The U.S. Food and Drug Administration has proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. The rules are aimed at cigars, cigarettes, chewing tobacco, pipe tobacco, and vape products. From a cigar industry standpoint, these regulations target cigar factories and pre-industry facilities both domestic and foreign.

“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” commented Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

The FDA says that these proposed new requirements are aimed at ensuring that the public health is protected and products comply with the Federal Food, Drug, and Cosmetic Act. The FDA has cited an example of ensuring that the manufacture and distribution of tobacco products are not contaminated with any foreign substance. The FDA says these requirements will apply to both bulk and finished (packaged) tobacco products in both domestic and foreign facilities. In addition, the proposed new requirements call for traceability for all ingredients going into a tobacco product.

The proposed rules include the following:

  • Establishing tobacco product design and development controls
  • Ensuring that finished and bulk tobacco products are manufactured according to established specifications;
  • Minimizing the manufacture and distribution of tobacco products that don’t meet specifications
  • Requiring manufacturers to take appropriate measures to prevent contamination of tobacco products
  • Requiring investigation and identification of products that don’t meet specifications to institute appropriate corrective actions, such as a recall
  • Establishing the ability to trace all components or parts, ingredients, additives, and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of those that don’t meet specifications.

The FDA says the proposed rules will not extend to agricultural activities including growing, cultivation, or curing of raw tobacco. The FDA says it acknowledges that tobacco is an agricultural crop and, therefore, there is a likelihood that there will be a certain level of animals and pests (such as tobacco beetles) in the tobacco. At the same time, it is requiring manufacturers to take appropriate mitigations and actions to control things that can cause contamination. This could include mandating tobacco supplies use approved pesticides.

As with all proposed regulations, these proposed rules will go through a public comment period of 180 days which is required under the rulemaking process. In addition, the FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups, and the public.

The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations. The FDA intends to make TPSAC meeting materials available on its website no later than 48 hours before the meeting.

“We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law,” added Dr. King. “We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits a comment based on sound grounds, that can make an important difference in the agency’s decision-making.”

The proposed regulations are scheduled to be published to the Federal Register on March 10, 2023. A full copy of the regulations can be found here.