The Washington Post: The FDA faces a request to shut down Juul e-cigarettes

Blue Hole New Consumer Report, September 1 news, according to the Washington Post, U.S. health groups, Democratic lawmakers urged FDA agencies to reject JUUL and other e-cigarette products PMTA, but others said flavored e-cigarettes may help adult smokers quit smoking.

Juul Labs launched its flavored e-cigarettes in 2015 at an event called Vaporized, in which young models smoked with relish. Six years later, the once-popular company is scrambling to avoid being eliminated in the U.S. market.

The U.S. Food and Drug Administration should decide by Sept. 9 whether to allow the troubled company — which has been widely blamed for triggering a surge in teen vaping — to continue selling its products in the U.S., and if so, under what conditions?

The agency is also reviewing millions of other products produced by hundreds of cigar, pipe and e-cigarette companies.

The reviews are part of a comprehensive effort over the years to regulate tobacco products other than cigarettes to ensure they are fit to protect public health — a federal standard for staying on or entering the market. This means that, overall, the product must be more likely to help adults quit smoking than to induce young people to start vaping and possibly become addicted to nicotine.

The review process began last September, when manufacturers of e-cigarettes and other items needed to apply to the FDA for permission to continue selling their products. If the agency does not approve the products by September this year, the companies should stop selling their products or face FDA enforcement action, which could include fines or seizures.

Juul, originally a Silicon Valley startup, wanted to nod its head to continue marketing its e-cigarette devices and menthol and tobacco-flavored pre-reloaded cartridges. In recent years, after widespread criticism, it has stopped selling its popular mint and fruity flavors. The company denies ever targeting young people and says its products offer a safer alternative than cigarettes to nicotine-addicted adult smokers.

But many health groups, Democratic lawmakers and parents say Juul led to a surge in teen vaping between 2017 and 2019 and argue that there is little evidence that its products help smokers quit.

Erika Sward, assistant vice president of national advocacy at the American Lung Association, said there would be an epic storm on Capitol Hill and the public health community if the FDA did not take Juul out of the market.

The FDA has regulated cigarettes since the enactment of the Household Smoking Prevention and Tobacco Control Act of 2009, which prohibits cigarette flavors other than menthol. But the agency didn't get authorization for e-cigarettes, pipes, cigars and hookahs until 2016. Since then, it has worked to review these products, but this effort has been repeatedly delayed by industry opposition and political intrigue.

Juul's officials, who have faced numerous lawsuits and investigations in recent years, argue that they orchestrated a sweeping reset to show their commitment to working with regulators and helping adult smokers.

"I think the reset is critical to the future of Juul and, to some extent, to the future of the entire category, in order to take advantage of the huge opportunity that we have to really make progress on the smoking ban." Juul's chief regulator and a former executive at Altria Group said the tobacco giant bought a 35 percent stake in Juul in 2018.

Juul's critics scoff at the concept of reform.

"Restart?" Give me a break." Meredith Berkman, co-founder of parents of nonprofit parents against e-cigarettes, said. "They're addicted. If you want to do the right thing, you're going to close the door."

Some tobacco control experts disagree. Clifford E. Douglas, director of the University of Michigan Tobacco Research Network and former vice president of tobacco control at the American Cancer Society, said Juul should not be punished retroactively for past actions. His products should be treated as scientifically valuable as those of other manufacturers, he said.

He added: "We need to be able to chew gum while walking while protecting young people while helping adult smokers, where 480,000 people die each year from smoking in the United States."

Other tobacco control advocates who agree with him argue that many health organizations and the media focus too much on the risks of flavored e-cigarettes to young people without considering the potential benefits for smokers.

For the FDA, the decision on Juul and other manufacturers could represent a milestone as it attempts to implement an ambitious tobacco regulatory agenda. In April, the FDA said it was taking steps to ban menthol cigarettes. It continues to work on the potential requirement to set the level of nicotine in cigarettes at a minimum level of addiction — a potential game-changer that the White House needs approval.

The DEADLINE the FDA's Sept. 9 review of about 2 million marketing applications for e-cigarettes and other products is the result of a lawsuit filed by a public health organization that seeks to speed up the process. The number of applications is high because bottled e-cigarette liquids sold in adult e-cigarette stores come in a variety of flavors and nicotine intensities, each of which must be reviewed.

The FDA said in a recent statement that an unprecedented number of applications would make it difficult to complete the review by September 9, but it created a separate cohort for the products with the largest market share — putting Juul at the top of the list.

On Thursday, the agency issued its first substantive decision on the application, ordering three small e-cigarette makers not to sell their flavoring products. According to the FDA's order, manufacturers — JD Nova Group LLC, Great American Vapes, and VaporSalon — must withdraw 55,000 existing or planned flavorings from the market or risk FDA enforcement action.

Regulators say the companies' applications fail to provide sufficient evidence that their products provide net public health benefits for adult smokers, compared to the threat posed by well-documented and alarming levels of adolescent use of flavored e-cigarettes.

Representatives of Great American Vapes and VaporSalon declined to comment. The owner of JD Nova Group did not immediately respond to a request for comment.

Steven A. Schroeder, former president and CEO of the Robert Wood Johnson Foundation and head of the UCSF Smoking Cessation Leadership Center, said that ideally, he would preserve flavored e-cigarette options for adult smokers while keeping them away from young people.

But he acknowledges that that balance is hard to achieve: Kids are attracted to taste, but so are adults.

Many health organizations, including the American Heart Association and the American Academy of Pediatrics, are adamantly opposed to nearly all flavored e-cigarettes — cartridge-based varieties sold by Juul and other large companies such as Reynolds American Inc., as well as e-cigarette fluids in refillable can systems used in adult e-cigarette stores.

In particular, health advocates and a group of bipartisan attorneys general strongly urged the FDA to reject mint-flavored e-cigarettes, which became more popular with teenagers after sweet and fruity cartridges were voluntarily withdrawn or banned.

Health groups say they are less concerned about tobacco-flavored e-cigarettes that are unpopular among young people. But they say Juul is an exception. They want all of Juul's products, including tobacco-flavored cartridges, to be withdrawn from the market because they say the cartridges are too high in nicotine and that the company is not credible based on past behavior.

"As long as flavored and high nicotine products, including Juul, continue to be sold, we will not end the popularity of teen e-cigarettes." Matthew M. Thompson, president of the nonprofit Children's Movement for Tobacco-Free Children, said that he would not be able to do so L. Miles.

Juul's nicotine concentrations of menthol and tobacco-flavored cartridges are 3% by weight and 5%, respectively. 5% of cigarette bombs contain about one pack of cigarettes in nicotine equivalent.

At a House hearing in June, Democratic lawmakers urged ACTING FDA Commissioner Janet Woodcock to take aggressive action against flavored e-cigarettes, including Juul's. She said she couldn't prejudge the agency's decision at the Tobacco Product Center, but added that she thought menthol made it harder to stop vaping or smoking. It seems to me to me that there are actually higher concentrations of nicotine in any delivery system.

Juul was publicly ridiculed in 2018 after its launch in 2015, when Scott Gottlieb, then director of the FDA, accused the company of igniting an e-cigarette epidemic among young people. In the months that followed, Juul took most of its flavored products from retail stores and shut down its social media accounts.

A year later, another Altria veteran, KC Crosthwaite, became chairman and CEO. A few months before the Trump administration partially banned bullet-based e-cigarettes, the company suspended sales of e-cigarettes other than tobacco and menthol flavors. The company moved its headquarters from San Francisco to Washington, D.C.

At the same time, teen vaping has increased dramatically in recent years and then declined — albeit to levels that remain worrisome for public health advocates. According to the National Youth Tobacco Survey, the proportion of high school students using e-cigarettes soared from 11.7% in 2017 to 27.5% in 2019. That percentage fell to 19.6 percent last year, in part because Congress banned the sale of tobacco products to people under the age of 21.

Juul's revenue in recent years reflects the ups and downs of the e-cigarette war, totaling $1.3 billion in 2018, $2 billion in 2019, and just under $1.5 billion in 2020. Juul's Murillo said it has continued to crack down on underage use.

Meanwhile, lawsuits involving the company have surged.

The FTC is suing Olchia, accusing the company of violating antitrust laws when investing in Juul. Recently, Juul agreed to pay North Carolina $40 million to settle allegations that the company actively marketed its products to young people; the company did not admit to misconduct. Another 13 states and the District of Columbia have also sued the company, and more cases brought by governments and individuals have been consolidated in federal courts in California.

Because the FDA has regulations for different products, it may find itself caught up in litigation.

"They can't make everyone happy." Desmond Jensen, a senior attorney at the Mitchell Hamlin Law School's Center for Public Health Law, said. "They're going to drive one or the other crazy."