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FDA Orders Juul To Stop Selling E-Cigarette Products

On Thursday, federal health officials from the Food and Drug Administration (FDA) ordered Juul to remove its electronic cigarettes from the U.S. market as it continues to battle against the popular and addictive products that have seen high usage amongst teen groups.

Under the ruling, Juul cannot sell its e-cigarette device, along with its four kinds of tobacco and menthol-flavored Juul pods. It’s a move that dates back to April, when the FDA gained the ability to regulate e-cigarettes and other products that utilize synthetic nicotine.

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“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,” FDA Commissioner Robert Califf, MD, said.

“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.”

The ban only affects the commercial distribution, importation, and retail sales of Juul’s products and not those currently owned and used by a consumer. Juul had previously sought approval from the FDA in regards to its device and pods.

However, the FDA noted that Juul lacked “sufficient evidence” regarding the toxicological profile of their products in order to show their marketing would be appropriate for public health. Additionally, Juul’s studies also raised questions due to conflicting data — particularly in regard to genotoxicity and potential chemicals leaking from their pods — that were not addressed.

While the FDA said it didn’t receive any information that suggests an immediate hazard associated with using Juul products, their ban shows that the lack of health data played a critical part in the regulatory process.

E-cigarettes have become a staple of the country’s current youth. According to the Center for Disease Control (CDC), a 2021 survey found that 43.6% of high school students and 17.2% of middle school students reported using e-cigarettes on 20 or more of the last 30 days. One in four high schools smoke e-cigarettes daily, while that number is one in 12 for middle schoolers.

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The study also found that 53.7% used a disposable device, while 28.7% used a prefilled or refillable pod or cartridge device. Juul was found to have been the fourth-most used brand among students at 6.8% (130,000) behind Puff Bar, Vuse, and SMOK.

It’s another blow for a company that has often been blamed for starting the e-cigarette epidemic. It’s seen its total revenue fall from $2 billion in 2019 — when it possessed 600,000 daily users under 21 — to $1.3 billion in 2021, while its market share has endured similar falls.

That decline in sales can also be attributed to the FDA, which banned flavored e-cigarettes in 2018. Altria, which purchased a 35% stake in Juul Labs for $12.8 billion in 2018, already felt the heat in the form of a 10% stock drop Wednesday. This year, Altria values that stake at $1.6 billion, just 13% of their original purchase.

Meanwhile, the FDA will continue to review and regulate other e-cigarette products, many of which have never been through the application process before. The administration previously stated it’s reviewing 6.5 million applications from 500 companies, and have already rejected over 950,000.

E-Cigarettes Using Synthetic Nicotine To Go Under FDA Regulation

This past Thursday, the Food and Drug Administration (FDA) gained the power to regulate e-cigarettes and other products that utilize synthetic nicotine, which has been the source of legal ambiguity.

According to the administration, the change allows them to “protect the public health from the harms of tobacco products, regardless of the source of nicotine.” With the regulation, companies now have to register with the FDA and submit their products for review within 30 days.

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Companies in the e-cigarette industry had attempted to use the synthetic nicotine as a loophole for their products to bypass FDA requirements. Previously, the law — which was introduced in 2009 — stated that a tobacco product was defined as being made or derived from tobacco.

Synthetic nicotine copies the nicotine alkaloid that’s found in tobacco plants, but without possessing any extracts that connect it to tobacco. Thus, the products didn’t fall under those restrictions. The new regulation will target Puff Bar and several other prominent manufacturers that engaged in those loopholes.

“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” FDA commissioner Robert Califf said in a press release last month.

“We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine.”

While the FDA won’t immediately ban Puff Bar’s or other companies’ products, they’ll still fall under the same guidelines that previous tobacco-extracted nicotine products fell under. In September of last year, the FDA stated they were reviewing over 6.5 million tobacco-“deemed” products, rejecting almost 950,000 of the applications.

At the time, the majority of those applications were e-cigarettes — or more formally, “electronic nicotine delivery systems” — which the FDA noted had never been through the application process before. Some of those products were on the market already, while others had been proposed by the companies.

The Associated Press explained that Stanford researchers had found synthetic nicotine products were up for sale online at sites like Ebay, Amazon, and Target, which under the old law wouldn’t have been able to sell tobacco-based products. The new law will now ensure synthetic sales face those same sale restrictions.

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According to the Center for Disease Control and Prevention (CDC), 40 million adults in the U.S. smoke cigarettes, while around 2.5 million teenagers in middle and high school use at least one tobacco product.

The youth is a particularly targeted demographic by e-cigarette companies, with 85.8% of high school students and 79.2% of middle school students stating they used a flavored e-cigarette within the past 30 days in 2021. The CDC also found e-cigarettes are the most common tobacco product used by youth since 2014.

Those facts were heavily implemented within the FDA’s regulation process. “Assessing the impact of potential or actual youth use is a critical factor in our determination as to whether the statutory standard for marketing is met,” the release stated.

Vaping

Is Vaping Safer than Smoking?

When e-cigarettes were first introduced to the American public, they were marketed in large part as a safe tobacco-cessation aid, promising to help people quit smoking by allowing them to gradually reduce their nicotine intake over time. E-cigarettes and vaping generally were also marketed as healthier alternatives to cigarettes, as e-cigarette vapor does not contain much of the same tar and other harmful chemicals as cigarette smoke. In fact, Juul, one of the world’s largest e-cigarette companies, was found to have directly marketed to high-school kids, leveraging designs and flavors meant to appeal to teens and telling them that their products were “totally safe.” E-cigarette use has exploded in popularity in particular among young people, threatening decades of work done by the government to dissuade the younger generation from using recreational drugs like nicotine.

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While e-cigarettes have long been assumed to be safe due to the lack of combustion involved, recent events have introduced doubt about the safety of these devices. A few months ago, a string of vaping-related hospitalizations, some of which led to death, renewed fears that vaping is in fact more dangerous than companies like Juul have let on. In the aftermath of these mysterious illnesses, Walmart decided to stop selling e-cigarette devices, and some states even moved to ban flavored vaping products in an effort to minimize use among children and teenagers. The federal government has contemplated banning the sale of flavored e-cigarette ingredients as well, but has not yet done so. Eventually, the CDC tied the incidences of sudden, severe lung illness to counterfeit THC cartridges that were distributed in the black market, but an overall attitude of skepticism towards vaping in general persisted. Specifically, the researchers found that the ingredient vitamin E acetate, which is used as an additive to alter the consistency of THC oil, was to blame in this particular phenomenon.

While this year’s major health scare related to vaping turned out to be limited to counterfeit products, perceptions about the dangers of vaping persist and are supported by new evidence that suggests vaping can be responsible for some long-term illnesses. Specifically, an article published in the American Journal of Preventive Medicine details a large study that compared the lungs of people who used e-cigarettes with cigarette smokers and those who did not consume nicotine over three years. Unsurprisingly, the last group had the lowest risk of developing a lung illness, but while e-cigarettes were found to cause problems in their own right, they were nonetheless considered safer and healthier than smoking.

“E-cigarettes should not be recommended.”

While differing in severity, the long-term health complications associated with vaping are similar to those associated with smoking cigarettes, and include chronic bronchitis and emphysema. The most dangerous form of nicotine consumption mentioned in the study was “dual use,” which is a combination of vaping and smoking, as not only does this practice maximize the amount of nicotine one consumes but it also exposes the lungs to the most amount of smoke or vapor. Dual use is the most common pattern of use the researchers found, signalling trouble for the millions of teenagers whose nicotine addictions are fueled by multiple vectors of drug consumption. The results of the three-year study corroborated animal studies on the effects of vapor on the lungs. Worryingly, the study also found that certain harmful ingredients, like propylene glycol, diacetyl, and even metals were present at a higher concentration in e-cigarette vapor than in combusted cigarette smoke. 

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Overall, the study is extremely critical of e-cigarettes, suggesting they are only valuable in a limited number of cases, and it concludes with the line “E-cigarettes should not be recommended.” In a small number of cases, e-cigarettes can be a good option for people who are trying to quit smoking as long as they use the devices with discipline and respect. While still harmful, e-cigarette vapor is less harmful than smoke, and vaping formulas can be adjusted over time to gradually reduce their nicotine content. That being said, as a result of the high prevalence of “dual use,” using e-cigarettes while trying to quit smoking can backfire, and indeed for most people using an e-cigarette is connected with an even lower chance of successfully quitting smoking. Other tobacco cessation aids, like nicotine-infused chewing gum or skin patches, are more effective in helping people quit and pose no threat to the health and safety of the lungs.

Girl Vaping

Health Scares Spell Trouble for Vaping Industry

Recently, a string of vaping-related hospitalizations made headlines and led to growing concerns about the safety of e-cigarettes marketed as healthier alternatives to cigarettes and other tobacco products. In the aftermath of this news, a number of states have moved to ban flavored vaping products, and the federal government even contemplated the idea of banning all flavors of vapor except tobacco nationwide. This sudden spike in concern has led to problems for the vaping industry, as blame is being placed squarely on the manufacturers of nicotine-containing products for the public health epidemic, and as the growing popularity of vaping among teenagers and young people threatens to undo the work of several decades of public campaigns aimed at curbing nicotine addiction.

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Juul, a brand which has become synonymous with vaping as it controls roughly 70% of the e-cigarette market, recently saw a change of leadership as it replaced its CEO with a former tobacco executive. A sudden change in leadership is never a good sign for a company, particularly one as large as Juul, and this news comes amidst other troubling developments for the company. Recently, the F.D.A. claimed that Juul broke the law by implying that e-cigarettes were safer than traditional cigarettes despite the lack of scientific evidence concerning the long-term health effects of using the products. Even more disconcertingly, the F.D.A found that Juul was marketing their products to teenagers in high schools as part of a campaign ostensibly targeted at reducing tobacco use by young people. Juul has said that it intends on fully cooperating with the F.D.A.’s regulations, and has announced it will not fight a proposed ban on flavored nicotine cartridges. Next year, e-cigarettes are scheduled to be banned in San Francisco, and Juul is considering whether or not they should abandon a ballot initiative to overturn the ban.

In order to stay on the market in the United States, Juul and other similar companies have to be able to prove that their products promote public health more than they harm it, which is growing increasingly difficult as the news reports of vaping-related hospitalizations and an epidemic of nicotine addiction in young people. While initially envisioned as a tool to help people quit smoking, vaping has instead become a fashionable trend, and many who are addicted to nicotine have no history of smoking cigarettes. The rise in popularity of e-cigarettes has been explosive, and while F.D.A. regulations concerning the sale of nicotine products have long been in effect, regulatory bodies have yet to catch up with the specific public health problems that e-cigarettes in particular pose. 

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Health professionals across the country are in virtual consensus in advising against the use of e-cigarettes, except as replacements for cigarettes as smoking cessation devices. Even then, there are nicotine delivery systems, such as chewing gum and patches, that are likely safer than vaping as they do not involve any inhalation of chemicals. The director of the National Institute on Drug Abuse, Dr. Nora Volkow, said that e-cigarettes should be clinically tested to determine whether they are effective as smoking cessation tools, and if they are they should only be available by prescription, which is the same standard to which other potentially dangerous drugs are held.

While recent develops certainly don’t bode well for the e-cigarette industry, it’s difficult to make any concrete predictions about the fate of affected companies. Famously, the tobacco industry spent millions of dollars lobbying against the notion that cigarettes cause cancer and other health problems, and were very successful in doing so for several years. Vaping has become so widespread that its popularity perhaps even eclipses that of the tobacco products that preceded it, and as a result, the industry has a lot of money to spend on resisting regulatory efforts. However, the government has fought Big Tobacco before, pioneering widespread public health campaigns in an attempt to stop tobacco use, and as such has plenty of relevant experience to apply to fighting Juul and similar companies. Meanwhile, a meaningful segment of an entire generation of young people who otherwise would not have been exposed to nicotine are addicted to vaping, and only time will tell how they will be able to get their nicotine fix in the years to come.

Girl Vaping

After String of Vaping-Related Hospitalizations, Walmart Ends E-Cigarette Sales

On Friday, Walmart said that it would stop selling all e-cigarettes after their inventory runs out, citing “the growing federal, state, and local regulatory complexity and uncertainty regarding e-cigarettes.” The announcement comes in the midst of a number of reports linking use of e-cigarettes, or other electronic vapor inhalation devices, to health issues, including hospitalizations and in a few cases death. Walmart joins Rite-Aid, Costco, and Dollar General in retailers who have decided to stop selling electronic nicotine delivery systems. And Target, Walmart’s biggest competitor, has never sold e-cigarettes and stopped selling cigarettes in 1996. That being said, Walmart is the largest retailer in the country, and other retailers tend to follow Walmart’s lead, as Walmart Chief Executive is the chairman of the Business Roundtable, an influential lobbying organization that includes among its members some of the biggest companies in the world.

While the exact causes of the recent string of vaping-related health scares are as of yet unknown, many affected individuals reported vaping THC products, including some which were acquired illegitimately, and some patients reported using nicotine products. Nevertheless, Walmart’s decision reflects a rapidly-rising anti-vaping sentiment, as e-cigarette use among adolescents has skyrocketed, owing in part to the success of Juul, a company that manufacturers nicotine cartridges and diffusers which can easily be mistaken for USB drives. 

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The Trump administration had seriously considered banning all flavored vape products in an effort to curb their appeal among young people, but abruptly changed course. Other ways of fighting the popularity of vaping among youth, such as ultra-sensitive vapor detectors which can be installed in schools and other public places, have been proposed. And while manufacturers like Juul claim their products are intended as smoking cessation aids, to allow nicotine addicts to gradually reduce their intake of the drug, these manufacturers profit tremendously off of the sales of e-cigarettes to people who have no intention of quitting, particularly young people. The National Institute on Drug Abuse this week released survey results indicating that the prevalence of vaping among teenagers has doubled since 2017.

Walmart’s action will likely have little impact, as there’s no end in sight for the resilient and centuries-old tobacco industry, which now has more loyal customers than ever before.

It should be noted that Walmart continues to sell regular cigarettes, which have been found definitively to cause major health problems, including cancer, lung disease, and early death, whereas the long-term negative health effects of vaping are still unknown. Additionally, Walmart continues to sell assault-style weapons even in the aftermath of a string of mass shootings in the United States, though the company has imposed limits on the sale of ammunition and discourages open carry of guns in stores. Three major television stations, CNN, CBS, and Viacom have also said they’d stop airing advertisements from e-cigarette companies on their networks in response to fear about illnesses. Additionally, several politicians have returned donations that they received from e-cigarette companies like Juul, unwilling to be associated with companies that have the potential to become the face of a public health epidemic in this country. 

Some fear that Walmart’s decision will drive people who ordinarily vape to take up smoking cigarettes instead, as the retailer still offers the latter nicotine product. Others criticize the view that flavored e-cigarettes should be banned, noting that adults also enjoy flavored e-cigarettes, and banning flavors would negatively impact those who use e-cigarettes as a smoking cessation tool. Regardless of Walmart’s decision to no longer sell e-cigarettes, the nicotine products are easy to find and acquire, even for teenagers, as they continue to be featured in gas stations, convenience stores, and smoke shops. As such, Walmart’s action will likely have little impact, as there’s no end in sight for the resilient and centuries-old tobacco industry, which now has more loyal customers than ever before.

Featured image credit: https://www.flickr.com/photos/vaping360/31014695273