FDA Provides Update on Talc Meeting

The US Food and Drug Administration today issued an update intended to provide what it is calling “additional clarity regarding information posted on our website and discussed at a public meeting earlier this year regarding testing methods for asbestos in cosmetic products containing talc.”
 
On Feb. 4, 2020, the FDA held a public meeting to discuss and obtain scientific data and information on topics related to cosmetic products that contain talc as an ingredient, including testing methodologies, terminology, and criteria that could be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (also known as EMPs) that may be present as contaminants in such products. The meeting included presentations by members of an interagency working group called the Interagency Working Group on Asbestos in Consumer Products or IWGACP as well as other stakeholders. The FDA also opened a public docket for comments on these topics.
 
As part of the meeting materials, the 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, said FDA.
 
Recently, the FDA was 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 new content to FDA’s webpage for cosmetics and talc to clarify the intent of the Executive Summary, and to address information provided in connection with the public meeting. Specifically, the update is 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.
 
The FDA and members of the IWGACP continue to evaluate the scientific literature and public feedback to the docket and do 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information it received as part of the public meeting and comments to the public docket or otherwise, it would issue draft guidance for public comment.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.