FDA Guidelines on Tobacco Product Analysis and Testing Methods Validation

On January 6, the U.S. Food and Drug Administration (FDA) released the final version of the "Validation and Confirmation of Tobacco Product Analysis Methods" guidance, providing information and recommendations for tobacco manufacturers to support their submissions.

This guide provides detailed instructions for manufacturers on how to submit verified and validated data on analysis procedures and testing methods to the FDA for use in submissions including premarket tobacco product applications, substantial equivalence reports, and modified risk tobacco product applications.

Before being able to legally sell new tobacco products or modified risk tobacco products in the United States, companies must first submit an application to the FDA and receive approval. These applications typically require data and information to support the analytical methods used for testing tobacco products, and this guideline provides manufacturers and laboratories with scientifically sound information organization and presentation methods.

The principles described in this guide can also be applied to the writing of reports on harmful and potentially harmful constituents data required by tobacco product manufacturers and importers.

The draft version of this guide was released in 2021, allowing the public to provide feedback on the content. After considering this feedback, the FDA made adjustments to the final version of the guide, including updating the definition of "tobacco products" to include non-tobacco nicotine, adjusting the content to reflect the final PMTA and SE regulations, and updating and adding definitions for multiple terms. The final version of the guide also includes updated examples of alternative validation methods.

These suggestions are not legally binding and do not create legal obligations. In addition, the FDA acknowledges that there may be alternative validation procedures, such as statistical testing, that differ from the recommendations in this guide.

For applicants looking to introduce new tobacco products into the market, the FDA promises to continue providing information and resource support, including this recently released guide. The FDA has already issued regulations such as the PMTA final rule and regularly posts additional resources on its website and social media, such as application tips and webinars.

Compliance experts and consultants have provided the following analysis of the guidelines.

The U.S. FDA has issued this guide to provide tobacco manufacturers with guidance on conducting scientific validation and confirmation of analytical testing methods when submitting PMTA (premarket tobacco product application), SE (substantial equivalence application), and MRTPA (modified risk tobacco product application). This guide focuses on analytical testing of tobacco product ingredients, components, and additives, as well as issues related to chemical stability testing of finished tobacco products. It can also be used to guide testing and analysis of harmful and potentially harmful constituents (HPHC) in finished tobacco products, as well as other smoke or aerosol emissions. The guide aims to assist tobacco product manufacturers and analytical laboratories in collecting and presenting scientifically valid data and information to support analytical methods for submission to regulatory authorities for finished tobacco products. The recommendations in this guide will help the FDA better understand and evaluate the reliability of the data provided in regulatory submissions.

Click to read the final version of the guidelines for the validation and confirmation of analytical methods for tobacco products.

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