FDA white paper on asbestos in talc-containing cosmetics

8 Feb 2022 --- In October 2018, the US Food and Drug Administration (FDA) formed the Interagency Working Group on Asbestos in Consumer Products (IWGACP).

The group was established as a result of concerns regarding the presence of asbestos in talc-containing cosmetic products and following several recalls of powder formulation cosmetic products by retailers in the US and globally. These include Health Canada, the Dutch Food Safety Authority and Taiwan’s FDA, who have also detected asbestos in the same cosmetic brands and also issued product recalls, the FDA shares.

The FDA, in its efforts to protect public health, conducts ongoing sampling and testing to assess for the presence of asbestos in talc-containing cosmetics. Its testing uses both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) to detect asbestos. It has published a white paper - a consensus document written by Subject Matter Experts (SMEs) from the IWGACP. 

Click to EnlargeSummarizing the contents of the white paper, FDA Spokesperson Courtney Rhodes says: “It contains scientific opinions on the testing of talc-containing cosmetics for the possible presence of asbestos, a known human carcinogen with well-documented health risks. The IWGACP white paper presents the opinion of this workgroup that these methods are better able to detect asbestos compared to the current voluntarily testing method adopted by the cosmetics industry in 1976, known as the Cosmetic, Toiletry, and Fragrance Association (CTFA) J4–1 method.” 

The white paper addresses fiber size and supports the development of standardized testing methods to improve the sensitivity and consistency of analyses, and inter-laboratory concurrence when reporting asbestos and other similar mineral particles in talc that could potentially affect consumer’s health following cosmetic use. It provides scientific opinions on testing methods for talc and talc-containing cosmetics for the FDA's consideration. These opinions include the following related advice: 

Utilizing both PLM and TEM to identify and report the presence of asbestos; reporting all asbestos and other similar particles greater than or equal to 0.5 micrometer (µm) in length with a length to width aspect ratio greater than or equal to 3-to-1; providing analytical reports with adequate documentation of findings; and establishing policies and procedures covering training, quality assurance, and quality control, to accompany testing methods, to ensure laboratories are qualified and their qualifications are reviewed on a regular basis.

The safety of talc-based cosmetics

Findings of the most recent sampling assignment released in October 2021 report that asbestos fibers were not detected in any of the 50 samples tested, the FDA states. In comparison, in 2019, tremolite and/or chrysotile asbestos was reported in nine of 52 cosmetic products (demonstrating a 17% detection). 

“The FDA is planning to test 50 additional samples in 2022 and will post a report when available,” shares Rhodes. “If any samples test positive for asbestos, the agency will promptly inform the public of the results and will work closely with the companies involved to help to remove affected products from the market.” 

Click to EnlargeRhodes confirms: “The opinions provided by the IWGACP will inform and lead to improved testing methods that reduce the risk of asbestos contamination in cosmetics, which pose a health concern to consumers.” The FDA also recognizes that, based on the IWGACP efforts, other organizations such as the United States Pharmacopeia (USP) and American Society for Testing and Materials (ASTM) have also accelerated their efforts to improve test methods for asbestos. 

Under the Federal Food, Drug, and Cosmetic Act - the law governing the FDA's oversight of cosmetics - products and their ingredients, with the exception of color additives, do not undergo FDA review or approval prior to being sold to American consumers, the FDA details. “This statutory framework has also not been modernized to take into account an enormous growth in the domestic industry and in foreign imports,” explains Rhodes. “Despite limited authorities over cosmetics, the FDA continues to monitor for potential safety problems with cosmetic products on the market, and it remains committed to taking action when needed to help keep consumers safe from contaminated cosmetic products.”

The spokesperson shares some steps consumers can take with regards to cosmetic safety:

• Follow labeled directions and heed all warning statements.
• If you are concerned about certain ingredients, check the label. The FDA requires all cosmetics marketed on a retail basis to consumers to bear a list of ingredients. A major reason for this requirement is to enable consumers to identify ingredients they wish to avoid.
• Stay informed. The FDA publicizes safety information in a number of ways including posting it on its website and Twitter alerts.

Commenting on whether the FDA has any guidance for consumers when selecting talc-based cosmetics, Rhodes expresses: “The FDA does not endorse or recommend the use of specific cosmetic products.”

Talc, in powder form, has many uses in cosmetics. 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.

The law does not require cosmetic companies to share safety information with the FDA, but it 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,” shares Rhodes. Click here for more details about the FDA's Authority Over Cosmetics.

“The release of the white paper concludes the efforts of the IWGACP,” states Rhodes. The FDA’s next steps include preparing an external peer review of the White Paper and Technical Appendices, and continuing the agency’s testing of talc-containing cosmetic products for asbestos in 2022. Any steps in a regulatory process will go through a public consultation to allow interested parties to provide comments to the agency.

By Natasha Spencer-Jolliffe, BPC Insights Senior Journalist