Source: FDA, 12/12/16

Today, the FDA is issuing the third edition of the guidance for industry titled Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 3). This new edition has been revised to reflect the decision by the U.S. District Court for the District of Columbia that a modification to an existing product’s label does not result in a “new tobacco product.”

Based on the court’s 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. 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.

In scenarios when a product quantity is the only change to a tobacco product eligible for the SE pathway, a manufacturer may submit a streamlined SE application referred to as a “Product Quantity Change SE Application.” These applications require less information from manufacturers than full SE applications, and will better enable the agency to quickly review them. This edition of the guidance answers many questions on these types of streamlined applications, in addition to questions about changes to additives and the SE application process in general.

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