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Juul files lawsuit against FDA seeking details about proposed ban of its e-cigarette products

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Juul Vaping Settlement

Juul Labs Inc. has filed a federal lawsuit against the Food and Drug Administration.

Juul Labs Inc. has filed — as expected — a federal lawsuit against the Food and Drug Administration as part of its attempt to keep its controversial electronic-cigarette products available on retail shelves.

The lawsuit was filed Tuesday in the federal District Court for the District of Columbia.

On July 6, the FDA backed off — for now — on proceeding with a ban of Juul e-cigarettes that it announced June 23.

The decision comes after a federal judge issued on June 24 a temporary hold on the marketing denial order. The hold allows Juul to continue selling its e-cigarettes and related products.

“We took this necessary action as we remain concerned about the inequitable treatment of our applications given the political pressure on the agency to reach a specific result,” Juul said in a statement.

“This action will help us obtain information about the FDA review of our applications relevant to our continued appeal of the agency’s decision.”

In the complaint, Juul is requesting the FDA respond to two Freedom of Information Act requests for the scientific disciplinary reviews underlying its regulatory decision.

“The agency invoked one of the most widely abused exemptions — the deliberative process privilege — to withhold the majority of those materials,” according to the complaint.

“But, the withheld materials are central to understanding the basis for FDA’s marketing denial order, whether FDA balanced the public health benefits and risks of Juul Labs’ products as the Family Smoking Prevention and Tobacco Control Act requires, and whether FDA’s reasoning is scientifically sound.”

The manufacturer said that “the public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years, especially where even FDA recognizes its order is suspect.”

FDA response

The FDA said it does not comment on active litigation.

In July, the FDA updated its stance on Juul products by posting “the agency has determined that there are scientific issues unique to the Juul application that warrant additional review.”

“This administrative stay temporarily suspends the marketing denial order during the additional review, but does not rescind it.”

The FDA did not indicate how long the additional scientific review would take.

The tweets represent a significant change in message and tone from its June 23 announcement.

At that time, the FDA said it had rejected Juul’s pre-market tobacco product applications, saying they “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

In the pre-market application process, the FDA considers products’ risks and benefits to the population as a whole, including users and non-users. An FDA authorization is required for products to be legally marketed in the U.S.

The FDA previously said Juul “must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action.”

FDA Commissioner Dr. Robert Califf said in a June 23 statement that the step was “further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”

Marketplace effect

Tobacco industry analysts have cited the legal and regulatory uncertainty about Juul products for a significant market-share decrease this year.

For example, the market-share gap between Vuse and Juul electronic cigarettes has stretched to a double-digit lead for Vuse in the latest Nielsen analysis of convenience-store data. The analysis, released Tuesday, covers the four-week period ending Sept. 10.

Vuse’s market share rose from 39% in the previous report to 39.7%, compared with Juul declining from 29.4% to 28.1%.

Vuse also edged ahead of Juul in the year-over-year comparison at 32.9% to 32.7%, respectively.

According to Barclays, Nielsen largely covers the big chains. For the smaller chains, the group extrapolates trends, which is why trend changes don’t appear immediately in Nielsen.

Juul settlements

On Sept. 6, Juul reached a settlement agreement with 32 states that’s worth up to $438.5 million, according to a joint attorneys’ general statement Tuesday.

The settlement resolves a two-year, bipartisan investigation into the e-cigarette manufacturer’s marketing and sales practices, particularly toward youths.

Juul said terms of the agreement “are aligned with our current business practices, which we started to implement after our company-wide reset in the fall of 2019.”

The multi-state settlement follows a landmark June 2021 agreement between Juul and N.C. Attorney General Josh Stein in which the manufacturer agreed to pay the state $40 million over six years to resolve Stein’s legal complaint.

Stein said North Carolina was the first state “to successfully hold Juul accountable for its role in spiking teen use and dependence on e-cigarettes.”

In November, Juul reached a settlement with Arizona’s attorney general in which it agreed to pay $14.5 million.

Each settlement requires Juul to make drastic changes to the way it conducts business, particularly marketing campaigns that have proven attractive to youths.

The multi-state investigation found that Juul “relentlessly marketed to underage users with launch parties, advertisements using young and trendy-looking models, social media posts and free samples.”

Juul said it has been attempting to reset the FDA’s view of its products and its reputation over the past year.

“As part of that process, the company reduced its product portfolio, halted television, print and digital product advertising, built up its science and evidence-based capabilities, and supported the Trump administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence,” the company said.

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@rcraverWSJ

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