The FDA stands by as the vaping industry flouts its orders

WASHINGTON — The Food and Drug Administration has spent more than four years trying to decide whether retailers should be able to sell products like cotton candy-flavored liquids, vapes made to look like fidget spinners, and disposables filled with more nicotine than 200 cigarettes. And so far, the agency has explicitly ordered hundreds of them off the market.

But a STAT investigation found that vape companies are regularly flouting the FDA’s orders. They’re making, stocking, and selling the illicit goods. And the agency is just letting it happen.

The defiance is on display at thousands of smoke shops around the country, and at countless more online retailers.

Take EJuiceDB.com, a website that sells over 7,000 vape liquids. The FDA hasn’t formally greenlit a single one of those flavors, meaning they’re all technically illegal. But in several cases, the agency has gone further and explicitly banned certain products — and they’re still for sale, too. A banned “sunset sherbert” flavor, for example, is one of the site’s best sellers.

It’s not just flavored liquids, either. For instance, Wizman Limited, a Hong Kong-based company, is still selling a vape holder shaped like a Gameboy, even though the FDA banned it two years ago, saying teens might use it to hide vaping from their parents.

STAT’s investigation examined the main way the FDA has tried to crack down on vape companies selling illegal products. It’s ordered more than 100 vape manufacturers to stop making more than 250 specific flavors and vapes — but we found scores of companies, across the country, that are defying the FDA’s demands.

The reporting reveals, too, just how reluctant the FDA is to use its power to rein in bad actors. The agency has sweeping legal authorities to crack down on vape companies that ignore its bans, ranging from levying seven-figure fines to physically pulling products off shelves. But the FDA has never used those powers, according to its own data. In several cases, it’s even dropped cases against companies that it knows are still selling illegal products.

The agency’s approach has been so conservative in certain cases that one legal expert compared it to a cop pulling someone over for running a red light while drunk — and then writing them a ticket for the traffic violation and sending them on their way.

The “FDA has been a toothless tiger that the industry isn’t afraid to ignore,” said Matt Myers, the president of the Campaign for Tobacco-Free Kids. (The Campaign, like STAT, receives funding from Bloomberg Philanthropies.)

The FDA declined STAT’s request for an interview with either FDA Commissioner Robert Califf or the head of the FDA’s Center for Tobacco Products, Brian King. But a spokesperson implied the agency may soon get tougher against companies that ignore its orders.

“The agency is currently working on further enforcement in situations where companies that have [been banned from the market] continue to sell illegal products,” the spokesperson wrote in an email. “The FDA is currently engaged in discussions with the Department of Justice (DOJ) regarding specific potential enforcement actions.”

Vape shops, for their part, argue that the FDA’s orders aren’t clear enough. Until they understand exactly what’s illegal and what’s not, they’ll keep operating.

“[Vape shops] are doing their best, despite a complete lack of clarity or transparency from the agency, to piece together what products are still legally able to be sold,” said Amanda Wheeler, the president of the American Vapor Manufacturers. “It would be legally and morally irresponsible for us to recommend that companies should voluntarily close down their businesses because FDA cannot sort out their filing systems.”

The way the FDA regulates vapes and vape liquids was shaped both by Congress’s 2009 law empowering it to regulate tobacco and a regulation — fiercely opposed by vape shops — that extended the rules governing cigarettes and cigars to e-cigarettes. Technically, every company that manufactures a vaping product — whether that’s mass-producing millions of disposable e-cigs in a Chinese factory or mixing up e-liquid in the back of a corner-store shop — is supposed to get the FDA’s permission before selling its wares stateside.

Originally, companies were supposed to ask FDA’s permission to sell by November 2018, a step also known as filing an application with the agency. But the FDA and a federal court pushed that deadline to September 2020.

In the intervening years, countless companies sold their products without FDA permission, and the vaping industry boomed. Juul grew from a small, 200-person company to a $15 billion enterprise with a 1,500-person workforce. Overall, e-cigarette sales increased six-fold, from $304.2 million in 2015 to $2.06 billion in 2018, according to a recent government study.

Last year, the FDA finally started formally denying some companies’ requests to sell their products. In many cases, the companies just ignored them, complaining that the regulatory process was too burdensome or even “over-reaching.”

The agency’s response has been to send letters to companies alerting them that they’re selling illegal products. Just one or two pages, but exceedingly formal in tone, the letters suggest the FDA will take legal action if the companies don’t stop. The FDA has issued hundreds of so-called “warning letters” in recent years.

STAT reviewed 120 letters issued to vaping companies between August 2021 and May 2022, covering bans on some 274 named products. According to company websites and information provided by vape shops by phone, at least 139 of the products are still being sold — more than 50% of the products named in those warnings.

Those eager for vape liquid flavored like strawberry milk can easily purchase it from Vape Craft Inc., despite the FDA’s warning to the company in November 2021. Those more enticed by watermelon limeade can acquire that from Nevada-based Baton Vapor.

“If a large portion of the vaping products FDA has ordered off the market are still being sold, I’m baffled,” said Bill Schultz, a former deputy FDA commissioner who also served as the federal health department’s top lawyer and who represents the Campaign for Tobacco Free Kids among other clients. “Congress gave the agency the authority to act decisively and they should be using it.”

STAT’s investigation likely underestimates the level of intransigence among vape companies because it focused on those that have shown themselves most willing to play by the FDA’s rules. STAT only analyzed warning letters sent to companies that formally asked the agency for permission to sell their products, and then had that request denied. It did not focus on the hundreds more companies that received warning letters for never asking the FDA for permission at all.

The review also did not count products in its tally when it was impossible to determine whether the manufacturer was making the product illegally or if the retailers were simply selling leftover stock of a discontinued product. More than 30 other banned products are still available online through third party sellers, for example.

Tobacco-control advocates blasted the findings as further proof of the shortcomings in the FDA’s approach toward enforcing the tobacco law, which has focused entirely on issuing these warning letters.

Eric Lindblom, a former FDA official who is now a senior scholar at Georgetown University, argued that the FDA’s slow piecemeal approach is enabling bad behavior from vaping companies.

“FDA’s enforcement has to be clearer, quicker, and sharper,” said Lindblom. “It just takes too damn long.”

Even some people who support vaping as an alternative to smoking were also alarmed by the findings. They argued that the industry’s intransigence and the FDA’s lack of action could actually hurt the effort to expand access to vaping.

“All [these vape shops] are doing is reinforcing the views of those people that want to make vaping go away. … There is no legitimacy in ignoring the law,” said Peter Pitts, a former FDA official, who has frequently spoken about the promise of vaping and whose organization has previously received funding from Juul.

Jasjit Ahluwalia, a professor at Brown University who has publicly urged the FDA to approve vaping devices to help smokers quit, said the agency should step up its enforcement game against bad actors.

“I say hit them with big fines,” he said.

Wheeler, the president of the American Vapor Manufacturers, argued there are multiple legitimate reasons why vape shops are staying on the market after the FDA bans them.

She noted, for example, that many companies have tried to file “administrative appeals” with the FDA, challenging the agency’s decisions on their products. But the FDA never formally decided how to respond to those requests. (The FDA does not disclose which companies file such appeals, so it is impossible to say definitively how many companies have done so.)

She also argued that multiple companies whose products the FDA had banned had filed new applications with the agency when they started making products with nicotine cooked up in a lab, rather than extracted from a tobacco leaf. Those new requests haven’t yet been denied, so they believe they should be allowed to keep selling in the interim. (Technically, this is also illegal.)

Vape shops have also insisted that their products help people quit smoking, and that they are being unjustly put out of business.

“Thousands of businesses have already been shuttered, investments wiped out, employees laid off, innovation strangled, and customers left in the cold, many of them corralled back into smoking cigarettes,” Wheeler added.

It’s true that several studies have shown that vaping can be helpful to help people quit smoking. A recent literature review, for example, found that “nicotine e-cigarettes probably do help people to stop smoking for at least six months [and] they probably work better than nicotine replacement therapy and nicotine-free e-cigarettes.”

Public health officials argue, however, that the FDA’s reviews should be trusted, especially given that the tobacco law tasks the FDA explicitly with determining whether authorizing the sale of each vape product is “appropriate for the protection of public health.” Public health groups have also raised concerns about e-cigarettes’ ability to addict users, particularly kids, to nicotine. They’ve raised concerns, too, about the potential health risks associated with the chemicals vape users are inhaling when they use e-cigarettes.

For an agency tasked with policing the tobacco industry, the FDA is remarkably easy to placate.

In some surprising cases, the agency has closed its cases with vape manufacturers even when it knows the companies are selling illegal products.

Take, for example, Rocky Top Vapor, which operates five stores in Tennessee. The FDA ordered that company to stop selling its Berry Shake and Pink Lemonade vape juice in April 2021. This July, the agency sent them a so-called “close-out letter” because Rocky Top had stopped selling those two products. But just one paragraph later, the letter makes it clear the FDA knows Rocky Top is still selling other products that it hasn’t greenlit.

“I’m completely nonplussed by almost all FDA inaction but even this [scenario] is incredibly egregious to me,” said Desmond Jenson, the lead senior staff attorney for federal regulation at the Public Health Law Center. “This is just about as lazy as enforcement gets …There’s no incentive to play by the rules if you can get away with this.”

The FDA has also closed cases against companies that are still selling the exact products the agency took issue with in the first place.

The agency ordered the Tennessee-based vape shop Nashville Vapor to stop selling two products in October 2021. And then it issued a so-called “close-out letter” this July, saying “it appears that you have taken steps to address the violations contained in the Warning Letter.” But both products are still for sale, even now, a Nashville Vapor salesperson confirmed to STAT.

The agency did the same with Vapor Maven in Arkansas. The FDA ordered the company to stop selling two e-liquids in February 2021 and later issued the company a “close-out letter” that was almost identical to the one it issued Nashville Vapor. But a salesman for the company confirmed that both of those products are still for sale, too.

It’s not as clear in those cases whether the agency knows the products are still for sale. The FDA spokesperson declined to comment.

It’s not an easy thing for the FDA to seize a company’s products or shut them down entirely. The FDA typically works directly with the Justice Department to make a legal case against a bad actor – and that process takes time. It took the FDA two years, for example, to ask a court to shut down a company that sold illegal sexual enhancement supplements.

The FDA, across its entire portfolio of food, drugs, and supplements, has sought 15 injunctions and conducted two product seizures in the last two and a half years. Not a single one has involved a tobacco company.

There’s also an open question of whether taking a company to court would be the smartest course of action for the agency, argued Marc Scheineson, a partner at the law firm Alston & Bird who has represented vapor companies.

Scheineson argued that the FDA’s approach toward vape shops has been “unnecessarily overkill” and said that the FDA may have trouble convincing the Department of Justice to take small vape shops to federal court. If the agency lost its case, moreover, it might significantly set back its regulation of vaping writ large.

“I can’t believe … anybody is going to want to use the full resources of the Justice Department to go after Vape Store Number One in Cody, Wyoming,” said Scheineson, who was previously an associate commissioner at the FDA.

But the agency has an intermediate step at its disposal, one that legal experts say the agency has much more leeway to use.

The FDA has the authority to fine vaping companies that don’t play by the rules, and it can do so virtually as soon as it has issued a warning letter and then conducted a follow-up inspection.

And the FDA is no stranger to fining — in the last decade, it’s issued more than 2,300 fines to retailers that sold vapes to teens employed as secret shoppers. But the FDA has never used the same power to fine a vaping company that is selling illegal products, even though every warning letter underscores that the FDA can fine the company if it doesn’t comply.

The lack of serious enforcement action is striking, not just because vape manufacturers have shown themselves willing to ignore the FDA’s orders, but also because of the sheer number of legal violations the FDA has found throughout the tobacco industry.

The agency has issued 115,331 warning letters to smoke shops, cigarette makers, vape makers and other tobacco companies since 2009. It only issued 1,865 letters to pharmaceutical companies over the same period.

Sometimes, warning letters work. A series of such missives, co-signed by the FDA and the Federal Trade Commission in 2018, ordering vape companies to stop selling products made to look like kids’ candy, was largely successful. The majority of the companies the agencies chastised then have stopped selling their products. The others have largely changed their labels to make the products look less like candy.

But even then, the agency has failed at keeping similar copy-cat products from simply filling the void.

While the FDA was successful in ordering Elite Vaporworks to stop selling its “Whip’d Strawberry” vape liquid, those looking for a similar flavor can still buy it from several companies, including Caribbean Cloud Company, a company whose own label mimics the ice cream chain Baskin Robbins. (Caribbean Cloud Company said in a statement that its  Strawberries & Cream e-liquid “accounts for less than .01% of our sales” and that the company complies with all FDA regulations.)

There is a chance that the FDA’s approach toward vaping is beginning to change. The agency appointed a new director for the center in July, after the longtime former head retired.

Brian King insists he’s ready to get tough on vaping companies.

“I will not stand by as illegal products with the potential to cause a new generation of youth to become addicted to nicotine, proliferate in the marketplace,” King wrote in a recent blog post.

So does Commissioner Robert Califf, who has acknowledged that the tobacco center has “faced a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations.” He has ordered an independent probe of the center’s operations, and told a prominent lawmaker that “optimizing our enforcement activity” will be a “major focus” of that probe.

An FDA spokesperson also emphasized that the FDA is looking at ways to improve its approach toward enforcement.

“We are looking at ways to be more efficient and effective,” she said.

This article was supported by a grant from Bloomberg Philanthropies.