Synthetic nicotine | Unregulated and increasingly popular

To users, these vapes are identical. But because of an obscure loophole, they skirt the FDA’s regulatory umbrella.

While top tobacco regulators dawdle over the fate of the e-cigarette industry, another class of vape is quietly restocking the market with unregulated, flavored products — and it’s drawing in a growing number of kids.

To users, these vapes are identical. But because of an obscure loophole, they skirt the Food and Drug Administration’s regulatory umbrella. Rather than containing tobacco-derived nicotine, the addictive stimulant found in traditional cigarette and vape products, these vapes have a lab-made version.

That difference puts synthetic vapes beyond the FDA’s reach, which means that manufacturers freely sell fruity- or dessert-flavored products popular among teens. While these products are only legally available to adults over 21, teenagers are increasingly finding ways to obtain them: A 2021 survey from the Centers for Disease Control and Prevention found that 28.6 percent of middle and high school students who vape used a synthetic nicotine brand called Puff Bar, making it the top choice of brands among a list that includes power players like Juul and NJOY, both of which use traditional nicotine. Puff Bar’s popularity is up from 7.3 percent the year prior, even as overall youth vaping rates have declined.

“Whatever drops in the bucket they’ve made to try to combat youth e-cigarette use, synthetic nicotine has completely undermined it,” said Natalie Hemmerich, a senior staff attorney at the Public Health Law Center, who focuses on federal tobacco policy.

The FDA insists it is looking into the issue, but it’s a growing concern for anti-smoking advocates and lawmakers.

Sen. Tammy Baldwin (D-Wis.,) grilled Robert Califf, President Joe Biden’s embattled FDA nominee, over synthetic nicotine’s growing popularity among children during his confirmation hearing in December.

“We’ve got to close this loophole so that we make sure that we understand the risks and benefits and particularly deal with the issues in children,” Califf said at the hearing.

The FDA began regulating e-cigarettes as tobacco products in 2016, with the mission of weeding out vapes that could lure young people or non-smokers. Over the past five years, the agency has issued decisions that have removed closed-system flavor pods, as well as flavored disposable vapes and flavored vape juice. It has yet to decide the fate of some 55,000 vape products, most of which hail from major market players accused of hooking teens in years past. The FDA’s actions inadvertently helped clear away the competition for synthetic vapes. Removing flavored closed-system pods, for example, led to the rise of disposable, flavored pods — even before some companies switched to using synthetic nicotine.

“I don’t know how to interpret that action, other than a big welcome sign,” said Tony Abboud, the executive director of the Vapor Technology Association, a trade group for the e-cigarette industry.

Synthetic nicotine, like nicotine derived from tobacco, is addictive and can become a lifelong habit for the young kids initially drawn to the flavored forms.

And unlike traditional vaping products, which can be regulated by the FDA, consumers have no way of knowing exactly how a synthetic product is made.

“You can’t say for certain … whether they’re more addictive or not, whether they might have posed additional health hazards or not,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. “And there’s certainly no regulation over the content of the flavorings.”

Puff Bar pivoted to synthetic — or tobacco-free — nicotine in early 2021, after the FDA ordered it to stop selling its tobacco-derived flavored products in 2020.

Patrick Beltran, the chief executive officer and co-founder of Puff Bar, said the move is meant to serve their adult customers looking for an alternative to cigarettes.

“Adults like the flavors,” he said. “Just because we have flavors doesn’t necessarily mean that we’re marketing to kids.”

Beltran said that if kids are using his product it’s because vendors aren’t checking their age, or they’re getting it from someone else.

“It’s like kids, now, and how they get alcohol,” he said. “You go to any high school party there’s gonna be alcohol there.”

The FDA, he said, should focus more on sales enforcement, and protection against counterfeit synthetic vapes. Currently, there is no way to easily distinguish tobacco-derived nicotine products from synthetic products.

Advances in manufacturing technology are also making it easier for vape juice manufacturers to switch to synthetic products. Lab-made nicotine has been available since 2014, although at the time, it was so expensive to produce that most companies avoided it. But lab synthesis has gotten cheaper, making the proposition more enticing for manufacturers. Even though lab-made nicotine is still more expensive than tobacco-derived nicotine, some vape manufacturers use products from U.S. companies, while others, including Puff Bar, use tobacco-free nicotine manufactured in China.

Eric Lindblom, a former official at FDA’s Center for Tobacco Products who is now a senior scholar at the Georgetown University Law Center, said the FDA needs to act soon before the industry becomes so entrenched that courts and lawmakers are loath to step in.

“FDA has been sitting on his hands on this issue for years,” he said. “The longer FDA does nothing, the more likely the courts are going to start being sympathetic — much more sympathetic for the manufacturers than they are for the public health or for FDA.”

Lindblom said he tried to create regulations for synthetic nicotine, but others within the agency didn’t see it as a priority due to its high costs of years’ prior. “People said, ‘No, no, no, that’ll never happen. Synthetic nicotine is so expensive, we don’t have to worry about it,’” he said. “Well, they do now.”

Rep. Mikie Sherrill (D-N.J.) introduced legislation last year that would allow the FDA to regulate synthetic nicotine, but the bill hasn’t gained much traction.

Absent congressional action, FDA could create a rule or take other action to expand its authority to regulate synthetic nicotine. But many are skeptical there is the will to do so given the uncertainty surrounding the top of the agency — Califf may not have the votes to be confirmed, and Mitch Zeller, the head of FDA’s tobacco branch, is set to step down in April.

“Having no leadership at FDA and having the Center for Tobacco Products director also leaving means that, in government, nobody’s going to make these decisions,” Abboud said. “They’re not going to want to take this on with such flux.”

A spokesperson for the FDA emphasized that the agency has been making progress on all other e-cigarettes it has jurisdiction over. So far, it has made decisions on 99 percent of the 6.7 million e-cigarettes that submitted applications, most of which were ordered off the market. The FDA is in the final stages of the review for the remaining 55,000 applications, including those from the largest companies on the market.

While some feel the agency could try to regulate synthetic nicotine as a drug under existing authority, the FDA, on its website, says it will handle those products on a “case-by-case basis.”

“The FDA is actively investigating this issue and considering how best to address such products,” the spokesperson from the FDA said. “In the short term, the agency is exploring how best to address the growing number of products where regulatory jurisdiction is in question due to the source of the nicotine.”

While synthetic nicotine lingers in regulatory limbo, kids are picking it up as a habit, according to Jessica Barrington-Trimis, an assistant professor of population and public health sciences at the Keck School of Medicine at the University of Southern California.

She studies trends in youth vaping and said that three years ago, they didn’t even ask participants if they used synthetic nicotine vapes. Now, though, “it’s definitely not a negligible proportion of people who report using synthetic nicotine,” she said. The exact figure is hard to pin down because some teens don’t even realize they’re using it.

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Katherine Ellen Foley – Politico – 2022-02-07.