October 14, 2016
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions, Guidance for Industry—Status of Recommendations Related to Label Changes (“SE FAQ Guidance”):
The U.S. District Court for the District of Columbia recently held that “a modification to an existing [tobacco] product’s label does not result in a ‘new tobacco product’” and does not give rise to the substantial equivalence review process. See Philip Morris USA Inc. v. United States Food and Drug Administration, No. 15-cv1590 (APM)(D.D.C. Aug. 16, 2016). The court vacated the SE FAQ Guidance “insofar as it interprets a labeling change as creating a ‘new tobacco product’ under the [Tobacco Control Act]." The court also held that a change in product quantity “creates a new tobacco product that triggers premarket or substantial equivalence review.”
FDA is currently revising the SE FAQ Guidance consistent with the court’s decision and intends to issue the updated version shortly.