Blue Hole New Consumer Report, February 8 news, according to foreign reports, while top tobacco regulators are distressed about the fate of the e-cigarette industry, another type of e-cigarette is quietly replenishing the market with unregulated flavored products - it attract more and more children.

For the user, these e-cigarettes are the same. But thanks to an unknown loophole, they bypassed the FDA's regulatory umbrella. These e-cigarettes do not contain tobacco-derived nicotine, the addictive stimulant found in traditional cigarettes and vaping products, but are lab-made versions.

The difference puts synthetic e-cigarettes out of the FDA's reach, meaning manufacturers are free to sell fruit- or dessert-flavored products popular among teens. While these products are only legally available to adults over the age of 21, teens are increasingly finding ways to obtain them.

A 2021 survey by the Centers for Disease Control and Prevention found that 28.6 percent of middle school students vaping used a device called the Puff Bar, making it the top choice for brands including power players like Juul and NJOY, which use traditional nicotine. The popularity of Puff Bars is up from 7.3 per cent the year before, although overall teen vaping rates have fallen.

"Whatever they do to combat youth e-cigarette use, synthetic nicotine has completely destroyed it," said Natalie Hemmerich, a senior attorney at the Public Health Law Center, which focuses on federal tobacco policy.

The FDA insists it is investigating the issue, but it is increasingly drawing attention from anti-smoking advocates and lawmakers.

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

"We have to close this loophole to make sure we understand the risks and benefits, especially dealing with children," Califf told the hearing.

The FDA began regulating e-cigarettes as tobacco products in 2016 with a mission to phase out e-cigarettes that may appeal to young people or non-smokers. Over the past five years, the agency has issued decisions to eliminate closed-system flavored pods, as well as flavored single-use e-cigarettes and flavored e-cigarette juices. It has yet to decide the fate of some 55,000 vaping products, most from major market players accused of attracting teens over the past few years.

The FDA action inadvertently helped clear competition from synthetic e-cigarettes. For example, deflavored closed-system pods led to the rise of single-use flavored pods—even before some companies switched to synthetic nicotine.

Tony Abboud, executive director of the Vapor Technology Association, a trade group for the vaping industry, said: "I don't know how to explain the action, other than a big welcome sign.

Synthetic nicotine, like nicotine derived from tobacco, is addictive and can become a lifelong habit in young children who are initially drawn to flavored forms.

"We have to close this loophole to make sure we understand the risks and benefits, especially dealing with children."

Unlike traditional vaping products regulated by the FDA, consumers cannot know exactly how synthetic products are made.

"You can't say for sure ... whether they are more addictive, whether they pose additional health hazards," said Matthew Myers, president of the Campaign for Tobacco Free Kids. "And of course there is no regulation on the amount of seasoning."

Puff Bar switched 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, CEO and co-founder of Puff Bar, said the move is aimed at serving adult customers looking for an alternative to cigarettes.

"Adults love the taste," he said. "Just because we have flavors doesn't necessarily mean we're marketing to kids."

Beltran said that if kids use his products, it's because the supplier didn't check their age, or they got it from someone else.

"It's like kids these days and how they get alcohol," he said. "You go to any high school party and there's alcohol there."

He said the FDA should focus more on sales enforcement and protections against counterfeit synthetic e-cigarettes. Currently, there is no way to easily distinguish between tobacco-derived nicotine products and synthetic products.

Advances in manufacturing technology have also made it easier for vape juice makers to switch to synthetic products. Lab-made nicotine has been on the market since 2014, though at the time it was so expensive to produce that most companies avoided it. But lab synthesis has become cheaper, making the proposition more attractive to manufacturers. While lab-made nicotine is still more expensive than tobacco-derived nicotine, some e-cigarette makers use products from U.S. companies, while others, including Puff Bar, use tobacco-free nicotine made in China.

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

"For years, the FDA has sat on this issue," he said. "The longer the FDA is inactive, the more likely the courts will begin to sympathize -- far more sympathy with manufacturers than with public health or the FDA."

Lindblom said he tried to create regulations for synthetic nicotine, but others at the agency didn't make it a priority because it was expensive a few years ago. "People say, no, no, no, this will never happen. Synthetic nicotine is very expensive and we don't have to worry about it," he said. "Well, they do it now."

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

Without congressional action, the FDA could create rules or take other actions to expand its powers to regulate synthetic nicotine. But many doubted there was a desire to do so because of uncertainty at the top of the agency — California may have no pending votes, and the head of the FDA's tobacco division, Mitch Zeller, will step down in April.

“The absence of leadership at FDA and the departure of the director of the Center for Tobacco Products means that, in government, no one is making these decisions,” Abboud said. "They wouldn't want to take on this with so many changes."

An FDA spokesperson emphasized that the agency has been making progress with all other e-cigarettes under its jurisdiction. So far, it has made a decision on 99% of the 6.7 million e-cigarettes that have submitted applications, most of which were ordered from the market. The FDA is in the final stages of reviewing the remaining 55,000 applications, including applications from the largest companies on the market.

While some believe the agency may try to regulate synthetic nicotine as a drug under existing authorizations, the FDA says on its website that it will "treat" these products "on a case-by-case basis."

"The FDA is actively investigating this issue and considering how best to address such products," an FDA spokesman said. "In the short term, the agency is exploring how best to address the growing number of products that are subject to regulatory jurisdiction issues due to their nicotine source."

While synthetic nicotine is still on the fringes of regulation, kids are using it as a Habit.

She looked at vaping trends among young people and said that three years ago, they didn't even ask participants if they used synthetic nicotine vaping. Now, though, "there's definitely not a negligible percentage of people reporting synthetic nicotine use," she said. The exact number is hard to pin down because some teens don't even realize they're using it.

"Synthetic nicotine undermines the FDA's efforts to eliminate flavored e-cigarettes that appeal to children," Myers said. "It could broadly undermine the FDA's overall jurisdiction over e-cigarettes, as it is an avenue for any company that wants to evade regulation."

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