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.
Press Contacts:
Ernie Knewitz
(732) 524-1090
media-relations@its.jnj.com
Jake Sargent
(202) 569-5086
JSargen3@ITS.JNJ.com
Investor Contacts:
Christopher DelOrefice
(732) 524-2955
CDeloref@its.jnj.com
Lisa Romanko
(732) 524-2034
LRomank3@its.jnj.com
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SOURCE Johnson & Johnson Consumer Inc.