[Federal Register Volume 90, Number 227 (Friday, November 28, 2025)]
[Proposed Rules]
[Pages 54603-54604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-21407]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 730
[Docket No. FDA-2023-N-4225]
RIN 0910-AI82
Testing Methods for Detecting and Identifying Asbestos in Talc-
Containing Cosmetic Products; Withdrawal
AGENCY: Food and Drug Administration, Department of Health and Human
Services.
[[Page 54604]]
ACTION: Proposed rule; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the withdrawal of the proposed rule entitled ``Testing
Methods for Detecting and Identifying Asbestos in Talc-Containing
Cosmetic Products,'' which published in the Federal Register of
December 27, 2024. FDA is taking this action in response to comments
received during the comment period for the proposed rule that warrant
further consideration and assessment prior to issuing final regulations
to establish and require standardized testing methods for detecting and
identifying asbestos in talc-containing cosmetic products pursuant to
the Modernization of Cosmetics Regulation Act of 2022.
DATES: The proposed rule published December 27, 2024 (89 FR 105490) is
withdrawn as of November 28, 2025.
FOR FURTHER INFORMATION CONTACT: Elizabeth Anderson, Senior Policy
Analyst, Food and Drug Administration, 240-402-4565,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of December 27, 2024
(89 FR 105490), FDA issued the proposed rule entitled ``Testing Methods
for Detecting and Identifying Asbestos in Talc-Containing Cosmetic
Products'' as part of its implementation of the Modernization of
Cosmetics Regulation Act of 2022 (MoCRA), which 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.
The proposed rule, if finalized, would require manufacturers of
talc-containing cosmetic products to test their talc-containing
cosmetic products or the talc cosmetic ingredient prior to using the
talc to manufacture a talc-containing cosmetic for asbestos, and to
keep records to demonstrate compliance with the rule. Failure to comply
with the rule's testing or recordkeeping obligations would result in
FDA deeming a cosmetic product to be adulterated under the Federal
Food, Drug, and Cosmetic Act (FD&C Act), as would the presence of any
asbestos in a talc-containing cosmetic product, talc used in a cosmetic
product, or talc intended for use in a cosmetic. FDA received 49
comments on the proposed rule.
FDA proposed that the rule would apply to all manufacturers of
talc-containing cosmetic products, including cosmetic products that are
subject to the requirements of chapter V of the FD&C Act (Drugs and
Devices). Therefore, the proposed rule, if finalized, would apply 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.
FDA proposed to define ``asbestos'' to include ``amosite,
chrysotile, crocidolite; asbestiform tremolite, actinolite,
anthophyllite, winchite, and richterite; and other asbestiform
amphibole minerals.'' 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.
MoCRA requires FDA to establish and require standardized testing
methods for detecting and identifying asbestos in talc-containing
cosmetic products. The proposed rule was issued pursuant to MoCRA and
sections 601 and 701 of the FD&C Act. 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.
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.
While the Agency is withdrawing the proposed rule, FDA will issue a
proposed rule to meet its statutory obligations under section 3505 of
MoCRA.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-21407 Filed 11-25-25; 8:45 am]
BILLING CODE 4164-01-P