NATO: FDA Requests Courts to Extend PMTA Application Deadline

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FDA Requests Courts to Extend PMTA Application Deadline

The following article was submitted by the National Association of Tobacco Outlets (NATO)

Yesterday, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration (FDA), submitted letters to 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 premarket tobacco product application filing deadline. In the letter to the U.S. District Court, the DOJ states that the FDA is seeking the extension due to the exceptional circumstances presented by the coronavirus outbreak.  The new filing deadline, if allowed by these courts, would be September 9, 2020.

Background
The Family Smoking Prevention and Tobacco Control Act, the law that authorizes the FDA to regulate tobacco products, required cigarettes, smokeless and RYO tobacco first introduced into the marketplace or modified after February 15, 2007 to receive marketing authorization from the FDA prior to being offered for sale.  Effective August 8, 2016, this same marketing authorization application requirement was later extended by the FDA to cigars, pipe tobacco, electronic cigarettes, vapor products, hookah, alternative nicotine products, and heated tobacco products, all referred to as “deemed” products by the agency. In general:

All tobacco products on the market on or before February 15, 2007 are “grandfathered” and exempt from the premarket authorization application requirement. This means that manufacturers are not required to submit either Substantial Equivalency (SE) or Premarket Tobacco Applications (PMTA) for grandfathered products to remain on the market, but the products must comply with all other FDA tobacco regulations.

New cigarettes, smokeless and RYO products introduced between February 15, 2007 and March 22, 2011 were required to file marketing authorization applications by March 22, 2011. Products which did so are referred to as “provisional” and may continue to be marketed unless 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” tobacco products, including cigars, pipe tobacco, electronic cigarettes, vapor products, hookah, alternative nicotine products, and heated tobacco products introduced between February 15, 2007 and August 8, 2016 are required to have either a SE or PMTA application filed with the FDA.