FDA Proposal to Require Asbestos Testing of Talc Cosmetics (2024)

Table of Contents

1. What the FDA Proposed
2. Why Talc and Asbestos: What the Proposal Says
3. The Law Behind the Proposal
4. The Two Microscopy Methods
5. Why the FDA Judged Existing Talc Tests Not Enough
6. What Would Have Counted as a Positive Result
7. Who Would Have Been Covered, How Often, and What Records
8. Costs and Benefits the FDA Estimated
9. The November 2025 Withdrawal and Its Stated Reasons
10. What the Proposal Does Not Do
11. Dates and Legal Status as of 11 October 2026
12. The Work That Led to the Proposal
13. Primary Documents
14. Key Research Papers
15. Connections

1. What the FDA Proposed

The proposed rule appeared in the Federal Register on Friday, 27 December 2024, volume 89, pages 105490–105504, under Regulation Identifier Number (RIN) 0910-AI82. It is dated 17 December 2024 and signed by Robert M. Califf, Commissioner of Food and Drugs. Its action line reads “Proposed rule.” A proposed rule is a draft regulation published for public comment; it has no legal force unless the agency later publishes a final rule.

The summary states that the FDA was “proposing to require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc,” together with “corresponding adulteration provisions.” It describes asbestos as “a potential contaminant in talc, which is used in certain cosmetic products,” and as “a known human carcinogen.”

The proposal would have created a new part of the Code of Federal Regulations, 21 CFR part 730, titled “Requirements for Talc-Containing Cosmetic Products,” with one operative section, § 730.3. In outline, the proposal would have required manufacturers to:

• test a representative sample of each batch or lot of a talc-containing cosmetic for asbestos using both Polarized Light Microscopy (PLM, with dispersion staining) and Transmission Electron Microscopy with Energy Dispersive Spectroscopy and Selected Area Electron Diffraction (TEM/EDS/SAED);
• or, as an alternative, test each batch or lot of the talc ingredient before using it, or rely on a certificate of analysis from a qualified talc supplier, provided the talc was tested with both PLM and TEM/EDS/SAED;
• keep records showing compliance.

Public comments on the proposal were due by 27 March 2025; comments on its information-collection (paperwork) burden were due by 27 January 2025. The docket, FDA-2023-N-4225, is the public file in which the proposal, supporting documents and comments are kept.

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2. Why Talc and Asbestos: What the Proposal Says

The proposal describes talc as a mineral “mined as a naturally occurring hydrous magnesium silicate” that is used in various cosmetic products. It states that asbestos “is found in the same rock types that host talc deposits and so may be found in commercial talc mines and may be inseparable from talc in the mining process,” so that talc used in cosmetics “sometimes contains asbestos fibers from serpentine or amphibole minerals present in proximity to talc deposits.”

On health effects, the document states that there is “general agreement among U.S. Federal Agencies, and the World Health Organization, that there is no established safe threshold for adverse health effects from asbestos exposure.” It adds that the FDA was “concerned about even low levels of asbestos in cosmetics, given that such products are applied to the body and used by many people on a regular, daily basis, throughout their lives,” and that the risk of harm “is higher with repeated and long-term exposure.”

According to the proposal, inhalation is the primary route of exposure to asbestos from talc-containing cosmetics, “although ingestion and perineal exposures also occur.” It lists effects of inhaled asbestos ranging from inflammation to pleural disease, asbestosis, lung cancer and mesothelioma, noting that these “rarely occur acutely” and typically appear “one or more decades later.” It states that asbestos can migrate through tissues to sites remote from the original exposure, including the larynx, gastrointestinal tract and ovaries, and that positive associations have been observed between asbestos exposure and cancer of the pharynx, stomach and colorectum.

The proposal also reports the FDA’s own sampling:

• In 2010, an FDA contract laboratory tested 34 talc-containing cosmetic powder products and samples of cosmetic-grade talc from suppliers, and found no asbestos using PLM and TEM/EDS/SAED.
• In 2019, the contract laboratory tested 52 talc-containing powder cosmetics; in March, June, August and October 2019 the FDA confirmed asbestos in nine of them, which were voluntarily recalled by the companies.
• Since 2019, the contract laboratory had tested more than 200 samples of talc-containing cosmetics with a TEM/EDS/SAED method that, the FDA states, “can reliably detect a single asbestos fiber in a sample aliquot.”

The document adds that laboratories testing the same product with sensitive electron microscopy “may reach different conclusions about the presence of asbestos,” and attributes this in part to the lack of a standardized testing method and to the uneven distribution of asbestos within samples.

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3. The Law Behind the Proposal

The proposal was issued under section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). According to the proposal, MoCRA was part of the Consolidated Appropriations Act, 2023, signed into law on 29 December 2022, and it “requires the promulgation of proposed and final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.” In other words, the law itself directs the FDA to write such a rule.

The proposal also relies on three provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as the document explains them:

• Section 601(c): a cosmetic is “adulterated” (the legal term for a product that may not lawfully be sold) if it “has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The FDA proposed to treat failure to test, or failure to keep testing records, as making the product adulterated under this section.
• Section 601(a): a cosmetic is adulterated if it “bears or contains any poisonous or deleterious substance which may render it injurious to users” under its labeled or customary conditions of use. The FDA proposed to state explicitly that a cosmetic containing asbestos, or made with talc containing asbestos, is adulterated, and that talc containing asbestos intended for cosmetic use is itself an adulterated cosmetic, because the Act counts “articles intended for use as a component” of a cosmetic as cosmetics.
• Section 701(a): the FDA may issue regulations “for the efficient enforcement” of the Act. The recordkeeping and record-access requirements rested on this authority.

The proposal notes that it is a prohibited act under section 301(a) of the FD&C Act to introduce or deliver an adulterated cosmetic into interstate commerce. It also quotes the Act’s definition of cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance,” a definition that, the document says, excludes soap.

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4. The Two Microscopy Methods

The core of the proposal was the requirement to use two complementary microscopy techniques together:

• Polarized Light Microscopy (PLM) with dispersion staining — an optical (light) microscope method. Asbestos would be identified by comparing optical crystal properties (colour and pleochroism, refractive indices, birefringence, extinction characteristics and sign of elongation) and particle shape against reference data and images. The proposal would have required analysts to refer to the PLM images of asbestos in Annex D of the international standard ISO 22262-1:2012(E).
• Transmission Electron Microscopy with Energy Dispersive Spectroscopy and Selected Area Electron Diffraction (TEM/EDS/SAED) — an electron microscope method that also reads a particle’s chemical elements (EDS) and crystal structure (SAED). Analysts would have been required to refer to Figure C.1 in Annex C of ISO 10312:2019(E).

The proposal explains why both: PLM has “much lower magnification than TEM/EDS/SAED by about two orders of magnitude,” but allows a larger amount of sample to be examined. “Therefore, combining TEM, which enables detection of smaller fibers, with PLM, which enables testing of larger samples, gives the best chance of detecting asbestos.” The document states that the minimum fiber width TEM/EDS/SAED can routinely characterize is on the order of 0.04 micrometres, “corresponding to the typical width of single chrysotile fibrils.”

To keep results consistent between laboratories, the FDA proposed that at least 0.1 micrograms of talc or talc-containing product be viewed on a TEM grid on which the sample is uniformly distributed. The proposal describes scanning electron microscopy (SEM/EDS) as a possible complement but “not as a substitute for TEM/EDS/SAED.”

The FDA stated that its choice of both optical and electron microscopy was aligned with the scientific opinions of the Interagency Working Group on Asbestos in Consumer Products (IWGACP), described in section 12 below.

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5. Why the FDA Judged Existing Talc Tests Not Enough

The proposal states that, among the published standards and methods it reviewed, the FDA “did not find any that can be recognized in its entirety as an appropriate standardized testing method to test for asbestos in talc or talc-containing cosmetics.” It singles out the only two published methods for asbestos in talc used in cosmetics and pharmaceuticals:

• CTFA method J4-1, “Asbestiform Amphibole Minerals in Cosmetic Talc,” a cosmetics-trade-association method. According to the proposal, it was designed for talc as an ingredient, not finished products; it targets amphibole asbestos and, on the FDA’s review, has no useful sensitivity for chrysotile; and it first screens talc by X-ray diffraction (XRD), with PLM only if XRD is positive. The XRD screen has a nominal detection limit of 0.5 percent by weight, so “if the talc contains less than 0.5 percent asbestos by weight, potentially representing billions of asbestos fibers per gram of talc, the asbestos would not be detected.”
• The U.S. Pharmacopeia (USP) talc monograph test, “Absence of Asbestos,” which uses infrared spectroscopy (IR, nominal detection limit about 1 percent) or XRD as a screen, followed by optical microscopy that does not require polarized light. The proposal states that optical microscopy without polarized light “lacks specificity.” It also describes USP’s own March 2022 proposal to revise that test, including deleting the IR option and requiring PLM even when XRD is negative, and notes that even the revised approach, without electron microscopy, “remains limited.”

The proposal adds that, in the absence of a standardized method, many laboratories had adapted methods originally developed for asbestos in air or building materials, which “could, at least in part, account for discrepancies in laboratory findings that have been reported.”

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6. What Would Have Counted as a Positive Result

Under proposed § 730.3(d), a sample found to contain asbestos by either PLM or TEM/EDS/SAED would have been regarded as positive. The threshold was the limit of detection: “if any asbestos is detected when the sample is tested as required … the sample must be regarded as positive for asbestos.”

The proposal explains the numbers behind that choice. The FDA’s contract laboratory reports gave an estimated limit of detection of a single asbestos fiber by TEM/EDS/SAED and a limit of quantification of four fibers. With at least 0.1 micrograms examined, detection of one fiber corresponds to an estimated 10⁷ (ten million) fibers per gram of talc or product, or approximately 10⁻⁵ percent asbestos by weight. The document notes that the FDA had previously used the limit of quantification as its basis for a positive sample, and proposed to move to the limit of detection “based on FDA’s historical testing data and our current better understanding of the sensitivity, accuracy, and precision” of the methods. It states that suitable negative controls (laboratory blanks) can give assurance that a single fiber detected is a true positive.

The proposal also defined “asbestos” broadly, as quoted in the 2025 withdrawal notice: “amosite, chrysotile, crocidolite; asbestiform tremolite, actinolite, anthophyllite, winchite, and richterite; and other asbestiform amphibole minerals.” The proposal explains that other federal regulations generally use a “commercial” definition covering six minerals, and that the FDA chose a “mineralogical” definition, adding winchite and richterite (which, the document states, have been identified in talc samples from certain regions) and all other asbestiform amphiboles, because the commercial definitions “do not include all hazardous asbestiform amphibole minerals that might be detected.”

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7. Who Would Have Been Covered, How Often, and What Records

Who. The requirements would have applied to all manufacturers of a talc-containing cosmetic product. The proposal notes that section 3505 of MoCRA is not among the exemptions in section 613(a) of the FD&C Act for certain cosmetic products and facilities that are subject to the Act’s drug and device requirements, so “cosmetic products that are also drugs, are subject to this proposed rule.”

How often. At a minimum, a representative sample of each batch or lot of each talc-containing product, or of the talc ingredient, would have been tested. A “representative sample” was defined as units drawn on rational criteria, such as random sampling, to accurately portray the material. A manufacturer relying on a supplier’s certificate of analysis would have had to verify the reliability of the supplier’s asbestos results on receipt of the first certificate and annually thereafter, by its own testing or another laboratory’s.

The proposal states that, based on discussions with industry representatives, it is the FDA’s understanding that testing talc before adding it to cosmetics is common industry practice. Its economic analysis assumed that all manufacturers would rely on supplier certificates.

Records. Manufacturers would have kept testing records — including raw data such as microscopy images, spectra, diffraction patterns and bench sheets, plus any supplier certificates and supplier-qualification documents — for 3 years after each record was created. Records would have had to be made available to the FDA within 1 business day on request, including electronically, and in English or with an English translation. The paperwork estimate in the proposal counts 801 recordkeepers, about 13,961 records a year and 251,298 total annual hours.

When. The FDA proposed that any final rule take effect 30 days after its publication in the Federal Register.

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8. Costs and Benefits the FDA Estimated

The proposal’s preliminary economic analysis lists the expected health benefits as fewer asbestos-related illnesses, “such as mesothelioma, lung cancer, larynx cancer, and ovarian cancer,” but states: “We lack data to quantify these public health benefits, so we instead discuss them qualitatively.” The only monetized benefit was cost savings to manufacturers from fewer recalls.

The figures above are those in the proposal’s executive summary and its Table 1. Costs included reading and understanding the rule, asbestos testing by talc suppliers, maintaining qualified suppliers, and retesting new batches of talc when an initial sample tested positive. The Office of Information and Regulatory Affairs determined the proposal was not a “significant regulatory action” under Executive Order 12866, section 3(f)(1), and the FDA proposed to certify that it would not have a significant economic impact on a substantial number of small entities.

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9. The November 2025 Withdrawal and Its Stated Reasons

On 28 November 2025 the Federal Register published “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal” (90 FR 54603–54604, FR Doc. 2025-21407), with the action line “Proposed rule; withdrawal.” It carries the same docket (FDA-2023-N-4225) and RIN (0910-AI82) and is signed by Robert F. Kennedy, Jr., Secretary of Health and Human Services. Its dates line reads: “The proposed rule published December 27, 2024 (89 FR 105490) is withdrawn as of November 28, 2025.”

The summary states that the FDA was withdrawing the proposal “in response to comments received during the comment period for the proposed rule that warrant further consideration and assessment prior to issuing final regulations.” The notice reports that the FDA received 49 comments, and it describes three groups of them:

• Scope. Because the proposal would have applied to cosmetic products that are also drugs, “FDA received comments that suggested the proposed rule would have unintended consequences for many consumer products containing talc, including but not limited to talc-containing cosmetic products.”
• The definition of asbestos. “FDA received comments that requested consistency with the established definitions or approaches used by other Federal agencies, including the Department of Labor (Occupational Safety and Health Administration and Mine Safety and Health Administration) and Environmental Protection Agency, to avoid unnecessary confusion.”
• Legal authority. “FDA received comments regarding the Agency’s statutory authority under law to add a specific adulteration provision relating to talc testing and regarding its authority to consider a cosmetic containing any amount of asbestos to be adulterated.”

The notice then gives its reasons in full:

“Good cause exists to withdraw the proposed rule at this time. On the basis of the Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply, the highly scientific and technical issues addressed in public comments the Agency has received, and the complexity of asbestos testing and legal considerations under the Administrative Procedure Act, we are withdrawing the proposed rule to reconsider best means of addressing the issues covered by the proposed rule and broader principles to reduce exposure to asbestos, and to ensure that any standardized testing method requirements for detecting asbestos in talc-containing cosmetic products help protect users of talc-containing cosmetic products from harmful exposure to asbestos.”

Its final sentence reads: “While the Agency is withdrawing the proposed rule, FDA will issue a proposed rule to meet its statutory obligations under section 3505 of MoCRA.” The withdrawal notice does not give a date for that new proposal.

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10. What the Proposal Does Not Do

• It never took effect. Because it was withdrawn before any final rule, no testing requirement exists under it.
• It does not ban talc in cosmetics. The proposal concerned testing talc and talc-containing cosmetics for asbestos contamination, not the use of talc itself.
• It does not name or address any particular product. The FDA’s 2019 sampling results and recalls are reported in the proposal only as background.
• The withdrawal does not remove the underlying legal duty. The withdrawal notice itself states that MoCRA requires standardized testing methods and that the FDA will issue a new proposed rule under section 3505.

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11. Dates and Legal Status as of 11 October 2026

• 17 December 2024 — proposed rule dated and signed by the Commissioner of Food and Drugs.
• 27 December 2024 — proposed rule published, 89 FR 105490.
• 27 January 2025 — deadline for comments on the information-collection (paperwork) provisions.
• 27 March 2025 — deadline for comments on the proposed rule.
• 28 November 2025 — proposed rule withdrawn, 90 FR 54603, after 49 comments.

Status as of 11 October 2026: withdrawn. The proposal was never finalized. A query of the Federal Register for FDA documents on talc or asbestos published from January 2025 through 11 October 2026, and for all documents in docket FDA-2023-N-4225, returned only the November 2025 withdrawal; no replacement proposed rule had appeared in the Federal Register by that date.

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12. The Work That Led to the Proposal

The proposal’s “History of Rulemaking” section lists the steps the FDA took before publishing it:

• Fall 2018 — the FDA formed the Interagency Working Group on Asbestos in Consumer Products (IWGACP).
• February 2020 — a public meeting, “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc,” at which the working group’s preliminary scientific opinions were presented.
• January 2022 — the FDA released the IWGACP’s final scientific opinions in a White Paper and Technical Appendices, both peer-reviewed. The working group concluded that XRD or IR screening followed by PLM only if the screen is positive is not specific or sensitive enough to detect asbestos.
• 29 December 2022 — MoCRA enacted, requiring proposed and final regulations on standardized asbestos testing of talc-containing cosmetics.

The proposal states that it was also informed by comments to the 2020 public-meeting docket, by published studies, and by the FDA’s experience overseeing talc-containing cosmetics. The proposal was one of several FDA rulemakings of 2024 collected on the FDA Actions of 2024 hub; other 2024 proposals on the hub include the oral phenylephrine proposal.

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13. Primary Documents

1. Food and Drug Administration, HHS (2024). Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Proposed Rule. Federal Register 89:105490–105504, 27 December 2024. Docket No. FDA-2023-N-4225; RIN 0910-AI82; 21 CFR Part 730 — FR Doc. 2024-30544 (official PDF, govinfo.gov)
2. Food and Drug Administration, HHS (2025). Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal. Federal Register 90:54603–54604, 28 November 2025. Docket No. FDA-2023-N-4225; RIN 0910-AI82 — FR Doc. 2025-21407 (official PDF, govinfo.gov)
3. Interagency Working Group on Asbestos in Consumer Products (2022). White Paper: IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc, 13 January 2022 (Ref. 22 of the proposed rule). Docket FDA-2020-N-0025 — regulations.gov FDA-2020-N-0025-0053
4. Public docket FDA-2023-N-4225 — regulations.gov FDA-2023-N-4225

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Key Research Papers

1. Baumann F, Ambrosi JP, Carbone M (2013). Asbestos is not just asbestos: an unrecognised health hazard. Lancet Oncology 14(7):576-578 — PubMed PMID: 23725699
2. Heller DS, Gordon RE, Westhoff C, Gerber S (1996). Asbestos exposure and ovarian fiber burden. American Journal of Industrial Medicine 29(5):435-439 — PubMed PMID: 8732916
3. Suzuki Y, Kohyama N (1991). Translocation of inhaled asbestos fibers from the lung to other tissues. American Journal of Industrial Medicine 19(6):701-704 — PubMed PMID: 1882849
4. Cook PM, Olson GF (1979). Ingested mineral fibers: elimination in human urine. Science 204(4389):195-198 — PubMed PMID: 219478
5. Rosner D, Markowitz G, Chowkwanyun M (2019). “Nondetected”: the politics of measurement of asbestos in talc, 1971-1976. American Journal of Public Health 109(7):969-974 — PubMed PMID: 31095409
6. Miller E, Beckett EM, Cheatham D, Comerford CE, Lewis RC, Krevanko C, Mandava N, Pierce JS (2024). A review of the mesotheliogenic potency of cleavage fragments found in talc. Toxicology and Industrial Health 40(7):398-424 — PubMed PMID: 38619498
7. Filetti V, Vitale E, Broggi G, Hagnäs MP, Candido S, Spina A, Lombardo C (2020). Update of in vitro, in vivo and ex vivo fluoro-edenite effects on malignant mesothelioma: a systematic review. Biomedical Reports 13(6):60 — PubMed PMID: 33149905

All seven papers are listed among the references of the December 2024 proposed rule (its Refs. 29, 15, 16, 14, 37, 25 and 7). The proposal cites the 1979, 1991 and 1996 papers for its statement that asbestos can reach tissues remote from the site of exposure, the 2013 commentary and the 2020 review in its discussion of non-commercial asbestiform minerals, the 2019 historical paper in its discussion of XRD detection limits, and the 2024 review among the studies it considered.

PubMed Topic Searches

1. PubMed: asbestos in talc cosmetics
2. PubMed: detecting asbestos in talc by electron microscopy
3. PubMed: talc and mesothelioma

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Connections

• FDA Actions of 2024
• FDA and Regulation
• Asbestos
• Mesothelioma
• Asbestosis
• Heavy Metals in Cosmetics
• Personal Care and Household Toxins
• Lead in Ground Cinnamon (2024)
• PFAS Food Packaging Phase-Out (2024)
• Oral Phenylephrine Removal Proposal (2024)
• Laboratory-Developed Tests Rule (2024)
• Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)

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