SILVER SPRING, Md. -- Retailers wanting the latest interpretations of revised federal “deeming” rules can now access an updated Food and Drug Administration (FDA) guide, which includes a U.S. District Court ruling that modifies new-product definitions.
The document, titled Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 3), addresses a U.S. District Court for the District of Columbia’s ruling on what defines a new tobacco product (and subsequently is subject to the FDA’s new-product application process).
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, said officials with the FDA, Silver Spring, Md.
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, FDA officials said. The new 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, officials said.
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