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New Requirements for Tobacco Product Manufacturing Practices

author-icon Suorin Team date-icon Mar 9, 2023


March 8th, the US Food and Drug Administration (FDA) announced that it is developing new rules for tobacco product companies. The proposed rules will apply to all FDA-regulated loose and finished tobacco products. It's including e-cigarettes, cigarettes, cigars, chewing tobacco, etc..The rules will be released on March 10th.

The FDA stated that this will help to prevent these tobacco manufacturers' products from being contaminated. Establishing standards for their manufacturing and packaging processes can help regulatory agencies and consumers to accurately understand the ingredients involved of the tobacco products.

The FDA stated that these proposed new rules will help ensure the protection of public health. And the rules will comply with the law of Federal Food, Drug, and Cosmetic Act.

For example, these rules will help minimize or prevent the contamination of tobacco products from foreign substances such as metals, glass, and plastics. These had been found in some tobacco products before.

The proposed rules will also address issues related to inconsistencies between the labeling of e-cigarette liquids and their actual concentrations. This inconsistency may mislead consumers and could exacerbate addiction and exposure to toxins.

In addition, the proposed rules will establish several requirements related to identifying, tracking, and correcting non-compliant or contaminated tobacco products (including those already on the market). If problems arise, these requirements will require manufacturers to take corrective action. It can include recalls all the products.


The proposed rules establish a framework for tobacco product manufacturers to follow 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.

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

The FDA will hold a public hearing on April 12th regarding the proposed rule. When finalizing its rule, the FDA will balance public viewpoints along with those from stakeholders such as tobacco companies and solicit public comments for 180 days.

The FDA will also convene its Tobacco Product Scientific Advisory Committee on May 18th to hear from independent experts.

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