Regulatory information | FDA proposes new rules for the manufacture of electronic cigarettes. The U.S. regulatory agency will seek the opinions of its advisory committee and the public on the proposed rules.

The United States Food and Drug Administration is putting forward new requirements to tobacco product manufacturers on the manufacture, design, packaging and storage of electronic cigarettes and other tobacco products.

According to the FDA statement, the proposed requirements will help protect public health by ensuring product consistency to minimize or prevent pollution and limit additional risks.

"Although no tobacco products are safe, this proposed rule aims to minimize or prevent the additional risks associated with these products."


Brian King, director of the FDA Tobacco Products Center, said. "Once finalized, it will put forward requirements for tobacco product manufacturers, which will help protect public health."

The proposed new requirements will help manufacturers comply with the Federal Food, Drug and Cosmetic Act and help minimize or prevent the manufacture and distribution of tobacco products contaminated by foreign substances (such as metal, glass and plastic) found in tobacco. The proposed rules will also help solve the problems related to the inconsistency between the label of electronic liquid products and the actual concentration in electronic liquid. "This variability may mislead consumers, and may aggravate addiction and exposure to toxins," the agency said.

The proposed rules will also establish a number of requirements related to identification, tracking and corrective measures for tobacco products that do not conform to specifications or are contaminated (including tobacco products already sold).

If problems occur, these requirements will require the manufacturer to take corrective actions, which may include recalls.

The proposed requirements apply to manufacturers of finished and bulk electronic cigarettes and other tobacco products. As stated in the proposed rules, the finished tobacco product is a tobacco product, including any components or parts, sealed in the final packaging; For example, an electronic cigarette, a pack of cigarettes or a can of wet snuff.

Bulk tobacco products are tobacco products that are not sealed in the final packaging but are suitable for consumer use.

The proposed rules establish a framework for manufacturers to comply with, including:

Establish tobacco product design and development control;

Ensure that finished and bulk tobacco products are manufactured according to established specifications;

Minimize the manufacture and distribution of substandard tobacco products;

Require manufacturers to take appropriate measures to prevent pollution of tobacco products;

It is required to investigate and identify the products that do not meet the specifications to take appropriate corrective measures, such as recall; And establish the ability to track all ingredients or components, ingredients, additives and materials as well as each batch of finished or bulk tobacco products to help investigate products that do not meet specifications.

FDA will hold a public oral hearing on April 12 to collect more comments from stakeholders, including industry, scientific community, advocacy groups and the public.

The proposed rules will also seek public opinion for 180 days. As part of the rulemaking process of this ground rule, the agency will review all comments.

"We remain committed to transparency and stakeholder participation, including providing clarity to the industry so that they can comply with the law," Jin said. "We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits comments based on reasonable reasons, this will have an important impact on the decision-making of the institution."

FDA will also hold a meeting of the Scientific Advisory Committee on Tobacco Products (TPSAC) on May 18 to seek the advice of the agency's external expert group on the requirements specified in the proposed rules. As part of the TPSAC meeting, the public will have the opportunity to make oral statements. FDA intends to provide TPSAC meeting materials on its website within 48 hours before the meeting.