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
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% 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
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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
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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
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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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