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 The FDA said it would work with Congress to update the regulatory
framework that the agency has been operating under for more than 80
years for cosmetics. It said there are currently no legal
requirements for any cosmetic manufacturer selling goods to American
consumers to test their products for safety.
In its safety alert, the FDA identified the products as Claire's eye
shadows, contour palette and compact powder and cited the talc used
in the products.
Claire’s disputed the FDA test results, saying they “show
significant errors” and have “mischaracterized fibers in the
products as asbestos.”
The retailer, which emerged from bankruptcy in October, said, “There
is no evidence that any products sold by Claire’s are unsafe.”
However, out of an abundance of caution, it said it removed the
three products in question from stores as well as “any remaining
talc based cosmetic products.”
The FDA has come under intensifying pressure from lawmakers and
consumer advocates to investigate possible asbestos contamination of
talc following a report published by Reuters on Dec. 14 about talc
in Johnson & Johnson powders. The Reuters report detailed that J&J
knew that the talc in its raw and finished powders sometimes tested
positive for small amounts of asbestos from the 1970s into the early
2000s. J&J did not disclose its test results to regulators or
consumers.
The alleged presence of asbestos in talc products is at issue in
thousands of lawsuits filed against J&J. Last month, J&J said it had
received federal subpoenas for the first time related to the
asbestos litigation and said it is cooperating with the inquiries.
J&J and its talc supplier, Imerys Talc America, have said numerous
studies and tests by regulators worldwide have shown their talc to
be safe and asbestos-free.
In response to the FDA’s call on Tuesday for new rules, J&J said it
supports the agency’s efforts to “reaffirm the safety of cosmetic
talc products.” The company said it has backed previous legislative
efforts to modernize FDA’s regulatory authority over cosmetics.
J&J also reiterated Tuesday that “for decades global independent
laboratories and health authorities have tested Johnson’s Baby
Powder and have never found asbestos.”
"SHIFT THE SAFETY PARADIGM"
The FDA on Tuesday said it would investigate cosmetics
manufacturers' sources for talc and what steps they take to test the
raw material or their finished products. The agency did not name
specific companies.
"We also want to know how many cosmetics products contain talc and
whether manufacturers have received adverse event reports associated
with talc-containing products," the FDA said.
In a joint statement on Tuesday, FDA Commissioner Scott Gottlieb,
who separately announced his resignation, and the director of the
agency's Center for Food Safety and Applied Nutrition, Susan Mayne,
said federal rules have not keep pace with the cosmetic industry's
substantial growth and a global supply chain.
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"To significantly shift the safety paradigm of cosmetics in the
U.S., we would need to work with stakeholders, including Congress,
to modernize the outdated regulatory framework that the FDA has been
operating under for more than 80 years when it comes to cosmetics,"
they said in the statement.
The FDA said the new rules for cosmetics manufacturers may require
companies to report adverse events, provide access to consumer
complaints during routine inspections and disclose known allergens
on a product’s label.
In the meantime, U.S. regulators are asking cosmetics firms to
voluntarily register their products and a list of ingredients,
including talc, with the FDA.
Asbestos is a mineral often found near talc, a common ingredient in
many cosmetics, and if steps are not taken to purify raw talc
sufficiently the talc put in consumer products may be contaminated
with asbestos, the FDA said.
Talc may be used in cosmetics, for example, to prevent caking or to
make facial makeup opaque.
In 2017, the FDA said it became aware of reports of asbestos
contamination in several cosmetics sold by Claire's and another
retailer, Justice, which is owned by Ascena Retail Group Inc. The
two retailers subsequently removed certain products, such as glitter
creams, eye shadows and make-up sets.
The FDA then ordered independent tests and the results received in
late February confirmed asbestos in three Claire's products and one
from Justice. The Justice product had already been recalled from the
market.
In a statement on Tuesday, Justice said it “quickly and responsibly
issued a voluntary recall in 2017 out of an abundance of caution.”
The FDA said Claire's had refused to comply with its request to
recall the products that tested positive for asbestos. The FDA said
it does not have the authority to mandate a recall, so it issued the
safety alert.
The United States Public Interest Research Group last May reported
the health and safety regulator for the Netherlands ordered Claire's
to remove several makeup products from Dutch shops after a study by
U.S. PIRG showed contamination with asbestos.
Claire's in March 2018, in a statement, questioned the accuracy of
asbestos testing by Dutch authorities. It said its own testing at
independent laboratories in the European Union and the United States
labs found that Claire's products were “compliant with all relevant
cosmetic safety regulations.”
Claire's, based in the Chicago suburb of Hoffman Estates, operated
2,471 stores in North America and Europe as of August 2018.
The FDA said the warning pertains to: Claire’s Eye Shadows – Batch
No/Lot No: 08/17; Claire’s Compact Powder – Batch No/Lot No: 07/15;
and Claire’s Contour Palette – Batch No/Lot No: 04/17.
(Reporting by Chad Terhune; Additional reporting by Ankur Banerjee
in Bengaluru; editing Leslie Adler)
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