Vapes and E-Cigarettes

Minnesota Attorney General Keith Ellison has filed a lawsuit against High Light Vapes, a Los Angeles-based e-cigarette manufacturer, charging it with marketing to minors. The lawsuit alleges violations of state laws prohibiting the marketing of tobacco products to children and consumer fraud. 

Ellison has also launched an investigation into Loon, a Minnesota-based e-cigarette manufacturer, to determine potential violations of similar laws.

High Light Vapes is accused of designing and promoting its products to appeal to school-age children by mimicking highlighters. The complaint alleges the company marketed these e-cigarettes as a "stealthy" way to vape, highlighting their resemblance to actual highlighters. 

The products come in various flavors such as strawberry cheesecake and sour apple, which are particularly attractive to young consumers. Ellison demonstrated the similarity between these vapes and real highlighters at a press conference, emphasizing the deceptive nature of their marketing strategy.

"My job as attorney general is to protect Minnesotans — especially our children — when corporations try to harm us to make a profit," Ellison stated. "I will not allow any corporation to illegally manufacture, market, and sell dangerous and addictive e-cigarette products to Minnesota youth."

Other states are taking similar actions

The legal actions are part of a broader effort by a bipartisan coalition of attorneys general across the United States to combat the proliferation of flavored disposable e-cigarettes, which are often illegally imported from China. These products have seen a 1,500% increase in the U.S. market since 2020, despite federal regulations requiring FDA approval for new e-cigarettes. 

The coalition of state leaders aims to hold companies accountable for unlawfully manufacturing, distributing, and marketing these products to young people.

Ellison's office has also served a civil investigative demand on Loon, requiring the company to provide documents and answer questions under oath. This investigation seeks to uncover any potential violations of Minnesota's consumer protection and deceptive vaping laws by Loon.

This lawsuit follows Minnesota's landmark settlement with Juul and Altria in 2023, where the companies agreed to pay $60.5 million over eight years for their role in marketing e-cigarettes to youth. The settlement funds are dedicated to preventing youth smoking and e-cigarette use, marking a significant public health achievement in the state's ongoing battle against tobacco use among minors.

Berry-flavored vapes can weaken the lungs' natural defenses and make it harder to fight infections, according to new research. The study compared the effects of flavored and unflavored e-cigarettes.

While all vaping can be harmful, the researchers found that added flavors can make it even worse.

McGill Assistant Professor Ajitha Thanabalasuriar and Erika Penz from the University of Saskatchewan exposed mice to e-cigarette vapor and used live imaging to study their lung immune cells. The study, published in PNAS, showed that chemicals in berry vapes paralyze these immune cells, making the lungs more prone to infections. Unflavored vapes did not have the same effect.

“We need to be careful about the types of flavors that we're including in these products," Thanabalasuriar said. "They can have detrimental effects. I think that's really the take-home message, especially some of these vaping products that are marketed for kids — the way they're sold, the type of containers they are sold in — it's very colorful, it's really attractive to children, and this can be a really bad thing for our future,” she said.

More studies are needed to identify the exact compounds causing these effects and to see if the same results apply to humans.

The study was funded by the Canadian Institute of Health Research and other organizations.

Flavored vapes more appealing

The wide range of appealing flavors, such as berry, candy, and dessert-inspired options, combined with vibrant, eye-catching packaging, makes vaping products more enticing to younger audiences.

This marketing strategy often targets the youth demographic by using bright colors and appealing designs that resemble candy or toys, making them more likely to try vaping.

Research has shown that these flavors and visual appeals contribute to the initiation and continued use of vaping among young people.

The combination of sweet or fruity flavors and attractive packaging can create a perception that vaping is less harmful than smoking traditional cigarettes, encouraging younger individuals to start and maintain the habit.

Present and former users of JUUL e-cigarettes may be eligible to receive a share of $255 million the company has agreed to pay to settle false advertising claims.

No proof of purchase is required, but in some cases, proof of purchase could result in a larger share of the settlement.

JUUL was sued by plaintiffs in a class-action lawsuit that claimed it marketed its products to minors and concealed the addictive nature of its nicotine delivery products. Though developed as a tool to help smokers give up cigarettes, JUUL and several other manufacturers were accused of targeting young people who had never smoked.

In agreeing to the settlement, JUUL did not admit to any wrongdoing but said it would make the payment to resolve the case. Consumers included in the suit will be paid a sum based on several factors, including how much they paid for the products.

To be eligible for compensation a consumer has to have purchased and used JUUL products prior to December 7, 2022. As yet, there is no estimate for payment amounts.

Who gets what

Here are some of the factors that will determine compensation:

• Where JUUL products were purchased by an underage consumer, the settlement shares will be multiplied by four.

• Purchases made between 2015 and 2018 will be assigned a multiple of two when determining compensation.

• Without proof of purchase, the maximum compensation is $300. Receipts will be required for purchases of more than $300.

JUUL users who purchased products directly from the JUUL website are not required to provide proof of purchase since there is an existing record of their purchases. 

The settlement must still be approved by the court but consumers who think they are eligible should apply using a valid claim form – found here – by July 14, 2023.

In addition to the class action, JUUL was sued by the State of Massachusetts in 2020 for its alleged role in encouraging young people to “vape.” Before he left office, former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb was also highly critical of the company’s marketing tactics he said were aimed at teenagers.

The U.S. Food and Drug Administration (FDA) has taken action to suspend its own order banning Juul e-cigarette products from the market. The FDA said the order is stayed, not rescinded.

It may be a simple technicality. After the FDA issued its order to remove Juul products from the market, a federal judge intervened and stopped the ban from being enforced while Juul appeals the decision.

On its Twitter feed, the FDA said it is staying its order while it conducts a further review. In the meantime, Juul products remain on store shelves.

The agency took action against Juul last month under new rules it has established for the vaping industry. To sell e-cigarettes, companies must show that their products are safe and help adult cigarette smokers kick their traditional smoking habits.

At the same time, companies also have to show that they are discouraging the products from being used by young people who have never smoked cigarettes.

Long history with the FDA

Juul has repeatedly run afoul of the FDA on the youth vaping point. The company popped up on the FDA’s radar four years ago when its vaping products achieved a high level of popularity among teens and other underage users. Critics said the products were stylish and offered fruit flavors that were popular with teens.

After drawing the attention of regulators, Juul made changes to its marketing. Under pressure from the FDA, it dropped its fruit flavor cartridges before the FDA banned them in 2020.

Former FDA Administrator Dr. Scott Gottlieb has been a longtime Juul critic. He says the company's products consistently find favor with underage users. In an interview with Vox, just before he stepped down in 2019, Gottlieb said there’s “no question” that Juul -- which marketed a device that looked like a USB drive -- “drove a lot of the youth use.”

“I’m not willing to concede the point that the Juul product was responsible — at least in part — for the sharp uptick in youth use,” Gottlieb said.

In issuing the stay, the FDA said it discovered "there are scientific issues unique to the Juul application that warrant additional review." At the same time, the agency made clear that it expects Juul to suspend marketing and shipping while the review is completed.

Consumers who use Juul electronic cigarette products will still be able to find them in stores for the foreseeable future. A federal appeals court has stayed the U.S. Food and Drug Administration’s (FDA) ban while the company appeals.

Juul filed its appeal, asking the court to stop what it called an "extraordinary and unlawful action" that essentially would put it out of business. Late last week, the FDA denied Juul’s application to sell its tobacco- and menthol-flavored e-cigarettes in the U.S., effectively removing those products from the U.S. market.

The company and the government have tangled in the past over charges that Juul aimed some of its vaping products, which contain nicotine, at underage consumers. In particular, the FDA has cracked down on fruit-flavored vaping products popular with young people.

But the FDA’s action banning Juul products from the market was not officially connected with past issues. Rather, the agency said it hinged on product safety.

‘Lack of evidence’

“After reviewing the company’s premarket tobacco product applications (PMTAs), 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,” the FDA said in a statement. 

The FDA continued, "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."

In filing its appeal, Juul said it submitted enough data and other information to address all of the safety questions the agency raised. In addition to the toxicity questions, Juul and other e-cigarette makers are required to show that their products help adult smokers quit while not attracting young users.

In their emergency appeal, Juul’s lawyers argued that it gave the FDA plenty of evidence in support of its case, including a 125,000-page document that contained several studies looking at vaping’s health risks.

Juul claimed that the FDA cannot argue that there was a "critical and urgent public interest" in removing its products from the market so urgently when the agency allowed them to be sold in the two years since that document was submitted.

A target?

Juul’s popularity with young people perhaps raised its profile with regulators. In addition to once offering fruit-flavored cartridges for its devices, the design of the devices themselves became an issue. Critics charged the sleek design and an appearance resembling a computer flash drive is especially appealing to young people.

While the issue of underage use was not officially part of the FDA’s order, it has not completely disappeared. Late last month, researchers at the University of California San Diego issued a study finding that underage vaping had dramatically increased between 2017 and 2019.

The study found more than 1 million teens between the ages of 14 and 17 years old became daily tobacco users during that time. By 2019, the study said more than three-quarters of those young smokers were vaping on a daily basis.

After years of heightened scrutiny of Juul’s marketing of e-cigarette products, the U.S. Food and Drug Administration (FDA) may be preparing to take aggressive action.

According to the Wall Street Journal, the agency is planning to order Juul to take its vaping products off the market. Citing “people familiar with the matter,” the Journal reports that the FDA will issue a “denial of marketing” order that will block the sale of Juul’s e-cigarettes in the U.S.

The company popped up on the FDA’s radar four years ago when its vaping products achieved a high level of popularity among young people, including underage users. Critics said the products were stylish and offered fruit flavors that were popular with teens.

After drawing the attention of regulators, Juul made changes to its marketing. Under pressure from the FDA, it dropped its fruit flavor cartridges before the FDA banned them in 2020.

A longtime FDA target

Despite Juul making changes, its actions haven't been enough for the FDA. As he was preparing to leave office in 2019, then-FDA Administrator Dr. Scott Gottleib blamed the company for a huge increase in teen vaping, noting that many young people referred to vaping as “Juuling.”

In an interview with Vox, Gottlieb said there’s “no question” that Juul -- which marketed a device that looked like a USB drive -- “drove a lot of the youth use.”

“I’m not willing to concede the point that the Juul product was responsible — at least in part — for the sharp uptick in youth use,” Gottlieb said.

Gottlieb’s successors have kept up the pressure by launching an investigation into the company’s business practices, including its marketing. 

Investigating the entire industry

The FDA is currently investigating the entire vaping industry to determine if there are ways to discourage or prevent underage use. While the current tobacco- and menthol-flavored vaping products are viewed as a way to wean smokers off of tobacco cigarettes, regulators want to prevent use by teens who could become addicted to nicotine.

E-cigarettes are battery-powered devices that convert liquid into vapor, allowing users to inhale nicotine without the tobacco and other toxic components of traditional cigarettes. The products may be a safer alternative to cigarettes, but critics maintain that they aren’t completely safe.

Some vape devices, like cigarettes, have been found to contain formaldehyde and other cancer-causing chemicals. And some users, particularly people who modify their vape pens, have submitted reports of the products randomly exploding, a defect that can cause disfiguring injuries.

If and when the FDA moves against Juul, the company could appeal the decision through the agency or challenge the decision in court.

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Update: 6/23/22 @ 11:32 a.m. (EST)

As reported above, the FDA has issued a marketing denial order for all Juul products in the U.S. marketplace. The agency's full announcement can be read here.

A new study conducted by researchers from the University of California San Diego explored one of the most common questions about e-cigarettes: do they help you quit smoking? 

According to their findings, the popular smoking devices aren’t associated with helping smokers quit traditional cigarettes. In fact, using e-cigarettes was linked with a higher risk of going back to regular cigarettes within one year of quitting. 

“Our findings suggest that individuals who quit smoking and switched to e-cigarettes or other tobacco products actually increased their risk of a relapse back to smoking over the next year by 8.5 percentage points compared to those who quit using all tobacco products,” said researcher John P. Pierce, Ph.D. “Quitting is the most important thing a smoker can do to improve their health, but the evidence indicates that switching to e-cigarettes made it less likely, not more likely, to stay off cigarettes.” 

Not a long-term solution

For the study, the researchers analyzed data from nearly 14,000 people enrolled in the Population Assessment of Tobacco and Health (PATH) study between 2013 and 2015. The researchers followed the participants’ smoking habits over the course of two years to determine any trends related to e-cigarettes and quitting smoking. 

“Our goal in this study was to assess whether recent former smokers who had switched to e-cigarettes or another tobacco product were less likely to relapse to cigarette smoking compared to those who remained tobacco free,” explained researcher Karen Messer, Ph.D. 

After the first year of the study, the researchers learned that roughly 9.5% of the participants quit smoking; however, more than 37% of them picked up a tobacco habit again, and nearly 23% opted for e-cigarettes. 

By the second year, the study showed that using e-cigarettes complicated the participants’ efforts to quit smoking. Compared to participants who gave up smoking, those who transitioned into using e-cigarettes were 8.5% more likely to go back to using traditional cigarettes. 

Making more attempts at quitting

Though e-cigarettes may make it harder for smokers to avoid tobacco products long-term, the researchers also found that participants who opted for e-cigarettes were also more likely to continue trying to quit smoking. 

Moving forward, the researchers hope that more work is done in this area to better understand what role e-cigarettes play in consumers’ long-term efforts to quit smoking. 

“This is the first study to take a deep look at whether switching to a less harmful nicotine source can be maintained over time without relapsing to cigarette smoking,” said Dr. Pierce. “If switching to e-cigarettes was a viable way to quit cigarette smoking, then those who switched to e-cigarettes should have much lower relapse rates to cigarette smoking. We found no evidence to this.” 

The U.S. Food and Drug Administration (FDA) has, for the first time, authorized the marketing of three nicotine vaping products.

The products, technically known as “electronic nicotine delivery system (ENDS) products,” were developed by the R.J. Reynolds (RJR) Vaping Company. They are specifically designed to help people using traditional tobacco products to stop smoking.

Under the order, RJR is granted permission to market its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. The FDA said the tobacco company subsidiary submitted data that showed the products would be useful in reducing the number of cigarette smokers.

“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. 

Targeting young people

Critics of vaping products, including former FDA Commissioner Dr. Scott Gottlieb, have warned that their use by teenagers and young adults who don’t smoke cigarettes can lead to a new generation of people who are addicted to nicotine. Zeller makes clear that the approved products are to only be used to wean smokers off tobacco.

“We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth,” Zeller said. “We will take action as appropriate, including withdrawing the authorization.”

In the past, the FDA has cracked down on vaping products that it determined were being marketed to young people by using fruit flavors. The agency said vaping products designed as a smoking cessation aid must be tobacco flavored.

The FDA said it granted approval to the RJR products because it determined that “study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes.”

Research also showed the products getting the FDA seal of approval are “significantly less toxic than combusted cigarettes” based on available data comparisons and results of nonclinical studies.

In the end, the FDA concluded that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, as long as steps are taken to limit sales to adult smokers.

The U.S. Food and Drug Administration (FDA) has issued marketing denial orders to block the sale and distribution of 55,000 e-cigarette products. The action marks the first time the agency has ever used that authority.

The FDA said the products, from three different companies, lacked evidence that they could help adults quit smoking but would not be appealing to young people. The products are produced by JD Nova Group LLC, Great American Vapes, and Vapor Salon. 

The FDA said the products are not tobacco flavored -- which young people don’t seem to like -- but include youth-appealing flavors like Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.

“We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed,” said Acting FDA Commissioner Dr. Janet Woodcock.

Products already for sale must be removed

The FDA said the products not yet on the market will be blocked from distribution, and those already available to consumers must be withdrawn. If they aren’t, the companies could face enforcement action.

E-cigarettes are electronic devices that use a battery to create vapor from a nicotine-containing liquid, which is then inhaled like cigarette smoke. It was introduced more than a decade ago as a tool to help smokers quit. However, millions of teenage non-smokers began using them, causing alarm among health officials.

Health experts at Johns Hopkins University say “vaping” is generally less harmful than smoking cigarettes, but they note that it carries its own health risks. Research suggests that it can be harmful to the heart and lungs and can create an addiction to nicotine.

Sales are up 300%

The Centers for Disease Control and Prevention (CDC) estimates that e-cigarette sales in the U.S. rose by nearly 300% between November 2016 and August 2019. Many of these devices ended up being used by kids in high school and middle school.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, says flavored e-cigarettes are extremely popular among young people, and companies that make and sell these products must demonstrate that their benefits to adult smokers outweigh their risk to young people.

“The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health,” he said. “If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”

Juul Labs, one of the most well-known e-cigarette companies, will pay $40 million to the state of North Carolina to settle charges that it marketed its products to teens and misled the public about their safety. Officials say the money will be paid over six years and will go towards young people who have been negatively impacted by e-cigarettes.

The lawsuit was originally filed back in 2019 by state attorney general Josh Stein. Under the settlement, Juul will no longer be able to sell flavored e-cigarettes in North Carolina and it will need to change its marketing practices. 

“Juul must abandon all marketing strategies and content that appeals to young people. Juul will be prohibited from influencer advertising, outdoor advertising near schools, sponsoring sporting events and concerts, and most importantly, most social media advertising. Juul cannot use anyone under the age of 35 years in their advertising. Juul cannot make any claims that its e-cigarettes are safer or better for your health than combustible cigarettes,” Stein said. 

In addition to those mandates, Juul will also be required to implement a barcode age-verification system at establishments that sell its products. Consumers who shop online will only be able to buy two of Juul’s e-cigarette devices and 60 of its pods per month, with a cap of 10 devices per year.

Juul has faced a lot of legal headwinds from various states over the past few years. The company saw actions taken against it in California, Massachusetts, New York, and other states over similar claims of marketing to teens and youths. In September 2019, the legal pressure became so immense that the company’s CEO stepped down and it decided to suspend advertising efforts in the U.S.

A new study conducted by researchers from the University of California at San Diego found yet another health risk associated with smoking e-cigarettes. 

According to their findings, consumers who vape are increasingly more susceptible to a condition known as leaky gut. This happens when holes have developed in the gut lining that bacteria can leak through, which can ultimately cause inflammation throughout the entire body. 

“This is the first study that demonstrates how chronic exposure to e-cigarettes increases the gut’s susceptibility to bacterial infections, leading to chronic inflammation, and other health concerns,” said researcher Soumita Das, PhD. “Given the importance of the gut barrier in the maintenance of the body’s immune homeostasis, the findings provide valuable insight into the potential long-term harmful effects chronic use of e-cigarettes [has] on our health.” 

Risks to gut health

To better understand how gut health is impacted by e-cigarettes, the researchers created 3D models of the human intestinal system using stem cells. They then used the models to mimic the process of smoking an e-cigarette and analyzed the effects of smoking on the models’ gut reaction. 

The researchers found that chemical additives used in e-cigarettes -- specifically propylene glycol and vegetable glycerol -- are responsible for damage to the intestines. Ultimately, these chemicals damage the gut’s protective barrier, which is what initiates gut inflammation. 

While this is concerning for overall gut health, the researchers explained that it can also have greater complications for consumers’ immune systems. Once these chemicals break through the intestines, they have direct access to the immune system, which can make consumers more susceptible to infections. 

“The safety of e-cigarettes has been debated fiercely on both sides,” said researcher Dr. Pradipta Ghosh. “Nicotine content, and its addictive nature, has always been the major focus of those who argue against its safety, whereas lack of chemicals in the carcinogens that are present in the cigarette smoke has been touted by the makers of e-cigarettes when marketing these products as a ‘healthy alternative.’ In reality, it’s the chemicals making up the vapor liquid that we should be more concerned about as they are the cause of gut inflammation.” 

Though vaping rates have declined in recent months -- especially for young people -- the researchers hope that consumers understand the severity of the long-term risks associated with smoking e-cigarettes. 

“The gut lining is an amazing entity,” said researcher Dr. Ghosh. “It is comprised of a single layer of cells that are meant to seal the body from trillions of microbes, defend our immune system, and at the same time allow absorption of essential nutrients. Anything we eat or drink, our lifestyle choices in other words, has the ability to impact our gut microbes, the gut barrier, and overall health. Now we know that what we smoke, such as e-cigarettes, negatively impacts it as well.”