The recall, which is limited to one lot of baby powder bottles produced and shipped in the United States last year, comes in response to a US Food and Drug Administration test that found levels of chrysotile asbestos contamination in samples from a bottle purchased online, according to the company.
"I understand today's recall may be concerning to all those individuals who may have used the affected lot of baby powder," Acting FDA Commissioner Dr. Ned Sharpless said in a statement on Friday. "I want to assure everyone that the agency takes these concerns seriously and that we are committed to our mandate of protecting the public health."
"The FDA continues to test cosmetic products that contain talc for the presence of asbestos to protect Americans from potential health risks," Sharpless said.
People with a bottle of Johnson's Baby Powder from lot #22318RB, which includes 33,000 bottles, are advised to discontinue using the product and can contact the company for a refund.
The company noted that the levels found were no greater than 0.00002%, and that at this early stage of its investigation into the matter, it cannot confirm whether cross-contamination occurred, whether the sample came from a bottle with an intact seal or whether the tested product is authentic.
The FDA stands by the quality of its testing and results, and noted that the agency is not aware of any adverse events related to exposure to the lot of affected products.
"FDA handling of the sample and testing followed standard operating procedures for laboratory analysis and FDA sees no indication of cross-contamination," FDA spokeswoman Lyndsay Meyer wrote in an email to CNN on Friday.
"FDA will be working with Johnson & Johnson to facilitate further investigation to substantiate that the product is authentic. At this time, there is no indication that the product is counterfeit. Additionally, FDA is not aware of any records pointing to counterfeit Johnson's baby powder in the US market," Meyer's email said.
Johnson & Johnson "has immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results," the company said in its announcement.
The company "has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA's own testing on prior occasions -- and as recently as last month -- found no asbestos. Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos."
The FDA noted in its statement that it has been conducting an ongoing survey of cosmetic products for asbestos since 2018 and to date has tested about 50 cosmetic products.
As part of that testing, two samples of Johnson's Baby Powder were tested: one sample from lot #22318RB, which was found to be positive for asbestos, and a second from lot #00918RA, which tested negative for asbestos.
The agency said that it expects to issue the full results from this survey by the end of the year.
Talc is an ingredient used in many cosmetic products, such as baby powder and blush. The FDA has been conducting ongoing research into the potential contamination of talc with asbestos.
For instance, in March, the agency announced tests found asbestos contamination in certain cosmetic products sold by Claire's and Justice retailers.
"Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently," according to the FDA.
Johnson & Johnson said in its Friday announcement that the "company is acting out of an abundance of caution."
The company has faced previous allegations of asbestos contamination in its talcum powder.
A Reuters report published last year said that the company was aware for decades of asbestos in its baby powder but did not disclose that information to the public.
Lawsuits have been filed against the company in the United States alleging that asbestos in its talcum powder causes cancer. Some of those cases carried verdicts against Johnson & Johnson with multi-million dollar awards to plaintiffs.
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