As previously reported in CStore Decisions, the U.S. Department of Justice, on behalf of the Food and Drug Administration (FDA), submitted letters on March 30, 2020, to the U.S. District Court for the District of Maryland and the U.S. Circuit Court of Appeals for the Fourth Circuit with a request for a 120-day extension of the court-ordered May 12, 2020, pre-market tobacco product authorization (PMTA) application filing deadline.
The FDA sought the 120-day extension due to the exceptional circumstances presented by the COVID-19 outbreak. The new filing deadline, if allowed by these courts, would be Sept. 9, 2020.
In response, the U.S. Circuit Court of Appeals for the Fourth Circuit and the U.S. District Court for the District of Maryland issued orders approving the FDA’s 120-day extension request and changing the May 12, 2020, PMTA filing deadline to Sept. 9, 2020.
The FDA will now enforce the new Sept. 9, 2020, marketing authorization requirement based on product type and date of availability in the market.
In General
All tobacco products on the market on or before Feb. 15, 2007, are “grandfathered” and exempt from filing premarket authorization applications.
New cigarettes, smokeless and roll-your-own (RYO) tobacco products introduced between Feb. 15, 2007, and March 22, 2011, were required to file marketing authorization submissions by March 22, 2011. Products which did so are referred to as “provisional” and may continue to be marketed unless the FDA issues an order otherwise.
New cigarette, smokeless and RYO products introduced after March 22, 2011, must receive a marketing order from the FDA prior to being offered for sale.
“Deemed” products — including cigars, pipe tobacco, electronic cigarettes, vapor products, hookah, alternative nicotine products and heated tobacco products — introduced into the market between Feb. 15, 2007 and Aug. 8, 2016, must now have either a Substantial Equivalence (SE) or a PMTA application filed with the FDA by Sept. 9, 2020.
Since there were no electronic cigarette, vapor or alternative nicotine products on the market as of Feb. 15, 2007, all of these products will need a PMTA filed with the FDA by the Sept. 9 deadline. Then, the FDA may allow these products to remain on the market for up to one year, or potentially even longer, during the agency’s application review period.
For any new tobacco product that manufacturers planned or plan to introduce into the market after Aug. 8, 2016, the manufacturer must first file a PMTA with the FDA and receive a marketing approval order from the FDA before selling the product to the public.
This means that retailers and wholesalers will need to rely on manufacturers to inform them of whether they have submitted timely SE or PMTA applications and whether the FDA issues a marketing approval order authorizing the sale of the products in the marketplace.
Thomas Briant is the executive director of the National Association of Tobacco Outlets (NATO). He can be reached at [email protected].
