The U.S. Food and Drug Administration (FDA) seeks to create a universal testing process of asbestos in talc.
The FDA announced a proposed rule on Dec. 26, 2024 that would establish and require a standardized testing method for asbestos in talc-containing asbestos products. This namely includes cosmetics, which for decades have contained talc as a main ingredient.
Asbestos in talc can cause mesothelioma, which is a rare and fatal type of cancer that forms in the lining of the lungs and abdominal cavity. Consumers have developed mesothelioma due to asbestos in products.
Details on the FDA Proposed Rule
The proposed rule is titled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.”
It would require manufacturers of talc-containing cosmetic products to test for asbestos using two methods: Polarized Light Microscopy (PLM) (with dispersion staining) and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED). Using both methods will help detect and identify the presence of asbestos.
The FDA’s proposed rule also would require manufacturers to test representative samples of each batch or lot of talc-containing cosmetic product or on representative samples of each batch or lot of the talc ingredient used in the manufacture of cosmetic products. Manufacturers have a testing alternative: rely on a certificate of analysis from the talc supplier.
Manufacturers would have to keep records to demonstrate compliance with the rule.
If the proposed rule is finalized, cosmetic products would be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if a manufacturer fails to operate in compliance with either the testing or recordkeeping requirements. The proposed rule also states that if asbestos is present in a cosmetic product, or in talc used in a cosmetic product, that cosmetic product is tainted and considered unsafe under the FD&C Act; and that if asbestos is present in talc intended for use in a cosmetic, that talc is tainted under the FD&C Act.
“For many years the FDA has been sampling and testing talc-containing cosmetics for asbestos as well as working with our federal partners on efforts to reduce consumers’ risk of exposure to asbestos, a known human carcinogen, from contaminated talc-containing cosmetic products,” said Linda Katz, MD, MPH, director of the FDA’s Office of Cosmetics and Colors. “We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products.”
The FDA encourages public comment on this proposed rule. The comment period will end 90 days after the date of publication in the Federal Register. After the comment period closes, the FDA will review and consider comments as it develops the final rule.
You submit comments through Regulations.gov.
Dangers of Asbestos in Talc
Talc is a naturally occurring mineral that absorbs moisture and keeps skin dry. Manufacturers have created cosmetic products – such as blush, eye shadow, mascara and more – by grinding talc into a talcum powder since the 20th century and into the 21st century.
The health issue is talcum powder is sometimes contaminated with asbestos, which is another naturally occurring mineral that can cause cancer and other deadly diseases. Asbestos is the only known cause of mesothelioma.
Many people have developed mesothelioma after using cosmetic products with talcum powder. This has led to a public outcry of no longer using talc in cosmetics – instead using alternatives like cornstarch. There is also a push from scientists to improve testing of asbestos in products that still contain talc.
Companies that produce and sell talc cosmetics are facing a legal onslaught due to asbestos exposure for consumers. Johnson & Johnson faces approximately 60,000 lawsuits due to Johnson & Johnson Baby Powder and some of the company’s other products causing fast-spreading cancers such as mesothelioma and ovarian cancer.
Other companies facing lawsuits include Claire’s, Avon, and Chanel. Avon, for example, was ordered to pay $24 million in a mesothelioma lawsuit. The company has filed for bankruptcy in an effort to avoid paying other asbestos lawsuit verdicts in the future.
Sources & Author
- FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc. Accessed: 12/29/2024.
- FDA Issues Proposed Rule on Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-proposed-rule-testing-methods-detecting-and-identifying-asbestos-talc-containing-cosmetic. Accessed: 12/29/2024.
Sources & Author
