Dec 26 (Reuters) - The U.S. Food and Drug Administration
is proposing that cosmetic products containing talc should be
tested using standardized methods to detect asbestos, a
potential contaminant, according to documents posted on the
federal register on Thursday.
WHY IT'S IMPORTANT
Asbestos, a known human carcinogen, can be injurious to
consumers if found in talc-containing cosmetic products as there
is no established "safe level" threshold for exposure to the
substance.
If finalized, the rule can help protect consumers from
harmful exposure to asbestos, leading to fewer illnesses such as
lung and ovarian cancers, the health regulator said.
CONTEXT
Johnson & Johnson ( JNJ ) is facing lawsuits from more than
62,000 claimants, who have alleged that the company's baby
powder and other talc products were contaminated with asbestos
and caused ovarian and other cancers.
The healthcare giant seeks to resolve the claims through an
approximately $10 billion settlement in bankruptcy. It has
denied the allegations and called its products safe.
In its proposed rule, the FDA would require manufacturers to
test a sample of each batch of a talc-containing cosmetic
product for asbestos by using methods such as polarized light
and transmission electron microscopy, which produces images by
illuminating samples with an electron beam.
If the manufacturer fails to comply with testing and
record-keeping requirements, the proposed rule allows the FDA to
declare that product as adulterated under the Federal Food,
Drug, and Cosmetic Act.
WHAT'S NEXT
The FDA is seeking comments on the proposed rule from the
public and industry representatives for the next 90 days before
finalizing the requirements.