FDA Announces New Requirements for Tobacco Manufacturers

The FDA is aiming to protect people from hazardous and unauthorized products with new requirements.

On February 22, the FDA filed a civil money penalty (CMP) complaint against four tobacco manufacturers for selling e-cigarettes. On March 8, two weeks after the official complaint, the FDA announced its initiative.

The agency's new requirements will help protect the public from unauthorized tobacco products. They will only allow products that align with the Federal Food, Drug, and Cosmetic Act. The new rules would prevent manufacturers from distributing and selling tobacco products contaminated with hazardous materials, including glass and metal. It will require e-liquid products to have correct labelings and accurate concentrations to safely inform consumers of the products they're exposing themselves to.

"While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products," says the director of the FDA’s Center for Tobacco Products, Brian King, Ph.D., M.P.H. "Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health."

Additionally, the new rule would handle the identification, tracing, and corrective actions for all tobacco products that previously didn't meet the standards, including products that have already been distributed. If complications occur, the new requirements will require all manufacturers to rectify or recall the products.

The agency will ask manufacturers to label their tobacco products according to the new rules, including finished and bulk tobacco products. A finished tobacco product refers to any tobacco product, including the packaging. Bulk tobacco refers to a product that hasn't been sealed in its final packaging but is still acceptable for consumer use.

Currently, the new rules will include but are not limited to:

  • Institute tobacco product design and development process to make sure all finished and bulk tobacco products meet the standards
  • Diminish all manufacturing and distribution of tobacco products that do not align with specifications
  • Demand all manufacturers to prevent any contaminated tobacco products from being manufactured and distributed
  • Require inspection and identification of tobacco products that do not align with specifications to ensure safety for consumers, even if it means a recall
  • To get rid of tobacco products that don't meet specifications, establish the ability to track all components or parts, ingredients, additives, and materials, as well as each batch of finished or bulk tobacco products.

The agency is scheduled to have a public oral hearing on April 12 to gain supplementary comments from stakeholders, and the proposed rules will also be out to the public for comments. The FDA will evaluate all public comments for consideration in the rule making course.

"We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law," continues 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 meet for the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to receive guidance from experts outside of the agency. The public will have access to the meeting materials online.


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