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In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being appropriate for the protection of the public health, he added

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As a result, the analysis might not have been able to capture the associated intricacies in different regions, underscoring the significance of context-specific interventions tailored to specific needs of individual countries or regions

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