Document 1QO4L1EwmO4vg3LZGYagbOwoK

Selected Cosmetic Ingredients > Talc in Cosmetics Page 1 of 6 Home Cosmetics Product and Ingredient Safety Selected Cosmetic ingredients Cosmetics Talc in Cosmetics 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 iabeled, 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 Mg3Si4O 10(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 ink, or if such a (ink 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 essentia! to select talc mining sites carefully and take steps to purify the ore sufficiently. PLAINTIFF'S EXHIBIT How FDA followed up on the latest reports CAM-34 DEPOSITION EXHIBIT Mn KATHLEEN MANES EVANS REPORTING SERVICE littn - //n m n i, F,To iT m r/rntm (> tif> c/P rnH i irta n H T n a re H Ip n t^ n fe l-v /S ip ip rte rl( ''n ^ m e t ir ln o r p r iip n t i/ii X/1 6 /9 0 1 9 CPC-BCALTRSCPT00001180 Selected Cosmetic Ingredients > Talc in Cosmetics Page 2 of 6 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 materia! 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, 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 Ingrdient 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 fortesting included tow, 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 talccontaining 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." Cosmetic-grade raw m aterial tac: S u p p lie r Product Ide n tity Rio Tinto Mlnerals/Luzenac America Imperial 200 USP Imperial 250 USP Imperial 400 USP Olympic H USP Lot # H118 H1QQ18 H06049-43 H04018 Asbestos /o Asbestos by PLM by TEM NAD NAD NAD NAD NAD NAD NAD NAD -fro ^ fis/ii f i/ 1 f i . J 'J W '7 CPC-BCALTRSCPT00001181 Selected Cosmetic Ingredients > Talc in Cosmetics Page 3 of 6 Supreme H USP Lot 2 H09219-79 NAD Supra H USP H10018 NAD Suprafino H USP M6309-78 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 NAD NAD NAD S u p p lie r Product Identity Lot # % Asbestos by PLM Presperse Micro Ace P-2 33070516 NAD Micro Ace P-4 37080823 NAD Rose Talc 2008-09 NAD Talc NK-48 017 0306 NAD TaiCiear BH 070608 NAD TalClear LH 070529 NAD PLM average limit of quantitation and limit of detection = 0.22% 0.01 TEM average limit of detection - 0.0000021% 3.G099E-0S TEM average limit of detection = 0.021 ppm 0,003 TEM average limit of quantitation = 0.43% 0,02 % Asbestos by TEM NAD NAD NAD NAD NAD NAD S u p p lie r Product Identity Lot # /o A sbestos by PLM Sensient Cosmetic 28355 Talc PP W249-06 NAD Technologies 28368 Talc NBSB W08072 NAD 28460 Talc F-MS W53-08 NAD 61631 Talc LCW 26449 NAD R0175 Talc FHC W041397 NAD R0255 Taic SI W05630 NAD R0435 Taic AS 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 Q/o Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD Supplier Product Identity Lot # /o A sb esto s by PLM Brenntag Talc IMP BC IMP1886L H0118 NAD Specialties, Inc, Supra H USP BC H 10016 NAD (*1718) Imperial 400 USP BC H01017 NAD C+1883) Talcron MP 60-30 USP B8141N1 NAD (1745) Talc IMP BC IMP1820L H07018 NAD Taic Imperial USP BC H10017 NAD IM P 18851 Lo-Micron USP BC 2755 B7375N2 NAD PLM average limit of quantitation and limit of detection = 0.23% 0.01 TEM average limit of detection = 0.0000021% 2.10373E-Q9 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; / A n r t i / f v i o f r r^' r/ T^rt c,r Yi ^ t i r , c / P r A r l i i r ,,t f ? nc l T ^O`r P ir l i p n t S v * n t c / n R/l I 0 CPC-BCALTRSCPT00001182 Selected Cosmetic Ingredients > Talc in Cosmetics Page 4 of 6 Blush: Brand Maybetline New York Expert Wear Blush N.Y.C. New York Color Cheek Glow Powder Blush NARS Blush Shade % Asbestos by PLM Gentle Rose 109EWBR- NAD 30 West Side Wine 652A NAD Torrid 4017 NAD % A sbestos by TEM NAD NAD NAD Eye Shadow: Brand Shade Physician's Formula Hazel Eyes 2222 Shimmer Strips Custom Eye Enhancing Shadow & Liner Black Radiance Retro Chic 8805 Eyeshadow Quartet Stitla Eye Shadow Trio Venus 5461-03 Dior 5-Colour Iridescent Petal Shine 809 Eyeshadow % Asbestos by PLM /o Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD NAD Foundation: Brand Black. Opal True Color Liquid Foundation Laura Merder Foundation Powder Shade Heavenfy Honey Number 2 % A sbestos by PLM /o Asbestos by TEM NAD NAD NAD NAD Face Powder: Brand Shade Asbestos by PLM LA Colors Pressed Nude BPP32G NAD Powder Revlon Color Stay Fair 810 NAD Pressed Powder Cover Girl TruBlend Translucent Fair 40S NAD Mineral Loose Mineral Powder Physician's Formula Moonlight/Light NAD Summer Eclipse Bronzer 3104 Bronzing & Shimmery Face Powder Wet n Wild Bronzer Light/Medium 701 NAD Iman- Luxury Pressed Clay Medium Dark NAD Powder Coty Air Spun Loose Translucent 070-24 NAD Face Powder Black Opal Color Fusion Mosaic Raspberry NAD Powder Bronzer Biack Radiance Pressed Rich Mahogany Acajou NAD Powder riche 86Q7B Posner Finishing Touch Honey Beige 53124 NAD Pressed Powder /bAsbestos by TEM NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD / A i m m i 1 f `A n f^r,t> r1 ~ 1r C tn f= * ttr'sT-nOrr#'' # > n f `2/Tl ft/1 CPC-BCALTRSCPT00001183 Selected Cosmetic Ingredients > Talc in Cosmetics Page 5 of 6 N.Y.C. New York Color Translucent 741A NAD Loose Face Powder Aimay Nearly Naked Light/pa le 100 NAD Loose Powder Clinique Stay Matte Invisible Matte 101 NAD Sheer Pressed Powder BeneFit Hello Flawless Me Vain? Champagne NAD Custom Powder Cover- 1B168 Up for Face SPF 15 Smashbox Fusion Soft Baked Stardust DL 106 NAD Lights Intermix Pressed Powder Gueriain Meteorites Mythic Parfait 01 NAD Poudre de Perfes Illuminating Perfecting Pressed Powder Urban Decay Baked Gilded NAD Bronzer NAD NAD NAD NAD NAD NAD NAD Body Powder; Brand Shade % Asbestos by PLM Johnson's Baby Powder n/a NAD CVS Brand Baby n/a NAD Powder PJte Aid Baby Powder n/a NAD Anti Monkey Butt n/a NAD Powder Assured Shower & Bath n/a NAD Absorbent Body Powder Angel of Mine Baby n/a NAD Powder Family Dollar Mild Baby n/a NAD Powder Shower to Shower n/a NAD Morning Fresh Absorbent Body Powder PLM average limit of quantitation and limit of detection = 0.19% 0.04 TEM average limit of detection = 0.0000044% 1.76229E-Q8 TEM average limit of detection = 0.044 ppm 0.018 TEM average limit of quantitation - 0,39% 0.08 % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD NAD Page Last Updated: 04/12/2012 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-838-INFO-FDA (1-888-463-6332) Email FDA nr* t<rs r* , .. <n 1 CPC-BCALTRSCPT00001184 Selected Cosmetic Ingredients > Talc in Cosmetics Page 6 of 6 I.KVijOV. . k i .... For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness Internationa! Programs News & Events Training and Continuing Education Inspections/Com pii anee State & Local Officials Consumers Industry Health Professionals D epartm ent df H eaffli St. Human Services Links on this page: CPC-BCALTRSCPT00001185