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U.S. Department of Health and Human Services

Cosmetics

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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 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 Mg3Si4O10(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

 
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.
 

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.”  
 
Cosmetic-grade raw material talc:
 
Supplier
Product Identity
Lot #
% Asbestos by PLM
% Asbestos by TEM
Rio Tinto Minerals/Luzenac America
Imperial 200 USP
H10018
NAD
NAD
Imperial 250 USP
H10018
NAD
NAD
Imperial 400 USP
H06049-43
NAD
NAD
Olympic H USP
H04018
NAD
NAD
Supreme H USP Lot 2
H09219-79
NAD
NAD
Supra H USP
H10018
NAD
NAD
Suprafino H USP
H6309-78
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
Product Identity
Lot #
% Asbestos by PLM
% Asbestos by TEM
Presperse
Micro Ace P-2
33070516
NAD
NAD
Micro Ace P-4
37080823
NAD
NAD
Rose Talc
2008-09
NAD
NAD
Talc NK-48
017 0306
NAD
NAD
TalClear BH
070608
NAD
NAD
TalClear LH
070529
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
Product Identity
Lot #
% Asbestos by PLM
% Asbestos by TEM
Sensient Cosmetic Technologies
28355 Talc PP
W249-06
NAD
NAD
28368 Talc NBSB
W080720
NAD
NAD
28460 Talc F-MS
W053-08
NAD
NAD
61631 Talc LCW
26449
NAD
NAD
R0175 Talc FHC
W041397
NAD
NAD
R0255 Talc SI
W05630
NAD
NAD
R0435 Talc AS
W061176
NAD
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
 
 
Supplier
Product Identity
Lot #
% Asbestos by PLM
% Asbestos by TEM
Brenntag Specialties, Inc.
Talc IMP BC IMP1886L
H01018
NAD
NAD
Supra H USP BC (*1718)
H10016
NAD
NAD
Imperial 400 USP BC (*1883)
H01017
NAD
NAD
Talcron MP 60-30 USP (1745)
B8141N1
NAD
NAD
Talc IMP BC IMP1820L
H07018
NAD
NAD
Talc Imperial USP BC IMP1885L
H10017
NAD
NAD
Lo-Micron USP BC 2755
B7375N2
NAD
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
 
Cosmetic products containing talc:
 
Blush:
 
Brand
Shade
% Asbestos by PLM
% Asbestos by TEM
Maybelline New York Expert Wear Blush
Gentle Rose 109EWBR-30
NAD
NAD
N.Y.C. New York Color Cheek Glow Powder Blush
West Side Wine 652A
NAD
NAD
NARS Blush
Torrid 4017
NAD
NAD
 
Eye Shadow:
 
Brand
Shade
% Asbestos by PLM
% Asbestos by TEM
Physician’s Formula Shimmer Strips Custom Eye Enhancing Shadow & Liner
Hazel Eyes 2222
NAD
NAD
Black Radiance Eyeshadow Quartet
Retro Chic 8805
NAD
NAD
Stilla Eye Shadow Trio
Venus S461-03
NAD
NAD
Dior 5-Colour Iridescent Eyeshadow
Petal Shine 809
NAD
NAD
 
Foundation:
 
Brand
Shade
% Asbestos by PLM
% Asbestos by TEM
Black Opal True Color Liquid Foundation
Heavenly Honey
NAD
NAD
Laura Mercier Foundation Powder
Number 2
NAD
NAD
 
Face Powder:
 
Brand
Shade
% Asbestos by PLM
% Asbestos by TEM
LA Colors Pressed Powder
Nude BPP320
NAD
NAD
Revlon Color Stay Pressed Powder
Fair 810
NAD
NAD
Cover Girl TruBlend Mineral Loose Mineral Powder
Translucent Fair 405
NAD
NAD
Physician’s Formula Summer Eclipse Bronzing & Shimmery Face Powder
Moonlight/Light Bronzer 3104
NAD
NAD
Wet n Wild Bronzer
Light/Medium 701
NAD
NAD
Iman Luxury Pressed Powder
Clay Medium Dark
NAD
NAD
Coty Air Spun Loose Face Powder
Translucent 070-24
NAD
NAD
Black Opal Color Fusion Powder
Mosaic Raspberry Bronzer
NAD
NAD
Black Radiance Pressed Powder
Rich Mahogany Acajou riche 8607B
NAD
NAD
Posner Finishing Touch Pressed Powder
Honey Beige 53124
NAD
NAD
N.Y.C.  New York Color Loose Face Powder
Translucent 741A
NAD
NAD
Almay Nearly Naked Loose Powder
Light/pale 100
NAD
NAD
Clinique Stay Matte Sheer Pressed Powder
Invisible Matte 101
NAD
NAD
BeneFit Hello Flawless Custom Powder Cover-Up for Face SPF 15
Me Vain? Champagne 1B168
NAD
NAD
Smashbox Fusion Soft Lights Intermix Pressed Powder
Baked Stardust DL 106
NAD
NAD
Guerlain Meteorites Poudre de Perles Illuminating Perfecting Pressed Powder
Mythic Parfait 01
NAD
NAD
Urban Decay Baked Bronzer
Gilded
NAD
NAD
 
Body Powder:
 
Brand
Shade
% Asbestos by PLM
% Asbestos by TEM
Johnson’s Baby Powder
n/a
NAD
NAD
CVS Brand Baby Powder
n/a
NAD
NAD
Rite Aid Baby Powder
n/a
NAD
NAD
Anti Monkey Butt Powder
n/a
NAD
NAD
Assured Shower & Bath Absorbent Body Powder
n/a
NAD
NAD
Angel of Mine Baby Powder
n/a
NAD
NAD
Family Dollar Mild Baby Powder
n/a
NAD
NAD
Shower to Shower Morning Fresh Absorbent Body Powder
n/a
NAD
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

 

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