Details on the Food and Drug Administration’s proposed rule requiring lower nicotine levels in cigarettes are expected to be published by October.
The agency laid out this deadline, as well as other planned regulatory actions like banning menthol as a characterizing flavor in cigarettes and all flavors in cigars, in the 2022 Unified Regulatory Agenda and Regulatory Plan. The plan outlines regulatory actions federal agencies are considering in the coming months, according to the White House.
The proposed initiatives are aimed at reducing the addictiveness to certain tobacco products and reducing death and disease from smoking, among other things. Each year, 480,000 people die prematurely from a smoking-attributed disease, making tobacco the leading cause of preventable disease and death in the United States, the FDA said.
Here's a look at regulation affecting the tobacco industry:
- Lowering nicotine levels in cigarettes. The FDA has said it will require tobacco companies to reduce the nicotine in all cigarettes sold in the United States to minimal or nonaddictive levels.The proposal would apply to cigarettes and certain finished tobacco products, but no formal rule has been published yet. The agency plans to do this by October, according to the Unified Regulatory Agenda. After that, it would still have to follow a nine-step rulemaking processbefore the new regulation is potentially adopted.
- Banning menthol as a characterizing flavor in cigarettes. In April 2022, the FDA proposed a product standard prohibiting the use of menthol as a characterizing flavor in cigarettes, roll-your-own tobacco and heat-not-burn products. The agency received about 175,000 public comments on the ban, and now said it will issue a final rule in August. The effective date of the rule, however, has not yet been set. The FDA collected public comments on delaying the effective dates two years from when the final rule is published, rather than the usual one-year effective date delay. The earliest it could take place would be in August 2024.
- Banning flavors in cigars. The FDA plans to ban characterizing flavors in cigars, including menthol, to decrease the likelihood of experimentation and the development of nicotine dependence. Like the menthol cigarette rule, the comment period for this proposal has already passed, and it received feedback from about 71,000 people. The FDA also expects this final rule to be published by August, and has previously said its effective date would be one after the final rule is published, so likely August 2024.
With all the proposed rules, deadlines are not final and if litigation is brought against them the effective date may be extended beyond the estimated effective dates.