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Substantiation of Modified Risk Information 08082018

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Substantiation of Modified Risk Information 08082018 R. J. REYNOLDS TOBACCO COMPANY (RJRT) MODIFIED RISK TOBACCO PRODUCT APPLICATIONS Presented by: Deirdre Lawrence Kittner, PhD, MPH Deputy Director, Division of Population Health Science Office of Science Center for Tobacco Products U.S. Food and Drug Administration Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy. September 13-14, 2018 CENTER FOR TOBACCO PRODUCTS DISCLAIMER The information in these materials does not represent agency position or policy. The information is being provided to TPSAC to aid in its evaluation of the issues and questions referred to the committee. This presentation contains information prepared by the FDA for the members of the TPSAC. The presentation describes assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. This presentation may not include all issues relevant to FDA’s decision on the applications and instead is intended to focus on issues identified by FDA for discussion by TPSAC. The FDA will not make its determination on the issues at hand until input from TPSAC and from the public comments has been considered and all FDA reviews have been finalized. FDA’s determination may be affected by issues not discussed at the TPSAC meeting. 1 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS AGENDA • Statutory framework for modified risk tobacco products and review process • Summary of RJRT applications under review • Questions for the committee 2 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS MRTP STATUTORY FRAMEWORK AND REVIEW PROCESS 3 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS MODIFIED RISK TOBACCO PRODUCTS (MRTPS) DEFINED • Tobacco products sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products; this includes tobacco products whose – Label, labeling or advertising represents, implicitly or explicitly, that: • The product is less harmful or presents a lower risk of tobacco-related disease than one or more commercially marketed tobacco products • The product or its smoke contains a reduced level of, presents a reduced exposure to, or does not contain/is free of a substance 4 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS MRTP CONTEXT • Before an MRTP can be marketed in the United States, an order from FDA under section 911(g) of the FD&C Act must be in effect with respect to the tobacco product • To legally sell an MRTP that is also a new tobacco product, a company must have authorization from FDA under section 911 (i.e., an MRTP order) and also comply with the premarket requirements of section 910 – RJRT submitted premarket tobacco product applications (PMTAs) and SE reports for Camel Snus 5 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS RISK MODIFICATION ORDER STANDARD - 911(G)(1) The FD&C Act requires FDA to determine if a proposed MRTP, as it is actually used by consumers, will: (1) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and (2) benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products 6 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS EXPOSURE MODIFICATION ORDER STANDARD - 911(G)(2) For products that • it is appropriate to promote the public health; • the label, labeling, and advertising is limited to a claim that the cannot receive an product does not contain or is free of a substance or contains a order under 911(g)(1), reduced level or presents a reduced exposure; FDA may issue an • scientific evidence is not available, and cannot be made available without conducting long-term epidemiological studies, order under 911(g)(2) for an application to meet the standard for a 911(g)(1) order; if it determines that • scientific evidence that is available demonstrates that a the applicant has reduction in morbidity or mortality is reasonably likely; and • testing shows that consumers will not be misled into believing demonstrated that, that the product has been demonstrated to be less harmful or among other things: present less risk. 7 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS QUESTIONS RELEVANT TO THE MRTP EVALUATION These questions are relevant to the evaluation of whether the applicant has met the applicable 911 standard: 1. Is there adequate scientific substantiation of the proposed modified risk information? 2. What are the health risks of the MRTP to individual tobacco users? 3. How do consumers perceive and understand the modified risk information? 4. What are the potential benefits and harms to the health of the population as a whole? 8 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS MRTPA REVIEW PROCESS 9 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS RJRT MRTP APPLICATIONS 10 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS RJRT CAMEL SNUS MRTPA PRODUCTS The applicant is seeking an order under Section 911(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for each of its six Camel Snus products – Camel Snus Frost – Camel Snus Frost Large – Camel Snus Winterchill – Camel Snus Robust – Camel Snus Mellow – Camel Snus Mint (Source: Section 3.1.3 of MRTPAs) 11 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS RJRT REQUESTS MODIFIED RISK ORDERS TO MARKET THESE PRODUCTS WITH THE FOLLOWING “KEY” MODIFIED RISK CLAIMS Smokers who switch completely from cigarettes to Camel SNUS can significantly reduce their risk of lung cancer, oral cancer, respiratory disease, and heart disease. Smokers who SWITCH COMPLETELY from cigarettes to Camel SNUS can greatly reduce their risk of lung cancer, oral cancer, respiratory disease, and heart disease. Smokers who SWITCH COMPLETELY from cigarettes to Camel SNUS can greatly reduce their risk of lung cancer and respiratory disease. 12 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS ADDITIONAL MODIFIED RISK INFORMATION IN ADS Smokers who use Camel SNUS instead of No smoke means... cigarettes can significantly reduce their health No hassle risks from smoking. No lingering smoke smell More freedom Fewer carcinogens Less risk for you and those around you Scientific studies have shown that Camel SNUS contains fewer carcinogens than cigarette smoke. Switching to SNUS means ... Less of the harmful chemicals found in cigarette smoke Scientific studies have shown that Camel SNUS Less risk for you and those around you contains less of the harmful chemicals than No lingering smoke smell cigarette smoke. Hassle-free tobacco Swap the smoke for more freedom and less risk. No smoke. Less risk. Choose SNUS. NO SMOKE = LESS RISK *Modified risk information is bolded 13 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS LINES OF EVIDENCE Evidence Related Consumer Likelihood of Use to Substantiation perception and of the Proposed of the Modified understanding MRTPAs Risk Information Product chemistry Observational Studies Toxicological assessments Pharmacokinetic Consumer Likelihood of use studies perception studies study Clinical trials Epidemiological Clinical trials studies 14 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS FOCUS OF TPSAC DISCUSSION & RECOMMENDATIONS FDA will present the product chemistry, nonclinical and clinical studies, and epidemiological evidence used to assess the scientific accuracy of EVIDENCE RELATED TO the statements. HEALTH RISKS AND SUBSTANTIATION TPSAC will be asked to discuss the evidence and scientific accuracy of these statements. 15 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications CENTER FOR TOBACCO PRODUCTS FOCUS OF FDA TPSAC DISCUSSION & RECOMMENDATIONS CONSUMER FDA will present the ads submitted by the applicant and the result of the consumer perception studies. PERCEPTIONS AND TPSAC will be asked to discuss consumer perceptions and understanding of the modified risk UNDERSTANDING information. FDA will present data from observational studies to describe characteristics of Camel Snus users, patterns of use, and transitions from cigarette smoking to snus, as well as RJRT’s clinical studies and LIKELIHOOD OF USE OF likelihood of use studies. PROPOSED MRTPS TPSAC will be asked to discuss the potential use behaviors with respect to the proposed modified risk tobacco products, including the likelihood that cigarette smokers will switch completely to the six Camel Snus products. 16 September 13-14, 2018 TPSAC Meeting | RJRT Modified Risk Tobacco Product Applications
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