Some Vaping Companies Are Turning to Synthetic Nicotine to Outsmart the FDA

Troy Johnston swears he wanted to play by the rules. Johnston, who owns the Texas-based vaping company VaporSalon, tried to follow the U.S. Food and Drug Administration’s (FDA) guidelines for selling e-cigarette products, which required all manufacturers to file paperwork known as premarket tobacco product applications (PMTAs) by Sept. 9, 2020. In these applications, companies…

Some Vaping Companies Are Turning to Synthetic Nicotine to Outsmart the FDA

Troy Johnston swears he wanted to play by the rules.

Johnston, who owns the Texas-based vaping company VaporSalon, tried to follow the U.S. Food and Drug Administration’s (FDA) guidelines for selling e-cigarette products, which required all manufacturers to file paperwork known as premarket tobacco product applications (PMTAs) by Sept. 9, 2020. In these applications, companies were tasked with proving that their products were, on balance, good for U.S. public health—namely by giving adult smokers a less-dangerous alternative than traditional cigarettes.

As required, Johnston filed applications for all 47,000 nicotine e-liquids his company sells, an undertaking that he says cost his business thousands of dollars and countless hours of work. But he wanted a back-up plan, just in case the FDA’s decision didn’t go his way. So in August, he looked into purchasing synthetic nicotine—a product that some in the vaping industry argue the FDA doesn’t have the power to regulate as it does other e-liquids, since it is not derived from tobacco.
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When the agency rejected the vast majority of VaporSalon’s PMTAs on Aug. 26, Johnston was ready. “VaporSalon is switching to TOBACCO FREE NICOTINE,” he posted from VaporSalon’s Facebook page that day, adding that “the main purpose” was to skirt FDA regulations. “We never wanted to switch to [synthetic nicotine], but the FDA forced us to make that decision as we have so many adults relying on us” for alternatives to cigarettes, Johnston wrote in an email to TIME.

Johnston may have been unusually candid in his post, but he’s not alone in searching for a savior in synthetic nicotine. The FDA has so far rejected PMTA paperwork for more than 5 million e-cigarette products, many of them flavored vaping liquids. Faced with the choice of removing their products from the market entirely or working in a regulatory gray area, some of those manufacturers are embracing uncertainty and pivoting to synthetic nicotine.

Tony Abboud, executive director of the Vapor Technology Association, a trade group for the e-cigarette industry, says there are plenty of non-regulatory reasons a company might want to use synthetic nicotine—its purity, for example, or freedom from traditional tobacco, with all its baggage and sordid history. But he concedes that the FDA authorization process has forced some hands. “The process has been so convoluted and so opaque that, without question, it’s driven companies in this direction,” he says.

Read more: How Juul Hooked Kids and Ignited a Public Health Crisis

The FDA has had the power to regulate tobacco products since 2009, when then-President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act. That law defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption.”

Under a literal reading, synthetic nicotine falls outside that definition, since it is lab-made and not derived from tobacco. Some e-cigarette companies are using that largely unlitigated loophole as a lifeline.

The Germany-based nicotine wholesaler Contraf-Nicotex-Tobacco GmbH primarily sells tobacco-derived product. But Torsten Siemann, the firm’s managing director, says in recent months there’s been a noticeable increase in interest, particularly from U.S. companies. “There are quite some companies who want to try to avoid [the FDA’s review process],” Siemann says, adding that his company supports synthetic nicotine regulation and would stop sales “as soon as this starts to be an illegal market.”

Whether using synthetic nicotine actually places companies outside the FDA’s grasp is up for debate. An FDA spokesperson, in an email, said only that the agency is “aware of a number of electronic nicotine delivery systems (ENDS) claiming to contain only synthetic nicotine (not nicotine sourced from tobacco). We are considering how best to address such products.” On its website, the FDA says it will handle synthetic nicotine regulation on “a case-by-case basis.”

The issue is “definitely gray,” says Marc Scheineson, a partner at the Washington, D.C. law firm Alston & Bird and a former FDA associate commissioner. For example: while the FDA may not have the authority to regulate synthetic nicotine as a tobacco product, it may be able to regulate it as a drug, he says, since the agency could argue that synthetic nicotine alters the structure and function of the body, one of the definitions the FDA uses to designate something a drug. Congress could also choose to amend the definition of a tobacco product to include non-tobacco-derived nicotine, if it saw fit.

In 2010, a Washington, D.C. circuit court ruled that e-cigarettes that use tobacco-derived nicotine must be regulated as tobacco products, not drugs. But that decision specified that the FDA could regulate other nicotine products—such as patches and gums marketed for smoking cessation—as drugs. That seems to clear a path for regulating synthetic nicotine as a drug, says Dennis Henigan, vice president of legal and regulatory affairs at the anti-smoking Campaign for Tobacco-Free Kids (CTFK).

“We think that’s crystal clear,” Henigan says. “FDA, on the drug side, has the authority to enforce the law against [synthetic nicotine products] right now.”

CTFK, along with six other health groups, argued as much in a Sept. 2 letter to the FDA, noting that some companies were already using synthetic nicotine to circumvent FDA processes. Many of those companies had previously manufactured tobacco-based nicotine products, but were not granted marketing authorization because they could not prove their flavored liquids were beneficial enough to adult smokers to outweigh their risks of appealing to underage users—and now, those manufacturers can make the same flavored juices using synthetic nicotine.

“Continued agency inaction on synthetic nicotine e-cigarette products will undermine the regulatory system established by Congress, both for drugs and for tobacco products,” CTFK and its partners wrote. “And continued inaction will allow the manufacture, sale, and widespread availability of flavored products—exactly the products that caused the current epidemic of youth e-cigarette usage and nicotine addiction—to flourish.”

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This isn’t the first time public-health groups have argued that the FDA needs to crack down on synthetic nicotine. CTFK first wrote to the FDA about it in 2018, in response to marketing by the synthetic nicotine supplier Next Generation Labs. (Next Generation Labs did not respond to TIME’s request for comment.) The same year, several public-health-focused attorneys argued in a Boston College Law Review article that the FDA was leaving open a loophole that companies could “exploit it in order to evade regulation” and “can, and should, address this problem by regulating synthetic nicotine products as drugs.”

Neither missive did much. In March of this year, the Wall Street Journal reported that Puff Bar—which makes a popular line of disposable, flavored e-cigarettes—was using synthetic nicotine to avoid agency regulation, sparking another letter to the FDA from CTFK and other health groups.

Abboud, from the Vapor Technology Association, says he fears that if the FDA regulates synthetic nicotine as a drug, many e-cigarette companies will go out of business, potentially handing the market back to traditional cigarette companies. “The drug [approval] pathways are even more cumbersome, even more time-consuming, and more expensive than any other [regulatory] pathway,” he says.

That may be true. But Henigan, from CTFK, says it’s unacceptable for companies to simply sell products as they see fit. “These companies are proceeding under the assumption that they’re simply unregulated,” he says. “That’s a dangerous situation.”

Source : Time More   

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‘Couldn’t have been placed in better hands’

When a cardiac arrest knocked Mark Erickson off his bike, the perfect passerby saved his life.

‘Couldn’t have been placed in better hands’

Ask Mark Erickson to recount what happened to him on the afternoon of July 31, 2020, and he’ll shake his head in near disbelief—even now, more than a year later.

That’s the day Erickson came face to face with his mortality.

He lived to tell the story because the health care system worked, from end to end. And because the right person came by at the right time with the right response.

‘He wasn’t breathing’

That sunny Friday, Erickson, 54, a mortgage underwriter, and his daughter Kayla, 20, a university student, did what they often do at the end of a workday: get outside.

Residents of Comstock Park, Michigan, the two like to hop on the nearby White Pine Trail to go walking, biking or inline skating.

“That’s where we go—‘Hey, let’s go hit the trail.’ ‘OK,’ boom. And off we go,” Erickson said.

This time they grabbed their bikes and headed north toward Rockford.

Seven miles into their ride, where the trail crosses Childsdale Avenue, Erickson blacked out and crashed to the ground, lifeless.

Kayla, cycling ahead of him, sensed his absence. She stopped, saw him lying on the path and tore back, terrified.

A couple driving north on Childsdale happened to see Erickson fall. They pulled over to call 911.

Coming upon the scene a half-minute later, Tyler Nickels followed suit and jumped out of his car.

“My first reaction to seeing him—he was pale gray, basically no color in his face,” Nickels said. “I could tell just the second I got out of the car he wasn’t breathing.”

Nickels, a Spectrum Health clinical data analyst, had an ace up his sleeve. For four years, until just eight months earlier, he’d worked as a nurse in the Spectrum Health Fred and Lena Meijer Heart Center.

He knew what to do for Erickson.

Checking for a pulse and not finding one, he started chest compressions.

When he couldn’t get Erickson breathing after nearly a minute of hands-only CPR, Nickels wanted to supplement chest compressions with rescue breaths.

But this was the summer of 2020, at the height of the coronavirus pandemic—not a good time for mouth-to-mouth resuscitation.

“If it wasn’t for COVID, I probably would have done it myself, but without knowing him and just being a stranger, I asked if there was a family member that could do some breaths.”

Though her father’s collapse had left her frantic and distraught, Kayla stepped up to help.

The two worked together until first responders arrived—first a Rockford police officer, then crews from the Plainfield Township Fire Department, Kent County Sheriff’s Office and Rockford Ambulance.

Stepping back, Nickels had doubts about Erickson’s chance of survival; he didn’t seem to be coming around. But as concerned as he was about the man’s future, he worried even more about how this event would affect Kayla.

Eventually, unable to do more, Nickels and his wife continued on to a brewery around the bend, where they were meeting friends.

There they ran into the couple from the first car, the 911 callers. They’d gotten Kayla’s phone number and agreed to let Nickels know what they learned about Erickson’s status.

Cardiac arrest

Nickels later learned that the paramedics successfully revived Erickson and rushed him to Spectrum Health Butterworth Hospital, where he underwent a series of tests.

According to Araya Negash, DO, the cardiologist on call when Erickson arrived in the trauma bay, EKG testing didn’t show evidence of an acute heart attack. Erickson therefore didn’t need an emergency heart procedure.

Tests did show bleeding in his brain, likely related to his fall. Erickson received sedation medications and was moved to the ICU for close monitoring and evaluation by the neurosurgery team.

As doctors dialed back his sedation medications, Erickson began to recover.

Further testing showed him to be neurologically intact, Dr. Negash said, and stable enough to undergo heart catheterization to explore the cause of his collapse.

Dr. Negash threaded a catheter through a thin tube inserted in an artery and took pictures of the arteries around Erickson’s heart. The images showed severe coronary artery disease—blockages in several vessels, including the left main coronary artery.

Though Erickson hadn’t experienced heart disease symptoms, these blockages had triggered an irregular heartbeat, or arrhythmia, which led to sudden cardiac arrest.

“A cardiac arrest at its core is an electrical issue, so your heart goes into an arrhythmia that oftentimes is fatal,” Dr. Negash said.

“In this case, it was a blocked artery issue that sparked an electrical issue—ventricular fibrillation.”

Because of the number and location of the blockages, Dr. Negash decided against stenting and called in the cardiothoracic surgery team.

Their evaluation led to a four-vessel bypass surgery, performed by Stephane Leung, MD.

To reduce the risk of a repeat cardiac arrest, Erickson also underwent surgery with Michael Brunner, MD, an electrophysiologist, who placed an implantable cardioverter-defibrillator below his collarbone. The defibrillator will deliver a lifesaving shock if Erickson develops another lethally fast heart rate.

Perfect timing

During his recovery, Erickson received a visit one day from a nurse who had heard Nickels’ story about the White Pine Trail rescue. In talking with a colleague, she’d matched Erickson to the story.

This nurse was Nickels’ mother-in-law, a longtime staff member at Fred and Lena Meijer Heart Center.

“So she walked into his room one day and said, ‘Hey, you may not know me, but I know you,’” Nickels said. “‘My son-in-law actually was the one that did compressions when you collapsed on the bike trail.’”

Eager to express his gratitude, Erickson asked for Nickels’ phone number. The two men have been in communication ever since—initially by text, then by phone and more recently in person.

“The whole thing just makes my head spin—just thinking about all the things that fell into place perfectly and how the Good Lord put everyone in my life like that,” Erickson said.

He still chokes up thinking about the way events unfolded that day.

“(Tyler) was everything to me, he really was. CPR doesn’t start up, and I’m not here, honestly. … As I told him, ‘You had to be the perfect person in the perfect spot at the perfect time for me to be here.’”

Kayla’s role in his rescue also sparks powerful emotions.

“She stepped up and was a true hero,” he said. “I just can’t imagine putting my child through that. But she did it. … She’s just been amazing through the whole thing.”

Erickson’s ability to work through his emotions has contributed to his strong recovery.

“He’s processed this whole event in a very healthy way,” Dr. Negash said. “He’s really kind of taken to the emotional part of getting better a lot faster than most of my patients—men and women.”

Erickson’s physical recovery has taken a fast track, too.

“When he walked in the clinic the first time I saw him back, I was expecting a very different person. If you saw him in the waiting room, you would assume that he was driving somebody else to their appointment. … I didn’t expect him to come in bright-eyed and bushy-tailed, with no real complaints.”

Erickson tells a similar story. His physical therapists had to develop a custom training regimen to keep him challenged.

And throughout his 23-day hospital stay, staff regularly told him his appearance didn’t match the things reported in his medical chart.

“I’m like, ‘I don’t know what that means. … Everyone keeps coming in and saying I don’t look like my chart. Is this good or bad?’ And they looked at me and they go, ‘Oh, it’s good.’”

His story, Erickson said, is a tale of perfect timing, of selfless heroes, of faithful family members and of “phenomenal” medical staff, all along the way.

“I couldn’t have been placed in better hands.”

Source : Health Beat More   

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