Views:5 Author:Site Editor Publish Time: 2020-08-25 Origin:Site
A group of small vaping manufacturers and trade organizations has requested that the FDA ask a federal court for permission to postpone the Sept. 9 PMTA deadline for 180 days. The companies say they have been prevented from complying with the process by the coronavirus pandemic. Now they have just two weeks before applications are due.
The request came in the form of a “citizen petition” filed yesterday by Azim Chowdhury of Washington, D.C. law firm Keller Heckman. It included declarations provided by 20 individuals from the businesses and organizations behind the petition.
The previous May 12, 2020 PMTA deadline was postponed until Sept. 9 by the FDA after the agency received permission from both the 4th Circuit Court of Appeals and U.S. District Judge Paul Grimm in April. The agency had requested the delay on March 31, citing “extraordinary circumstances” caused by the coronavirus crisis.
The reasons the FDA cited for the previous postponement still apply, say the vaping industry petitioners in the new request:
Laboratory testing delays
Environmental assessment delays
Supplier response delays
Employee health concerns
Additionally, they say, small vaping manufacturers have an extra challenge now on top of what they faced in April. Because the pandemic has forced many vaping businesses to be closed for extended periods, there is less income to devote to preparing PMTAs.
“Since the breakout of COVID-19, small manufacturers have seen a dramatic fall in revenues (e.g., ranging between 20%-60%), as well as store closures, which have limited the financial resources that can be dedicated to the PMTA process….In order to just survive day-to-day, these businesses have thus had to curtail what they spend on testing, consulting, legal advice, and scientific experts,” says the petition.
Unlike tobacco companies, small vape businesses have no dependable revenue stream from cigarette sales to finance their vapor product marketing applications to the FDA. Vaping product sales are a vape company’s only business, and their products are primarily sold in vape shops, which—unlike convenience stores and gas stations, where cigarettes are sold—have been closed for part or all of the health crisis.
The petitioners are asking the FDA to grant the delay only for “certain small vapor product manufacturers” that have been working “in good faith” to meet the PMTA deadline. Specifically, they write, each manufacturer receiving a postponement of the deadline would have to show “through documentation and other evidence” that they:
Have fewer than 50 employees and/or less than $10 million in annual revenue
Only manufacture open-system products
Have taken steps to prohibit access by and sales to underage customers
Will only market to adults
Are otherwise in compliance with Tobacco Control Act/Deeming Rule requirements
Have made progress toward completing their PMTA, but have been “materially delayed” due to COVID-19
“If FDA does not seek an additional extension due to COVID-19, these small businesses will likely be forced out of business and have to lay-off thousands of employees soon after the deadline expires,” write the petitioners. “Moreover, adult smokers, who rely on open systems to move away from more dangerous combustible cigarettes, will no longer have access to these products. As evidence is now growing that former smokers are already moving back to cigarettes with current restrictions on vaping products (e.g., flavor bans), it is imperative that these small businesses be given adequate time to assemble and file complete PMTAs.”
The FDA, if it chooses to grant a postponement to small vaping businesses, will again have to request permission from the federal court. That’s because Maryland U.S. District Court Judge Paul Grimm ruled last year that the then-current PMTA deadline was improperly decided by the agency. Judge Grimm changed the deadline to May 12, 2020, and then allowed the agency to move the date to Sept. 9. Any changes the FDA makes to the PMTA process must now be approved by Judge Grimm.
A citizen petition to the FDA allows members of the public—including businesses—to ask the FDA commissioner to “issue, amend, or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.” By law, the agency must respond to the request. Citizen Petitions are often used by pharmaceutical companies to ask the FDA to delay generic drug applications.
In May 2017 vape company NJOY employed a citizen petition to ask the FDA to delay implementation of the Deeming Rule, including the Premarket Tobacco Application (PMTA) deadline. Two months later, new FDA Commissioner Scott Gottlieb announced a four-year postponement of the final PMTA deadline (that date has since changed). It’s uncertain if the citizen petition had an effect on Gottlieb’s decision.
DO NOT USE THIS PRODUCT IN THE FOLLOWING SITUATIONS:
• Are under the legal age of purchase
• Are pregnant or breastfeeding
• Have heart disease, stomach or duodenal ulcers, liver or kidney problems, throat disease, or difficulty breathing due to bronchitis, emphysema, or asthma
• Have an overactive thyroid or pheochromocytoma a tumor of the adrenal gland that can affect blood pressure)
• Are taking certain medications, such as theophylline, ropinirole, or clozapine .