The Food and Drug Administration revised its guidance on Substantial Equivalence (SE) applications to reflect a court ruling that modifying an existing tobacco product label does not create a new product requiring FDA approval.

“Based on the (US District Court, Washington DC) ruling, modifications to an existing product’s label alone—such as a product with a new name that is otherwise identical to its predicate product—would not require the manufacturer to submit a Substantial Equivalence (SE) application,” the FDA said. “However, any changes to an existing product’s quantity—such as changing the number of cigarettes in a package from 20 to 24—does result in a “new tobacco product” and would require a submission for premarket authorization. FDA’s interpretation regarding product quantity changes was upheld in the court’s final decision.”