FDA Proposes New Regulatory Framework for Tobacco Manufacturers, Importers

FDA is proposing new tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products, it said in a notice scheduled for publication in the March 10 Federal Register. The proposed regulations, which would include requirements for manufacture, pre-production design validation, packing and storage, would also apply to foreign manufacturers and importers finished and bulk tobacco products, FDA said.

The proposed new regulation at 21 CFR 1120 would establish tobacco product design and development controls to prevent or minimize certain risks; ensure that finished and bulk tobacco products are manufactured in line with established specifications; and minimize the likelihood of the manufacture and distribution of nonconforming tobacco products, FDA said.

The new regulation also would require investigation and identification of nonconforming products, including those that have been distributed, in order to institute appropriate corrective actions, the agency said. Those actions include conducting a recall; requiring manufacturers to take steps to prevent contamination of tobacco products; and establishing traceability to "account for all components or parts, ingredients, additives and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of nonconforming tobacco products," the agency said.

The requirements would apply to tobacco product manufacturers, defined to include importers, repackers and relabelers of tobacco products. FDA also said that “foreign manufacturers of finished or bulk tobacco products that are imported or offered for import” would be covered under the rule.

Under the proposed rule, “finished tobacco product” means “a tobacco product, including any component or part, sealed in final packaging; for example, a pack of cigarettes or a can of moist snuff,” FDA said in a news release. “A bulk tobacco product is a tobacco product that isn’t sealed in final packaging, but is otherwise suitable for consumer use,” it said.

Among other things, the new 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 news release said. “The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids; such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins.”

The proposal also would “require manufacturers to take corrective actions, which may include conducting a recall,” FDA said.

FDA will hold a public hearing on the proposal April 12 to gather input from stakeholders, it said in another notice. The agency also will hold a meeting of its Tobacco Products Scientific Advisory Committee on May 18 to seek recommendations from an outside panel of experts on the requirements laid out in the proposed rule, FDA said. Comments on the proposal are due Sept. 6.