Excerpt:
When Congress enacted the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act or TCA), it prohibited the use of characterizing flavors, other than menthol, in cigarettes because Congress concluded that flavors in cigarettes made the products appealing to adolescents. The TCA also directed FDA to consider the need for a prohibition on menthol as a characterizing flavor in cigarettes as well. The TCA’s elimination of flavors in cigarettes contributed to the reduction in youth usage of cigarettes. However, the same kid-friendly flavors that had been prohibited in cigarettes—plus thousands more—have proliferated in other combusted and non-combusted tobacco products, enhancing the popularity of these products with kids. The presence of flavors in these other tobacco products is an important reason why, despite the steep decline in youth cigarette smoking, youth usage of tobacco products overall has not declined. Until the issuance of the deeming rule, these products were not subject to FDA jurisdiction, but now that FDA has asserted jurisdiction over all of them, the question of flavors in these products—and their effect on youth initiation—has become critically important.
In order to protect kids from these products, FDA should publish a proposed, and then final, rule prohibiting characterizing flavors in all combusted and smokeless tobacco products as soon as possible. That rule should also prohibit characterizing flavors in e-cigarettes unless the manufacturer demonstrates, for a specific flavor in a specific product, that the presence of the flavor helps smokers quit tobacco products entirely or at least switch completely to an ecigarette, that the flavoring does not attract kids, and that the flavor is not toxic, carcinogenic or teratogenic.
It is also time for FDA to prohibit the use of menthol as a characterizing flavor in cigarettes. Despite a finding by the Tobacco Products Scientific Advisory Committee (TPSAC) that prohibiting menthol in cigarettes would benefit the public health, and despite an exhaustive independent study by FDA itself concluding that menthol as a characterizing flavor in cigarettes was contributing to youth smoking initiation and addiction and suppressing cessation, FDA has taken no action on menthol as a characterizing flavor in cigarettes. During these years, despite the reduction in non-menthol cigarette usage, sales of menthol cigarettes have remained robust and menthol cigarettes have continued to facilitate initiation of cigarette smoking by kids and retard cessation in adults, particularly in the African-American community.
Read Full Comments on Flavored Tobacco Products ANPRM 7.19.18