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FDA aims to restrict Juul products; WVU studies the dangers of vaping

By Kaitlyn Eichelberger

E-cigarettes have been an area of discussion in the medical field for years, specifically concerning their appeal to teenagers and misinformation surrounding health risks. This has led to widespread research efforts and regulations. 

On June 23, the FDA ordered Juul, the best-selling e-cigarette company in the United States, to halt all sales of its vaping devices and flavored cartridges. The following day, a federal appeals court temporarily blocked that ban. On July 5, the FDA agreed to further review Juul’s products. 

“I think the current measures are the first step in the FDA trying to regulate these products and understand what they do,” said Dr. Mark Olfert, professor at WVU’s School of Medicine and director of the Clinical & Translated Science Ph.D. program. “I think the vast majority of health professionals support [the ban].”

The FDA’s review intends to determine whether or not a company’s products are detrimental to public health. The company must prove that its products fulfill their intended use as smoking cessation methods, without encouraging teenagers to become addicted. After companies submit information about their marketing practices, the contents of their product, and any associated risk, the FDA will determine whether it’s a severe public health risk before approving or denying the application. This pre-market approval does not mean a product is FDA-approved, just that the FDA is allowing the products to be sold after meeting their guidelines.

“The approval for those products is not suggesting that these products are safe,” said Olfert. “Simply that these companies are behaving in a manner that is consistent with the FDA’s expectations for the distribution and sales in a way that is not expected to entice minors.”

Some companies have received pre-market approval, while Juul has not. This is partially due to Juul’s history of marketing to teenagers, said Olfert. Although Juul has stated its products are for adults only, advertisements appeal to a younger audience.

E-cigarettes, first introduced over a decade ago, are electronic devices used to inhale the vapor from e-liquid cartridges. E-liquids are made up of nicotine, flavorings and other chemicals. Some contain nicotine, while others do not.

As described by the CDC, e-cigarette aerosols can contain harmful substances, including nicotine, ultrafine particles, diacetyl, a chemical linked to lung disease, volatile organic compounds, cancer-causing chemicals and heavy metals.

The heavy metals, Olfert explained, are from degrading metal coils in the heaters of e-cigarettes.

“The coils they use to heat are made out of different metals,” said Olfert. “We’re finding these metals in the cloud. Stainless steel, when you heat it, eventually it starts to flake and break off.” Chromium, lead, nickel and tin are metals found in e-cigarette aerosols.

What makes e-cigarettes so appealing, despite these harmful ingredients, is the flavoring. 

Although the FDA only allows the sale of menthol and tobacco-flavored pods, the flavored e-liquids can still be purchased separately and used to refill cartridges.

“The FDA has banned all flavors, but there’s a huge loophole or backdoor that is not yet regulated,” said Olfert. “I can go into any vape shop and I can get strawberry-flavored e-liquid in a bottle. The liquid in a pre-packaged pod is regulated. The liquid that I buy off the shelves is not regulated.”

In West Virginia, vaping rates are rising faster than in the rest of the country. In 2020, the DHHR reported e-cigarette use in more than one in three (35.7%) West Virginia high school students and more than one in six (15.3%) middle school students. Nationally, the CDC reports that 20.8% of high school students have used e-cigarettes in the past 30 days; this is well below West Virginia’s figure.

Despite this, West Virginia has not dedicated much funding to anti-tobacco messaging.

Based on the amount of tobacco advertising that occurs in West Virginia, the CDC recommends $27.4 million be used on tobacco prevention programs annually. From 2008 through 2013, the state spent $5.7 million annually on anti-tobacco programs. This number dropped to $3 million by 2017; nothing was spent in 2018-19. 

“West Virginia has placed zero priority in protecting the health of our kids,” said Olfert. “They invest zero dollars in anti-tobacco messaging.”

In 2020, state funding increased to $500,000, then to $400,000 in 2021.

This presents a multitude of risks for West Virginia youth. 

“Smoking is a primary lung disease and creates secondary cardiovascular complications,” said Olfert. “We’re finding that vaping is primary cardiovascular disease with secondary pulmonary.”

Cardiovascular complications include stroke, aneurysms and heart attacks. These occur as a result of blood vessel stiffening, which leads to premature aging.

The CDC states that life expectancy for cigarette smokers is at least 10 years shorter than for non-smokers. Olfert anticipates vaping will cause a similar decrease in lifespan.

“I’m predicting, based on the animal work we’re doing, that people will still die early,” said Olfert. “Probably the same amount of time early, 10-15 years. I think vapers are going to have the same thing due to premature aging and vascular complications.”

Lung function doesn’t fully mature until late teens, raising additional concerns over the long-term effects of vaping at a young age. The brain is also developing during this time. 

“Exposure to nicotine at this stage in brain development results in permanent changes to the brain that can impact cognitive ability, mental health and predisposition to addiction for a lifetime,” said the DHHR. “Nicotine addiction at adolescence can change the brain’s reward center and increase the risk of future addiction to other drugs.”

In a state with existing substance abuse issues, this presents a greater concern. Many teenagers who vape witness the impact of smoking on their relatives, but don’t associate the dangers of vaping with the severe impacts of smoking.

“Some of the kids don’t think vaping is the same thing as smoking,” said Olfert. “They’ll say, ‘No, I saw my parents suffer, smoking is terrible, I would never touch a cigarette.’ In their minds, they don’t equate.”

What makes vaping so different — and potentially more dangerous than smoking — is the customization aspect.

What really makes vaping dangerous is the variables, Olfert explained. On the lowest heat setting, it’s about the same or lower than a cigarette. At the highest setting, it’s about five times higher than what is put out by a cigarette.

In one scenario, a vape may be less harmful than a cigarette. In another scenario, it may be far worse. 

WVU’s research aims to study these effects further.

“Somebody needs to answer these questions and we’re well-equipped to do it,” said Olfert. 

Using rats, Olfert’s team is studying the effects of vaping on the cardiovascular system, the lungs, pregnancy and more. 

“The muscle and vascular biology of rats are highly reproductive in terms of human outcomes,” Olfert explained. Historically, what happens to the rats also happens to humans. 

In order to study the cardiovascular and pulmonary effects of vaping, they expose rats to vapes and run a variety of tests.

Pregnant rats are exposed to vaping for the entire pregnancy, leading to vessel dysfunction and stiff arteries in their pups. As this research expands, they plan to vape pregnant rats for only the first trimester, in order to determine if the same issues present themselves. Olfert believes they will.

“Our hypothesis is that the first trimester is the critical part,” said Olfert. “That’s when the vascular system is being developed. If we find that they end up with the same deficits, that’s bad news for humans.”

Most women don’t know they’re pregnant until near the end of their first trimester. If someone vapes and plans to quit once they know they’re pregnant, the damage may already be done. 

Olfert’s team is one of the leading labs to show vascular dysfunction from vaping and their research is ever-expanding.

“It’s an investigation,” said Olfert. “We follow the leads and try to understand the damage and what’s causing it. We are pursuing everything that we can.”

Olfert’s goal is to inform the public of the risks of vaping, allowing people to make educated decisions about vape use.

“My main issue with this is the truth about what it is,” said Olfert. “Should we ban this altogether and make it completely inaccessible? We don’t live in that kind of society. We do live in a society that says, ‘if you’re going to sell this to me, you have to be truthful about what’s in it and if it’s going to harm me.’”

His priority is keeping children from vaping and becoming addicted.

“We’ve got to protect the younger generation from getting hooked on this,” said Olfert. 

“Is it possible that there’s a safe e-cigarette out there? I can’t dismiss the possibility, but we haven’t found one yet.”

Ready to quit vaping? You don’t have to do it alone.

Truth Initiative, This is Quitting: text DITCHVAPE to 88709

Smokefree: text QUIT to 47848

West Virginia Tobacco Quitline: call 877-966-8784 or text 304-583-4010

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