[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Page 51035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0025]


Availability of FDA Statement Added to the Docket for Public 
Meeting Related to Cosmetic Products Containing Talc

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a statement added to the docket for the public meeting 
entitled ``Testing Methods for Asbestos in Talc and Cosmetic Products 
Containing Talc'' to address information provided in connection with 
the public meeting. FDA held the public meeting on February 4, 2020, 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 meeting included presentations by members of an 
interagency working group (the Interagency Working Group on Asbestos in 
Consumer Products or IWGACP).

FOR FURTHER INFORMATION CONTACT: Deborah Smegal, Office of Cosmetics 
and Colors, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Campus Dr., College Park, MD 20740, 240-402-1130.

SUPPLEMENTARY INFORMATION:

I. Background

    We opened a public docket and held a public meeting on February 4, 
2020, 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 EMPs 
that may be present as contaminants in such products. The meeting 
included presentations by members of an interagency working group 
(IWGACP).
    As part of the meeting materials, FDA made available 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 FDA or any other Federal 
Agency.
    Recently, we have been made aware of concerns that some external 
parties may consider the Executive Summary to be FDA recommendations. 
As a result, we are announcing the availability of a statement in the 
public docket to address information provided in connection with the 
public meeting. We have also added corresponding content on FDA's web 
page for cosmetics and talc (https://www.fda.gov/cosmetics/cosmetic-ingredients/talc).
    These updates are intended to clarify that 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. FDA and members of the IWGACP continue to 
evaluate the scientific literature and public feedback to the docket. 
FDA does not have any recommendations at this time. Should 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, 
FDA would propose any related regulations through a public notice and 
comment process.

II. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the document at either https://www.fda.gov/cosmetics/cosmetic-ingredients/talc or https:/www.regulations.gov.

    Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18181 Filed 8-18-20; 8:45 am]
BILLING CODE 4164-01-P


