Tobacco grandfather date may remain unchanged.
The federal omnibus budget bill that recently passed through the U.S. Senate and House of Representatives did not offer any relief to concerned members of the tobacco industry.
According to a report from NATO, the U.S. Senate and House of Representatives did not include in the bill language that would have (1) changed the predicate/grandfather date for newly deemed tobacco products like cigars, pipe tobacco and electronic cigarettes from Feb. 15, 2007 to the effective date of the proposed deeming regulations, or (2) granted an exemption for premium cigars from FDA regulatory authority.
Unless Congress takes action in the future to adopt the predicate date change and/or premium cigar exemption, then once the FDA’s proposed deeming regulations are finalized, manufacturers will need to compile and submit either Substantial Equivalence (SE) applications or Pre-Market Tobacco Applications (PMTA) for many cigar and pipe tobacco products and virtually all e-cigarette and vapor products. In addition, premium cigars would also be subject to existing and future FDA tobacco regulations.