E-cigarette maker Juul Labs Inc. agreed to pay $462 million to settle claims by six U.S. states that it unlawfully marketed its addictive products to minors. What do you think?
“They’ll have to market to a lot more kids to pay for this.”
Joshua Meyer, Aviary Guard
“Damn. I never would have made my kid quit if I knew there was going to be such a big payout.”
Cleo Yardley, Bayonet Cleaner
“Good. No company makes my kid look like a douchebag and gets away with it.”
Anthony Champlin, Unemployed
CNN
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The US Department of Justice took legal action against six e-cigarette manufacturers Tuesday, seeking permanent injunctions against the manufacturers on behalf of the US Food and Drug Administration. The flurry of complaints marked the first time the FDA has taken this step against e-cigarette manufacturers to enforce its premarket review requirements for new tobacco products.
The six manufacturers failed to submit the necessary premarket applications for their e-cigarette products “and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law,” the FDA said in a statement.
“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, director of the FDA’s Center for Tobacco Products. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
The Federal Food, Drug, and Cosmetic Act requires that companies submit applications to the FDA and get them approved before manufacturing, selling or distributing new tobacco products. Companies that had products on the market before this provision took effect still had to submit applications.
The FDA says it issued nearly 300 warning letters between January 2021 and September 9, 2022, for failure to submit applications, and most of those companies have removed their products from the market. This month, the agency sent a warning letter to the maker of Puff Bar products, which are especially popular among young people, for operating without a marketing authorization order. In June, the agency ordered e-cigarette giant Juul Labs to remove its products from the market, but a court blocked that ban, so those products are still available.
Advocates have criticized the FDA as too slow to act on a majority of the premarket applications. In May, the agency announced that it would not finish reviewing all the premarket applications from e-cigarette companies until June 2023, nearly two years past its court-ordered deadline to make a decision about those products.
Erika Sward, assistant vice president for national advocacy for the American Lung Association, said Tuesday’s actions send “a very important message to manufacturers that that they need to follow the law.”
“This is a monumental first step forward for FDA and DOJ, and we are really encouraged by this action,” she said. “I’m really pleased that this is the kind of step forward. This is what FDA needed to do from the beginning, and we’re very pleased to see this.”
Sward credited King, who was named director of the Center for Tobacco Products in July, with providing the impetus for the increased actions.
“We are very hopeful that this indicates that FDA and DOJ will take more of these steps against other recalcitrant manufacturers,” she said. “And we also very much hope the manufacturers get the message that under Dr. King’s leadership, this is a different Center for Tobacco Products.”
The complaints were brought against manufacturers that the FDA alleges continued to make and distribute nicotine products even after they were warned that they were in violation of the law. According to the court filings, the six manufacturers all received warning letters from the FDA informing them that they were manufacturing tobacco products that lacked the required approval.
Several of the defendants also participated in teleconferences with the FDA after receiving the warning letters, the government said. Some of the manufacturers allegedly told the agency that they would cease manufacturing and distributing the nicotine products in question, but follow-up inspections showed that the products were still being manufactured and sold, according to the complaints.
“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” Principal Deputy Assistant Attorney General Brian M. Boynton, who leads the DOJ’s Civil Division, said in a statement. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
The six companies named in Tuesday’s court filings are Morin Enterprises Inc., doing business as E-Cig Crib, in Minnesota; Soul Vapor LLC in West Virginia; Super Vape’z LLC in Washington; Vapor Craft LLC in Georgia; Lucky’s Convenience & Tobacco LLC, doing business as Lucky’s Vape & Smoke Shop, in Kansas; and Seditious Vapours LLC, doing business as Butt Out, in Arizona. The companies have not yet responded to CNN’s requests for comment.
“Mr. King seems delighted to kick in the doors of small businesses but turns a blind eye to the millions of Americans who rely on nicotine vaping to quit cigarettes,” Amanda Wheeler, president of the American Vapor Manufacturers Association, said in a statement. “The ongoing result is countless people being driven back to smoking.”
CNN
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E-cigarette company Juul Labs is seeking US authorization to sell a “next-generation” vape with age verification capabilities in the United States.
To verify a user’s age, the proposed vape pairs with a phone app, requiring a customer to either upload their government ID and a real-time selfie or input personal information and allow a third-party database to verify their identity, according to a Juul spokesperson.
A unique Pod ID chip within the Juul device can also detect counterfeit cartridges made by other companies, many of which have flooded the market with illegal fruity flavors that appeal to minors.
The mission of the new platform is twofold, according to the company: Encourage adult smokers to switch from combustible cigarettes to e-cigarettes while restricting underage access.
The legal age to purchase e-cigarettes in the United States is 21.
“We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity,” Juul’s Chief Regulatory Officer Joe Murillo said in a company news release.
If authorized by the US Food and Drug Administration, Juul Labs hasn’t yet decided on the name to market their new product in the US. In the UK and Canada, where it’s already for sale, it’s called the JUUL2.
Advertising itself as an alternative nicotine product, Juul publicly advises that adults vape only as a replacement for combustible cigarettes.
But Juul has a troubled history in US markets.
“They were the spark that ignited the flame,” said Robin Koval, CEO of the nonprofit Truth Initiative, organizers of the nation’s largest campaign for youth to quit vaping. “This is not a company known to tell the truth.”
Juul Labs has settled more than 5,000 cases brought by approximately 10,000 plaintiffs since its vaping devices initially skyrocketed in popularity in 2016, with some alleging the company deceived or failed to warn consumers about the risks of its products. The e-cigarette maker also agreed to pay $462 million to six US states and Washington, DC, in April after a lawsuit accused Juul Labs of directly promoting its products to high school students. In total, Juul Labs has agreed to pay more than $1 billion in its various legal settlements.
Juul dominated over 70% of the US e-cigarette market at its peak in late 2018. In the same year, 27% of high school students and 7.2% of middle school students said they used tobacco for one or more days in the month, according to the 2018 National Youth Tobacco Survey.
Juul is now a less favored brand among youth. When asked what e-cigarette brands they used in the past 30 days, youth e-cigarette users in the 2022 National Youth Tobacco Survey answered Puff Bar most frequently (29.7%), followed by Vuse (23.6%) and then Juul (22%), with the first two being disposable vaping products.
In 2019, Juul suspended all flavors other than tobacco and menthol and suspended broadcast, digital and print publication marketing.
Even with limited flavors, the FDA banned Juul products in the US last year after reviewing Juul’s applications seeking marketing authorization for their devices. The FDA determined that the applications lacked “sufficient evidence” within the toxicological profile of the vaporizers to prove that marketing the products would be in the interest of public health.
The FDA has placed the ban on hold while Juul Labs appeals.
Juul Labs submitted its most recent application to the FDA on July 19, as all e-cigarette manufacturers are required to do before their product can be marketed and sold legally in the United States. This first filing concerns just one flavor, Virginia Tobacco, with a nicotine concentration of 18 mg per mL.
Although Juul’s new platform has age verification capabilities, the company does not intend to lock all their new pods before use. For example, the Virginia Tobacco pods will not come automatically locked. The spokesperson for Juul said doing so could create “friction” for the adult smokers the tobacco flavor is most likely to target.
“If you’re an adult smoker and you go to buy a cigarette, it’s pretty easy to use the product,” a Juul spokesperson told CNN. “If you add in another barrier before product use, that creates some level of friction.”
Using the new Pod ID feature, Juul’s new vaping device could tell a Virginia Tobacco pod apart from a menthol-flavored pod. It could then require age verification to activate only the latter, according to the spokesperson.
Juul has researched other flavors that combine tobacco and menthol with fruity tones to potentially submit to the FDA following this filing. Juul currently sells the flavor Autumn Tobacco in the UK, which contains “tangy apple notes,” according to its website.
Just because e-cigarette companies are required to comply with the FDA doesn’t mean all of them do. In fact, most don’t. To date, the FDA has authorized only 23 specific e-cigarette products, all of which are tobacco flavored.
Yet more than 2.5 million US middle and high school students said they use e-cigarettes as of last year, according to the 2022 National Youth Tobacco Survey. Almost 85% consume fruity, candy or other flavored products, despite them being illegal.
Koval of Truth Initiative said the tobacco industry “floods the market” with products such that the FDA can’t keep up.
“It is a little bit like Whac-a-Mole for the FDA and for those of us who are trying to promote healthier behaviors for young people,” Koval said. The total number of e-cigarette brands increased by 46.2% between January 2020 and December 2022, from 184 to 269, according to a study from the Centers for Disease Control and Prevention.
To gain FDA authorization for its latest platform, Juul must prove to the FDA that in aiding the public health crisis of adult smoking, it is not further exacerbating the spread of youth vaping.
“This is only the beginning of new tech being developed and refined for the US market and abroad to eliminate combustible cigarettes and combat underage use,” Juul’s Chief Product Officer Kirk Phelps said.
The movement urges officials to see the film and send a message to Congress to support legislation to keep vapor products on the market.
Press Release
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Oct 26, 2016
Hollywood, CA, October 26, 2016 (Newswire.com)
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The national movement Hands for a Billion Lives was nationally recognized on Saturday, October 22, when thousands of participants in cities across the country as well as countries abroad, joined hands at precisely 2:22 p.m. local time, to symbolize a protective barrier to protect the billion lives estimated to die because of smoking-related disease this century. Hands for a Billion Lives supports federal legislation that will keep vapor products on the market. Thousands of vapers joined hands to bring awareness to the award-winning documentary “A Billion Lives,” which sparked this movement.
Hands for a Billion Lives was joined by Matt Bradley of ‘The Deadliest Catch’ and actor Eric Roberts who said, “As a smoker for nearly 30 years, I am so pleased to finally be part of the solution. ‘The Billion Lives’ movie brings to the foreground, the profound importance of this movement. “The hands” ceremony was a gloriously fitting tribute to the memory of the lives lost, and the spirit of the lives that will be saved by this worthwhile mission. I am honored to have played a small role, in something so meaningful.”
The World Health Organization projects that a billion people will die early this century from smoking. The movie notes that while new technologies evolved to help addicted smokers, money has corrupted the government departments and nonprofit organizations responsible for helping to fix the problem. To uncover the truth, director Aaron Biebert traveled across four continents to create the documentary.
In April 2016, The Royal College of Physicians released a study that stated electronic cigarettes are 95 percent less harmful than tobacco cigarettes. In August 2016, the Food & Drug Administration started regulating the vaping industry, and only those who go through a lengthy and costly approval process, will survive. The new regulatory landscape set forth by the FDA has created an enormously cost-prohibitive environment for manufacturers to market their products to adult smokers and vapers and will largely hand the market over to only large manufacturers, such as big tobacco. These small businesses provide an aspect that the FDA has ignored, the support and education needed to remain successful, and if closed down, potentially millions of adult vapers will return to smoking and thousands of small businesses will be shut down, putting an estimated 37,000 to 57,000 employees out of work.
“We hope the movie and the national movement will send an important message to Congress to consider how their unnecessary imposed regulations could do further harm to those who are using these products as an alternative for harm reduction,” says Schell Hammel, the organizer of Hands for a Billion Lives. “This is bigger than any one of us. This is about lives that will be lost if these regulations go through as written and Congress does not change the predicate date in the Tobacco Control Act.”
“A Billion Lives” has already debuted in other countries and on October 26th at 6:30pm, the movie makes its Hollywood premiere at the famous Cinerama Dome Theatre on Sunset Blvd. It will continue to play regularly at Laemmle Music Hall four times a day for a full week from October 28th through at least November 4th. For more information, visit ABillionLives.com.
About Hands for a Billion Lives
Hands for a Billion Lives is a national campaign to encourage everyone – vapers, smokers, non-smokers and non-vapers, as well as elected officials – to see the film “A Billion Lives” and support federal legislation that will keep vapor products on the market. To learn more and join the movement, visit HandsforaBillionLives.com.
Media Contact:
Schell Hammel
schellhammel@gmail.com
214-608-8031
Source: Hands For A Billion Lives
