Tobacco category managers and manufacturers will have to wait longer than expected to learn more details on the Food and Drug Administration’s plan to lower the allowed nicotine levels in cigarettes.
That proposed rule is now set to be published in December rather than October, as the agency previously said. This, and more updates on tobacco regulation, comes from the White House Office of Management and Budget’s Spring 2023 Regulatory Agenda.
The agenda is an update on pending regulations being considered by federal government agencies and potential regulations that those agencies plan to propose, according to the National Association of Tobacco Outlets (NATO). Updates from the FDA on tobacco-related items include a new product standard for menthol cigarettes, flavored cigars, nicotine levels of certain tobacco products and more.
Here’s a roundup of some of the tobacco-related items on the agenda:
Maximum Nicotine Level
While the FDA previously said it expected to release a rule on establishing a maximum nicotine level in cigarettes by October, the latest Regulatory Agenda pushes that date back to December.
The rule would apply to cigarettes and certain other finished tobacco products, the agency has said. While it hasn’t specified what level of nicotine would be allowed in cigarettes, the FDA said it would be “minimal or nonaddictive levels.”
Nicotine is a highly addictive chemical compound present in a tobacco plant, according to the FDA. Nicotine is what keeps people using tobacco products; however, it is the thousands of chemicals contained in tobacco and tobacco smoke that make tobacco use so deadly, the agency has said. Reducing the addictiveness to certain tobacco products would give addicted users a greater ability to quit and help prevent experimenters—mainly youth—from initiating regular use and becoming regular smokers, according to the proposal.
Reducing nicotine levels in cigarettes has been tried before, though, and a rule would likely take several years to take effect, if ever.
Menthol Cigarettes
The FDA announced its proposed product standards to ban menthol as a characterizing flavor in cigarettes in April 2022. A final rule on the standard, which would apply to cigarettes, roll-your-own tobacco and heated tobacco products, is expected in August.
Menthol is a flavor additive with a minty taste and aroma that reduces the irritation and harshness of smoking. This increases appeal and makes menthol cigarettes easier to use, particularly for youth and young adults, and makes it harder for people to quit smoking, according to the FDA. The agency received about 175,000 comments from the public on the proposed rule.
While the rule is set to be finalized in August, it could take one to two years for the ban to take effect.
Flavored Cigars
The FDA also plans to have a final rule on banning characterizing flavors in cigars by August.
The goal of this rule is to reduce the tobacco-related death and disease associated with cigar use, according to the agency. Flavored tobacco products appeal to youth and may be more likely to initiate tobacco use with such products, the FDA said.
Characterizing flavors in cigars, including strawberry, grape, orange and cocoa, enhance the taste and make these products easier to use, the FDA said. More than half a million youth in the U.S. use flavored cigars, it said.
The effective date for this rule is not yet set but will be included in the final published version of the regulation, NATO said.
Other Rules
Several other proposed regulations that are set to be released in 2024 include:
- Proposed regulation that would prescribe the format, content and procedures for establishment registration and tobacco product listings for both domestic and foreign manufacturers of tobacco products. The registration submission would include a manufacturer submitting general information about the manufacturing operation, like the name of the company, facility location and telephone number. The product listing submission would include information about the tobacco products it manufactures.
- Proposed requirements for the administrative detention of tobacco products that would allow FDA to administratively detain tobacco products encountered during inspections of manufacturers or other establishments that manufacture, process, pack or hold tobacco products that an authorized FDA representative conducting the inspection has reason to believe are adulterated or misbranded.
- A rule that would establish content and format requirements to ensure that modified risk tobacco product (MRTP) applications contain sufficient information for FDA to determine whether it should permit the marketing of a modified risk tobacco product. The proposed rule would also set forth the basic procedures for MRTP application review.