The U.S. Food and Drug Administration recommended new manufacturing, design, packaging, and storage regulations for tobacco product makers on March 8. These suggested regulations would protect public health by eliminating or preventing contamination and limiting extra risks by assuring product consistency.
Director of the FDA’s Center for Tobacco Products Brian King, Ph.D., M.P.H., stated, “Although no tobacco product is risk-free, this proposed regulation aims to limit or prevent extra risks associated with these products.” If finalized, it will impose rules for manufacturers of tobacco products that will aid in protecting public health.
These proposed new criteria would contribute to the protection of public health and compliance with the Federal Food, Drug, and Cosmetic Act. For instance, these regulations would aid in minimizing or preventing the manufacture and distribution of tobacco products containing foreign substances, such as metal, glass, and plastics, which have been discovered in cigarette products.
The proposed rule would also help address issues connected to variations between e-liquid product labeling and actual concentrations in e-liquids; such variability can mislead users, potentially escalating their addiction and exposure to contaminants.
In addition, the proposed rule would impose a number of identification, tracing, and remedial action requirements for tobacco products that do not meet specifications or are contaminated, including those that have already been distributed. In the case of a problem, producers would be required to take corrective action, which might include a recall, under these guidelines.
This proposal applies to makers of both finished and bulk tobacco products. According to the proposed regulation, a finished tobacco product is a tobacco product, including any component or part, that is sealed in final packagings, such as a pack of cigarettes or a can of moist snuff. A bulk tobacco product is an unpackaged tobacco product that is suitable for consumer usage.
The proposed rule offers a framework for manufacturers to follow, including the following:
- Establishing design and development controls for tobacco products, ensuring that finished and bulk tobacco products are manufactured in accordance with defined specifications.
- Minimizing the manufacture and distribution of tobacco products that do not meet specifications;
- Requiring manufacturers to take appropriate measures to prevent contamination of tobacco products;
- Requiring investigation and identification of products that do not meet specifications in order 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 fi re-lighting tobacco products.
The FDA will convene a public oral hearing on April 12 in order to collect more feedback from the industry, the scientific community, and advocacy groups. Also, the proposed regulation would be open for public comment for 180 days. As part of the rulemaking process for this fundamental rule, the agency will consider all feedback.
Dr. King stated, “We remain dedicated to transparency and stakeholder engagement, including providing clarification to industry so they can comply with the law.” “We invite the participation of all interested persons and organizations in the rulemaking process. When the public provides a well-reasoned comment, it can have a significant impact on the agency’s decision-making.”
The FDA will also convene the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to solicit advice from the agency’s external panel of experts regarding the draft rule’s requirements. The public will have the option to make oral presentations at the TPSAC meeting. The FDA aims to post TPSAC meeting materials on its website at least 48 hours prior to the meeting.