FDA is proposing a new set of rules for tobacco manufacturers to minimize or prevent contamination and ensure product consistency. Photo credit: Marco Verch, Creative Commons 2.0.
The US Food and Drug Administration (FDA) is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing, and storage of their products. These proposed requirements would 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 FDA’s Center for Tobacco Products (CTP).
These proposed new requirements would help ensure that products comply with the Federal Food, Drug, and Cosmetic Act. For example, these 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; such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins.
The proposed rule would also establish several requirements related to the identification, tracing, and corrective actions for tobacco products that don’t meet specifications or are contaminated, including for tobacco products that have already been distributed. In the event of an issue, these requirements would require manufacturers to take corrective actions, which may include conducting a recall.
These proposed requirements apply to manufacturers of finished and bulk tobacco products. As laid out in the proposed rule, a finished tobacco product is a tobacco product, including any component or part, sealed in final packaging; for example, a pack of cigarettes or a can of moist snuff. A bulk tobacco product is a tobacco product that isn’t sealed in final packaging, but is otherwise suitable for consumer use.
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;
- 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; and
- 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.