Source: https://www.fda.gov/tobacco-products/advertising-and-promotion/rj-reynolds-tobacco-company-modified-risk-tobacco-product-mrtp-applications
Timestamp: 2020-07-11 02:53:41
Document Index: 353260694

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6', 'art 7']

R.J. Reynolds Tobacco Company Modified Risk Tobacco Product (MRTP) Applications | FDA
On December 18, 2017, FDA filed for substantive scientific review six Modified Risk Tobacco Product (MRTP) Applications from R.J. Reynolds Tobacco Company for the following smokeless tobacco products:
Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been added or check this webpage regularly. The latest set of application materials from R.J. Reynolds Tobacco Company were added on March 5, 2019.
FOIA Cover Letter (PDF – 18 KB) – added December 18, 2017
Executive Summary (PDF – 123 KB) – added December 18, 2017
Module 1: Cover Letters (PDF – 4 MB) – added December 18, 2017
Module 2: Table of Contents, Glossary, Summary & References (zip – 27.5 MB) – added December 18, 2017
Module 3: Descriptive Information for Camel Snus Smokeless Tobacco Products (zip – 225 MB) – added December 18, 2017
Module 4: Labels, Labeling and Advertising (zip – 26 MB) – added December 18, 2017
Module 5: Environmental Assessments (zip – 69 MB) – added December 18, 2017
Module 6: Summary of All Research Findings – added September 6, 2018
6.1: Health Risks of the Tobacco Product
6.1 Health Risks of the Tobacco Product (PDF – 595 KB) – (added September 6, 2018)
6.1.2: Clinical Studies (PDF – 7.2 MB) – (added September 6, 2018)
6.1.3: In Vitro Toxicology Studies (PDF – 560 KB) – (added September 6, 2018)
6.1.4: In Vivo Toxicology Studies (PDF – 345 MB) – (added September 6, 2018)
6.1.5: Chemistry (PDF – 4.5 MB) – (added September 6, 2018)
6.1.6: Abuse Liability (PDF – 115 KB) – (added September 6, 2018)
6.2: Comprehension and Perception
6.2: Comprehension and Perception (PDF – 640 KB) – (added September 6, 2018)
6.3: Likelihood of Use
6.3: Likelihood of Use (PDF – 547 KB) – (added September 6, 2018)
6.4: Effect on Population as a Whole
6.4: Effect on Population as a Whole (PDF – 2.2 MB) – (added September 6, 2018)
6.5: Tabulated Index
6.5: Tabulated Index (PDF – 13.2 MB) – (added September 6, 2018)
Protocol – Comprehension and Perception, Execution 1 (PDF – 67.2 GB) – (added September 6, 2018)
Protocol – Comprehension and Perception, Execution 2 (PDF – 76.2 GB) – (added September 6, 2018)
Protocol – Comprehension and Perception, Execution 3 (PDF – 73.9 GB) – (added September 6, 2018)
Protocol – Likelihood of Use, Execution 1 (PDF – 62.1 MB) – (added September 6, 2018)
Protocol – Likelihood of Use, Execution 2 (PDF – 59.6 MB) – (added September 6, 2018)
Protocol – Likelihood of Use, Execution 3 (PDF – 86.4 MB) – (added September 6, 2018)
New Tobacco Product “Attractiveness” Study: An Algorithm to Predict Usage of New Tobacco Products Prior to Market Launch (PDF – 3.8 MB) – (added September 6, 2018)
A systematic, critical review of the literature pertaining to the risks of oral and lung cancers, cardiovascular disease and respiratory diseases among snus and smokeless tobacco users (PDF – 2.2 MB) – (added September 6, 2018)
An Assessment of Camel Snus Abuse Liability (PDF – 3 MB) – (added September 6, 2018)
Adult Perceptions of the Relative Harmfulness of Tobacco Products: Descriptive Findings from Wave 1 of the PATH Study, 2013-14 (PDF – 864 MB) – (added September 6, 2018)
Population Modeling of Modified Risk Tobacco Products Accounting for Effects of Cigarettes per Day (PDF – 1.6 GB) – (added September 6, 2018)
Module 7: Scientific Studies and Analyses — added May 9, 2018; updated March 5, 2019
7.1: Chemistry
7.1: Chemistry (zip – 72 MB) – added August 17, 2018
7.2: In Vitro – added March 5, 2019
M194A-GLP (AMES) – Determination of Mutagenic Response of Camel Snus and Other Tobacco Products
01_M194A (zip – 149 MB) (added March 5, 2019)
M914B-GLP (NRU) – Determination of Cytotoxic Response of Camel Snus and Other Tobacco Products
02_M194B (zip – 297 MB) (added March 5, 2019)
M125 (SCE) – Toxicology of Tobacco Products – Sister Chromatid Exchange Genotoxicity
06_M125_SCE (zip – 48 MB) (added March 5, 2019)
M100 (NRU) – Toxicology of Smokeless Tobacco Products – Neutral Red Cytotoxicity
M100 (NRU) Part 1 (zip – 29 MB) (added March 5, 2019)
M100 (NRU) Part 2 (zip – 45 MB) (added March 5, 2019)
M100 (NRU) Part 3 (zip – 18 MB) (added March 5, 2019)
M100 (MN) – Toxicology of Smokeless Tobacco Products – In Vitro Micronucleus Assay
M100 (MN) Part 1 (zip – 32 MB) (added March 5, 2019)
M100 (MN) Part 2 (zip – 40 MB) (added March 5, 2019)
M97 (AMES) – Toxicology of Smokeless Tobacco Products – Bacterial Reverse Mutagenicity
08_M97_CF4 Part 1 (zip – 25 MB) (added March 5, 2019)
08_M97_CF4 Part 2 (zip – 27 MB) (added March 5, 2019)
08_M97_CF4 Part 3 (zip – 27 MB) (added March 5, 2019)
08_M97_CF4 Part 4 (zip – 27 MB) (added March 5, 2019)
08_M97_CF4 Part 5 (zip – 28 MB) (added March 5, 2019)
08_M97_CF4 Part 6 (zip – 27 MB) (added March 5, 2019)
08_M97_CF4 Part 7 (zip – 40 MB) (added March 5, 2019)
7.3: In Vivo
Two Week Investigational Study of the Palatability of Smokeless Tobacco Blend and Extract Formulated in NTP-2000 Diets for Rats (zip – 16 MB) – added May 9, 2018
Two Week Investigational Study of the Palatability of Smokeless Tobacco Blend and Extract Formulated in NTP-2000 Diets for Mice (zip – 15 MB) – added May 9, 2018
2-Week Repeat Investigational Study of the Palatability of Smokeless Tobacco Blend and Extract Formulated in NTP-2000 Diets for Mice at Higher Doses (zip – 14 MB) – added May 9, 2018
28-Day Repeated Dose Toxicity Study of Tobacco Blend and Aqueous Tobacco Extract in Wistar Han Rats (zip – 25 MB) – added May 9, 2018
28-Day Repeated Dose Toxicity Study of Tobacco Blend and Aqueous Tobacco Extract in CD-1 Mice (zip – 20 MB) – added May 9, 2018
90-Day Repeated Dose Subchronic Toxicity Study of Tobacco Blend and Aqueous Tobacco Extract in Wistar Han Rats (zip – 19 MB) – added May 9, 2018
90-Day Repeated Dose Subchronic Toxicity Study of Tobacco Blend and Aqueous Tobacco Extract in CD-1 Mice (zip – 35 MB) – added May 9, 2018
2-Year Chronic Toxicity/Carcinogenicity Feeding Study of Tobacco Blend and Aqueous Tobacco Extract in Wistar Han Rats (zip – 71 MB) – added May 9, 2018
7.4: Clinical
Clinical Study Report – Switching from Usual Brand Cigarettes to a Tobacco Heating Cigarette or Snus—A Multi-Center Evaluation of Health-Related Quality of Life Assessments and Biomarkers of Exposure and Harm (zip – 1024 MB) – added May 9, 2018
Camel Snus Mouth-Level Exposure Study (zip – 259 MB) – added May 9, 2018
Clinical Study Report – Switching from Usual Brand Cigarettes to Camel “Snus,” Camel Dissolvable Tobacco “Sticks,” “Strips,” or “Orbs,” Dual Use of Usual Brand Cigarettes and Snus, or Tobacco Abstinence– A Multi-Center Evaluation of Select Modern Smoke-Free Tobacco Products (zip – 1 GB) – added May 9, 2018
Post-Market Surveillance of Tobacco Products: A Multicenter Clinical Trial of Natural Adopters of Cigarettes, Moist Snuff, Camel SNUS, and Dual Use (zip – 995 MB) – added May 9, 2018
Ambulatory Study Comparing Ad Libitum Use of Usual Brand Cigarettes to Dual Use of Camel Snus with Reduced Smoking (zip – 10 MB) – added May 9, 2018
Assessment of Serum Nicotine Exposure from Modern Smoke-Free Tobacco Products (zip – 36 MB) – added May 9, 2018
Clinical Study Report – A Randomized, Multicenter Clinical Trial to Compare Smoking Cessation Rates with Camel Snus, with and without Smokeless Tobacco Health-Related Background Information, and a Nicotine Lozenge (zip – 1.4 GB) – added May 9, 2018
Clinical Study Report – Assessment of Smokers’ Nicotine Uptake and Urge to Smoke After Use of Smokeless Tobacco Products (zip – 92 MB) – added May 9, 2018
7.5: Consumer Perception
Camel SNUS Modified Risk Messaging: Preliminary Research on Comprehension and Perceptions among Tobacco Users and Non-Users (zip – 135 MB) – added May 9, 2018
Camel SNUS Modified Risk Messaging: Likelihood of Use among Tobacco Users and Non-Users – First Execution of Consumer Testing (zip – 113 MB) – added May 9, 2018
Camel SNUS Modified Risk Messaging: Comprehension and Perceptions among Tobacco Users and Non-Users – Second Execution of Consumer Testing (zip -- 465 MB) – added May 9, 2018
Camel SNUS Modified Risk Messaging: Likelihood of Use among Tobacco Users and Non-Users – Third Execution of Consumer Testing (zip – 131 MB) – added May 9, 2018
7.6: Modeling
7.6: Modeling (zip – 14 MB) – added May 9, 2018
7.7: Other
7.7: Other (zip – 172 MB) – added May 9, 2018
Module 8: Foreign Language Certification (PDF – 51 KB) – added December 18, 2017
Module 9: Proposed Post-market Surveillance Program for Camel Snus Products Under a Modified Risk Tobacco Product Order (zip – 1.3 MB) – added December 18, 2017
Amendments (updated February 28, 2019)
August 21, 2017 Amendment: Partial Response to July 25, 2017, FDA Advice and Information Request Letter (.zip – 22 MB) (added December 17, 2018)
September 8, 2017 Amendment: Partial Response to July 25, 2017, FDA Advice and Information Request Letter (.zip – 368 MB) (added December 17, 2018)
September 28, 2017 Amendment: Resubmission of Partial Response to July 25, 2017, FDA Advice and Information Request Letter Related to eSubmitter Compatibility Issues (.zip – 2.4 MB) (added December 17, 2018)
October 4, 2017 Amendment: Correction to Typographical Errors (.zip – 612 KB) (added September 6, 2018)
October 16, 2017 Amendment: Partial Response to July 25, 2017, FDA Advice and Information Request Letter (.zip – 307 KB) (added December 17, 2018)
October 20, 2017 Amendment: Partial Response to July 25, 2017, FDA Advice and Information Request Letter (.zip – 358 MB) (added December 17, 2018)
March 5, 2017 Amendment: Response to February 28, 2018, FDA Inquiry (.zip – 762 KB) (added September 6, 2018)
March 26, 2018 Amendment: Correction to Transcription and Clerical Errors and Updated Figures (.zip – 674 KB) (added September 6, 2018)
June 13, 2018 Amendment: Correction to Typographical Errors in Table 3.1-3 and Material Supplier Certificates (.zip – 2.8 MB) (added September 6, 2018)
July 23, 2018 Amendment: Submission of Market Survey Data, Amended Sections 3.2.1.5.2 and 3.2.1.5.3, Amended Consumer Testing Report, Statistical Analysis Reports and Data for Stability and Population Health Testing (.zip – 82 MB) (added December 17, 2018)
November 1, 2018 Amendment: Response to August 10, 2018, FDA Advice and Information Request Letter (.zip – 15 MB) (added February 28, 2019)
November 20, 2018 Amendment: Response to August 10, 2018, FDA Advice and Information Request Letter (.zip – 184 MB) (added January 15, 2019)
December 21, 2018 Amendment: Response to August 10, 2018, FDA Advice and Information Request Letter (.zip – 13 MB) (added February 28, 2019)
February 6, 2018 Amendment: Response to January 24, 2018, FDA Inspection Request Letter (.zip – 7.4 MB) (added September 6, 2018)
Tobacco Products Scientific Advisory Committee: September 2018 Meeting Announcement