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JUUL

Nicotine’s Affect on Children

All leading health authorities support the three major conclusions of a 1988 report by the Surgeon General of the United States regarding nicotine and tobacco:

  1. Cigarettes and other forms of tobacco are addictive;
  2. Nicotine is the drug in tobacco that causes addiction;
  3. The physiological and behavioral processes that determine tobacco addiction are similar to those that determine heroin and cocaine

Nicotine fosters addiction through the brain’s “reward” pathway. Both a stimulant and a relaxant, nicotine affects the central nervous system; increases in blood pressure, pulse, and metabolic rate; constricts blood vessels of the heart and skin, and causes muscle relaxation. When nicotine is inhaled it enters the bloodstream through membranes in the mouth and upper respiratory tract and through the lungs. Once nicotine in the bloodstream reaches the brain, it binds to receptors, triggering a series of physiologic effects in the user that are perceived as a “buzz” that includes pleasure, happiness, arousal, and relaxation of stress and anxiety. These effects are caused by the release of dopamine, acetylcholine, epinephrine, norepinephrine, vasopressin, serotonin, and beta endorphin. With regular nicotine use, however, these feelings diminish and the user must consume increasing amounts of nicotine to achieve the same pleasurable effects.

Nicotine causes neurological changes that create addiction. Repeated exposure to nicotine causes neurons in the brain to adapt to the action of the drug and return brain function to normal. This process, called neuroadaptation, leads to the development of tolerance in which a given level of nicotine begins to have less of an effect on the user.

Once a brain is addicted to nicotine, the absence of nicotine causes compulsive drug-seeking behavior, which, if not satisfied, results in withdrawal symptoms including

  • Anxiety;
  • Tension;
  • Depression;
  • Irritability;
  • Difficulty concentrating;
  • Disorientation;
  • Increased eating;
  • Restlessness;
  • Headaches;
  • Sweating;
  • Insomnia;
  • Heart palpitations;
  • Tremors;
  • Intense cravings for nicotine.

Though smokers commonly report pleasure and reduced anger, tension, depression and stress after smoking a cigarette, many of these effects are actually due to the relief of unpleasant withdrawal symptoms that occur when a person stops smoking and deprives the brain and body of nicotine.

Nicotine causes permanent brain changes. The effects of nicotine exposure on the brain of youth and young adults include addiction, priming for use of other addictive substances, reduced impulse control, deficits in attention and cognition, and mood disorders.

Nicotine is also a carcinogen and is associated with a wide variety of very serious health issues, including:

  • Various cardiovascular problems, including an increased risk of Coronary Vascular Disease by producing acute myocardial ischemia and peripheral arterial disorders;
  • Various reproductive health problems;
  • Immunosuppressive problems;
  • Adverse effects to the heart, eyes, lungs, kidneys, and reproductive organs;
  • Increased blood pressure;
  • Increased risk of stroke;
  • Increased risk of heart attack;

Adolescents are particularly susceptible to neurological injuries as a result of nicotine exposure. Nicotine affects neurological development in adolescents, and exposure to nicotine during adolescence produces an increased vulnerability to nicotine addiction. Adolescent nicotine addiction causes “substantial neural remodeling” including those parts of the brain governed by dopamine or acetylcholine, which play central roles in reward functioning and cognitive function, including executive function mediated by the prefrontal cortex.

Other brain changes from nicotine include increased sensitivity to other drugs and heightened impulsivity. As a result, public health authorities have concluded that e-cigarettes are unsafe for anyone under age 26.

Marketing to Children

JUUL has been very successful at doing something very terrible—marketing their highly addictive product to children. According to a recent report from National Public Radio (NPR) and the Center for Environmental Health—a nonprofit organization aimed at protecting the public from exposure to toxic chemicals—the number of teenage children who vape doubled between 2017 and 2018, and rose even higher in 2019.

The rise in vaping among children can be traced back to JUUL’s child-centric design decisions and marketing tactics.

JUUL DESIGNED ITS PRODUCT FOR CHILDREN

When they redesigned their vape device, they arguably did so to make it better suited to a young audience. Engineers working for the company fashioned a new line of vape devices that were designed so that they mimicked the look of a USB flash drive. Not only this, but they can be plugged into your computer, just like a USB device would be. This means that middle school and high school students are able to hide their devices in plain sight. They could charge their vape at school and their teacher would be none the wiser because it looks like a USB flash drive. We can deduce that this has been done purposely to hit the younger audience market. After all, any adult that is looking to quit smoking is going to want something that mimics the look and feel of a conventional cigarette. This would help them to more effectively quit smoking. However, the JUUL products do not adhere to this at all. Many people have concluded that this is because they wanted to have a special and unique appeal to the youth audience across the United States, and this has certainly worked.

A lot of critics also believe that the fun range of flavors found within the JUUL product range is also designed to appeal to children. After all, when someone is trying to quit smoking, they are going to want something that reminds them of a traditional cigarette. They are not going to want something that is pancake syrup or strawberry milk flavored. These are the sorts of flavors that appeal to teens and children, as they are based on candy and other sweet treats. If that was not bad enough, a lot of the skins features cartoons, photos of animals, artwork, mascots, and school colors too. This is much more likely to appeal to a young person than it is an adult who is genuinely looking to quit smoking.

JUUL MARKETED ITS PRODUCT FOR CHILDREN

The National Institute on Drug Abuse (NIDA) compiled alarming statistics about JUUL targeting teenage children in their advertising and discovered that

  • 70% of teenagershave been regularly exposed to vaping ads.
  • Retail adsreach about 53% of middle schoolers and 56% of high schoolers.
  • Internet adsreach about 36% of middle schoolers and 43% of high schoolers.
  • TV and movie ads reach about 34% of middle schoolers and 38% of high schoolers.
  • Printed ads reach about 25% of middle schoolers and 35% of high schoolers.

Following the success of its Big Tobacco predecessors, JUUL created a long-term, viral marketing campaign specifically aimed and teenage children. Like Big Tobacco’s ads from the generations prior, this campaign extends and expands upon deceptive advertising tropes used by tobacco companies to exploit the psychological needs of consumers—especially youth—to convert them into smokers.

JUUL combines this child-centric marketing and advertising with vape cartridges specifically flavored to appeal to children. Watermelon, strawberry milk, crème brulee—these are just a few of the flavored nicotine products JUUL created and marketed for America’s youth.

JUUL’s marketing and product design efforts have been wildly successful. Since its launch, JUUL is now the fastest growing e-cigarette in the country. Because the JUUL delivers more nicotine in a shorter amount of time than any other product, delivers that nicotine in a sweetened vapor that causes no irritation, and does so through a concealable device that can be consumed discretely in class, at home, and in the car, nicotine naïve users like Plaintiff frequently spiral into patterns of addiction with no historical precedent. It is not uncommon for teenagers to consume two JUULpods a day, the nicotine equivalent of at least as many—and likely more—packs of cigarettes.

Because of the product’s highly addictive nature, once the children try a vape product for the first time, they are often hooked. According to Dr. Stan Glantz, Professor of Medicine at the Center for Tobacco Control Research and Education,

They get addicted to Juul faster than they used to get addicted to cigarettes, and I think the reason for that is the technology. The use of nicotine salts allows the kids to inhale a much higher dose of nicotine per puff.

After over 1,500 cases of serious lung disease and 33 deaths linked to vaping, JUUL finally agreed to stop marketing its deadly, addictive product to teenagers and children. In October 2019, JUUL entered into an agreement with the Center for Environmental Health  that requires JUUL to cease marketing to children and specifically prohibits JUU: fromq

  1. Advertising at sporting events that allow people under the age of 21
  2. Advertising at concerts that allow people under the age of 21
  3. Prohibit JUUL from making appearances at schools
  4. Using models in their ads that are under the age of 28

The Center for Environmental Health is going to be keeping a close eye on JUUL to ensure they follow the settlement’s rules. In an interview with NPR, Michael Green, the Center’s CEO, confirmed that the Center will be closely monitoring JUUL throughout this process:

We think that their entire business model is based on addicting a new generation of young people, so the fact that it’s court-enforceable means that we are going to watch them very closely. And if they violate it by one inch, we can go right back to court, and we can force them to stop.

While the settlement is very technically only enforceable in California for a specific period, it is progress towards preventing big tobacco from turning a new generation into nicotine addicts.

The negative health effects of exposure to nicotine
  • Nicotine exposure in the utero has been connected with a number of different behavioral and neurodevelopment effects. Examples include poorer scholastic achievement, global intelligence, language development, memory reading, deficits in learning, and academic outcomes.
  • Research has linked the chronic pulmonary obstructive disease with vaping.
  • Research has shown that kids have more asthma, resulting in a greater number of days off school, because of nicotine use.
  • Nicotine can lead to heart diseases because it stimulates the cardiovascular and nervous systems.
  • Nicotine can make cancer worse. This is because it interacts with cancer cells that are present in the body.
  • Prenatal exposure to nicotine also primes the adolescent brain for nicotine addiction and depression in later years.
  • There are a number of different childhood and neonatal complications that are linked with exposure to nicotine. This includes behavior issues, attention deficit disorder, cognitive and affective disorders, smaller head circumference, renal dysfunction, type 2 diabetes mellitus, and postnatal obesity.
  • Nicotine is genotoxic. The toxic impact of nicotine continues to manifest in a fetus, even if the person in question is no longer exposed to it.
  • It is well-known that nicotine can impact a number of different organs in a developing fetus and the consequences can be life-long.
The Danger of Using JUUL to Quit Smoking

PDF Download (with footnotes)

In recent marketing measures, JUUL encourages smokers to use its products as a smoking cessation aid. While it doesn’t overtly say that its nicotine pods can be used to quit smoking, JUUL’s new ad campaign touts it as a way to “make the switch”—the switch from cigarettes to vaping products, of course. Commercials are featuring adults sharing their personal stories of hwo they used JUUL to finally kick their smoking habit.

In July 2019, the House Committee on Oversight and Reform’s Economic and Consumer Policy subcommittee held a two-day hearing to investigate JUUL’s marketing and health claims that its nicotine pods are a safer alternative to traditional cigarettes and are a took to help people quit smoking.

The Food and Drug Administration (FDA) has not approved any e-cigarettes for use as smoking cessation aids. Approval requires a formal review backed by scientific data. JUUL of course has none of these.

JUUL began this “smoking cessation aid” campaign after receiving intense scrutiny for its marketing to children and its products skyrocketing popularity with teenagers. Specifically, the FDA began to question its child-centric advertising tactics. In the face of that criticism, JUUL turned its marketing to target adult smokers and used a marketing scheme designed to give JUUL the appearance of a smoking cessation aid.

But what JUUL is not including in this marketing campaign is the fact that its nicotine pods deliver substantially more nicotine than the cigarettes it’s helping you quit.

According to the National Institutes of Health, the “amount and speed of nicotine delivery . . . plays a critical role in the potential for abuse of tobacco products.” The cigarette industry has long known that “nicotine is the addicting agent in cigarettes” and that “nicotine satisfaction is the dominant desire” of nicotine addicts.

For this reason, cigarette companies spent decades manipulating nicotine in order to foster and maintain addiction in their customers. For example, R.J. Reynolds Tobacco Company (“RJR”) developed and patented nicotine salt additives such as nicotine benzoate to increase nicotine delivery in cigarette smoke. As detailed in an RJR memorandum titled “Cigarette concept to assure RJR a larger segment of the youth market,” manipulating the pH of nicotine was expected to give cigarettes an “additional nicotine ‘kick’.” This kick was attributed to increased nicotine absorption associated with lower pH.

JUUL used the RJR research and conclusions to produce a similar nicotine kick, and thereby promoting increased use and sales of JUUL e-cigarettes. In U.S. patent No. 9,215,895 (“the ‘895 patent”), assigned to “Pax Labs, Inc.” and listing JUUL executive Adam Bowen as an inventor, JUUL describes a process for combining benzoic acids with nicotine to produce nicotine salts, a formulation that mimics the nicotine salt additive developed by RJR decades earlier.

In a 2015 interview, Ari Atkins, a JUUL research & development engineer and one of the inventors of the JUUL device said this about the role of acids: “In the tobacco plant, there are these organic acids that naturally occur. And they help stabilize the nicotine in such a way that makes it …” He pauses. “I’ve got to choose the words carefully here: Appropriate for inhalation.”

JUUL’s manipulation of nicotine pH directly affects the palatability of nicotine inhalation by reducing the “throat hit” users experience when vaping. Benzoic acid reduces the pH of solutions of nicotine, an alkali with a pH of 8.0 in its unadulterated, freebase form. This reduction in pH converts naturally-occurring unprotonated nicotine, which causes irritation in the throat and respiratory tract, to protonated nicotine, which is not be absorbed in the throat or   upper respiratory tract and, therefore, does not irritate the throat. A recent study found that JUUL’s e-liquid had a pH of under 6.0, suggesting that the JUUL contains almost no freebase (i.e., non-salt form) nicotine.

The vapor from JUUL’s e-liquid contains about the same ratio of free-base nicotine—and hence causes the same amount of irritation—as a nearly nicotine-free 3 mg/mL e- liquid.

The same chart further shows that the Duell Study authors found that the low freebase fraction in its aerosols suggested a “decrease in the perceived harshness of the aerosol to the user and thus a greater abuse liability.”

The authors noted that “tobacco company documents suggest that products [like JUUL] with high nicotine levels but a low [percentage of freebase nicotine] will yield vape aerosols of much reduced harshness as compared to products with even only moderate nicotine levels” but high percentages of freebase nicotine.

JUUL’s creation of a product with low levels of harshness and minimal throat “hit” is consistent with the goal of producing a product for young non-smokers. The non- irritating vapor product is easier for non-smokers to consume without negative side effects like coughing or irritation. The design also shows that JUUL’s intention was to recruit nonsmokers, not existing smoker, because smokers are already tolerant of the throat hit and have even been habituated into associating the “throat hit” with getting their nicotine fix. Minimizing the throat “hit” of JUUL e-cigarettes is therefore unnecessary to providing an alternative for adult smokers, but is crucial to luring a new generation of users.

The Duell study concluded that JUUL’s use of nicotine salts “may well contribute to the current use prevalence of JUUL products among youth.”

JUUL’s lack of throat hit increases the risk of using the product, because it masks the amount of nicotine being delivered, by eliminating the throat sensory feedback normally associated with a large dose of nicotine. The “throat hit” is part of the body’s alert system, letting a person know he is inhaling something harmful. Eventually, the irritation to the throat will cause even the most compulsive addict to wait before the next inhalation. Reducing or removing this feedback impairs the user’s ability to ascertain that he is consuming a toxin. As a result, the cravings for nicotine can be satisfied nonstop, fostering addiction or aggravating an existing addiction, and repeatedly exposing the user to the health risks associated with the product, such as significantly increased blood pressure.

JUUL sells products that contain relatively low amounts of throat-irritating freebase nicotine, yet contain and deliver far higher concentrations of nicotine than cigarettes or other electronic nicotine delivery systems (“ENDS”) containing freebase nicotine.

Blood plasma studies in the ‘895 patent show that vaping nicotine benzoate increases nicotine delivery compared to cigarettes or vaporized solutions of freebase nicotine. In fact, nicotine uptake was up to four times higher for nicotine salt formulations than traditional cigarettes (approximately 4 ng/mL/min compared to approximately 1 ng/mL/min). JUUL’s data also indicates that nicotine salt solutions produce a higher heart rate in a shorter amount of time (a 50 beats/minute increase within 2 minutes for nicotine salt, versus a 40 beats/minute increase in 2.5 minutes for a Pall Mall cigarette). Nicotine salts also cause a faster and more significant rise in heart rate than placebo or vaporized freebase nicotine.

The following figure from the ’895 patent shows that a 4% solution of benzoic acid and nicotine salt, which is the formula used in JUULpods, causes a peak nicotine-blood concentration (“Cmax”) of approximately of approximately 15 ng/mL, compared to a Cmax of 11 ng/mL for a Pall Mall cigarette. (To make the figure more readable, JUUL’s 4% nicotine benzoate data is highlighted in red, and the Pall Mall data is highlighted in
blue.)

JUUL’s ‘895 patent shows that a 4% solution of benzoic acid nicotine salt causes a peak nicotine-blood concentration (“Cmax”) of approximately 15 ng/mL, compared to a Cmax of 11 ng/mL for a Pall Mall cigarette.

As high as the reported nicotine dose reported for JUULpods is, the actual dose is likely higher. Though the strongest benzoic acid concentration mentioned in the ‘895 patent is 4% (i.e., 40 mg/mL of benzoic acid), one study tested four flavors of JUULpods and found a 4.5% benzoic acid (44.8 ± 0.6) solution. That study found that JUULpods contained a concentration of 6.2% nicotine salt (about 60 mg/mL), rather than the 5% nicotine (about 50 mg/mL) advertised. JUULpods containing an absolute nicotine concentration 1.2% higher than the stated 5% on the label (a relative increase of over 20%) coupled with more benzoic acid than listed in the ‘895 patent produce higher nicotine absorption than expected for the advertised formulation.

Other studies have reported even higher actual concentrations of nicotine in JUULpods. Some experts estimate that JUULpods contain the same nicotine as two packs of cigarettes.

In any event, JUUL is delivering doses of nicotine that are materially higher than delivered by combustible cigarettes. As a paper published by the European Union citing the United Kingdom Medicines and Healthcare Products Regulatory Agency notes, “an e-cigarette with a concentration of 20 mg/ml delivers approximately 1 milligram of nicotine in 5 minutes (the time needed to smoke a traditional cigarette, for which the maximum allowable delivery is 1 mg of nicotine).” With at least 59 mg/mL of nicotine delivered in a salt form that increases the rate and efficiency of uptake (and even with a lower mg/mL amount), a JUULpod will easily exceed the nicotine dose of a traditional cigarette. Not surprisingly, the European Union has banned all e-cigarette products with a nicotine concentration of more than 20 mg/ml nicotine, and Israel is seeking to do the same. As Israel’s Deputy Health Minister has noted, “a product that contains a concentration of nicotine that is almost three times the level permitted in the European Union constitutes a danger to public health and justifies immediate and authoritative steps to prevent it from entering the Israeli market.”

Comparison of available data regarding per puff nicotine intake corroborates the other JUUL studies (mentioned above), indicating that JUUL delivers about 30% more nicotine per puff. Specifically, a recent study of JUULpods found that “[t]he nicotine levels delivered by the JUUL are similar to or even higher than those delivered by cigarettes.” The Reilly study tested JUUL’s Tobacco, Crème Brulee, Fruit Punch, and Mint flavors and found that a puff of JUUL delivered 164 ± 41 micrograms of nicotine per puff. By comparison, a 2014 study using larger 100 mL puffs found that a Marlboro cigarette delivered 152—193 μg/puff. Correcting to account for the different puff sizes between the Reilly and Schroeder studies, this suggests that, at 75ml/puff, a Marlboro would deliver between 114 and 144 μg/puff. In other words, empirical data suggests that JUUL delivers up to 36% more nicotine per puff than a Marlboro.

Because “nicotine yield is strongly correlated with tobacco consumption,” a JUULpod with more nicotine will strongly correlate with higher rates of consumption of JUULpods, generating more revenue for JUUL. For example, a historic cigarette industry study looking at smoker employees found that “the number of cigarettes the employees smoked per day was directly correlated to the nicotine levels.” In other words, the more nicotine in the cigarettes, the more cigarettes a person smoked.

At the same time, as discussed above, the throat “hit” from nicotine salts is much lower than that for combustible tobacco products, making it easier to inhale. According to researchers, the “high total nicotine level (addictive delivery)” of a JUUL coupled with its easily inhalable nicotine vapor is “likely to be particularly problematic for public health.”

This powerful combination—highly addictive and easy to inhale—also repeatedly exposes users to the toxic chemicals in the vapor, compounding the health risks to users, as described above.

In addition to its nicotine content, the “Cool” Mint pods pose additional risks. The FDA’s Tobacco Products Scientific Advisory Committee in March 2011 issued a report on menthol cigarettes, concluding that the minty additive was not just a flavoring agent but had drug-like effects, including “cooling and anesthetic effects that reduce the harshness of cigarette smoke.” Mint could also “facilitate deeper and more prolonged inhalation,” resulting in “greater smoke intake per cigarette.”

WHAT CHEMICALS ARE IN JUUL

Before we can take a look at the negative impact that JUUL products have had on the younger generation, it is first important to understand why JUUL vaping is dangerous. Therefore, we need to look at the chemicals that are contained in their products. A JUUL cartridge contains liquid that is made up of benzoic acid, flavoring, propylene glycol, glycerol, and 40 mg of nicotine. When compared with the other vaping devices that are on the market today, JUUL contains a very high level of nicotine. When compared with other devices, like the Blue vape cartridge, JUUL contains more than twice the concentration of nicotine. This makes the addiction risk very high.

In fact, there was a study that was carried out by the Royal College of Psychiatrists in the United Kingdom. It showed that nicotine is more addictive than anti-anxiety drugs and alcohol. They also concluded that it was on the same level of addictiveness as cocaine.

This is not the only negative impact that is associated with nicotine. While it is highly addictive, there have been a lot of different pieces of scientific research that have shown that nicotine is known to impair lung development and brain development if it is utilized during adolescence, as well as being toxic to fetuses.

Plus, it is also worth pointing out that it is not just the nicotine that is bad in JUUL products. While these vaping products do not contain a lot of the bad stuff that you would find in tobacco, there are other bad things in them. In fact, 42 additional chemicals, aside from the five main vape liquid ingredients, have been identified in the vapor. A number of these different chemicals are known carcinogens. For example, when compared with other vaping products out there, JUUL products contain a higher amount of benzoic acid. This is worrying because benzoic acid is known to cause vomiting, nausea, abdominal pain, sore throat, and coughs if someone has constant exposure to it, which will certainly be the case if you are using JUUL vape products.

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