STAUNTON – “The simple message is, let's not throw the baby out with the bathwater,” says Scott Ballin. “There is a population out there of 30 million adult smokers who are looking for alternatives. If you indiscriminately take vaping away from them, their solution, what happens to them, is they go back to smoking.”

While sitting at his dining room table in his Staunton home, Ballin sat down to discuss why a ban on e-cigarettes is a mistake. He also lives in Washington, D.C., where he's worked more than 40 years in public health, focusing on tobacco and nicotine-related issues.

As former vice president and legislative counsel for the American Heart Association and chairman of the Coalition on Smoking or Health, the precursor to the Campaign for Tobacco-Free Kids, Ballin is familiar with the history of what has transpired, and why this public health threat surfaced in the first place. He wrote and filed the petitions to get the U.S. Food and Drug Administration to regulate tobacco.

Ballin wants to talk about the elephant in the room; given the position health officials have taken in response to the severe lung illness. He believes the biggest threat to public health is cigarette smoking. And ex-smokers who took up vaping to rid themselves of cigarettes are going to return to smoking, the leading cause of preventable deaths in the United States with 480,000 deaths in the last year. They will still need their nicotine fix.

Ballin and others, including university public health professors, say, the message being sent on the federal level is irresponsible.

Some will continue to vape and use the vaping device and liquid they have been using for years. And some will stop and wait for federal and state agencies to find the answer, and in doing so, pick up a deadly habit they spent years trying to kick.

Ballin sees a clear message being sent from the U.S. Centers for Disease Control.

“Obviously, they don't want anybody to use vaping products at all,” he says.

Inside the Vaping Story

Ballin says this needs to be sorted out, and no one is taking the lead to do it. This week it appears President Trump has decided to take the lead by taking action to ban the sale of all flavored e-cigarettes.

Ballin thinks the primary agency should be the FDA. Although they are federal regulators and partners with the CDC, their messages are very different, he says. The FDA, he says, is stating that the samples tested have identified the problem, but the CDC is taking conservative view, which is to stop the use of all e-cigarettes.

How vaping gets distorted

Oil being added to a delivery device and then burned and vaporized into the lungs is causing the severe lung illnesses and deaths, says Ballin matter of factly.

“It’s an adulterated product. Vaping products are not made for that.”

In a FDA warning advisory, samples tested from lung illness cases identified THC, a psychoactive component of the marijuana plant, along with significant amounts of vitamin E acetate.

Because consumers cannot be sure whether THC-vaping products contain vitamin E acetate, the FDA is urging consumers to avoid buying vaping products on the street and to refrain from using THC oil or adding any substances to products purchased in stores.

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Vape regulations

Ballin says this type of problem has been going on for years with products in the marketplace.

“Adulterated products being sold that are not meeting standards and making people sick. You’ve got to track back where that problem is occurring. And what has happened is some people are saying, it's the vaping. It's not the vaping. The vaping is the delivery device. The problem is that kids and others are using that device to deliver THC. And these products are not made for that. That's not their intended purpose.”

Instead, he says, the federal and state agencies have fallen into a public frenzy.

“They’re shutting down,” Ballin says, “and advising the public that no one use any vaping products. What are people who have been smoking for a long time, but now using vape products going to do to get their nicotine fix? They’re going to go back to smoking.

“The message is vaping products are just as bad as cigarettes, so why should I switch? And that's the wrong message being sent.”

Part of the problem that led to this happening in the first place, he says, is vaping was never clearly defined and regulated by the FDA.

“You've got to start defining what these products are and what they are not. Because the public is confused. And we're just making them more confused, so they don't know what to do anymore.”

He thinks back to the e-cigarette deeming process that took five years, and he says, it’s just as confusing today as it was then.

“The FDA decided that it would make e-cigarette tobacco products under the law, and they would deem them into their regulatory structure and regulate them along the lines of tobacco products. The statute does not define vaping. It defines cigarettes. It defines smokeless, but it has not been brought up to date to define specifically what a vaping product is.”

As a result, vaping products lacked regulations specific to what the product is to avoid what Ballin calls, bad actors, flooding the marketplace with bad products to make a profit. Not all vaping companies are bad, he says.

“These people come out of medical device backgrounds. They come out of scientific backgrounds. It's not some fly by night operation.”

But because it is such a profitable industry, you’ve got large number of companies entering that space, he explains.

“A lot of them small vaping companies. Some are good and following the rules and standards; others are cutting corners. And that's what has happened with this whole issue because they started to put in cannabis oil. That’s the real problem.”

While Ballin knows the FDA has identified vitamin E acetate oil as the likely culprit, used in THC-vape cartridges sold in the marijuana black market and CBD vape pens sold online; and recently discovered, to licensed dispensaries, he doesn’t want you to lose sight of what started it. Kids like to experiment, he says.

“People across the street, their kids, were talking about this stuff over two years ago—using vaping mechanisms to deliver the marijuana.”

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After the sudden onset of lung illnesses, websites selling vape products are either disappearing or pulling certain products off their online selection, including chemical makers who sell products with oil-based thickening agents.

Until marijuana is legalized and regulated on the federal level, the rule of thumb is buyer’s beware. The National Organization for the Reform of Marijuana Laws wants marijuana legalized to get the product off the street, regulated and sold behind the counter. Otherwise, you are going to have people buying it off the streets or in questionable shops.

"These unfortunate incidents reinforce the need for greater regulation, standardization and oversight of the cannabis market—principles which NORML has consistently called for in the cannabis space,” said Paul Armentano, NORML’s deputy director. “Consumers must also be aware that not all products are created equal; quality control testing is critical and only exists in the legally regulated marketplace.”

Last year, Virginia passed a law allowing doctors to recommend marijuana for any diagnosed condition. By the end of the year, five licensed dispensaries will be selling regulated products that contain THC.

Now licensed dispensaries are under scrutiny as new information surfaced about an Oregon cannabis extraction company selling an approved product containing vitamin E acetate.

Vitamin E acetate

After a vaping-related lung illness death was reported in Oregon, a cannabis extraction company revealed it sells THC-vape cartridges mixed with vitamin E acetate oil to a licensed cannabis dispensary in the state. The Oregon Liquor Control Commission approved the product for use in legal recreational marijuana products sold at licensed dispensaries.

“Furthermore, the owner of this company explained that recently, there was a revolutionary change: the widespread introduction of a new diluent thickening agent (a vitamin E acetate oil) that was soon adopted everywhere,” emphasized Michael Siegel, a medical doctor and professor in the Dept. of Community Health Sciences in Boston University's School of Public Health, who has been following the public health threat.

Either way, Ballin says, it’s oil, and these delivery devices were not intended for oil.

“Instead of a water-based solution, they’re mixing with oil. Oil can’t go into the lungs as it solidifies and coats the lungs after it is burned and vaporized to get into the lungs.”

Ballin, who spent his life bringing people to the table on tobacco and nicotine-related issues, says everyone needs to step back and look at this public health emergency as: How do we cooperate? He doesn't see this happening.

“A lot of the vaping companies and trade associations want to be a part of the solution, but they're being bashed as though every vaping product is bad. And that's not the case,” says Ballin. “It’s going to hurt smokers who will have no alternative but to go back to smoking cigarettes.“

Ballin says while this is not merely a two-sided issue, his position is middle of the road: “Vaping is lower in risk. It must be regulated.”

His message is two-fold: Adults who have been vaping to stop smoking should not stray away as long as the product is nicotine only in a water-based solution. Smoking cigarettes is the bigger problem.

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And stay away from anything that has oil in it, period.

“Because when oil reaches a certain temperature and then goes into the lungs, it solidifies and blocks your bronchial ability to take in oxygen.”

Vape vs. cigarettes

E-cigarette use is likely to be significantly less harmful for adults than smoking cigarettes because e-cigarettes do not contain or burn tobacco—a process that produces an estimated 7,000 chemicals, including at least 70 chemicals that cause cancer, says cancer.org. But the health effects of long-term use are not known, emphasizes the organization.

Advocates for vaping believe it is a safer alternative than smoking cigarettes. Dr. Jack Coleman from the Lung Health Institute disagrees.

“It's abundantly clear that despite what many e-cigarette companies have tried to advertise, vaping is not a healthy alternative to smoking but rather a gateway for young people to become hooked on nicotine,” said Coleman. “The chest x-rays I’ve seen of people who have become ill from vaping aren't all too different than the COPD cases I see every single day from people who have smoked for 20 plus years.”

Banning flavored vape products is an encouraging first step, Coleman says.

“The kids are one issue, and no child or adolescent should be using any nicotine product whatsoever, including vaping,” states Ballin.

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“At the same time, the 30 million addicted adult smokers in the United States need science-based lower risk alternatives that are regulated by the Food and Drug Administration. That includes a host of non-combustible products, including vaping regulations.”

The science as far as gateway differs depending upon who you talk to, says Ballin, and the use of e-cigarettes and whether kids are migrating to smoking should be monitored closely.

“We can’t say that cigarette smoking is going down, and vaping is causing youth to smoke more—that is an inconsistent comparison. You have everybody all over the place and failing to address the substantive issues.”

While much remains to be determined about the lasting health consequences of e-cigarettes, there’s evolving evidence about the health risks of e-cigarettes on the lungs, including irreversible lung damage and lung disease, says the American Lung Association.

What should I do?

Virginia Department of Health state epidemiologist Carrie Holsinger said the VDH is working with the FDA on collecting vaping products for testing by the FDA.

“At this time, VDH does not have any results on products recovered,” said Holsinger.

The FDA is analyzing 120 samples submitted by states for the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids, cutting agents such as vitamin E acetate, pesticides, opioids, poisons, heavy metals and toxins, said the CDC. Acting FDA commissioner Ned Sharpless stated that identifying compounds is only one piece of the puzzle and won't necessarily answer questions about causality.

Is it only products containing cannabinoids and oils used as thickening agents?

“Nationally, while most patients have reported a history of using e-cigarette products containing cannabinoids, such as THC or CBD, some have reported the use of e-cigarette products containing only nicotine and others have reported using both,” said Jayne Flowers, manager for the Tobacco Control Program at the Virginia Dept. of Health.

“No single product or substance is conclusively linked to the disease,” said Flowers. “Until a definitive cause is known, persons should consider not using e-cigarettes.”

The Vaping Technology Association points to studies conducted by the New England Journal of Medicine that found vapor products nearly twice as effective at helping adults quit smoking than any other nicotine replacement methods, and research conducted by Public Health England that concluded nicotine-vapor products are at least 95% safer than cigarettes.

“We agree with the FDA,” said Gregory Conley, president of the American Vaping Association. “If you don’t want to die or end up in a hospital, stop vaping illegal THC oils immediately.”

Ballin played an integral role in forming a coalition of health experts to regulate tobacco and reduce the number of nicotine-addicted cigarette smokers in the United States. He supports vaping as a safer alternative to cigarettes.

It's all about combustion

“It’s not the nicotine that causes the overwhelming harm, it is the combustion of tobacco and thousands of chemicals that cause the harm,” says Ballin. “Change the delivery system to cleaner forms of nicotine (combustible vs. non-combustible) and you significantly reduce risk. Bottom line is 'risk’ needs to be out to perspective. Nicotine is not the cause of cancer or other diseases. It’s how the nicotine is delivered and how much.”

As primary consultant for a tobacco, nicotine and alternative products harm reduction forum held at the University of Virginia’s Institute for Engagement and Negotiation, Ballin refers to the forum’s Nov. 2018 report on smoking replacement products:

“A growing spectrum of tobacco, nicotine and alternative products being introduced into the marketplace need to be more appropriately defined. These products have differing characteristic as well as differing ‘risk profiles,’ but all of them can be considered non-combustible products that are significantly lower in risk when compared to combustible/smoked products.”

The American Medical Association urged consumers to stop using electronic cigarettes in light of the increasing e-cigarette-associated lung illnesses and urges the public to avoid using them until health officials understand the cause.

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Lung illness cases

Six adults have died from vaping-related lung illnesses. Cases also involve young adolescents and young adults.

On Sept. 12, health officials confirmed 380 confirmed cases and probable cases in 36 states have reported to the CDC; a decrease from 450 cases last week which included possible cases. The updated figure is part of a new case definition that counts breathing illnesses with abnormal chest x-rays, a recent history of vaping and lab work done to rule out other possible causes.

“These cases look very much like overwhelming infection, like viral or bacterial pneumonia,” but lab tests fail to find germs in lung fluids and blood, said Dr. Zack Moore, chief epidemiologist for the North Carolina Department of Health and Human Services.

Resembling a lung inhalation injury, symptoms include shortness of breath, fatigue, chest pain, diarrhea and vomiting.

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As of Sept. 12, there have been 8 confirmed cases, 4 probable cases, and 0 reported deaths associated with this cluster of illness in Virginia, according to the VA Dept. of Health. One confirmed case and one probable case is in the northwest health region of the Shenandoah Valley.

E-cigarettes have been on the market since 2003. In 2006, they entered the European marketplace and then made their way to the United States within a year. Today, there are several million e-cigarette users globally.

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Health reporter Monique Calello can be reached at mcalello@newsleader.com.