FDA Proposes New Requirements for Tobacco Product Manufacturing

Public can comment on rule
Cigarette pack
Photograph: Shutterstock

The Food and Drug Administration is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. The changes would help protect the public health by minimizing or preventing contamination—like metal, glass and plastics, which have been found in tobacco products—and limiting additional risks by ensuring product consistency, the agency said.

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

The rule would also help address inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids and establish several requirements related to the identification, tracing and corrective actions for tobacco products that don’t meet specifications or are contaminated.

The suggested requirements apply only to manufacturers of finished and bulk tobacco products, like a pack of cigarettes or a can of moist snuff.

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.
  • 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 will hold a public hearing on April 12 to gather comments on the proposal from stakeholders. The proposed rule will be available for public comment for 180 days. The agency will review all comments as part of the rulemaking process for this foundational rule, like when the FDA collected more than 250,000 comments on its proposed menthol cigarette and flavored cigar ban.

The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee on May 18 to seek recommendations from the agency’s outside panel of experts.

Rulemaking can be a multi-year process, and does not necessarily mean the rule will ever be finalized. A version of the proposed rules, as well as additional information on the hearing and committee meeting, can be found on the Federal Register website.

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