A federal judge agreed Friday to give the Food and Drug Administration a 10-month timeline for tobacco manufacturers to apply to meet planned enhanced regulations.
Judge Paul Grimm for the District of Maryland ruled that manufacturers have until May 11 to file pre-market applications for electronic cigarettes and cigars.
The premarket standard requires the FDA to consider products’ risks and benefits to the population as a whole, including users and non-users.
A coalition of seven public-health and anti-tobacco groups sued the FDA in March 2018 to accelerate the timetable from August 2022. They asked Grimm to provide only four months from his final ruling.
Grimm wrote that a 10-month deadline for products in the marketplace would allow “sufficient time for application submissions that present the information that the FDA needs to access the e-cigarette products, while not delaying longer than necessary.”
Goldman Sachs analyst Judy Hong said the application deadline “is less onerous than what the plaintiffs had proposed.”
Products can remain in the marketplace for up to a year from the application submission date without being subject to FDA enforcement actions. The FDA can take enforcement actions against products that are not submitted for review.
Analysts said the extra six months could make it more feasible for some manufacturers to meet the deadline, particularly the Big Three of Altria Group Inc., R.J. Reynolds Tobacco Co. and ITG Brands LLC, as well as top-selling electronic-cigarette maker Juul Labs Inc.
Reynolds declined to comment on the ruling. The other manufacturers could not be immediately reached for comment on the ruling.
The FDA timeline could have the effect of limiting competition from smaller e-cigarette makers by “protecting only those products backed by very deep-pocketed companies,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigs and health studies.
“Which means tobacco companies, and perhaps Juul and Njoy, can compete with cigarettes, but much of the threat vaping posed to Big Tobacco due to all the innovative start-ups has just been greatly diminished.”
Criticism of FDA
In August 2017, the FDA agreed to allow certain flavored e-cigarettes to stay in the marketplace until August 2022 and cigars until August 2021 without pursing FDA authorization or being reviewed by the agency.
The public-health coalition claimed the FDA “deliberately abdicated” its responsibilities under the 2009 Tobacco Control Act. The manufacturers claimed it was the FDA’s authority to determine the deadline.
According to the ruling, the FDA said a four-month timeline “would create massive administrative burdens at the agency that would ultimately be counterproductive.”
“It would threaten to abruptly clear the market of e-cigarette products, creating a ‘genuine risk’ that adult former smokers addicted to nicotine would ‘migrate’ from potentially less harmful (electronic nicotine delivery systems) products back to combustible tobacco products.”
It is generally accepted that the burning of tobacco leaves in traditional cigarettes is the main carcinogen risk from smoking.
“The FDA’s goal of not driving e-cigarette products out of the market appears to be part of a broader attack on tobacco by encouraging the availability of potentially less-addictive products,” according to the ruling.
Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health, said, “I am concerned by the possibility that the FDA is ill-equipped to handle what will be dozens and dozens of applications in a timely fashion.
“Its experience with Swedish snus, Camel snus and IQOS (heat-not-burn traditional cigarette of Philip Morris International) should give us all pause and concern that things may not move along in a timely fashion,” Ballin said.
The coalition said in a statement that “the new deadline is a dramatic improvement of more than two years from the current deadline of August 2022.”
“’It is critical that the FDA use this legally required review process to remove from the market products that appeal to kids and have fueled the youth e-cigarette epidemic.”
The FDA said it plans to accelerate the premarket reviews of products that “are most attractive to youths,” such as flavored products.
Grimm wrote that the “record before me shows a purposeful avoidance by the industry of complying with the premarket requirements despite entreaties from the FDA that it can do so, and it establishes a shockingly low rate of filings.”
“The FDA has made clear that it is willing to work with manufacturers in the interim to provide informal guidance.”
Hong said that with Grimm’s ruling, “we believe the likelihood of a complete and outright ban on Juul is low given the potential negative public health impact that will likely be created as some legal-age smokers have shifted to Juul products.”
“FDA can also include other conditions, such as marketing restrictions, as part of its approval process.”
In July 2017, the FDA announced plans for a sweeping regulatory “road map” on tobacco and nicotine products that included limiting or eliminating flavorings, such as menthol in traditional cigarettes and candy and fruits in e-cigs and vaporizers, that the agency says appeal to youths.
Anti-tobacco advocates consider e-cigs — as well as smokeless tobacco and dissolvable tobacco products — as potential gateways to the use of traditional cigarettes.
Several studies, however, have demonstrated that there is no direct connection, particularly given that youth-smoking rates have declined throughout the decade even as e-cig usage among young people has increased.
“We think large manufacturers and ‘pod-based systems,’ such as Juul, will fall under heightened political scrutiny as part of this review process and will face enormous challenges receiving approvals on existing products as they are currently designed, Sandhills Strategy analyst Stefanie Miller said.
“This continues to mean in our view that if Juul Labs submits applications for its current suite of products, we think FDA is likely to reject those premarket applications.”