.43% 0.02 Supplier Sensient Cosmetic Technologies Sensient Cosmetic Technologies Sensient Cosmetic Technologies Sensient Cosmetic Technologies Sensient Cosmetic Technologies Product Identity Lot# % Asbestos by PLM 28355 Talc PP W249-06 NAD 28368 Talc NBSB W080720 NAD 28460 Talc F-MS W053-08 NAD 61631 Talc LCW 26449 NAD R0175 Talc FHC W041397 NAD % Asbestos by TEM NAD NAD NAD NAD NAD http://www.fda.gov/Cosmetics/Productslngredients/lngredients/ucm293184.htm Page 3 of 7 Ingredients > Talc 5/28/16, 12:12 PM Sensient Cosmetic Technologies Sensient Cosmetic Technologies R0255 Talc SI W05630 NAD R0435TalcAS W061176 NAD PLM average limit of quantitation and limit of detection = 0.22% 0.01 TEM average limit of detection = 0.0000022% 1.91529E-09 TEM average limit of detection = 0.022 ppm 0.002 TEM average limit of quantitation = 0.43% 0.01 back to top NAD NAD Supplier Brenntag Specialties, Inc. Brenntag Specialties, Inc. Brenntag Specialties, Inc. Brenntag Specialties, Inc. Brenntag Specialties, Inc. Brenntag Specialties, Inc. Brenntag Specialties, Inc. Product Identity Talc IMP BCIMP1886L Lot# H01018 % Asbestos by PLM NAD Supra H USP BC(*1718) H10016 NAD Imperial 400 USP BC (*1883) H01017 NAD Talcron MP 60-30 USP (1745) B8141N1 NAD Talc IMP BC IMP1820L H07018 NAD Talc Imperial USP BC IMP1885L Lo-Micron USP BC 2755 H10017 NAD B7375N2 NAD PLM average limit of quantitation and limit of detection = 0.23% 0.01 TEM average limit of detection = 0.0000021 % 2.10373E-09 TEM average limit of detection = 0.021 ppm 0.002 TEM average limit of quantitation = 0.46% 0.01 % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD Cosmetic products containing talc Blush: Brand Shade http://www.fda.gov/Cosmetics/Productslngredients/lngredients/ucm293184.htm % Asbestos by PLM % Asbestos by TEM Page 4 of 7 Ingredients > Talc Maybelline New York Expert Wear Blush Gentle Rose 109EWBR-30 N.Y.C. New York Color Cheek Glow Powder Blush West Side Wine 652A NARS Blush Torrid 4017 NAD NAD NAD NAD 5/28/16, 12:12 PM NAD NAD Eye Shadow: Brand Physician's Formula Shimmer Strips Custom Eye Enhancing Shadow & Liner Black Radiance Eyeshadow Quartet Stilla Eye Shadow Trio Dior 5-Colour Iridescent Eyeshadow Shade Hazel Eyes 2222 Retro Chic 8805 Venus S461-03 Petal Shine 809 % Asbestos by PLM % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD NAD Foundation: Brand Black Opal True Color Liquid Foundation Laura Mercier Foundation Powder Shade % Asbestos by PLM Heavenly Honey NAD Number 2 NAD % Asbestos by TEM NAD NAD back to top Face Powder: Brand LA Colors Pressed Powder Revlon Color Stay Pressed Powder Cover Girl TruBlend Mineral Loose Mineral Powder Physician's Formula Summer Eclipse Bronzing & Shimmery Face Powder Shade Nude BPP320 Fair 810 Translucent Fair 405 Moonlight/Light Bronzer 3104 http://www.fda.gov/Cosmetlcs/Productslngredients/lngredients/ucm293184.htm % Asbestos by PLM NAD NAD NAD NAD % Asbestos by TEM NAD NAD NAD NAD Page 5 of 7 Ingredients > Talc Wet n Wild Bronzer Iman Luxury Pressed Powder Coty Air Spun Loose Face Powder Black Opal Color Fusion Powder Black Radiance Pressed Powder Posner Finishing Touch Pressed Powder N.Y.C. New York Color Loose Face Powder Almay Nearly Naked Loose Powder Clinique Stay Matte Sheer Pressed Powder BeneFit Hello Flawless Custom Powder Cover-Up for Face SPF 15 Smashbox Fusion Soft Lights Intermix Pressed Powder Guerlain Meteorites Poudre de Perles Illuminating Perfecting Pressed Powder Urban Decay Baked Bronzer Body Powder: Light/Medium 701 NAD Clay Medium Dark NAD Translucent 070-24 NAD Mosaic Raspberry Bronzer NAD Rich Mahogany Acajou riche 8607B NAD Honey Beige 53124 NAD Translucent 741A NAD Light/pale 100 NAD Invisible Matte 101 NAD Me Vain? Champagne 1B168 NAD Baked Stardust DL 106 NAD Mythic Parfait 01 NAD Gilded NAD Brand Johnson's Baby Powder CVS Brand Baby Powder Rite Aid Baby Powder Anti Monkey Butt Powder Assured Shower & Bath Absorbent Body Powder Angel of Mine Baby Powder Family Dollar Mild Baby Powder Shade % Asbestos by PLM n/a NAD n/a NAD n/a NAD n/a NAD n/a NAD n/a NAD n/a NAD http://www.fda.gov/Cosmetics/Productslngredlents/lngredlents/ucm293184.htm 5/28/16, 12:12 PM NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD Page 6 of 7 Ingredients > Talc Shower to Shower Morning Fresh Absorbent Body Powder n/a NAD PLM average limit of quantitation and limit of detection = 0.19% 0.04 TEM average limit of detection = 0.0000044% 1.76229E-08 TEM average limit of detection = 0.044 ppm 0.018 TEM average limit of quantitation = 0.39% 0.08 back to top NAD 5/28/16, 12:12 PM http://www.fda.gov/Cosmetlcs/Productslngredients/lngredients/ucm293184.htm Page 7 of 7