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                Cosmetic Ingredients

Cosmetic Ingredients

                        Allergens in Cosmetics
          Alpha Hydroxy Acids
          Beta Hydroxy Acids
          Diethanolamine
          Fragrances in Cosmetics
          Latex in Cosmetics
          Parabens in Cosmetics
          Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics
          Phthalates in Cosmetics
          Talc Home
          Cosmetics
          Cosmetic Products & Ingredients
          Cosmetic Ingredients
          TalcCosmetic Ingredients Talc
  
  	
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December 7, 2022

FDA announces the release of the data from the agency’s 2022 testing of talc-containing cosmetic products for asbestos.

Constituent Update: FDA Releases Data from the Agency’s 2022 Testing of Talc-Containing Cosmetic Products for Asbestos


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. The law does not require cosmetic companies to share 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. Learn more about FDA's Authority Over Cosmetics.

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. 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.

Published scientific literature going back to the 1960s has suggested a possible association between the use of powders containing talc in the genital area 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. The FDA has ongoing research in this area. In addition, questions about the potential contamination of talc with asbestos have been raised since the 1970s.

Asbestos: What it is, Why it is 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 when inhaled. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently.

2022 Testing of Talc-Containing Cosmetics for Asbestos

The FDA has continued its testing for asbestos contamination in talc-containing cosmetics.  The products were selected based on various factors including, type of talc-containing cosmetic product, price range, popular products on social media and in advertisements, products marketed to children, and products marketed to women of color. Testing of samples was conducted by AMA Analytical Services, Inc. (AMA) on behalf of the FDA. Samples were analyzed using polarized light microscopy (PLM) and transmission electron microscopy (TEM). For additional information, see:

Constituent Update (December 7, 2022): FDA Releases Data from the Agency’s 2022 Testing of Talc-Containing Cosmetic Products for Asbestos
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 1 (01212022-1 to 01212022-14) (PDF - 70MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 2 (03022022-1 to 03022022-11) (PDF - 61MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 3 (03302022-1 to 03302022-13) (PDF - 62MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 4 (05022022-1 to 05022022-12)(PDF - 57MB)The summary table, “FDA Summary of Results from Testing of Official Samples of Talc-Containing Cosmetics for Asbestiform Fibers completed by AMA Laboratories in 2022” provides details for each of the talc-containing cosmetics that were analyzed in this survey, including product distributor/manufacturer, brand, product name, batch/lot #, FDA Sample ID #, and the findings from the testing.

Previous Activity
	**White Paper on Talc Testing Methods Released.** On January 13, 2022, the FDA announced the release of a white paper and technical appendices on testing methods for asbestos in cosmetic products containing talc.

Constituent Update: FDA Releases White Paper on Testing Methods for Asbestos in Cosmetic Products Containing Talc
	FDA News Release: FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products
	IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics)**2021 Testing of Talc-Containing Cosmetics for Asbestos**

The products tested in 2021 were selected based on various factors including, type of talc-containing cosmetic product, price range, popular products on social media and in advertisements, products marketed to children, and, if any, third party reports of potential asbestos contamination. Testing of samples was conducted by AMA Analytical Services, Inc. (AMA) on behalf of the FDA. Samples were analyzed using PLM and TEM methods. For additional information, see:

Constituent Update (October 25, 2021): FDA Releases Data from the Agency’s 2021 Testing of Talc-Containing Cosmetic Products for Asbestos
	FDA In Brief (October 25, 2021): FDA Makes Progress on Efforts to Understand Presence of Asbestos in Cosmetic Products
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 1 (02282020-1 to 02282020-12) (PDF - 52MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 2A (02232021-1 to 02232021-11) (PDF - 19MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 2B (02232021-12 to 02232021-13) (PDF - 2MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 3 (03242021-1 to 03242021-11) (PDF - 40MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 4 (04272021-1 to 04272021-14) (PDF - 65MB)The summary table, “FDA Summary of Results from Testing of Official Samples of Talc-Containing Cosmetics of Asbestiform Fibers completed by AMA Laboratories in 2021” provides details for each of the talc-containing cosmetics that were analyzed in this survey, including product distributor/manufacturer, brand, product name, batch/lot #, FDA Sample ID #, and the findings from the testing.

**2019 Talc Testing Results Released.**FDA release data from a year-long sampling assignment of testing talc-containing cosmetic products for the presence of asbestos. The FDA sampled cosmetic products following reports of asbestos contamination in talc-containing cosmetics. Testing of the samples was conducted on behalf of the FDA by the Occupational Safety and Health Administration (OSHA) and AMA. The summary table, “FDA Summary of Results from Testing of Official Samples of Talc-Containing Cosmetics of Asbestiform Fibers by AMA Laboratories During FY19" provides details for each of the talc-containing cosmetics that were analyzed in this survey. For additional information, see:

Constituent Update (March 9, 2020): FDA Releases Data from the Agency’s Year-Long Sampling Assignment to Test Talc-Containing Cosmetic Products for the Presence of Asbestos
	FDA In Brief (March 9, 2020): FDA Releases Final Report of Talc-containing Cosmetic Products Tested for Asbestos
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 1 (D-30 to D-31) (PDF – 4.6 MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 2 (D-32 to D-39) (PDF – 39.9 MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 3 (D-40 to D-47, D-51 to D-52) (PDF – 56.7 MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 4 (D-49 to D-50) (PDF – 33.5 MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 5 (D-53 to D-67) (PDF – 76.7 MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 6 (D-68 to D-82) (PDF – 86.4 MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Johnson & Johnson – Baby Powder Lot #22318RB (PDF - 7.68MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Timeless Beauty Palette (PDF - 8MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Matte Blush in Fuchsia (PDF - 8MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Shimmer Bronzer in Caramel (PDF - 5MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Bronzer in Sunset (PDF - 7MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus (PDF - 11MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Claire’s (PDF - 2MB)
	AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis (PDF - 3.9MB)
	OSHA Evaluation of Cosmetics and Cosmetic Talc for FDA (PDF- 2.6 MB)**Public Meeting on Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc**. On February 4, 2020, the FDA opened a public docket and held a public meeting to discuss and obtain scientific data and information on topics related to cosmetic products with talc as an ingredient, specifically, testing methodologies, terminology, and criteria that could be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in such products. The FDA made available, as part of the meeting materials, an  Executive Summary titled “Preliminary Recommendations on Testing Methods for Asbestos in Talc and Consumer Products Containing Talc” by the IWGACP. Neither the Executive Summary nor any of the presentations at the public meeting by members of the IWGACP, represent proposed or preliminary recommendations or policies of the FDA or any other federal agency. The Executive Summary and related presentations at the public meeting were meant solely to solicit scientific feedback on the issues raised and should not be used for any other purpose. The FDA and members of the IWGACP continue to evaluate the science and comments submitted to the docket. The FDA does not have any recommendations at this time. Should the FDA decide to develop recommendations with respect to standards or testing methods for asbestos in talc, as a result of the information it received as part of the public meeting and comments to the public docket or otherwise, it would issue draft guidance for public comment. Likewise, the FDA would propose any related regulations through a public notice and comment process.

**Warning to Consumers.**On October 18, 2019, the FDA updated a Safety Alert and issued a Constituent Update warning consumers not to use certain cosmetic products tested positive for asbestos.

Safety Alert (October 18, 2019): FDA Advises Consumers to Stop Using Certain Cosmetic Products
	Constituent Update (October 18, 2019): Baby Powder Manufacturer Voluntarily Recalls Product for Asbestos**Joint Institute for Food Safety and Applied Nutrition (JIFSAN) Scientific/Technical Meeting.** On November 28, 2018, the FDA and other government agency representatives attended a scientific and technical symposium designed to provide a forum for scientists to share their knowledge and experience in testing methods for analysis of talc, developing criteria used for fiber identification, and interpreting data. For the full transcripts from the symposium, see:

JIFSAN Symposium Asbestos in Talc Main Session Transcript(PDF - 1.1MB)
	JIFSAN Symposium Asbestos in Talc Breakout Session A Transcript(PDF - 490KB)
	JIFSAN Symposium Asbestos in Talc Breakout Session B Transcript(PDF - 292KB)
	JIFSAN Symposium Asbestos in Talc Breakout Session C Transcript(PDF - 397KB)**Formation of an Interagency Working Group on Asbestos in Consumer Products in the Fall of 2018.** The purpose of this government work group is to develop recommendations on topics related to testing methodologies, terminology, and criteria for data interpretation that can be applied to characterize mineral fibers present as contaminants in consumer products.

**FDA's Talc Survey of 2009-2010.** The FDA contracted with AMA to conduct a laboratory talc survey, which ran from September 28, 2009 to September 27, 2010. AMA analyzed the samples using PLM and  TEM methods. 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 of nine talc suppliers submitted samples and by the number of products tested. For these reasons, while the FDA found these results informative, they did not prove that most or all talc or talc-containing cosmetic products marketed in the United States at that time were likely to be free of asbestos contamination. The tables found in the FDA Summary of Results from Testing of Official Samples of Talc-Containing Cosmetics of Asbestiform Fibers by AMA Laboratories During 2009-2010 provided details for each of the cosmetic-grade raw material talc samples and cosmetic products containing talc that were analyzed in this survey.

                                                                                  Content current as of:
      12/07/2022
              
              
Regulated Product(s)
		 CosmeticsCosmetic Ingredients

          
                        Allergens in Cosmetics
          Alpha Hydroxy Acids
          Beta Hydroxy Acids
          Diethanolamine
          Fragrances in Cosmetics
          Latex in Cosmetics
          Parabens in Cosmetics
          Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics
          Phthalates in Cosmetics
          Talc
 
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