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Update on FDA Request to Extend PMTA Application Deadline

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their April 24th online bulletin. Reposted with permission.

As previously reported in the NATO News Bulletin, the U.S. Department of Justice, on behalf of the U.S. 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 application filing deadline.  The FDA sought the 120-day extension due to the exceptional circumstances presented by the coronavirus outbreak and the new filing deadline, if allowed by these courts, would be September 9, 2020.

On April 22, 2020, the U.S. District Court for the District of Maryland issued a final order approving the FDA’s 120-day extension request and changing the May 12, 2020 pre-market tobacco product application filing deadline to September 9, 2020.  A copy of the final court order can be found below.

 

FDA Issues Statement on Change in PMTA Filing Deadline

In response to the issuance of a final order by the U.S. District Court for the District of Maryland approving the FDA’s 120-day extension request and changing the May 12, 2020 pre-market tobacco product application filing deadline to September 9, 2020, the FDA issued the following statement:

For Immediate Release:  April 23, 2020

Statement From:  Stephen M. Hahn M.D., Commissioner, Food and Drug Administration

On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020. We have steadily been working toward that deadline, but the coronavirus pandemic has drastically impaired the ability to adhere to this timeline. Solely as a result of the pandemic and these exceptional and unforeseen circumstances, we requested on March 30, and on April 22, 2020 were granted by the court, a 120-day extension of the May 12 deadline.

The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.

Requesting this extension was not an easy decision for the FDA. COVID-19 is impacting all FDA-regulated industries, including tobacco product manufacturers. The agency has received numerous inquiries from the tobacco industry expressing concern they will be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad. At this time, the FDA believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading COVID-19 to others by trying to meet the previous May 12 deadline. In the more than a dozen requests for an extension that the FDA received, this public health concern was mentioned repeatedly.

Another consideration was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on COVID-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications. Many of those deployed are among the staff that had been playing a critical role as CTP prepared for this deadline. In addition, we are expecting more PHS deployments among the staff involved in these preparations, and the length of deployment for many of these PHS officers is likely to be extended.

Ultimately, a Sept. 9 deadline will better serve the public health by allowing manufacturers to prepare for, and the Agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period. Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. Although the FDA’s in-person compliance checks and vape shop inspections are currently on hold due to the pandemic, review of previous inspections continues, and we continue to monitor the online marketplace and will take action as appropriate. Accordingly, the January 2020 enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted, although we intend to update it for products for which the Sept. 9 date now applies.

Since the FDA began implementing the January 2020 guidance on Feb. 6, 2020, we have conducted more than 2,300 inspections of brick-and-mortar and online retailers and manufacturers. Physical inspections conducted prior to being halted due to COVID-19 concerns revealed the presence of certain flavored cartridge or pod-based ENDS products subject to current enforcement and warning letters have already been sent to 40 retailers.

The FDA remains acutely 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. We are committed to implementing the enforcement priorities outlined in the January 2020 guidance. Again, we struggled with the decision to request an extension of the May 12 deadline, but this was ultimately the decision that made the most sense for public health during this extraordinary time.

In the meantime, we strongly encourage applicants who are able to submit their applications to do so as soon as possible. Those that plan on submitting applications for a large number of products are encouraged to contact the Agency as soon as possible to discuss their plans and method of submission. Sharing information about the number and nature of applications being developed will help us to prepare more efficiently for the influx of applications, enabling review of quality applications.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

State Legislative Bill Actions

State tobacco-related legislative bills that have been acted on by a state legislative committee or state legislature are listed below alphabetically by state:

Kentucky:  CORRECTION:  House Bill 32, which was amended to repeal the vapor tax sections in previously adopted HB 351 and amended to include the same taxes on vapor products ($1.50 per cartridge of closed vapor cartridges and 15% of the distributor price for open vaping systems), was posted for passage on concurrence but failed when the legislature adjourned on April 15, 2020.  Therefore, House Bill 351, which was passed by the House and Senate and included the vapor taxes, was delivered to the Secretary of State on April 15, 2020.

Minnesota:  House File 331, which increases the tobacco sales age to 21 years of age and adds charter schools to the prohibition of tobacco in schools, will be heard in the Ways and Means Committee on April 27, 2020.