The U.S. Food and Drug Administration is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos. Consumers who have Johnson’s Baby Powder lot #22318RB should stop using it immediately and contact Johnson & Johnson for a refund. The FDA stands by the quality of its testing and results and is not aware of any adverse events relating to exposure to the lot of affected products.
During talc mining, if talc mining sites are not selected carefully and steps are not taken to purify the talc ore sufficiently, the talc may be contaminated with asbestos. Asbestos is a known carcinogen. It is important to note that the FDA has been conducting testing of talc-containing cosmetic products for asbestos. Not all talc contains asbestos and the majority of product samples tested by the FDA did not contain asbestos.
“I understand today’s recall may be concerning to all those individuals who may have used the affected lot of baby powder. 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,” said Acting FDA Commissioner Ned Sharpless, M.D. “The FDA continues to test cosmetic products that contain talc for the presence of asbestos to protect Americans from potential health risks.”
Since 2018, the FDA has been conducting an ongoing survey of cosmetic products for asbestos and to date has tested approximately 50 cosmetic products. As part of this testing, two samples of Johnson’s Baby Powder were tested: one sample from lot #22318RB was found to be positive for asbestos; a second Johnson’s Baby Powder sample, lot #00918RA, tested negative for asbestos.
The FDA expects to issue the full results from this survey, including all tested products having both positive and negative results, by the end of the year. Since undertaking the testing, the agency has warned consumers when products tested positive for asbestos, advising them to stop using affected products, including not to use certain products from Claire’s and Beauty Plus Global. The FDA will continue to update its safety alert with new information as it becomes available.
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Although the FDA doesn’t have pre-market review authority, the agency has the responsibility to monitor the cosmetics market and can take appropriate action to protect consumers in the post-market setting. Cosmetics must not be “adulterated” or “misbranded,” meaning they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. The agency is again calling on industry to register and list their products via the FDA’s Voluntary Cosmetics Registration Program although under current law, registration and listing are not required.
The FDA continues to focus on protecting Americans from unsafe products and will continue testing samples from cosmetic products containing talc in accordance with our limited available resources. The FDA’s current work related to cosmetics also focuses on reviewing reports of adverse events involving cosmetics that are received from consumers and health professionals; reviewing scientific literature; research; surveillance; education and outreach; and pursuing enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
Health care professionals and consumers are encouraged to report any adverse events associated with the use of a cosmetic to the FDA’s MedWatch Adverse Event Reporting program by completing and submitting the report online at MedWatch Online Voluntary Reporting Form or downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.