WASHINGTON, D.C. — The US Food and Drug Administration (FDA) has proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing, and storage of their products. The proposal aims to help protect public health by minimizing or preventing contamination and limiting additional risks by ensuring product consistency.
“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” said Brian King, 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 proposed requirements would help ensure that the public health is protected and products comply with the Federal Food, Drug, and Cosmetic Act. The requirements would help minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances such as metal, glass, and plastics, which have been found in tobacco products. The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids, potentially intensifying addiction and exposure to toxins.
Additionally, the proposed rule would establish requirements related to the identification, tracing, and corrective actions for tobacco products that do not meet specifications or are contaminated, including for tobacco products that have already been distributed. In the event of an issue, manufacturers would be required to take corrective actions, which may include conducting a recall.
The proposed requirements apply to manufacturers of finished and bulk tobacco products. The proposed rule establishes a framework for manufacturers to adhere to, including establishing tobacco product design and development controls, ensuring that finished and bulk tobacco products are manufactured according to established specifications, and minimizing the manufacture and distribution of tobacco products that do not meet specifications.
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 proposed rule will also be available for public comment for 180 days. The agency will review all comments as part of the rulemaking process for this foundational rule.
“We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law,” said 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 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.