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 needs to be examined utilizing standardized strategies to detect asbestos, a possible contaminant, in response to paperwork posted on the federal register on Thursday.

WHY IT’S IMPORTANT

Asbestos, a recognized human carcinogen, may be injurious to shoppers if present in talc-containing beauty merchandise as there is no such thing as a established “secure stage” threshold for publicity to the substance.

If finalized, the rule will help shield shoppers from dangerous publicity to asbestos, resulting in fewer diseases akin 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 have been contaminated with asbestos and brought on ovarian and different cancers.

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

In its proposed rule, the FDA would require producers to check a pattern of every batch of a talc-containing beauty product for asbestos through the use of strategies akin to polarized gentle and transmission electron microscopy, which produces photos 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 beneath the Federal Meals, Drug, and Beauty Act.

WHAT’S NEXT

The FDA is searching for feedback on the proposed rule from the general public and business representatives for the following 90 days earlier than finalizing the necessities.

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