The result is widespread confusion, with industry watchers predicting that many smaller manufacturers are likely to keep selling banned products until FDA’s enforcement strategy becomes clearer.
With the FDA’s limited enforcement capabilities, “I assume most places would keep selling [denied products],” said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy. It is possible that states could step in to add another layer of regulation, but that is far from guaranteed.
“If you’re giving [vape shops] a choice between closing business and filing for bankruptcy and continuing to sell their products to adult consumers … they’re going to keep selling,” said the chief compliance officer of an e-liquid manufacturer in Ohio, who requested anonymity because of their ongoing relationship with FDA. The agency told the Ohio firm to stop selling flavored products, but the company is waiting to learn whether it can continue selling menthol and tobacco e-liquids.
The likelihood that many vaping shops will continue to offer banned flavors — such as strawberry and watermelon — has raised doubts among industry and anti-smoking advocates alike about whether FDA’s recent regulatory decisions will benefit public health.
“The agency took a big step backwards in harm reduction,” said a senior tobacco industry official who requested anonymity because FDA is still reviewing e-cigarette applications. “If there’s no one who has a flavored product that can get through, people are going to be less likely to switch” from cigarettes, he said. “Or manufacturers — like smaller folks — will find a workaround.”
That attitude plays into the thinking of some shop owners who plan to continue to sell their banned flavors of e-cigarettes. “In the grand scheme of vices, [vaping] is probably worse than coffee, but better than cigarettes,” said one vape-store owner in Arizona who is still offering flavored products that FDA ordered off the market. “I never said that it was healthy … I don’t think I’m doing anything wrong from an ethical or moral standpoint.”
The Arizona shop owner, who requested anonymity due to fear of retaliation from the FDA, received a warning letter from the agency in late August regarding the sale of their e-cigarette products. Warning letters are the first step of enforcement the agency can take against e-cig manufacturers who sell products without FDA’s permission.
A spokesperson for FDA said that the agency employs roughly 5,000 regulatory-compliance officers, along with subject-matter experts. They work together to conduct unannounced inspections on all kinds of manufacturers, some of which specialize in tobacco. The agency also partners with third-party contractors to conduct inspections on vape shops that are manufacturers and retailers. Though physical, unannounced inspections have declined over the pandemic due to safety concerns for FDA officers, online monitoring and surveillance has not stopped.
FDA can send warning letters to companies that sell banned e-cigarette products or products they never submitted to the agency for marketing approval. In one July letter, FDA told a company to stop selling 15 million e-liquids for which it had not sought a federal review. If FDA determines that the company has continued offering these products after receiving the letter, the agency can issue increasing financial penalties amounting to hundreds or thousands of dollars. Eventually, it can order violators to stop selling tobacco products entirely for a period of time.
But less than a month after the Sept. 9 decision deadline, it’s hard to tell how aggressively the agency will move to enforce the new limits on flavored vapes. So far the agency has struggled to verify that e-cigarette companies are heeding its enforcement.
“By and large, the inspectors haven’t done much,” said Gregory Conley, an attorney and president of the American Vaping Association. But he said that may change now that so many companies have received official orders to take their products off the market.
Mitch Zeller, the FDA’s lead tobacco regulator, has said that the agency won’t be able to ensure that every affected vaping manufacturer is complying with FDA’s rules. Instead, Zeller said in his Sept. 9 statement, the agency will focus on products the agency rejected and those for which it never received an application, followed by products FDA considers most likely to appeal to youth.
An FDA spokesperson declined to say if the agency has additional plans to ramp up in-person inspections of vaping manufacturers or retailers.
The Arizona vape shop owner who received an FDA warning letter said they never filed an application for their products because it was unaffordable. “It would be incomplete and a joke,” they said. The agency then ordered the company’s products off the market because it never reviewed them. Technically, the shop owner could apply — but they doubt any of their products would receive market clearance because they include the sort of fruity, sweet flavors that FDA is working to stamp out.
The Arizona shop owner is still selling some of their products in defiance of the agency’s order. Although the store’s website says it no longer sells the products online, it offers $19.99 wristbands and $21.99 stickers — stand-ins for vape products the shop owner will still sell to clients they know personally. “These are long-term customers … and the average age of my web customers is probably 50,” they said. But, they added, “I’m certainly going to lose any potential new business.”
The Arizona shop owner also plans to keep selling their vape products in person — covertly. “My wife is from Senegal, so we’re going to convert this place into an African market … everything is going to be out of sight,” the owner said. Customers who know the shop owner would have to come in and ask for them by name.
Many smaller vape manufacturers say they can’t afford to stop selling products the FDA has ordered off the market. They also see a double standard at work because the agency has not acted on vaping applications from the industry’s biggest players.
“The simple fact of the matter is that Juul and Vuse are still for sale,” said the Ohio-based e-liquid manufacturer — arguing that those big companies’ vaping products are the most appealing and accessible to minors. If FDA is using its enforcement discretion for these brands, “then we should be able to continue to be sold so we can continue to fund our studies and our science, which the FDA says we cannot,” the Ohio manufacturer said.
Other vape shop owners are looking for legal ways around FDA’s orders. Some are toying with the idea of using synthetic nicotine in their e-liquids instead of nicotine derived from tobacco. That’s because FDA’s Center for Tobacco Control defines tobacco products as those that contain ingredients that come from the actual plant. And if vaping liquid doesn’t contain natural nicotine, it wouldn’t fall under FDA’s oversight.
“I’ve heard of several companies that have made plans to do that,” said a Texas vape shop owner. In February, Puff Bar, a major e-cigarette manufacturer, employed this strategy to resume selling its flavored products online, despite receiving orders to pull them from the market in 2020.
But it’s unclear whether switching to synthetic nicotine is a viable long-term strategy. A 2010 court decision gave the FDA authority to regulate all nicotine as a drug, even when it appears in products, such as smoking-cessation gum or patches. Synthetic nicotine would technically fall into this category, although the agency hasn’t said so explicitly.
Earlier this month, several public health groups, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics and the American Lung Association, wrote a letter to FDA urging the agency to regulate synthetic nicotine as a drug in order to stop vape shops from selling it without approval.
In the meantime, vape shops that are halting product sales in the wake of FDA’s recent decisions are considering whether to sue the agency. “In our association, the biggest thing that we’re hearing is a desire to pursue any available litigation avenues,” said Amanda Wheeler, the president of the American Vapor Manufacturers Association.
“We’re very committed to following the law,” Wheeler said. But she added that “there was a definite moving of goal posts that has happened through FDA throughout the course of the PMTA process,” which she and her member organizations found “concerning.”
Jenson, the commercial tobacco lawyer, believes that the legal path forward for vaping manufacturers won’t be easy. “It is a very uphill battle,” he said. The onus would be on the firms to prove that the FDA had acted in a way that was “arbitrary or capricious,” which is nearly impossible, he said.
Ultimately, public health experts believe that FDA will need help from states and the public to significantly crack down on unauthorized e-cigarettes.
“Like any public health problem, there need to be multiple mitigation strategies,” said Mary Hrywna, assistant professor at Rutgers-School of Public Health and a founding member of the Rutgers Center for Tobacco Studies. “We can’t only rely on the federal government to regulate what is a very complicated marketplace that continues to evolve.”