The U.S. Food and Drug Administration on Tuesday confirmed the 2017 finding of asbestos contamination in children’s cosmetic products sold by retailers Claire’s and Justice.

FDA Commissioner Scott Gottlieb and Susan Mayne, director of the Center for Food Safety and Applied Nutrition, released a joint statement announcing the results of independent tests that confirmed asbestos contamination in three of the product samples from Claire’s and one of the samples from Justice.

Asbestos is a naturally occurring mineral often found near talc, a key ingredient in many cosmetic products. Exposure to asbestos can lead to serious health conditions, including lung cancer and mesothelioma.

In September 2017, Justice voluntarily recalled its Just Shine Shimmer Powder and seven additional cosmetic products.

Claire’s, which filed for Chapter 11 bankruptcy in March 2018, initially refused requests from the FDA to recall the company’s makeup products in question.

In a statement released Tuesday evening, Claire’s said the FDA’s test results “show significant errors” and that reports have “mischaracterized fibers in the products as asbestos.”

The company did announce that it has removed the three products from stores and will also remove any remaining talc-based cosmetic products.

“Out of an abundance of caution, we have removed the three products identified by the FDA from our stores, and are also removing any remaining talc based cosmetic products,” the retailer said. “We will honor returns of any Claire’s talc based cosmetics.”

While the FDA works to protect consumers from unsafe cosmetics on the market, the agency has no authority to enforce a recall under provisions of the Federal Food, Drug and Cosmetic Act.

“The FDA requested that Claire’s recall the products because they should not be used by consumers,” the statement from Gottlieb and Mayne read. “These findings serve as an important reminder that under our current authority, the FDA has only limited tools to ensure the safety of cosmetics products.”

It was also announced Tuesday that Gottlieb, a 46-year-old physician who used his post to tackle difficult health issues such as youth vaping and the opioid crisis, has resigned as commissioner of the FDA. The resignation is effective in about a month, according to an agency official.

Asbestos in Makeup Find out how asbestos finds its way into cosmetic products. Learn More



FDA Warns Public Against Claire’s Makeup

In addition to the FDA’s statement Tuesday, the agency issued a Safety Alert warning consumers not to use the three Claire’s products that tested positive for asbestos.

Those products include:

Claire’s Eye Shadows — Batch No/Lot No: 08/17

Claire’s Compact Powder — Batch No/Lot No: 07/15

Claire’s Contour Palette — Batch No/Lot No: 04/17

Claire’s issued a recall of nine products in December 2017 after lab tests conducted by Scientific Analytical Institute found asbestos-contaminated talc in 17 products acquired from Claire’s stores across the country.

U.S. PIRG, a consumer and public interest research group, released a report in March 2018 that revealed the three products listed in the FDA’s Safety Alert tested positive for asbestos.

The testing for U.S. PIRG was conducted by STAT Analysis Corporation, which is accredited for the U.S Environmental Protection Agency’s Method for the Determination of Asbestos in Bulk Building Materials.

However, because the testing was done by third-party labs, the FDA believed it was important to scientifically confirm the reports. The Occupational Safety and Health Administration and AMA Analytical Services Inc. conducted the testing for the FDA.

The FDA received the results in late February and released the findings Tuesday along with the Safety Alert.

“We understand how concerning this finding is for any consumer and parents whose children may have used one of these products,” the FDA statement read. “We take these concerns, and our obligation to protect consumers, seriously.”

Protecting Consumers from Asbestos in Makeup

The FDA’s authority when it comes to cosmetics hasn’t changed since the Federal Food, Drug and Cosmetic Act was enacted in 1938.

Under the law, the FDA is not required to review and approve cosmetic products prior to U.S. retailers selling them. Cosmetic manufacturers are responsible for the safety and proper labeling of their products.

“This means that ultimately a cosmetic manufacturer can decide if they’d like to test their product for safety and register it with the FDA,” according to the FDA press release. “To be clear, there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety.”

In that statement, Gottlieb and Mayne outlined steps the agency is taking to reinforce the obligations of cosmetics manufacturers, including:

Requesting information about what procedures they use to ensure their cosmetics are safe.

Understanding how they ensure talc used in any cosmetic product is asbestos-free.

Investigating how they source talc with appropriate traceability.

Finding out how many cosmetics products contain talc an whether manufacturers have received adverse event reports associated with talc-containing products.

“We believe this information will help us better identify specific cosmetic products and raw ingredient suppliers that may be more likely to be contaminated and inform steps that the FDA may be able to take to better protect consumers,” the statement said.

The FDA is also calling upon manufacturers to voluntarily register their products with the agency and list ingredients, including talc.

Bill to Keep Children’s Makeup Asbestos-Free Falls Flat

Last year, U.S. Rep. Debbie Dingell introduced the Children’s Product Warning Label Act of 2018.

The legislation aimed to mandate a warning label on cosmetics marketed to children unless stricter testing showed the products were asbestos-free.

After it was introduced in the House, the bill was sent to two subcommittees and never gained traction.

“Parents across the country should have the peace of mind in knowing that the cosmetics they buy for their children are safe,” Dingell said in a statement introducing the bill. “No child should be exposed to asbestos through the use of common, everyday products.”

Sean Fitzgerald, director of research and analytical services at the Scientific Analytical Institute, conducted the initial test of the 17 Claire’s products.

“I would treat [these products] like a deadly poison because it is one,” Fitzgerald told The Mesothelioma Center at Asbestos.com in July. “I’m just trying to make people more aware they need to do testing, and not senselessly expose people to asbestos, especially kids.”