15 New Tests from the Same Bottle of Johnson’s Baby Powder Previously Tested by FDA Find No Asbestos
Over 60 New Tests of the Recalled Lot Conducted by Two Third-Party Laboratories Find No Asbestos
NEW BRUNSWICK, NJ, (OCTOBER 29, 2019) – Johnson & Johnson Consumer Inc. (the Company) today announced that 15 new tests from the same bottle of Johnson’s Baby Powder previously tested by the U.S. Food and Drug Administration (FDA) found no asbestos. An additional 48 new laboratory tests of samples from the single lot of Johnson’s Baby Powder that the Company voluntarily recalled on October 18 (Lot #22318RB) also confirm that the product does not contain asbestos. These tests were conducted by two third-party laboratories as part of the Company’s ongoing testing and investigation.
The Company stated, “Rigorous and third-party testing confirms there is no asbestos in Johnson’s Baby Powder. We stand by the safety of our product.”
Tests Demonstrate Positive Readouts are Possible Due to Lab Contamination
Following the voluntary recall, the Company contracted two third-party laboratories to expedite a large number of tests of the recalled lot of Johnson’s Baby Powder utilizing Transmission Electron Microscopy (TEM), Powder X-Ray Diffraction (XRD) and Polarized Light Microscopy (PLM) testing.
In addition to using their standard preparation rooms, one of the laboratories deviated from their normal protocol by using an auxiliary room. In that auxiliary room, five samples were prepared, and three initially tested positive for asbestos. Upon this finding, the laboratory undertook an investigation and determined that a portable air conditioner in use during sample preparation in the auxiliary room was contaminated with asbestos. No asbestos was detected in any of the samples when prepared in the standard room.
This finding underscores the importance of investigating any positive test result. Even when careful safeguards are followed, asbestos contamination may be introduced during sample division, storage, preparation and analysis, according to the American Society for Testing and Materials, an International Standards Organization that identifies contamination as a concern in asbestos analysis (ASTM 6620-19, Standard Practice for Asbestos Detection Limit Based on Counts, at 5.1.3(ii)).
The Company has posted reports of its testing discussed above. These can be accessed on FactsAboutTalc.com.
Decades of Product Testing Has Found No Asbestos in Johnson’s Baby Powder
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. Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards. The Company and its suppliers routinely test to ensure our talc does not contain asbestos. Our talc has also been tested and confirmed to be asbestos-free by a range of independent laboratories, universities and global health authorities.
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.
As was previously announced, out of an abundance of caution, Lot #22318RB of Johnson’s Baby Powder was recalled on October 18. 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.
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 JJCI 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.