US FDA Extends Comment Period for "Requirements for Tobacco Product Manufacturing Practice" Proposed Rule


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The U.S. Food and Drug Administration (FDA) has announced an extension of the comment period for the proposed rule titled "Requirements for Tobacco Product Manufacturing Practice." Originally set to close on September 15, 2023, the comment period will now remain open for an additional 30 days, closing on October 15, 2023.

The proposed "Requirements for Tobacco Product Manufacturing Practice" regulation sets out comprehensive controls and procedures for tobacco product manufacturing with the overarching goal of safeguarding public health. It encompasses a wide range of provisions, including organizational requirements, design and development controls, production and laboratory controls, packaging and labeling controls, as well as handling, storage, and distribution protocols. Additionally, the regulation covers recordkeeping, document controls, and specific considerations for small tobacco product manufacturers. It provides a framework for manufacturers to establish procedures tailored to their specific products and operations while ensuring conformity with established specifications and the prevention of nonconforming or contaminated tobacco products.

The proposed rule aims to enhance the safety and quality of tobacco products while aligning with legal authority and economic considerations, all within the context of broader environmental and federalism concerns.

These regulations could have far-reaching implications for the industry, impacting how tobacco products are produced, labeled, and marketed.

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