EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket authorization. Whether SE reports were submitted Provisionally, (products introduced into commercial distribution between February 15, 2007, and March 22, 2011) or are now submitted Regularly (SE Reports received after March 22, 2011), manufacturers must demonstrate that their new products have the same characteristics as a predicate product, or that any differences do not cause the new tobacco product to raise different questions of public health.
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Posted in FDA and USDA Regulatory Update.