(Reuters) – The U.S. Food and Drug Administration will require cosmetic products containing talc to be tested in a standardized manner to detect asbestos, a potential contaminant, according to a document published in the Federal Register on Thursday. is proposed.
Why is it important?
Asbestos, a known human carcinogen, may be harmful to consumers when present in cosmetics containing talc, as there is no established “safe level” threshold for exposure to this substance. there is.
If finalized, the rule could protect consumers from harmful exposure to asbestos and lead to a reduction in diseases such as lung and ovarian cancer, health regulators said.
context
Johnson & Johnson (NYSE:) faces lawsuits from more than 62,000 claimants alleging that its baby powder and other talc products were contaminated with asbestos and caused ovarian and other cancers I am doing it.
The healthcare giant is seeking to resolve the claims through a roughly $10 billion settlement in bankruptcy. The company denied the allegations and insisted its products were safe.
Under the proposed rule, FDA would require manufacturers to ensure that samples of each batch of talc-containing cosmetics are free of asbestos using methods such as polarized light or transmission electron microscopy, which generates images by shining an electron beam on the sample. Requires inspection to be carried out.
The proposed rule would allow FDA to declare a product adulterated under the Federal Food, Drug, and Cosmetic Act if a manufacturer fails to comply with testing and record-keeping requirements.
what’s next
FDA is seeking comments from the public and industry representatives on the proposed rule for the next 90 days before finalizing the requirements.
