Camel Snus MRTP Application
September 13-14, 2018
Tobacco Products Scientific Advisory Committee
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Frost. Frost Large. Mellow. Mint. Robust. Winterchill. Camel Snus Extracts Are. Less Cytotoxic than Cigarette Smoke.
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- Camel Snus MRTP Application Tobacco Products Scientific Advisory Committee September 13-14,
Introduction and Overview Michael Ogden, PhD Senior Vice President, Scientific & Regulatory AffairsRAI Services Company
An Important Consideration •
There is no one-size-fits-all approach to dramatically reducethe harm from smoking
Different types of reduced-risk products appeal to different people
Clearing the proposed MRTP advertising for Camel Snusis a scientifically sound step to reduce tobacco risk
Presentation Topics •
Camel Snus history, product development and design
Proposed modified risk advertising - Scientific evidence that individual health risk is reducedwhen smokers switch to Camel Snus - Consumer studies showing the proposed advertising willpromote beneficial behavioral changes in smokers - Statistical modeling indicating the population as a wholewill benefit from the resulting risk reductions
The Tobacco and Nicotine Product Risk Continuum
Consumers needaccurate informationabout the relativerisks of products toencourage them tomigrate to lessharmful products Product Switching Cigarettes Smokeless Tobacco Nicotine Replacement Therapies RelativeRisk forChronicDisease
Camel Snus Product Design •
Camel Snus is a spitless, pouched,smokeless tobacco product
Designed to have risk-reductioncharacteristics of Swedish snus - Made with low-toxicant tobaccos– Has same basic formulation– Flavors adapted for American palate using common smokeless tobaccoand food ingredients Each tin contains 15 pouches Finely milled tobacco,humectants and flavorings Fleece pouch
Camel Snus Production Process and Styles
Frost Mint Mellow Frost Large Winterchill Robust 600 mg 1000 mg
Production Process
- Low toxicant, finely milled tobaccos– Mixed with water, salt and heat-treated– Buffered with pH-stabilizing solution, further heat-treated– Humectants and flavors added
Camel Snus MRTP Messaging Topline •
Only seeking authorization for the specific modified risk messagesand layouts submitted to the FDA
Presents adult smokers with accurate, easily understoodcomparative risk information - No change to current product label or government smokeless tobacco warnings - Subject to post-market surveillance
Overview of Print Advertisement
Advertising Execution 2
Camel Snus MRTP Messages – 1
st
Panel
Advertising Execution 2 Maintains government warning Note cigarette crushed by snus tin Introduces opportunity for adult smokers to reduce risk
Camel Snus MRTP Messages – 3
rd
Panel
Advertising Execution 2 Balancing information Additional benefits of switching Key modified risk statement (variations among executions)
Camel Snus MRTP Messages – 3
rd
Panel
Advertising Execution 2
Variations in Key Modified Risk Statement – 3 rd Panel Execution 1 Execution 2 Execution 3
Camel Snus MRTP Messages – 3
rd
Panel
Advertising Execution 2