R.J. Reynolds Tobacco Company v. United States Food And Drug Administration

MOTION for Summary Judgment, MOTION for Preliminary Injunction

E.D. Tex.May 15, 2020

1 Attachments Table of Contents Description Attachment Appendix: Collected Excerpts from FDA Qualitative Studies 1 Declarations Declaration of Lamar W. Huckabee (“Huckabee Decl.”) 2 Declaration of Kim Reed (“Reed Decl.”) 3 Declaration of Francis G. Wall (“Wall Decl.”) 4 Declaration of Nooralam Erkin (“Erkin Decl.”) 5 Declaration of Suleman Ismail (“Ismail Decl.”) 6 Excerpted Documents RTI International, Qualitative Study on Cigarettes and Smoking: Knowledge, Beliefs, and Misperceptions (July 2015) (“First Qualitative Study Report”) 7 Siegel+Gale, FDA Graphic Health Warning Image Concept Testing (June 2016) (“Second Qualitative Study Report”) 8 RTI International, Qualitative Study on Consumer Perceptions of Cigarettes Health Warning Images (Apr. 2018) (“Third Qualitative Study Report”) 9 OMB, Notice of Office of Management and Budget Action, Experimental Study on Warning Statements for Cigarette Graphic Health Warnings, Ref. No. 201708-0910-011 (Jan. 29, 2018) (“OMB Notice”) 10 Case 6:20-cv-00176-JCB Document 34-3 Filed 05/15/20 Page 1 of 3 PageID #: 1302 2 RTI International, Experimental Study on Warning Statements for Cigarette Graphic Health Warnings: Study 1 Report (Apr. 2018) (“First Quantitative Study Report”) 11 RTI International, Experimental Study of Cigarette Warnings: Study 2 Report (May 2019) (“Second Quantitative Study Report”) 12 Final Summary Report: External Letter Peer Review of FDA’s Quantitative Consumer Research on Cigarette Health Warnings Required by the Family Smoking Prevention and Tobacco Control Act (Nov. 19, 2019) (“Peer Review Report”) 13 FDA, Response to External Peer Review of Quantitative Consumer Research on Cigarette Health Warnings Required by the Family Smoking Prevention and Tobacco Control Act (Feb. 4, 2020) 14 FDA, Experimental Study on Warning Statements for Cigarette Graphic Health Warnings: Study 2 Report (Feb. 2020) (“Revised Second Quantitative Study Report”) 15 FDA, Preliminary Regulatory Impact Analysis (Aug. 2019) (“Cost- Benefit Analysis”) 16 FDA, Final Regulatory Impact Analysis, Docket No. FDA-2019-N- 3065 (Mar. 2020) (“Final Regulatory Analysis”) 17 Comment Letter of RAI Services Co., Docket No. FDA-2019-N- 3065 (Oct. 11, 2019) (“Reynolds Comments”), including: • Exhibit C: Statement of Jonathan Klick, Ph.D., J.D. (“Klick Report”) • Exhibit D: Report of Prof. Jan-Benedict Steenkamp (“Steenkamp Report”) • Exhibit E: Samantha Iyengar, Ph.D., NERA Survey: Consumer Perceptions of Cigarette Warning Labels (“Iyengar Report”). • Exhibit F: Report of Dr. John E. Martin, Ph.D. (“Martin Report”) • Exhibit G: Declaration of Lawrence R. Brooks, MD (“Brooks Decl.”) 18 Case 6:20-cv-00176-JCB Document 34-3 Filed 05/15/20 Page 2 of 3 PageID #: 1303 3 • Exhibit H: Declaration of Jonathan M. Davidorf, MD (“Davidorf Decl.”) • Exhibit I: Declaration of Mark O. Farber, MD (“Farber Decl.”) • Exhibit J: Declaration of Kim R. Jones, MD, Ph.D. (“Jones Decl.”) • Exhibit K: Declaration of Robert Wagmeister, MD (“Wagmeister Decl.”) • Exhibit L: Declaration of Rachael B. Claxton (“Claxton Decl.”) • Exhibit P: Letter from Caitlyn Ozier to FDA with FOIA request (June 14, 2017) Comment Letter of RAI Services Co., Docket No. FDA-2019-N- 3065 (Nov. 25, 2019) (“Reynolds Supplemental Comments”) 19 Comment Letter of ITG Brands, Docket No. FDA-2019-N-3065 (Oct. 15, 2019) (“ITG Comments”) 20 Comment Letter of Altria Client Services, Docket No. FDA-2019- N-3065 (Oct. 15, 2019) (“Altria Comments”) 21 Comment Letter of Altria Client Services, Docket No. FDA-2019- N-3065 (Nov. 27, 2019) (“Altria Supplemental Comments”) 22 Case 6:20-cv-00176-JCB Document 34-3 Filed 05/15/20 Page 3 of 3 PageID #: 1304