Response to FDA Request for Information on Talc Johnson & Johnson Consumer Inc. (Jill-31.5 M E. R 1 111:. March 17,2016 US. Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Rd. Beltsville, MD 20705-1266 ATTN: Theresa Michele, MD, Director, Division of Nonprescription Drug Products, ODE IV Re: Response to FDA Request for Information on Talc Dear Dr. Michele: This submission is our written response to the following email request from CAPT Janice Adams-King, MSN, CRNP, CPHN (USPHS), Safety Regulatory Project Manager, Of_ce of Drug Evaluation IV, Division of Nonprescription Drug Products (DNDP), Center for Drug Evaluation and Research (CDER), dated 25 February 2016: “Please provide all safety literature and data regarding talc, including data in support of the safety of this active ingredient and data that shows potential harmful effects for this active ingredient, by March 17, 2016.” Following a recent jury verdict in a case that was heard in the City of St Louis, Missouri Circuit Court, concerning the use of talc and ovarian cancer, Johnson & Johnson Consumer Inc. (JJCI) contacted Capt. Janice Adams-King on 25 February 2016 to seek guidance on whom to talk to regarding this verdict, so that we could inform the agency about JJCI’s position regarding the verdict, offer our support to the agency by contributing relevant talking points in the event that the agency intended to issue a public statement regarding this verdict, and answer any questions the agency might have regarding this verdict. In addition, we noted that this JJCI strongly disagrees with the outcome of this litigation and plans to ask the court to overtum this decision through post-trial proceedings, including the appellate process if necessary. At Ms. Adams-King’s suggestion, JJCI immediately contacted Dr. Nakissa Sadrieh, Director, Cosmetics Staff, Of_ce of Cosmetics and Colors (OCAC), Center for Food Safety and Applied Nutrition via a phone call, followed by an email memo. Later on the same day (25 February 2016), DNDP requested a teleconference with JJCI, following which the referenced email request for additional information on talc was sent to JJ CI. The data and information contained in this submission constitute trade secrets and con_dential commercial information (see 21 C .F.R. 20.61). Johnson & Johnson Consumer Inc. hereby claims the legal protections ayforded such trade secret and con_dential information under 5. US. C. 552(1)), 21 US. C. 3310) and 18 US. C. 1905. Further dissemination may only be made with the eJquess written permission of Johnson & Johnson Consumer Inc. Page 1 of 2 Johnson & Johnson Consumer Inc. 199 Grandview Road, Skillman, NJ 08558 (908) 874-1702 COMPANY CONFIDENTIAL Page 1 of 446 Protected Document — Subject to Protective Order PLT-00075-0001 Response to FDA Request for Infonnation on Talc Johnson & Johnson Consumer Inc. CONSUMER INC. March 17, 2016 U.S. Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Arnrnendale Rd. Beltsville, MD 20705-1266 ATIN: Theresa Michele, MD, Director, Division of Nonprescription Drug Products, ODE IV Re: Response to FDA Request for Information on Talc Dear Dr. Michele: This submission is our written response to the following email request from CAPT Janice Adams-King, MSN, CRNP, CPHN (USPHS), Safety Regulatory Project Manager, Office of Drug Evaluation IV, Division of Nonprescription Drug Products (DNDP), Center for Drug Evaluation and Research (CDER), dated 25 February 2016: "Please provide all safety literature and data regarding talc, including data in ~upport of the ~afety ofthi~ active ingredient and data that shows potential harmful effects for this active ingredient, by March 17, 2016." Following a recent jury verdict in a case that was heard in the City of StLouis, Missouri Circuit Court, concerning the use of talc and ovarian cancer, Johnson & Johnson Consumer Inc. (JJCI) contacted Capt. Janice Adan1s-King on 25 February 2016 to seek guidance on whom to talk to regarding this verdict, so that we could inform the agency about JJCI's position regarding the verdict; offer our support to the agency by contributing relevant talking points in the event that the agency intended to issue a public statement regarding this verdict; and answer any questions the agency might have regarding this verdict. In addition, we noted that this JJCI strongly disagrees with the outcome of this litigation and plans to ask the court to overturn this decision through post-trial proceedings, including the appellate process if necessary. At Ms. Adarns-King's suggestion, JJCI immediately contacted Dr. ~akissa Sadrieh, Director, Cosmetics Staff, Office of Cosmetics and Colors (OCAC), Center for Food Safety and Applied Nutrition via a phone call, followed by an email memo. Later on the same day (25 February 2016), DNDP requested a teleconference with JJCI, following which the referenced email request for additional infonnation on talc was sent to JJCI. The data and infommtion contained in this submission constitute trade secrets and confidential corrmtercial infomwtion (see 21 C.F.R. 20.61). Johnson & Johnson Consumer Inc. hereby claims tile legal protections afforded such trade secret and confidential itifommtion under 5. U S.C. 552{b), 21 U S. C. 331 (J) and 18 U S. C. 190.5. Further dissemination may on~v be made with the xpress written pemlission ofJolmson & Johnson Consumer Inc. Page l of2 Johnson & Johnson Consumer Inc. 199 Grandview Road, Skillman. NJ 08558 (908) 874·1702 COMPANY CONFIDENTIAL Pagel of446 Protected Document - Subject to Protective Order PLT-000 75-0001 Response to FDA Request for Information on Talc Johnson & Johnson Consumer Inc. Response to FDA Request for Information on Talc This submission is our response to the referenced email request and includes a summary of key published reviews of talc safety and ovarian cancer, relevant post-marketing talc safety data, and information on chemistry, manufacturing, and controls. This submission is being provided on compact disk. As the size of this submission is over 20 MB, we are unable to transmit the submission via email, given our company’s email message size restriction of 10 MB for inbound and outbound messages. If you have any questions, please contact me at 908-874-1702 or by email at jekutaldiitsinj.com. Sincerely, Digitally signed by Jethro Ekuta h DN: c=US, o=JNJ, ou=Employees, e r O ou=1018932, cn=Jethro Ekuta, emai|[email protected] Reason: I am the author ofthis document. u a Date: 2016.03.15 17:19:15 -04'00' Adobe Acrobat version: 1 1.0.10 Jethro Ekuta, D.V.M., Ph.D., RAC, FRAPS Vice President, Regulatory Affairs North America Johnson & Johnson Consumer Inc. cc: CAPT Janice Adams-King, MSN, CRNP, CPHN (USPHS) — 15 CD Copies Safety Regulatory Project Manager Of_ce of Drug Evaluation IV, CDER/FDA Division of Nonprescription Drug Products 10903 New Hampshire Avenue, Building #22, Room 5416 Silver Spring, MD 20993 The data and information contained in this submission constitute trade secrets and con_dential commercial information (see 21 C.F.R. 20.61). Johnson & Johnson Consumer Inc. hereby claims the legal protections ajforded such trade secret and con_dential information under 5. US. C. 552 (b), 21 US. C. 3310) and 18 US. C. 1905. Further dissemination may only be made with the express written permission of Johnson & Johnson Consumer Inc. Page 2 of 2 COMPANY CONFIDENTIAL Page 2 of 446 Protected Document — Subject to Protective Order PLT-OOO75-0002 Response to FDA Request for Information on Talc Johnson & Johnson Consumer Inc. Response to FDA Request for lnfotmation on Talc This submission is our response to the referenced email request and includes a summary of key published reviews of talc safety and ovarian cancer, relevant post-marketing talc safety data, and information on chemistry, manufacturing, and controls. This submission is being provided on compact disk. As the size of this submission is over 20 MB, we are unable to transmit the submission via email, given our company's email message size restriction of 10 MB for inbound and outbound messages. Ify ou have any questions, please contact me at 908-874-1702 or by email at jekuta(ci;its. jnj.com. Sincerely, Digitally signed by Jethro Ekuta ON; c=US, o=JNJ, ou=Employees, Jethro ou=1018932, cn=Jethro Ekuta, [email protected] Reason: I am the aut1or of this document. Ekuta Date: 2016.03.15 17 :19;1 5 -04'00' Adobe Acrobat version: 11.0.10 Jethro Ekuta, D.V.M., Ph.D., RAC, FRAPS Vice President, Regulatory Affairs North America Johnson & Johnson Consumer Inc. cc: CAPT Janice Adams-King, MSN, CRNP, CPHN (USPHS)- 15 CD Copies Safety Regulatory Project Manager Office of Drug Evaluation IV, CDER/FDA Division ofNonprescription Drug Products 10903 New Hampshire A venue, Building #22, Room 5416 Silver Spring, MD 20993 The data and hifommtion contained in this submission constitute trade secrets and confidential commercial infomwtion (see 21 C.F.R. 20.61). Johnson & Johnson Consumer Inc. hereby claim~ the legal protections afforded such trade see~·e1 and confidential infomtation under 5. U.S.C. 552(b), 21 U.S. C. 331(j) and 18 U.S. C. 1905. Further dissemination may only be made with the express written pem1ission ofJohnson & Johnson Consumer Inc. Page2 of2 COMPANY CONFIDENTIAL Page 2 of446 Protected Document - Subject to Protective Order PLT-00075-0002 Response to FDA Request for Information on Talc Johnson & Johnson Consumer Inc. Response to FDA Request for Information on Talc Johnson & Johnson Consumer Inc. 17 March 2016 Confidentiality Statement The data and information contained in this submission constitute trade secrets and confidential commercial information (see 21 C.F.R. 20.61). Johnson & Johnson Consumer Inc. hereby claims the legal protections afforded such trade secret and confidential information under 5.U.S.C.