Addressing U.S. FDA’s population health standard for Camel Snus with modified risk messaging
R.J. Reynolds Tobacco Company has submitted Modified Risk Tobacco Product applications to the U.S. Food and Drug Administration seeking risk modification orders for Camel Snus advertising, which includes information that smokers who switch completely to Camel Snus can greatly reduce their risk of lung cancer, oral cancer, respiratory disease and heart disease. These applications provide results from scientific studies that assess the risks and benefits of the proposed advertising to the population as a whole. Studies examining consumers’ comprehension and perceptions of the advertising indicated that vast majorities understood and applied the risk information, as well as appropriate cautions. Only 4 % of consumers indicated smokers would receive a health benefit if they continued to smoke while using Camel Snus, while >80 % indicated Camel Snus is addictive, quitting tobacco use is the best choice, and non-tobacco users should not use Camel Snus. After viewing the proposed advertising for Camel Snus, consumers indicated their intent to purchase the product for trial, and intent ratings were converted to projected likelihoods of use by using a predictive algorithm. Modified risk advertising for Camel Snus differentially increased projected use among current smokers (8.2 %), while having minimal effect on former smokers (1.9 %) and never tobacco users (0.5 %). Projected use was lower among current smokers likely to quit (4.2 %) versus not likely to quit (8.7 %). Finally, statistical modeling was used to assess the overall effects on population mortality based on likely use of Camel Snus with modified risk advertising. Assuming 89-92 % risk reductions for Camel Snus, analyses that included age-specific primary and conservative secondary (e.g. gateway) transitions estimated a survival benefit of >25,000 individuals in a U.S. birth cohort of 4.1 million. Tipping point analyses indicated that if 1.5 % of continuing smokers switched completely to Camel Snus at each age interval, there would be a population health benefit.