Last week, Congress passed an omnibus spending bill for Fiscal Year 2018. However, despite significant industry efforts in an attempt to change the FDA Deeming Regulation predicate/grandfather date from February 15, 2007 to August 8, 2016, and to exempt premium cigars from these FDA regulations, the funding bill did not include these provisions.
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 August 8, 2016 and essentially grandfathered all cigars, pipe tobacco, e-cigarettes, vapor products and hookah products that were on the market as of August 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 August 8, 2021 for each product SKU that was not on the market as of February 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 August 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.