The Food and Drug Administration (FDA) has revised its guidance to manufacturers seeking regulatory approval for new tobacco products by demonstrating they are similar to ones already on the market.

New tobacco products require FDA approval, and a substantial equivalence (SE) application is the most common route. SE guidelines were revised based on comments received on the final guidance, FDA said.
“The guidance describes the FDA’s current thinking on whether and when a change to a tobacco product’s label, product quantity in the package, additives, or specifications renders that product a ‘new tobacco product’ subject to premarket review,” the agency said. “It explains that a manufacturer may submit streamlined SE reports for certain modifications to labels and changes to product quantity as an alternative to the more comprehensive SE reports described in the Demonstrating SE Guidance. The guidance also explains the FDA’s plans and processes for review of the streamlined SE reports.”