Federal Judge gives tobacco companies 10 months to comply with FDA's tougher regulation | Business

The pre-market standard requires the FDA to consider the risks and benefits of products for the entire population, both users and non-users.

A coalition of seven public health and anti-tobacco groups sued the FDA in March 2018 to speed up the schedule starting in August 2022. They asked Grimm to provide only four months from its final decision.

Grimm wrote that a 10-month deadline for products on the market would leave "enough time for requests containing the information the FDA needs to access e-cigarette products, without waiting longer than necessary" .

Judy Hong, an analyst at Goldman Sachs, said the application deadline "is less restrictive than that proposed by the plaintiffs."

The products may remain on the market for up to one year from the date of submission of the application without being subject to the FDA's enforcement actions. The FDA may take enforcement action against products that are not subject to review.

According to analysts, the additional six months would allow some manufacturers to meet the deadline, especially the Big Three of Altria Group Inc., RJ Reynolds Tobacco Co. and ITG Brands LLC, as well as the best-selling electronic cigarette manufacturer, Juul Labs Inc.

These manufacturers could not be immediately contacted to comment on the decision.

The FDA's timetable could have the effect of limiting competition from smaller electronic cigarette manufacturers by "protecting only products backed by highly cashed businesses," said David Sweanor, an associate professor of law at the University of Toronto. Ottawa and author of several articles. -cigs and health studies.

"This means that tobacco companies, and perhaps Juul and Njoy, can compete with cigarettes, but the threat posed by the Big Tobacco intrusion on behalf of all young innovative companies has been significantly reduced. "

In August 2017, the FDA agreed to allow some flavored electronic cigarettes to remain on the market until August 2022 and cigars until August 2021 without seeking FDA clearance or pending review by the agency.

The public health coalition said the FDA had "deliberately abandoned" its responsibilities under the 2009 Tobacco Control Act. The manufacturers claimed that the FDA had the power to set the deadline.

According to the ruling, the FDA has stated that a four-month delay "would create a huge administrative burden for the agency, which would ultimately be counterproductive".

"This could result in a sharp e-cigarette market, creating a" real risk "that former nicotine-dependent nicotine users" migrate "potentially less harmful products (electronic nicotine delivery systems) to combustible tobacco products. "

It is generally accepted that the burning of tobacco leaves in traditional cigarettes is the main carcinogenic risk of smoking.

"The FDA's goal of not excluding e-cigarette products from the marketplace seems to be part of a wider attack on tobacco by encouraging the availability of potentially less addictive products," the decision said.

Scott Ballin, former president of the Coalition Anti-Tobacco Alliance for Science or Health, said, "I'm afraid the FDA is not able to process dozens and dozens of applications quickly.

"His experience with Swedish snus, snus camel and IQOS (Philip Morris International's traditional cigarette without heat and without burning) should make us think and make us fear that things are not going as planned," he said. said Ballin.

The coalition said in a statement that "the new deadline represents a dramatic improvement of more than two years compared to the current deadline of August 2022".

"It is essential that the FDA use this statutory review process to remove products that attract children and fuel the e-cigarette epidemic among young people."

The FDA has announced its intention to accelerate pre-market reviews of products "that are most appealing to youth," such as flavored products.

Grimm wrote that "the record at my disposal reflects the fact that the industry is deliberately avoiding compliance with pre-market requirements, despite the FDA's authority to do so, and is establishing a extremely low rate of deposits ".

"The FDA has made it clear that it is willing to work with manufacturers in the meantime to provide informal advice."

Hong said that with Grimm's decision, "we believe that the likelihood of a complete and complete ban on Juul is low given the potential negative impact on public health that will likely be generated by the passage of some smokers of legal age to Juul products ".

"The FDA may also include other conditions, such as marketing restrictions, as part of its approval process."

In July 2017, the FDA announced that it was considering launching a comprehensive regulatory "roadmap" for tobacco and nicotine products, including limiting or eliminating flavors, such as menthol in traditional cigarettes, sweets and sprays. youth.

Advocates of tobacco control view electronic cigarettes – as well as smokeless tobacco and soluble tobacco products – as potential gateways to the use of traditional cigarettes.

However, several studies have shown that there is no direct link, particularly since youth smoking rates have decreased over the decade, even as the use of e-cigarettes among young people has grown.

"We believe that major manufacturers and pod-based systems, such as Juul, will be subject to a thorough political review as part of this review process and will face enormous challenges in obtaining Approval of existing products as designed, Stefanie Miller, Analyst at Sandhills Strategy. I said.

"This continues to mean, in our view, that if Juul Labs submits applications for its current product line, we believe the FDA will likely reject these pre-sale applications."