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Modified Risk Cigarettes
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the U.S. Food and Drug Administration (FDA) to evaluate modified risk (potentially less harmful) 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.
On March 30, 2012, the FDA issued Draft Guidance on Modified Risk Tobacco Product Applications. The FDA’s Draft Guidance provides the framework for applicants to submit data for modified risk product candidates. Goodrich Tobacco Company, 22nd Century’s subsidiary, has developed two types of modified risk cigarette candidates and applications for these cigarettes will be filed with the FDA late in 2013.