Federal judge gives tobacco manufacturers 10 months to comply with planned tighter FDA regulations | Business



A federal judge agreed Friday to give the Food and Drug Administration a 10-month period for tobacco manufacturers to request compliance with the planned enhanced regulations.

Judge Paul Grimm, of the District of Maryland, ruled that manufacturers have until May 11 to submit premarket applications for cigarettes and electronic cigarettes.

The pre-commercialization standard requires the FDA to consider the risks and benefits of the products to the general population, including users and non-users.

A coalition of seven public health and anti-smoking groups sued the FDA in March 2018 to accelerate the schedule since August 2022. Grimm was asked to provide only four months from his final decision.

Grimm wrote that a 10-month period for products on the market would allow "enough time to submit applications that present the information that the FDA needs to access electronic cigarette products, without delaying more than necessary."

Goldman Sachs badyst Judy Hong said the deadline for the request "is less onerous than what the plaintiffs had proposed."

The products can remain in the market for up to one year from the date the application is sent without being subject to FDA compliance measures. FDA can take enforcement action against products that are not subject to review.

Analysts said the additional six months could make it more feasible for some manufacturers to meet the deadline, particularly the big three from Altria Group Inc., R.J. Reynolds Tobacco Co. and ITG Brands LLC, as well as the best-selling electronic cigarette manufacturer, Juul Labs Inc.

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

The FDA timeline could have the effect of limiting the competition of smaller electronic cigarette manufacturers by "protecting only products backed by large companies," said David Sweanor, badistant professor of law at the University of Ottawa. and author of several publications. -cigs and health studies.

"Which means that the tobacco companies, and perhaps Juul and Njoy, can compete with cigarettes, but a lot of the threat that vaping represents for Big Tobacco because of all the new innovative companies has simply been greatly reduced."

Criticism of the FDA

In August 2017, the FDA agreed to allow certain flavored electronic cigarettes to remain on the market until August 2022 and cigars until August 2021 without requesting FDA authorization or being reviewed by the agency.

The public health coalition claimed that the FDA "deliberately gave up" its responsibilities under the 2009 Tobacco Control Act. The manufacturers claimed that it was the authority of the FDA to determine the deadline.

According to the ruling, the FDA said that a four-month deadline "would create mbadive administrative burdens on the agency that would ultimately be counterproductive."

"It would threaten to abruptly clear the market for electronic cigarette products, creating a" genuine risk "that former adult smokers addicted to nicotine" migrate "from potentially less harmful products (electronic nicotine distribution systems) to combustible tobacco products "

In general, it is accepted that the burning of tobacco leaves in traditional cigarettes is the main carcinogenic risk of smoking.

"The FDA's goal of not taking electronic cigarette products out of the market seems to be part of a broader attack on tobacco by encouraging the availability of potentially less addictive products," according to the ruling.

Scott Ballin, former president of the Health and Science Coalition against the anti-smoking alliance, said: "I am concerned about the possibility that the FDA is ill equipped to handle dozens and dozens of requests in a timely manner.

"His experience with Swedish snus, camel snus and IQOS (the traditional Philip Morris International cigarette that does not burn the heat) should give us a break and worry that things will not move in a timely manner," Ballin said.

Accelerated reviews

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

"It's critical that the FDA use this legally required review process to remove products that attract children from the market and have fueled the young people's e-cigarette epidemic."

The FDA said it plans to accelerate premarket reviews of products that "are more attractive to young people," such as flavored products.

Grimm wrote that the "dossier before me shows an intentional avoidance by the industry of complying with pre-market requirements despite the FDA's plea that it may do so, and establishes a surprisingly low rate of applications."

"The FDA has made it 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 that the likelihood of a total and absolute ban on Juul is low given the possible negative impact on public health that will likely be created as some smokers of legal age have switched 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 plans for a comprehensive regulatory "roadmap" on tobacco and nicotine products that included limiting or eliminating flavorings, such as menthol in traditional cigarettes and sweets and fruit in electronic cigarettes and vaporizers, according to the agency to young people.

Advocates of the fight against tobacco consider electronic cigarettes, as well as smokeless tobacco and soluble tobacco products, as possible inputs to the use of traditional cigarettes.

However, several studies have shown that there is no direct connection, especially given that the rates of tobacco use among young people have decreased over the decade, even as the use of young people's cig has increased.

"We believe that large manufacturers and pod-based systems, like Juul, will undergo more political scrutiny as part of this review process and face enormous challenges when receiving approvals of existing products. As they are currently designed, Sandhills Strategy badyst Stefanie Miller said.

"In our opinion, this means that if Juul Labs sends requests for its current set of products, we believe that the FDA is likely to reject those pre-market applications."


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