The Food and Drug Administration (FDA) has issued a 47-page draft guidance to manufacturers that provides steps to apply for classification as a modified risk tobacco product.

The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the FDA to evaluate modified risk (potentially “safer” or less hazardous) tobacco products that reduce exposure to harmful substances, as compared to leading brands. Upon demonstrating compelling scientific evidence of reduced exposure and that a reduction in morbidity and mortality is probable, the advantages of a modified risk tobacco product may then be conveyed to consumers (pursuant to the statutory requirements of the Tobacco Control Act).
The FDA document can be viewed under www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM297751.pdf
Comments and suggestions will be taken for 60 days following the 30 March publication of the draft guidance, the FDA said. (pi)