(Reuters) – The U.S. Food and Drug Administration proposes to test cosmetic products containing talc using standardized methods to detect asbestos, a potential contaminant, according to documents published in the Federal Register on Thursday.
Why is it important
Asbestos, a known human carcinogen, can be harmful to consumers if found in cosmetics containing talc as there is no set limit for a “safe level” of exposure to the substance.
The health regulator said that if the rule is finalized, it could help protect consumers from harmful exposure to asbestos, leading to fewer diseases such as lung and ovarian cancer.
Context
Johnson & Johnson (NYSE:) is facing lawsuits from more than 62,000 claimants, who claim that the company's baby powder and other talc products were contaminated with asbestos and caused ovarian and other cancers.
The healthcare giant is seeking to resolve the claims through a nearly $10 billion bankruptcy settlement. It denied the allegations and described its products as safe.
In its proposed rule, the FDA would require manufacturers to test a sample from each batch of cosmetics containing talc for asbestos using methods such as polarized light and transmission electron microscopy, which produces images by illuminating samples with an electron beam.
If a manufacturer fails to comply with testing and recordkeeping requirements, the proposed rule would allow FDA to declare that product adulterated under the Federal Food, Drug, and Cosmetic Act.
What's next
FDA is seeking comments on the proposed rule from the public and industry representatives for the next 90 days before finalizing the requirements.
