The U.S. Food and Drug Administration is imposing new requirements on tobacco product manufacturers regarding the manufacture, design, packaging and storage of e-cigarettes and other tobacco products. These proposed requirements will help 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 aims to minimize or prevent additional risks associated with these products," said Brian King, PhD, public health, director of the FDA's Center for Tobacco Products. "Once finalized, it will place requirements on manufacturers of tobacco products that will help protect public health."

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

The proposed rule would also establish a number of requirements related to identification, tracing and corrective action for off-spec or contaminated tobacco products, including those that have already been sold. If problems arise, the requirements will require manufacturers to take corrective action, which may include recalls.

These proposed requirements apply to manufacturers of finished and loose tobacco products. As described in the proposed rule, a finished tobacco product is a tobacco product, including any ingredients or parts, sealed in its final packaging; for example, a pack of cigarettes or a tin of moist snuff. Loose tobacco products are tobacco products that are not sealed in final packaging but are suitable for consumption by consumers.

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

establish tobacco product design and development controls;

ensuring finished and loose tobacco products are manufactured to established specifications;

Minimize the manufacture and distribution of non-compliant tobacco products;

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

Requiring investigation and identification of non-conforming product for appropriate corrective action, such as a recall;

Establish the ability to trace all ingredients or components, ingredients, additives and materials, and each batch of finished or loose tobacco products to aid in the investigation of products that do not meet specifications.

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

"We remain committed to transparency and stakeholder engagement, including providing clarity to the industry so they are empowered 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 reasons, 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 advice from the agency's external panel of experts on the requirements set forth in the proposed rule. The public will have the opportunity to make oral presentations as part of the TPSAC meeting. FDA intends to make TPSAC meeting materials available on its website within 48 hours of the meeting.

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