Tag: Juul Labs

Bentley: Juul Exit Bad For Harm Reduction

Photo: steheap
The Food and Drug Administration’s order to remove Juul products from the U.S. market threatens progress in tobacco harm reduction, according to Guy Bentley, director of consumer freedom at the Reason Foundation.
Guy Bentley
Writing on the foundation’s website, Bentley reminds his audience that e-cigarettes are not only less harmful than their combustible counterparts, but they are also more effective in helping smokers quit than FDA-approved therapies such as nicotine gum and patches
The FDA, he writes, acknowledged as much when it authorized Vuse e-cigarettes in 2021 and claims it recognizes the role these safer nicotine alternatives can play in reducing smoking.
If the Juul order is implemented, says Bentley, many Juul users will likely return to smoking, while a portion of smokers who would have transitioned to Juul will continue to light up.
Bentley says the FDA Juul denial makes a mockery of the claim that it’s evaluating science in the best interests of public health. A study published in the New England Journal of Medicine found e-cigarettes to be twice as effective as traditional nicotine replacement therapies.
According to Bentley, the decision also punctures a hole in the logic of the FDA’s recently announced policy to reduce nicotine levels in cigarettes to minimally or non-addictive levels. Without an acceptable legal alternative, smokers may simply smoke more cigarettes to get their nicotine fix.
“By banning the most popular e-cigarette among adults, the agency’s commitment to transitioning smokers to safer alternatives rings hollow,” writes Bentley.
June 30, 2022
Juul: FDA ‘Overlooked’ Aerosol Data

The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.
Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.
A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.
June 28, 2022
Motley Fool: Juul Exit Would Crown BAT King

Photo: BAT
The removal of Juul products would hand the U.S. market to British American Tobacco, according to Motley Fool.
Juul, which is partly owned by Altria Group, had been the undisputed e-cigarette leader, with a near-80 percent share of the market at the height of its success. The latest Nielsen data puts Vuse’s share at 35.1 percent compared to 33.1 percent for Juul. Third-place NJOY has a 3.1 percent share.
Last year, the U.S. International Trade Commission ruled that Philip Morris International’s IQOS heated tobacco device infringed on BAT’s patents, and that device was prohibited from being imported and sold in the U.S. Altria had partnered with PMI to market and distribute IQOS in the U.S., but the ITC ruling disrupted those plans.
Because Altria shelved its MarkTen e-cigarette brand in favor of partnering with PMI, the ITC ruling leaves it without a vapor product. The FDA has all but wiped out the rest of its investment in Juul. In 2018, Altria paid $12.8 billion for a 35 percent in the vapor company. As of the end of the first quarter of 2022, Altria had reduced the fair value of its Juul position to just $1.6 billion.
If the FDA is successful in eliminating Juul, BAT will essentially have no roadblocks in its way to market dominance.
Vuse turned profitable in the U.S. for BAT in the second half of last year, and it’s been able to grow its share because it discounted the device and the consumables to attract users. Earlier this month, BAT said it was now ready to raise prices on both. With a major competitor removed from the market, this should provide the company with a big boost in profits.
BAT’s vapor revenue grew 59 percent last year to £927 million ($1.14 billion), while its own heated tobacco products, marketed under the Glo brand, saw a 46 percent rise in sales to £853 million.
June 27, 2022
Juul Granted Emergency Stay of FDA Order

Photo: steheap
Court Grants Juul Emergency Stay of FDA Order
Juul Labs received an emergency stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
The U.S. Court of Appeals for the D.C. Circuit on June 24 granted Juul’s request to delay the FDA’s ban. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.
In its court filing, Juul argued that the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay, according to The Wall Street Journal.
Juul said that the requirement to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period.
The e-cigarette maker also questioned the agency’s handling of the announcement, noting The Wall Street Journal reported on the ban a day before it was announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
Former FDA Center for Products Director Mitch Zeller said that Juul’s e-cigarettes were judged solely on the strength of the company’s application. Political pressure to ban Juul didn’t influence the ruling, nor did Juul’s past actions, he said. “This was a scientific review conducted by subject-matter experts,” he said. “That’s the way the system is supposed to work.”
In a statement, Juul Labs it was exploring all its options under the FDA’s regulations and the law.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Juul Labs Chief Regulatory Officer Joe Murillo.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
Among other options, Juul is reportedly exploring a bankruptcy filing if the company is unable to get relief from the government’s ban, reports The Wall Street Journal, citing people familiar with the matter.
June 24, 2022
Juul Requests Stay of FDA Order

Photo: steheap
Juul Labs today asked a federal appeals court to temporarily block the U.S. Food and Drug Administration’s marketing denial order until it can petition the court for an emergency review.
In its filing, Juul said the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay.
On June 23, the regulatory agency ordered Juul Labs to remove its products from the market, saying the e-cigarette company had provided insufficient evidence in its premarket tobacco product application to demonstrate that its products are “appropriate for the protection of public health.”
In particular, the FDA noted that its concerns about genotoxicity and potentially harmful chemicals leaching from the Juul Labs’ proprietary e-liquid pods had not been adequately addressed.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Joe Murillo, chief regulatory officer at Juul Labs, in a statement.

We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
Joe Murillo, chief regulatory officer, Juul Labs
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
In its court filing, Juul said the FDA’s decision followed “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping, even though several of its competitors now have a larger market share and much higher underage-use rates,” according to The Wall Street Journal.
Juul said that the FDA’s order to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period. The e-cigarette maker also questioned the agency’s handling of the announcement, pointing to the fact that the order had reported in the press before it was officially announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
In a press note, Juul Labs said it is exploring all of its options under the FDA’s regulations and the law. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” the company wrote.

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Meanwhile, the announcement that Juul products must come off the market triggered a run on stores, according to various news outlets, including Bloomberg. “Gonna clear the shelves and hoard ’em like our incandescent bulbs!” one user wrote on Twitter following the news.
June 24, 2022
It’s Official: FDA Denies Juul Market Access

Photo: steheap
Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.
“Today’s action is 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,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.
After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications 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 particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.
“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
June 23, 2022
‘BAT key beneficiary of Juul MDO’

Photo: BAT
The removal of Juul products from the U.S. market would boost the prospects of British American Tobacco, create opportunities for Philip Morris International but represent a problem for Altria Group, according to Morgan Stanley.
In a letter to investors, the financial institution evaluated the impact of the U.S. Food and Drug Administration’s leaked plans to deny Juul Labs’ premarket tobacco product application (PMTA). While the FDA has not issued a formal statement yet, shares in Altria Group were down more than 9 percent in the immediate wake of the news. Altria owns about a third of Juul Labs.
According to Morgan Stanley, Juul is Altria’s only exposure to the growing vapor category. While a Juul marketing denial order (MDO) would give Altria an opportunity to terminate its noncompete agreement with Philip Morris International, allowing it to step-up its vapor product research and development or acquire vapor technology, the company would not be coming from a position of negotiating leverage, according to the investment bank.
“In addition, there are few larger scale independent e-vapor assets on the market,” wrote Morgan Stanley.
The investment bank believes that removing market leader Juul from U.S. store shelves would create opportunities for other products, such as PMI’s IQOS heat-not-burn device, which has already received PMTA approval.
The key beneficiary of a Juul MDO, however, would be British American Tobacco, according to Morgan Stanley.
Several of the company’s products have already received PMTA authorizations, the investment bank points out. Though its Vuse brands, BAT recently overtook Juul as the leading U.S. e-cigarette player with a market share of more than 33 percent. The company has gained significant momentum in the category over the past 24 months and a Juul MDO could lead to further BAT market share gains, according to Morgan Stanley.
June 23, 2022
FDA Poised to Order Juul Off the Market

Photo: Juul Labs
The U.S. Food and Drug Administration is preparing to order Juul Labs to take its e-cigarettes off the U.S. market, reports The Wall Street Journal, citing people familiar with the matter.
The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.
The future of Juul Labs has been uncertain since regulators started scrutinizing the company four years ago, when its fruity flavors and hip marketing were blamed for fueling a surge of underage vaping.
The company since then has been trying to regain the trust of regulators and the public. It limited its marketing and in 2019 stopped selling sweet and fruity flavors.
Once the undisputed U.S. market leader, Juul Labs has seen its sales nosedive in recent years.
The FDA has barred the sale of all sweet and fruity e-cigarette cartridges. However, the agency authorized Reynolds American and NJOY Holdings, to keep tobacco-flavored e-cigarettes on the market.
Industry observers had expected Juul to receive similar clearance.

The FDA’s misdirected efforts to limit nicotine, ban flavors in vapes, and now order Juul off the market, if fully implemented, will increase death and disease from combustible cigarettes.
Derek Yach, global health expert
Stocks of Altria Group, which owns about a third of Juul Labs, plunged after the news broke. The tobacco giant in 2018 paid $12.8 billion for a 35 percent in the e-cigarette company, valuing Juul Labs at about $35 million. Since then, Juul’s value has plummeted amid the regulatory crackdowns and declining sales. Altria valued its Juul stake at $1.6 billion as of March 31.
Wells Fargo analyst Bonnie Herzog, however, called the sell-off overdone, noting that Juul Labs has options to challenge any marketing denials orders (MDO), citing the example of Kaival Brands, which had its MDOs stayed in court.
With no detail available on the FDA’s rationale, Herzog said it was difficult to know how the agency is thinking about an MDO on Juul in the context of its broader efforts to encourage adult smokers to quit and/or move down the continuum of risk to less harmful “We have a hard time imagining the FDA would categorically remove highly popular e-cig brands without ensuring a suitable off-ramp for users (that isn’t back to combustible cigs),” she wrote in a note to investors.

This isn’t appropriate for the protection of public health, and it isn’t good for the industry. It hurts adult smokers because Juul is a product that is successful in helping smokers switch.
George Cassels-Smith, CEO, Tobacco Technologies.
Industry leaders and tobacco harm reduction advocates were aghast by the prospect of an MDO for Juul.
“The FDA’s misdirected efforts to limit nicotine, ban flavors in vapes, and now order JUUL off the market, if fully implemented, will increase death and disease from combustible cigarettes,” said public health expert Derek Yach. They should applaud Juul for their deep investments in science, innovations to end youth vaping, their commitments to reduce the 480,000 annual tobacco deaths in the USA. Let’s hope legal challenges succeed in opposing these measures.”
“For a company that has that has been a standard in this industry and has some of the highest quality products on the market, it’s shocking,” George Cassels-Smith, CEO of Tobacco Technologies, told Tobacco Reporter’s sister publication, Vapor Voice.
“The company has tried hard to move past its early issues of appealing to youth. This isn’t appropriate for the protection of public health, and it isn’t good for the industry. It hurts adult smokers because Juul is a product that is successful in helping smokers switch.”

While [Juul Labs] has certainly been at the epicenter of conflict, the amount of rigorous, peer reviewed science supporting their products’ ability to help smokers quit, raises serious questions about the FDA’s subjective balancing test, and whether public pressure campaigns will steer science policy.
Tony Abboud, executive director, VTA
The decision is likely celebrated by some anti-nicotine groups who blame Juul Labs for the rise in teen vaping (which had also declined dramatically in recent years).
Tony Abboud, executive director of the Vapor Technology Association (VTA) told Vapor Voice that he was surprised by the news because the industry had widely expected Juul Labs to receive marketing authorization.
“The reported denial of Juul’s PMTA application is stunning,” said Abboud. “While the company has certainly been at the epicenter of conflict, the amount of rigorous, peer reviewed science supporting their products’ ability to help smokers quit, raises serious questions about the FDA’s subjective balancing test, and whether public pressure campaigns will steer science policy.”
In 2019, Juul Labs announced it was suspending its print, broadcast and online advertising in the United States. That same year it halted the sale of its fruit and dessert flavors—including mango, creme brulee and cucumber—that were seen as a significant lure for teen users. The FDA also recently proposed a rule to ban flavored cigars and menthol in combustible cigarettes. The menthol ban will not yet cover next-generation tobacco products, such as e-cigarettes, but the FDA has the authority to include them if it sees fit.
Juul Labs submitted its PMTAs in July 2020. At the time, the company said its submission included comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.
June 22, 2022
Juul Labs Settles Louisiana Vape Suit

Photo: steheap
Juul Labs has agreed to pay $10 million to settle a lawsuit filed by the Louisiana Attorney General’s Office over the e-cigarette manufacturer’s marketing practices. Juul has settled similar cases in Washington state, Arizona and North Carolina.
“This settlement is another step in our ongoing effort to reset our company, and we applaud the Attorney General’s plan to deploy resources to combat underage use,” reads a statement from Juul Labs. “We will continue working with federal and state stakeholders to secure a fully regulated, science-based marketplace for vapor products.”
In the Louisiana case, Attorney General Jeff Landry had accused Juul Labs of marketing its e-cigarettes to youth, according to a news report.
In a 76-page filing in November, Attorney General Jeff Landry claimed Juul used marketing tactics that included designing sleek, concealable devices that featured “fun flavors like mango and cool mint” and edgy ad campaigns directed toward youth.
Landry also accused Juul of “deceptive marketing practices” regarding the device’s concentrations of nicotine. Landry’s office had sought to prevent Juul from selling the product to minors and wanted to limit available flavors to tobacco and menthol. Prosecutors also sought financial penalties from Juul.
April 19, 2022
Juul to Pay Washington State $22.5 Million for Youth Vaping

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Juul Labs has agreed to pay Washington State $22.5 million to settle claims that it unlawfully targeted underage consumers with deceptive advertisements.
“Juul put profits before people,” Washington Attorney General Bob Ferguson said on April 13 in a statement. “The company fueled a staggering rise in vaping among teens.”
Among other complaints, Washington State argued that Juul failed to disclose clearly that its products contain nicotine. For more than 20 months, from August 2016 until April 2018, it “unlawfully sold hundreds of thousands of vaping products to Washington consumers,” the state’s attorneys wrote in their complaint.
As part of the settlement, Juul committed to reforms, including stopping all advertising that appeal to youth and ending most social media promotion in the settlement, according to Bloomberg.
“This settlement is another step in our ongoing effort to reset our company and resolve issues from the past,” the company said in a statement. “We support the Washington state attorney general’s plan to deploy resources to address underage use, such as future monitoring and enforcement.”
The deal is the latest in a series of settlements of youth vaping-related court cases brought by U.S. states.
In November 2021, Juul agreed to pay $14.5 million and change its business practices as part of an agreement with Arizona. In June 2021, it settled a similar case brought by North Carolina for $40 million.
Juul Labs continues to face similar suits from several states, including New York and California.
April 17, 2022