(Reuters) – The U.S. Meals and Drug Administration is proposing that magnificence merchandise containing talc must be examined using standardized methods to detect asbestos, a attainable contaminant, primarily based on paperwork posted on the federal register on Thursday.
WHY IT’S IMPORTANT
Asbestos, a recognized human carcinogen, is likely to be injurious to prospects if current in talc-containing magnificence merchandise as there isn’t any established “protected diploma” threshold for publicity to the substance.
If finalized, the rule can help defend prospects from harmful publicity to asbestos, leading to fewer illnesses much like lung and ovarian cancers, the effectively being regulator talked about.
CONTEXT
Johnson & Johnson (NYSE:) is coping with lawsuits from better than 62,000 claimants, who’ve alleged that the company’s youngster powder and totally different talc merchandise had been contaminated with asbestos and prompted ovarian and totally different cancers.
The healthcare huge seeks to resolve the claims through an roughly $10 billion settlement in chapter. It has denied the allegations and known as its merchandise protected.
In its proposed rule, the FDA would require producers to test a sample of each batch of a talc-containing magnificence product for asbestos by using methods much like polarized gentle and transmission electron microscopy, which produces images by illuminating samples with an electron beam.
If the producer fails to regulate to testing and record-keeping requirements, the proposed rule permits the FDA to declare that product as adulterated beneath the Federal Meals, Drug, and Magnificence Act.
WHAT’S NEXT
The FDA is looking for suggestions on the proposed rule from most people and commerce representatives for the next 90 days sooner than finalizing the requirements.
