FDA imposes New requirements on e-cigarette manufacturers’ manufacturing practices


The US Food and Drug Administration is imposing new requirements on tobacco product manufacturers for the manufacture, design, packaging and storage of e-cigarettes and other tobacco products, foreign media reported today. These proposed requirements will help to protect public health by, inter alia, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.

“While no tobacco product is safe, this proposed rule is designed to minimize or prevent additional risks associated with these products.” Brian King, Ph.D., director of the FDA’s Center for Tobacco Products. “Once finalized, it will place requirements on tobacco product manufacturers that will help protect public health.”

These proposed new requirements will help ensure that public health is protected and that products comply with the Federal Food, Drug, and Cosmetic Act. For example, these requirements will help to minimize or prevent the manufacture and distribution of tobacco products from being contaminated by foreign substances, such as metals, glass and plastics, which have been found in tobacco products. The proposed rules would also help address issues related to inconsistencies between the labels of e-vape products and the actual concentrations in e-vape; This variability can mislead consumers, potentially exacerbating addiction and exposure to toxins.

The proposed rules would also establish a number of requirements related to identification, tracing and corrective actions for tobacco products that do not meet specifications or are contaminated, including those that have already been sold. If something goes wrong, the requirements would require manufacturers to take corrective action, which could include a recall.

These proposed requirements apply to manufacturers of finished and bulk tobacco products. As stated in the proposed rule, a finished tobacco product is a tobacco product that includes any ingredients or parts that are sealed in a final package; For example, a pack of cigarettes or a can of wet snuff. Bulk tobacco products are tobacco products that are not sealed in final packaging but are suitable for consumer use.

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

Establish tobacco product design and development controls;

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

Minimizing the manufacture and distribution of tobacco products that do not meet specifications;

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

Require investigation and identification of non-conforming products to take appropriate corrective action, such as recall;

Establish the ability to track all ingredients or components, ingredients, additives and materials as well as each lot of finished or bulk tobacco product to help investigate products that do not meet specifications.

The FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups and the public. The proposed rules will also be open for public comment for 180 days. As part of the rulemaking process for this ground rule, the agency will review all comments.

“We remain committed to transparency and stakeholder engagement, including providing clarity to the industry so they have the ability to comply with the law.” “Dr. King said. “We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits comments based on sound grounds, this can have an important impact on agency decision-making.”

The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s panel of outside experts on the requirements set out in the proposed rule. As part of the TPSAC meeting, the public will have the opportunity to make oral presentations. FDA intends to make TPSAC meeting materials available on its website within 48 hours prior to the meeting.


Leave A Reply