NEW BRUNSWICK, N.J., Dec. 3, 2019/PRNewswire/ -- Johnson & Johnson Consumer Inc. (NYSE: JNJ) (the Company) today reaffirmed that its Johnson's Baby Powder is safe and free of asbestos after a comprehensive investigation into the United States Food and Drug Administration's (FDA) earlier reported finding of sub-trace levels of asbestos (no greater than 0.00002%) in samples from a single bottle of Johnson's Baby Powder.
Tests conducted by two third-party labs show asbestos was not present in the single bottle that FDA's contracted lab, AMA Analytical Services, Inc. (AMA), tested, nor was it present in retained samples of the finished lot from which the bottle was produced. Additionally, the Company's investigation revealed that the testing protocol at AMA deviated from standard practice and that AMA did not execute a full asbestos confirmation as required by their lab's test method.
The Company's investigation concluded that the most probable root causes for the FDA's reported results were either test sample contamination and/or analyst error at the AMA lab.
The Company stated: "Our talc is safe and asbestos free, and these 150-plus tests, and the tests we routinely do to ensure the quality and safety of our talc-based products, are consistent with the results from renowned independent research labs over the past 40 years."
Over the course of the investigation, a total of 155 tests were conducted by two different third-party labs using four different testing methods on samples from the same bottle tested by AMA, the recalled lot of Johnson's Baby Powder, as well as three lots manufactured before the recalled lot and three lots manufactured after the recalled lot. All results confirm there is no asbestos in our talc. The results of 63 of these tests were released on October 29, and the Company today released the results of the 92 subsequent tests. Other than test sample contamination and/or analyst error at the AMA lab, there is no viable explanation for AMA's positive results in two out of three samples it tested, as compared to 32 third-party tests on samples from the same bottle finding no asbestos.
The Company has ruled out the mine and manufacturing supply chain as root causes for AMA's sub-trace asbestos findings. In its investigation, the Company also confirmed that the milling and mixing of Johnson's Baby Powder results in a uniform product, ensuring that its testing would reveal asbestos if it was present in the product.
The Company's investigation into AMA's test results has now concluded. The Company has shared its findings with the FDA and continues to work with the Agency in support of consumer safety.
The Company has now posted the results of all 155 tests, the complete AMA report as received from the FDA, and a summary of its investigation here. For more information about talc, visit FactsAboutTalc.com.
Despite the conclusions of the investigation and the tests showing no asbestos in the bottle or lot, the previously announced recall of Lot #22318RB of Johnson's Baby Powder, stays in effect. The recall was made out of an abundance of caution and before an investigation could be conducted, and, once initiated, it is not feasible to halt the recall. If you have questions about the recall, contact the Johnson & Johnson Consumer Care Center at www.johnsonsbaby.com or by calling +1 (866) 565-2229.
For 133 years, the Johnson & Johnson Family of Companies have been committed to putting the needs and well-being of the people we serve first, and we will continue to do so.
NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS: This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the results of subsequent testing related to the voluntary recall of one lot of Johnson's Baby Powder. The reader is cautioned not to rely on these forward-looking statements. The forward-looking statements in this press release are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Consumer Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; uncertainty of commercial success for new and existing products; the ability of the company to successfully execute strategic plans; manufacturing difficulties or delays, internally or within the supply chain; changes to applicable laws and regulations; changes in behavior and spending patterns of purchasers of health care products and services; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," in the company's most recently filed Quarterly Report on Form 10-Q and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Neither Johnson & Johnson Consumer Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. The Company expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.