FDA Proposed Three New Regulations for E-cigarette Manufacturing

The U.S. regulator seeks advisory committees and public comments on the proposed rule. 

The U.S. Food and Drug Administration (FDA) has proposed new requirements for manufacturing, designing, packaging, and storing e-cigarettes and other tobacco products. The proposed regulations will help protect public health, minimize or prevent contamination, and limit additional risks to ensure product consistency.

The requirements of the proposed regulations are related to finished and bulk e-cigarettes and other tobacco products. As stated in the proposed rule, a finished tobacco product is any product with components or parts enclosed in a final package, such as e-cigarettes, cigarette packs, or moist tobacco cans. Bulk tobacco products are tobacco products that are not held in final packaging but are suitable for consumption by consumers.

The new proposed rule will help manufacturers:

• Complying with the Federal Food, Drug, and Cosmetic Act to minimize or prevent contamination, such as metal, glass, and plastic, found in tobacco products.
• Solving the problem that e-cigarette oil product labels are inconsistent with the actual concentration.
• Establishing requirements related to the identification, traceability, and correction of substandard or contaminated tobacco products, including those that have already been distributed.

If something goes wrong, the rules will require manufacturers to take corrective action, which includes a recall.

The proposed rule establishes a framework for manufacturers to comply with, including the following:

• Establishing tobacco product design and development control;
• Ensuring that finished and bulk tobacco products are manufactured according to established specifications;
• Minimizing the manufacture and distribution of non-compliant tobacco products;
• Requiring manufacturers to take appropriate measures to prevent contamination of tobacco products;
• Requiring the investigation and identification of non-conforming products to enable appropriate corrective action, such as recalls;
• Establishing the ability to trace all components or components, ingredients, additives, and materials, and each batch of finished or bulk tobacco products to aid in investigating those products that do not meet specifications.

The FDA will hold a public hearing on April 12 to gather input from various sources, including industry, the scientific community, advocacy groups, and the public. The proposed rule will also be open for comment for 180 days. FDA will review all comments.

The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek advice from the agency's external panel of experts. The public can make oral presentations as part of the TPSAC meeting. In addition, FDA intends to post TPSAC meeting materials on its website 48 hours before the meeting.

2Firsts will interview relevant personnel on the new regulations and continue to follow up on the report.

Reference:

【1】FDA Proposes New Rules for Vape Manufacturing

【2】FDA Proposes New Requirements for Tobacco Product Manufacturing Practices

【2】Proposed Rule: Requirements for Tobacco Product Manufacturing Practice

【3】Tobacco Products Scientific Advisory Committee (TPSAC) Meeting

【4】Public Oral Hearing: Proposed Requirements for Tobacco Product Manufacturing Practice