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Reuters
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The U.S. Food and Drug Administration proposed that cosmetic products containing talc be tested using standardized methods to detect asbestos contamination, according to documents posted in the Federal Register on Thursday.
Asbestos, a known human carcinogen, has no established “safe level” of exposure to the material and can cause harm to consumers if found in cosmetic products containing talc.
If finalized, the rule will help protect consumers from harmful exposure to asbestos, leading to lower rates of diseases such as lung and ovarian cancers, the health watchdog said.
Johnson & Johnson has filed lawsuits against more than 62,000 claimants.
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The health care giant is seeking to settle claims for an estimated $10 billion in damages. She denied the allegations and called the products safe.
In the proposed rule, FDA would require manufacturers to test each batch of talc-containing cosmetic products for asbestos by irradiating samples using methods such as polarized light and transmission electron microscopy.
If the manufacturer does not meet the testing and recordkeeping requirements, the proposed rule would allow the FDA to declare that product adulterated under the federal Food, Drug, and Cosmetic Act.
FDA will seek comments from the public and industry representatives on the proposed rule over the next 90 days before finalizing the requirements.