FDA Releases Final Guidance on Analytical Testing Methods for Tobacco Product Applications

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The U.S. Food and Drug Administration (FDA) has issued a final guidance titled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides tobacco manufacturers with information and recommendations to support their tobacco product application submissions, including premarket tobacco product applications (PMTAs), substantial equivalence (SE) reports, and modified risk tobacco product (MRTP) applications.

The guidance outlines how manufacturers can provide the FDA with validated and verified data for the analytical procedures and test methods used in their application submissions. This information is crucial for companies seeking to legally market new tobacco products or modified risk tobacco products in the United States, as they must first submit an application to and receive authorization from the FDA.

Updating and Revising Draft Guidance

The FDA previously issued a draft version of this guidance in 2021, allowing the public to comment on its content. The agency considered these comments and made several changes in the final guidance, including:

  • Updating the definition of “tobacco product” to include non-tobacco nicotine
  • Revising the document to reflect provisions from the final PMTA and SE rules
  • Updating and adding definitions for several terms
  • Including updated examples for alternative validation approaches

The recommendations in the guidance are non-binding and do not establish legally enforceable responsibilities. The FDA acknowledges that there may be alternative validation procedures that differ from those outlined in the guidance, such as different statistical tests.

Commitment to Providing Resources

For applicants seeking to market new tobacco products, the FDA remains committed to providing information and resources, including this latest guidance. The agency has issued final regulations, such as the PMTA final rule, and regularly posts additional resources, such as application tips and webinars, on its website and social media channels.

As the vaping industry continues to evolve and navigate the regulatory landscape, it is essential for manufacturers to stay informed about the latest guidance and requirements from the FDA. By following the recommendations outlined in this guidance, manufacturers can ensure that their tobacco product applications contain scientifically valid information, increasing the likelihood of a successful submission.

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The General Department of Vietnam Customs also requires the Customs Departments to compile statistics on the remaining inventory of these goods within their jurisdictions, including components and raw materials for manufacturing e-cigarettes and heated tobacco products, semi-finished and finished products, and waste and scrap materials. The Customs Departments must propose handling measures and submit the data to the General Department of Vietnam Customs before January 10, 2025, for consolidation and further action.

This decisive step by the Vietnamese government aims to protect public health and maintain social order by curbing the availability and use of e-cigarettes and heated tobacco products in the country. The vaping industry will need to adapt to these new regulations and explore alternative markets or product lines to sustain their businesses.

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