On December 10, 2020 a
Exhibit,Appendix
was filed
involving a dispute between
Patsy Young,
and
Aventis Inc.,
Avon Products, Inc.,
Block Drug Company, Inc.,
Block Drug Corporation,
Brenntag North America, Inc.,
Brenntag Specialties, Inc. F K A Mineral Pigment Solutions, Inc.,
Charles B. Chrystal Company, Inc.,
Chattem, Inc.,
Colgate-Palmolive Company,
Cyprus Amax Minerals Company,
Cyprus Mines Corporation,
Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A K A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And
Novartis Consumer Health Inc.),
Gsk Consumer Health, Inc. F K A Novartis Consumer Health Inc. F K A Ciba Self-Medication, Inc.,
Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc.,
Insight Pharmaceuticals Llc,
Macy'S Inc. F K A Federated Department Stores, Inc.,
Novartis Pharmaceuticals Corporation,
Prestige Brands Holdings, Inc.,
Prestige Consumer Healthcare Inc. F K A Prestige Brands, Inc.,
Sanofi-Aventis U.S. Llc,
Sanofi Us Services, Inc.,
Whittaker Clark & Daniels, Inc.,
for Torts - Asbestos
in the District Court of Erie County.
Preview
FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023
EXH1BIT
S
FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023
f$r 9
JUL 11 1986 00
21 P 3
1986 JUL
Ibillippe Douillet
one Holyoke lane
Stony Broo1r, New York 11790
ite: Ibeket No. 83P-0404
Dear Mr. Douillet:
This respormis to your November 8, 1983, petition requestim that momette
tale he labeled with an ashestos warnim statement, infounstion on asbestos
particle size, and the proportion of tale impurities in the product.
You assert that, because the minim of tale almost itwariably includes the
mining of asbestos as well, cosmetic tale may antain singnificant smomes
of asbestos particles that present an inhalatim hazard to humans, Also,
you cite referaces to substantiate that sistnificant amounts of asbestos
have been fotni in ceramercial talc seaples, that asbestos inhalatim is
hazardous to humans, snd that asbestos contaminants in tale will produce
toxicological responsee when inhaled.
FDA recon;nizes that asbeston inhalation over extended periods is hazardous
to humans. The agemy is also aware that sane cosmetic tale produced in
the 1%0s ed early 1970s did contain ashestiform minerals. However, your
petition has not persuaded us that the cosmetic tale that is present3.y
heim produced mntains significant amounts of asbestiform minerals.
Durim the early 1970s, FDA beessie concerned about the possibility that
cosmetic tale did contain simpnificant amounts of this material. The agency
received several reports about snch cont;unination. Fowever, at that time,
the analytical procedures for determining asbeston in tale were not fully
developed, and most of the analytical work was cortfucted without scientific
agreement as to tich methods were well-suited for the identification of
asbestifoun minerals in tale. Consequently, FDA cSsidered all analytical
results to be of questionable reliability. This assessment proved to be
correct because many questions were subsequently raised about results
reported in the literature in the aarly 1970s (see enclosed copy of
National Bureau of Standards Special Publication 506 entitlai
"Minidentification of Asheston in Tale"). Because of the questionable
nature of the analytical results, the agency was not able to assess
reliably the levels of asbestiform minerals in cosmetic talc then in the
marketplace.
FDA00003601
FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023
Mr. Rtillippe Iboillet - Page 2
Under these circunatances, FDA decided that the most appropriate actions
that it could talie to protect the p lic health wmid be to make the
reports public and to request assistance free the affected industry in
devel.opirug accept41e analytical procedures. This approach apparently has
led to considerable improvement in the quality of this tale.
After FDL took these actism, nusty cometic manufacturers begat to analyze
their talc fbe asbeatiform minerals as part of their quality control
proarmes, and tale suppliers began to sell himber purity tales tw the
cosmetic industry. By 1976, asbestos analytical methodology tas
sufficiently developed that the Cosmetic, Toiletry, and Progrance
Association (CITA) could issue a specification (copy enclosed) for asmatic
tale. This specification required that sud tale be free of fibtotu
sqitibole (e.g., asbestos in the form of ambastiform treamlice) iming a
CTFA method of analysis that is capable of detecting 0.5 percent of
amphibole asbestos. This specification contributed to the continued
imprentment of cosmetic tale quality.
Tn addition, FDL surveillance activities that were conducted in the latter
partion of the 1970s showed ghat the quality of cosmetic tale had
significantly improved, and that even 4en asbestos was present, the levels
were so low that no health hazani existed. Our scientists recently
reviewed data from these surveillance activities and concluded that the
risk fran a worst-case estimate of exposure to asbestos fra cosmetic talc
would be less than the risk from environmatal backgromd levels of
exposure to asbeston (non-occupational exposure) over a lifetime.
Consequently, we find ther there is no basis at this time for the agency to
conclude that there is a health hazard attributshle to ashestos in cosmetic
tale. Without evidence of such a hazard, the agency concludes that there
is no need to require a warnirw label on cosmetic talc.
FIA should elso point out that, in reviewing yrmr petition, we fomd
several probles with the information on dich you relied. The publication
Powfers,"
"Ashestiform Impurities in Camercial Talcum 4ich you cite in
your petition, appears to contain a ntnber of significant errors that lead
us to question the accuracy of the findings that vere reported. For your
informatia, we have enclosed a copy of a Jme 8, 1973, rebuttal of this
publication that wim written by the Chief Minerologist of the Colorado
School of Mines Research Institute in Golden, Colorado. Also, your
petition's 1978 book reference to the Mt. Sinai School of Medicine findings
is too old to reflect present contamination levels, Further, we are not
convinced that the Mt. Sinai findings pertained to cosmetic tale. Your
reference states that cannon camercial tales were analyzed, but it does
not specify ether these comrnercial tales wre industrial grade or
cosmetic ta3.e.
FDA00003602
FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023
W. hillippe Dsuillet - Pas;e 3
For all
preitxfice
of titese
to the
reasons,
future
W
filirn
petition
of a petition
is denied.
a is
This
matter,
denial is wf.thout
acempanied by
all relevant data in support of the petition.
Sincerely yours,
Actirm Associate Qatissioner
for Regulatory Af faire
EHclosures
:
FDA00003603
Document Filed Date
March 03, 2023
Case Filing Date
December 10, 2020
Category
Torts - Asbestos
For full print and download access, please subscribe at https://www.trellis.law/.
Preview
FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023 EXH1BIT S FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023 f$r 9 JUL 11 1986 00 21 P 3 1986 JUL Ibillippe Douillet one Holyoke lane Stony Broo1r, New York 11790 ite: Ibeket No. 83P-0404 Dear Mr. Douillet: This respormis to your November 8, 1983, petition requestim that momette tale he labeled with an ashestos warnim statement, infounstion on asbestos particle size, and the proportion of tale impurities in the product. You assert that, because the minim of tale almost itwariably includes the mining of asbestos as well, cosmetic tale may antain singnificant smomes of asbestos particles that present an inhalatim hazard to humans, Also, you cite referaces to substantiate that sistnificant amounts of asbestos have been fotni in ceramercial talc seaples, that asbestos inhalatim is hazardous to humans, snd that asbestos contaminants in tale will produce toxicological responsee when inhaled. FDA recon;nizes that asbeston inhalation over extended periods is hazardous to humans. The agemy is also aware that sane cosmetic tale produced in the 1%0s ed early 1970s did contain ashestiform minerals. However, your petition has not persuaded us that the cosmetic tale that is present3.y heim produced mntains significant amounts of asbestiform minerals. Durim the early 1970s, FDA beessie concerned about the possibility that cosmetic tale did contain simpnificant amounts of this material. The agency received several reports about snch cont;unination. Fowever, at that time, the analytical procedures for determining asbeston in tale were not fully developed, and most of the analytical work was cortfucted without scientific agreement as to tich methods were well-suited for the identification of asbestifoun minerals in tale. Consequently, FDA cSsidered all analytical results to be of questionable reliability. This assessment proved to be correct because many questions were subsequently raised about results reported in the literature in the aarly 1970s (see enclosed copy of National Bureau of Standards Special Publication 506 entitlai "Minidentification of Asheston in Tale"). Because of the questionable nature of the analytical results, the agency was not able to assess reliably the levels of asbestiform minerals in cosmetic talc then in the marketplace. FDA00003601 FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023 Mr. Rtillippe Iboillet - Page 2 Under these circunatances, FDA decided that the most appropriate actions that it could talie to protect the p lic health wmid be to make the reports public and to request assistance free the affected industry in devel.opirug accept41e analytical procedures. This approach apparently has led to considerable improvement in the quality of this tale. After FDL took these actism, nusty cometic manufacturers begat to analyze their talc fbe asbeatiform minerals as part of their quality control proarmes, and tale suppliers began to sell himber purity tales tw the cosmetic industry. By 1976, asbestos analytical methodology tas sufficiently developed that the Cosmetic, Toiletry, and Progrance Association (CITA) could issue a specification (copy enclosed) for asmatic tale. This specification required that sud tale be free of fibtotu sqitibole (e.g., asbestos in the form of ambastiform treamlice) iming a CTFA method of analysis that is capable of detecting 0.5 percent of amphibole asbestos. This specification contributed to the continued imprentment of cosmetic tale quality. Tn addition, FDL surveillance activities that were conducted in the latter partion of the 1970s showed ghat the quality of cosmetic tale had significantly improved, and that even 4en asbestos was present, the levels were so low that no health hazani existed. Our scientists recently reviewed data from these surveillance activities and concluded that the risk fran a worst-case estimate of exposure to asbestos fra cosmetic talc would be less than the risk from environmatal backgromd levels of exposure to asbeston (non-occupational exposure) over a lifetime. Consequently, we find ther there is no basis at this time for the agency to conclude that there is a health hazard attributshle to ashestos in cosmetic tale. Without evidence of such a hazard, the agency concludes that there is no need to require a warnirw label on cosmetic talc. FIA should elso point out that, in reviewing yrmr petition, we fomd several probles with the information on dich you relied. The publication Powfers," "Ashestiform Impurities in Camercial Talcum 4ich you cite in your petition, appears to contain a ntnber of significant errors that lead us to question the accuracy of the findings that vere reported. For your informatia, we have enclosed a copy of a Jme 8, 1973, rebuttal of this publication that wim written by the Chief Minerologist of the Colorado School of Mines Research Institute in Golden, Colorado. Also, your petition's 1978 book reference to the Mt. Sinai School of Medicine findings is too old to reflect present contamination levels, Further, we are not convinced that the Mt. Sinai findings pertained to cosmetic tale. Your reference states that cannon camercial tales were analyzed, but it does not specify ether these comrnercial tales wre industrial grade or cosmetic ta3.e. FDA00003602 FILED: ERIE COUNTY CLERK 03/03/2023 08:35 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 177 RECEIVED NYSCEF: 03/03/2023 W. hillippe Dsuillet - Pas;e 3 For all preitxfice of titese to the reasons, future W filirn petition of a petition is denied. a is This matter, denial is wf.thout acempanied by all relevant data in support of the petition. Sincerely yours, Actirm Associate Qatissioner for Regulatory Af faire EHclosures : FDA00003603