FDA Exploring Whether to Require Product Standards for Tobacco Manufacturing

The U.S. Food & Drug Administration (FDA) says that it plans on exploring whether it should require certain requirements for the manufacturing, packing, and storage of tobacco products, which could include the agecny creating rules for how cigars are rolled.

While the idea is still in its early stages, FDA announced that it plans on making a formalized proposal in October 2021. Little is publicly known about the exact details of what FDA is considering, the agency announced its plans as part of its semi-annual Spring Unified Agenda:

The rule is proposing to establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This proposal would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This proposed rule provides manufacturers with flexibility in the manner in which they comply with the proposed requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health.

Currently, FDA has few procedural regulations regarding the manufacturing of cigars, most of which more or less amount to paperwork for domestic manufacturers. There are currently no requirements for how cigars must be made, including in the U.S.

The only other significant note is that it’s in the “Proposed Rule Stage” and that a noticed of proposed rulemaking (NPRM) is scheduled for October 2021.

When FDA announces the NPRM, the agency will give a formal update of what it is planning, its current thinking, and what it still has questions about. Furthermore, it will begin a process where both individuals and companies can submit comments about the proposed rules.