We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual regulation and policy guidance agenda, which “outlines rules and guidance documents that are in development or planned for development.” Below, we discuss CTP’s current priorities for new regulations. CTP’s policy agenda is important because it identifies the areas CTP views as most in need of regulation or guidance, and the key actions it plans to take in those areas.

• Tobacco Product Standard for Menthol in Cigarettes and Tobacco Product Standard for Characterizing Flavors in Cigars
  • As we previously stated regarding these proposed rules, FDA has authority to implement tobacco product standards, but this authority is not without limits. The proposed bans on menthol and flavored cigars would have a devastating economic impact and likely would drive these products into the black market. This is a particular concern at a time when FDA is ineffectively policing the plethora of unauthorized products currently on the market.
• Tobacco Product Standard for Nicotine Level of Certain Tobacco Products
  • FDA still intends to issue this proposed rule, which we expected to be issued last year. As we previously stated, the idea of lowering nicotine levels in combustible cigarettes is not a new one for FDA. In 2018, FDA issued an advanced notice of public rulemaking on this topic.
• Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
  • This proposed rule is long overdue and, when finalized, will implement the 2019 amendment to the Federal Food, Drug, and Cosmetic Act that raised the federal minimum age for sale of tobacco products from 18 to 21 years.
• Administrative Detention of Tobacco Products
  • FDA plans to issue a proposed rule that would allow it to detain, during inspections of manufacturers or other establishments that manufacture, process, pack, or hold tobacco products, tobacco products that it has reason to believe are adulterated or misbranded. Any such rule should provide basic due process rights to companies whose products are detained.
• Requirements for Tobacco Product Manufacturing Practice
  • As we previously discussed, the proposed rule is quite comprehensive and would entail significant changes for most manufacturers (foreign and domestic), and particularly for smaller ones. It is likely that the rule would entail substantial new costs for manufacturers, and it is not clear that FDA has adequately considered those costs.
  • Notably, if and when the proposed rule is finalized, larger manufacturers would have two years to comply, and smaller manufacturers (those with fewer than 350 employees) would have six years to comply.