The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their March 31st online bulletin. Reposted with permission.
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 pre-market 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 Pre-Market 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.
As a result of a lawsuit brought by health-related organizations against the FDA, on July 12, 2019, the U.S. District Court for the District of Maryland issued an order setting May 12, 2020 as the deadline for manufacturers to submit SE or PMTA marketing applications to the FDA. According to this court order, manufacturers that submit a marketing authorization application to the FDA by May 12, 2020 can continue to sell the product which is the subject of the application for up to one year while the FDA conducts a review of the application.
FDA’s Reasoning for the Deadline Extension Request: The DOJ letter outlines numerous reasons why the FDA is requesting the 120-day application deadline extension. These reasons, all focusing on the impact of the Coronavirus, include the closure or suspension of on-site work by many laboratories and research organizations being utilized by manufacturers to complete marketing applications, travel restrictions that have hampered travel necessary to gather information for the applications, lack of delivery of tobacco products that manufacturers need for testing for marketing applications, reassignment of some FDA employees to the U.S. Public Health Service, and almost the entire FDA staff responsible for reviewing submitted applications being required to work from home.
In a Declaration filed with the U.S. District Court for the District of Maryland and the U.S. Circuit Court of Appeals for the Fourth Circuit in support of the FDA’s request for a 120-day application deadline extension, FDA Director Mitchell Zeller states that there are currently 30 PMTA applications pending for electronic cigarettes, 28 SE applications for cigars, and 17 SE applications for pipes or pipe tobacco. Director Zeller goes onto state that a large number of additional applications is expected by the May 12, 2020 filing deadline.
Many manufacturers and trade associations submitted requests to the FDA requesting an extension of the May 12, 2020 filing deadline by a minimum of eight weeks and up to six months. In explaining why, the FDA is requesting a 120-day extension, Director Zeller states in his Declaration that “[t]his period is less than what may manufacturers have requested, but substantial enough to provide a significant measure of relief in these extraordinary circumstances.” As for the potential impact of the Coronavirus on the FDA’s ability to review marketing authorization applications in a 12-month time period, Director Zeller states:
“The requested extension would allow FDA staff to continue reviewing the premarket applications that have been submitted to date, and when new premarket applications are submitted before the proposed new deadline, FDA staff could then devote its attention to those new applications. It is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed.”
Procedural Court Steps Regarding the 120-Day Extension Request: Since the July 12, 2019 ruling by the U.S. District Court for the District of Maryland is currently on appeal to the U.S. Circuit Court for the Fourth Circuit, Federal Rules of Civil Procedure allow a federal district court to issue what is called an “indicative ruling” stating that the district court is inclined to grant a motion while the case is on appeal. The U.S. Circuit Court of Appeals must then issue a limited remand order which allows the federal district court to modify a previously issued order, while still maintaining jurisdiction over the appealed case.
That is, with regard to the FDA’s request for the 120-day extension, the U.S. District Court for the District of Maryland would need to issue an indicative ruling supporting the extension request and then the U.S. Circuit Court of Appeals for the Fourth Circuit would need to issue a limited remand order granting the district court the authority to modify the July 12, 2019 order to change application filing deadline to September 9, 2020. This procedural process can take several days to allow both courts time to respond to the FDA request.
Formal Announcement by FDA: This morning, the FDA issued a formal announcement regarding the agency’s request for a 120-day extension of the pre-market authorization filing deadline. The full announcement is reproduced below:
“Yesterday, Mar. 30, FDA filed a motion with the United States District Court for the District of Maryland requesting a 120-day extension of the premarket application deadline (currently set for May 12, 2020) for many e-cigarettes, cigars and other tobacco products. In the motion, the Agency states that it is seeking the extension solely because of the coronavirus outbreak and would not do so but for these highly unusual circumstances. The Agency is seeking this extension due to the challenges posed during these extraordinary circumstances. If granted, the 120-day extension would move the deadline to Sept. 9, 2020.
FDA remains aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review. The Agency is committed to implementing and enforcing the premarket requirements in the law. The Agency strongly encourages applicants who are able, to submit applications as soon as possible. The Agency also encourages applicants who plan on submitting applications for a large number of products to contact the Agency to discuss their plans and method of submission.
On July 12, 2019, the U.S. District court ordered FDA to require submission of applications for premarket review by May 12, 2020, for deemed new tobacco products on the market as of Aug. 8, 2016.
If the court grants this extension, FDA intends to revise its January 2020 enforcement priorities guidance to be consistent with the new deadline. Consistent with the original court order, the Agency would also intend to provide companies that submit timely applications with continued enforcement discretion for a period of up to one year from the date an application was submitted (up to Sept. 9, 2021 if the 120-day extension is granted) or unless a negative action is taken by FDA during that time.
Until a court decision is made, the May 12, 2020 deadline is in effect. FDA encourages manufacturers who have concerns about meeting that deadline for any reason to contact the agency directly.”