New lab tests didn’t find asbestos in recalled baby powder, Johnson & Johnson says
NEW YORK — Johnson & Johnson Consumer Inc. said Tuesday it didn’t find asbestos in the bottle of Johnson’s Baby Powder that was previously tested by the US Food and Drug Administration and found to be contaminated.
Earlier this month, the company recalled one lot of baby powder — about 33,000 bottles — produced and shipped in the United States last year. The recall came in response to an FDA test that found low levels of chrysotile asbestos contamination in samples from a bottle purchased online, according to the company.
The company advised people with a bottle of Johnson’s Baby Powder from lot #22318RB to discontinue using the product and contact the company for a refund. It also noted the levels found were not greater than 0.00002% and said that it could not confirm whether cross-contamination had caused a false positive test result.
Johnson & Johnson said Tuesday that 15 new tests of the same bottle of baby powder that had been tested by the FDA found no asbestos. An additional 48 new lab tests of samples from the recalled lot of Johnson’s baby powder also did not contain asbestos, the company said. The tests were performed by two third-party labs as part of the company’s testing and investigation.
“The Company has a rigorous testing standard in place to ensure its cosmetic talc is safe. Thousands of tests over the past 40 years, including FDA’s own testing as recently as last month, repeatedly confirm that Johnson’s Baby Powder does not contain asbestos,” Johnson & Johnson’s statement said.
The FDA also said it stands by its findings, adding that different testing methods may add “additional variability to the findings.”
“Sampling of talc-containing cosmetics is done on a small amount of product, 100 nanograms, which is a small proportion of a larger sample, in this case a 623 gram bottle,” the agency said in a statement.
“Given the powdered nature of the product, we expect non-uniformity in the distribution of any contaminant fibers in the product. As a result, different samples may provide different results. Out of our three aliquots (meaning a portion of the sample) of the same J&J product, one was negative and two were positive,” the agency said.
The FDA previously said it was not aware of any adverse events related to exposure to the 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 earlier this month.
“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.”
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.
In a statement earlier this month, Acting FDA Commissioner Dr. Ned Sharpless said the agency continues to test products that contain talc for the presence of asbestos.