US FDA proposes standardized testing to detect asbestos in talc merchandise

(Reuters) – The U.S. Meals and Drug Administration is proposing that beauty merchandise containing talc must be examined utilizing standardized strategies to detect asbestos, a possible contaminant, in keeping with paperwork posted on the federal register on Thursday.

WHY IT’S IMPORTANT

Asbestos, a identified human carcinogen, may be injurious to shoppers if present in talc-containing beauty merchandise as there isn’t any established “protected stage” threshold for publicity to the substance.

If finalized, the rule may also help shield shoppers from dangerous publicity to asbestos, resulting in fewer sicknesses corresponding to lung and ovarian cancers, the well being regulator mentioned.

CONTEXT

Johnson & Johnson (NYSE:JNJ) is going through lawsuits from greater than 62,000 claimants, who’ve alleged that the corporate’s child powder and different talc merchandise had been contaminated with asbestos and triggered ovarian and different cancers.

The healthcare large seeks to resolve the claims by means of an roughly $10 billion settlement in chapter. It has denied the allegations and referred to as its merchandise protected.

In its proposed rule, the FDA would require producers to check a pattern of every batch of a talc-containing beauty product for asbestos by utilizing strategies corresponding to polarized mild and transmission electron microscopy, which produces photographs by illuminating samples with an electron beam.

If the producer fails to adjust to testing and record-keeping necessities, the proposed rule permits the FDA to declare that product as adulterated underneath the Federal Meals, Drug, and Beauty Act.

WHAT’S NEXT

The FDA is in search of feedback on the proposed rule from the general public and trade representatives for the following 90 days earlier than finalizing the necessities.

(This story has been refiled to alter the picture, with no modifications to textual content)