12 May FDA on Predicate Products
We have received a number of questions on how to determine what constitutes a predicate product. Many inquiries from manufacturers have also been received requesting copies of the IPCPR Almanac from 2006 & 2007, which will be made available upon request.
FDA states, “an applicant may use as a predicate product any tobacco product commercially marketed in the United States on February 15, 2007 or previously found substantially equivalent.” Notably, if a product was available prior to February 15, 2007 but not commercially marketed on that date, it is not a grandfathered product (p. 20). FDA re-states its opinion that it “lacks authority to change the grandfather date which is set by statute” and that no comments received provided a legal theory to change that view.
FDA does not intend to enforce premarket authorization requirements where manufacturers make tobacco blending changes to address the natural variation of tobacco in order to maintain a consistent product.
IPCPR continues to pursue a legislative fix to change the predicate date to provide fairness to products released over the past 9 years. The U.S. House of Representatives has included provision in the FY17 Agriculture Appropriations bill to make this change. While this legislation has not yet moved to the House floor, we remain optimistic Congress will take action on this crucial resolution.