NATO outlines what this means for cigars and the tobacco industry.
Congress’ omnibus spending bill for Fiscal Year 2018 did not include language to exempt premium cigars from FDA regulations, nor did it change the FDA Deeming Regulation predicate/grandfather date from Feb. 15, 2007 to Aug. 8, 2016, the National Association of Tobacco Outlets (NATO) reported, despite a significant industry effort to have these provisions included.
NATO released the following information about the bill:
The funding bill originally contained a provision known as the “Cole-Bishop Amendment” that would have changed the date for cigars, pipe tobacco, e-cigarettes, vapor products and hookah products to remain on the market without the need to file a special substantial equivalency application (“SE”) or a pre-market tobacco application (“PMTA”) with the FDA.
The Cole-Bishop Amendment would have changed this predicate date to Aug. 8, 2016 and essentially grandfathered all cigars, pipe tobacco, e-cigarettes, vapor products and hookah products that were on the market as of Aug. 8, 2016 and eliminated the need for manufacturers of these products to file SE or PMTA applications for their products with the FDA.
This means that manufacturers of cigars, pipe tobacco and hookah tobacco will likely need to file SE or PMTA applications with the FDA by Aug. 8, 2021 for each product SKU that was not on the market as of Feb. 15, 2007 or which has been changed in some way by the manufacturer. The deadline for filing a SE or PMTA for electronic cigarette or vapor products is now Aug. 8, 2022. This means that these products can remain on the market up until these deadline dates for a SE or PMTA application. To remain on the market after these deadline dates, manufacturers will need to have filed a SE or PMTA application for their products and have the application either pending with the FDA or approved by the agency.
The premium cigar industry, including the Cigar Association of America, the International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America, worked diligently to have language included in the funding omnibus bill to define and exempt premium cigars from the FDA deeming regulations. The premium cigar industry continues to work toward finding a solution to the issue of FDA regulation of premium cigars.
