In connection with the FDA’s Advanced Notice of Proposed Rulemaking (“ANPR”) addressing flavored tobacco products, a group of State Attorneys General has recommended that the agency ban all flavored tobacco products. In their comments on the ANPR, the Attorneys General of New York, Idaho, Illinois, Maine, Massachusetts, New Mexico, Oregon, Pennsylvania and Rhode Island assert that the FDA should ban flavors (including menthol) in all tobacco products, including cigarettes, cigars and electronic nicotine delivery systems (“ENDS”). The existing flavor ban applies only to “characterizing” flavors in cigarettes, and allows for mentholated cigarettes.
The nine Attorneys General argue that flavors make tobacco products more palatable for new and younger consumers. They also assert that flavors – particularly menthol – have a disparate impact on minorities. Finally, they claim that the impact of flavored ENDS on smoking cessation is “speculative.” The Attorneys General apparently seek to ban all flavors, not just characterizing flavors.
More recently, two U.S. Senators –Richard Durbin and Lisa Murkowski – have introduced legislation that would ban characterizing flavors in all tobacco products, with an exemption for flavored ENDS under extremely limited circumstances. The bill would generally ban all characterizing flavors, although like the existing characterizing flavor ban in the Family Smoking Prevention and Tobacco Control Act, the bill does not define what a characterizing flavor is. The limited exemption for flavored ENDS would apply only where the FDA has issued an order finding that the product will increase the likelihood of smoking cessation, will not increase the likelihood of youth initiation, and will not increase the likelihood of harm to consumers. The law does not specify how these facts are to be proven, but if the process is at all similar to the process for marketing modified risk tobacco products, it would be extremely onerous and probably tantamount to a ban on flavored ENDS.