The FDA claims authority under Section 907 of the Family Smoking Prevention and Control Act, 2009 (TCA) to restrict the sale and distribution of flavored tobacco products. Section 907 authorizes the Secretary of Human Services and Health (HHS), through the FDA (a sub-agency of HHS), to “adopt standards on tobacco products … if the secretary considers that ‘a tobacco product standard is appropriate for the protection of public health. ” See 21 USC § 387g (a) (3) (A). In making such a finding, the FDA must take into account the scientific evidence regarding the risks and benefits to the population as a whole, including users and non-users of tobacco products; the increased or decreased likelihood that current users of tobacco products will stop using those products; and the increased or reduced likelihood that those who do not use tobacco products will start using these products. See 21 USC § 387 (g) (a) (3) (A), (B). The FDA must also consider the potential of the contraband trade when developing product standards. Any party who opposes the proposed standard on the basis that it will not reduce or eliminate the risk of illness or injury may provide scientific evidence to the FDA that demonstrates that the proposed standard will not reduce or eliminate the risk of illness or injury. risk of illness or injury. See 21 USC § 387 (g) (a) (3) (B).
The TCA banned characterizing flavors in cigarettes, with the exception of menthol cigarettes, but did not address flavored cigars. In its press release, the FDA states that after the TCA ban on flavored cigarettes, “the use of flavored cigars increased dramatically, suggesting that the public health objectives of the flavored cigarette ban have increased. may have been undermined by the continued availability of these flavored cigars. As such, the FDA states that “[t]its decision is based on clear science and evidence establishing the addiction and harms of these products and builds on important previous actions that banned other flavored cigarettes in 2009. ”
Notably in January 2021, a coalition of 23 attorneys general submitted a regulatory petition asking the FDA to ban menthol cigarettes. Attorneys General would have no enforcement powers under the finalized standards.
HHS Secretary Xavier Becerra expressed support for the measure in a declaration, indicating that the proposal reflects the administration’s priorities and that a new flavor ban will likely be finalized in some form after the completion of the review and comment rulemaking process .