The Food and Drug Administration (FDA) under President Biden is facing intense scrutiny for what critics have described as ineffective regulation of tobacco and nicotine, allegedly caving to political pressure to ban vapes and e-cigarettes as potential alternatives to traditional smoking while simultaneously allowing Chinese products to flood the U.S. market.
The FDA’s Center for Tobacco Products (CTP) is charged with regulating the manufacture, distribution and marketing of tobacco products. However, the CTP has been under fire for its approach to vapes, e-cigarettes and other electronic nicotine delivery systems (ENDS).
While the FDA is cracking down on ENDS, it’s also allowing illicit and unregulated products to flood the market — including from China.
The FDA has sent hundreds of warning letters to companies marketing illegal e-cigarettes containing tobacco-derived nicotine, but it’s unclear whether additional enforcement actions were taken. Reports have highlighted how vape companies regularly flout the FDA’s orders and make, stock and sell illicit goods that can be seen at countless smoke shops and online retailers that aren’t approved by the FDA.
Many of these products were made in China. Indeed, at least 20 brands continue to sell China-made disposable devices with kid-friendly flavors such as “peach blueberry candy” and “pineapple strawnana” at liquor stores, smoke shops and convenience stores across the U.S., according to Reuters.
Former FDA chief Scott Gottlieb is one prominent voice who’s spotlighted the problem.
“Synthetic nicotine is being used in products like Puff Bar, that are manufactured in China and other nations, and imported into the U.S. and specifically targeted to youth,” he tweeted. “This is exactly opposite what Congress intended through its public health efforts. There are also U.S. tobacco companies that are largely following the rules, that are making investment in potentially less harmful alternatives to combustible tobacco, that pay taxes and fees on products – all while the foreign-made synthetic products evade the same requirements.”
In Congress, meanwhile, Sheila Cherfilus-McCormick, D-Fla, in February introduced legislation to close loopholes concerning ENDS containing flavors that could be enticing to children.
“Chinese manufacturers and suppliers are flooding the U.S. market with unregulated, harmful substances that are altering our children’s brain development and live,” she said in a statement.
A month later, Senate Majority Leader Chuck Schumer, D-N.Y., called on the FDA to investigate Elf Bar, a new Chinese e-cigarette that is being advertised on social media.
“Elf Bar is littering TikTok and Instagram, using influencers they pay directly, to push the e-cig to kids and teens,” he said in a statement. “This kind of ploy might totally evade FDA advertising rules, and we have to get ahead of it.”
However, critics warn that targeting one company at a time won’t solve the problem, because replacements will just pop up, posing a particular challenge for children. According to the Department of Health and Human Service’s inspector general, the FDA’s approach to overseeing online tobacco retailers “raises questions about the effectiveness of FDA’s efforts to prevent youth access to tobacco products online. In the first 10 years of its oversight, FDA’s actions toward online tobacco retailers were limited to warning letters and its oversight has had poor transparency.”
Rep. James Comer, R-Ky., chairman of the House Oversight Committee, wrote a letter in March to FDA Commissioner Robert Califf demanding documents to conduct oversight of the agency’s regulation of tobacco and nicotine products through CTP. He didn’t hold back in expressing his concerns, arguing that the agency’s regulatory system has led to “enforcement failures” and “suspicions of political interference.”
“CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate,” wrote Comer. “Therefore, we seek documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions. . . . If products are allowed to go to market or stay on the market without authorized applications, then the entire regulatory effort would appear to be pointless.”
Comer’s letter came after the Reagan-Udall Foundation published a recent report at the request of Califf evaluating the CTP’s tobacco regulatory programs. The report — the product of a panel of independent experts who concluded that “fundamental policy and scientific issues remain unanswered that the center must address” — was unable to identify a comprehensive plan that clearly articulates CTP’s goals and priorities.
“CTP is perceived as being reactive and overwhelmed, versus proactive and strategic,” the report said, adding that the center lacks clarity and transparency in how it makes decisions — especially when it comes to weighing scientific information versus policy judgments.
“Failure to take timely enforcement action jeopardizes public health and undermines FDA’s credibility and effectiveness in tobacco product regulation,” the report added. “The agency has not been transparent regarding the reasons it has failed to clear the market of illegal products, or even whether its policy preference is to do so, contributing to stakeholder frustration and, in some situations, additional litigation.”
According to Comer, the evaluation shows that the agency “appears to be unable to perform its basic functions and ensure that Americans have access to products that have the potential to lower the rate of smoking-related disease and death.”
When reached for comment for this story, the FDA pointed Fox News Digital to recent agency statements concerning tobacco regulation. In the agency’s official response to the Reagan-Udall report, Brian King, director of CTP, indicated that it would place a newfound emphasis on strategic planning.
“Effective immediately, CTP will initiate the development of a comprehensive 5-year strategic plan, building upon the foundation of the center’s previous strategic plans,” King said in the response. “Given the profound impact of tobacco-related disparities across CTP’s programmatic portfolio, the plan will include advancing health equity as a central tenet and focus on being proactive in its activities.”
The agency also listed other ways it plans on responding to the report’s varied recommendations.
However, it is unclear how the FDA will address one of the major concerns of close observers: the politicization of agency decision-making.
“We have deep concerns that CTP’s decisions have been influenced by political concerns
rather than scientific evidence,” Comer wrote in his letter.
Such concerns are apparent in comments from FDA staff to the Reagan-Udall Foundation that are no longer available on its website but present an agency that is struggling to fulfill its mandate. According to the Tobacco Reporter, one commenter said that “scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods.” They added that leadership is “unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.” Another commenter said that “in cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.”
Meanwhile, the FDA is facing political pressure from Capitol Hill to prevent ENDS from going to market. For example, several Democrats in Congress have pushed the agency to deny the applications of Juul Labs Inc., an e-cigarette company, and remove its products from the market.
At a congressional hearing in June 2021, at which the FDA commissioner was testifying, Rep. Cori Bush, D-Mo., said that “e-cigarettes have hooked a generation of young people on nicotine. The FDA has an obligation to intervene and protect our children.” Fellow Democratic Rep. Debbie Wasserman-Schultz added, “To be clear, you should reject all of Juul’s products, all of them, given what we know about how Juul marketed and addicted kids to their product.”
Several other Democrats, including in the Senate, similarly demanded a ban on Juul.
The demands continued into 2022, with Democratic lawmakers writing letters to the FDA chief. Then, on June 22 of that year, Sen. Dick Durbin, D-Ill., issued a statement calling on Califf to more tightly regulate e-cigarettes or “step aside.” The next day, the FDA banned Juul products from being sold in the U.S. by issuing marketing-denial orders.
The day after that, Rep. Raja Krishnamoorthi, D-Ill., said he was “heartened” by the FDA’s decisions following a “long conversation” he had with agency officials. He added he’s “glad that at least we have an ally in the FDA commissioner.”
The agency has since put its order denying Juul on hold, saying that “there are scientific issues unique to the Juul application that warrant additional review.”
Beyond Juul and e-cigarettes, Democrats have similarly pressured the FDA to crack down on menthol vape products, arguing that ENDS flavored as anything other than tobacco can appeal to kids. Throughout 2021 and 2022, Democratic lawmakers repeatedly sent letters to the FDA chief and said in hearings that the agency should continue denying all flavored ENDS — especially menthol ones, despite the agency previously stating that kids prefer and use flavors such as fruit and mint “much more” than tobacco or menthol. In January 2020, before the Biden administration, the FDA said that tobacco and menthol-flavored ENDS were not among the agency’s enforcement priorities.
Nonetheless, following an ongoing campaign on Capitol Hill, the FDA in October 2022 issued its first marketing-denial orders for menthol ENDS based on a full scientific review.
Months later, the drug-focused publication Filter reported that internal FDA memos showed that the CTP’s Office of Science had actually recommended to authorize menthol-flavored vaping products as permissible to go to market. However, according to the report, the office later reversed course due to pressure from agency leadership after the office of CTP Director Brian King intervened.
“These documents appear to reveal substantial disagreement within CTP, one that could be framed as the agency’s scientists battling against its bureaucratic upper ranks, who have the FDA commissioner, and ultimately Congress, to answer to,” the Filter wrote of the documents it had reviewed. “It can all be viewed, in other words, as a fight between science and politics.”
In April, the watchdog group Protect the Public’s Trust filed a complaint accusing the FDA of “knowing dissemination of scientifically unfounded statements about the vaping industry that were contrary to the FDA’s own research” and “overruling its own scientists’ recommendations to authorize menthol-vapes without proper scientific justification and in contradiction of the FDA’s own research.”
A product is deemed permissible to go to market and appropriate for public health based largely on the likelihood of it transitioning adults away from cigarettes without introducing a new generation to nicotine.
An estimated 47 million U.S. adults currently use tobacco products, and nearly 80% of them use combustible products such as cigarettes, “which are responsible for the overwhelming burden of tobacco-related disease and death,” Califf and King note in a recent article they co-authored.
Since 2005, the percentage of adult smokers in the U.S. has decreased from 20.9% to 12.5%. However, there are still about 30 million adult smokers across the country, where cigarette smoking is responsible for more than 480,000 deaths per year, according to the Centers for Disease Control and Prevention.
According to one study cited by Califf and King in their article, “there was high certainty that quit rates were higher in people randomized to nicotine [e-cigarettes] than in those randomized to nicotine replacement therapy.”
Other research indicates that daily ENDS use “was significantly associated with an 8-fold greater odds of cigarette discontinuation compared with no e-cigarette use” for U.S. adults who had no plans to ever quit smoking.
The FDA, which maintains that no tobacco product can be considered safe, has not authorized a single menthol-flavored ENDS product to date. As of January, the agency had completed review of, and made determinations on, more than 99% of tobacco products and authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S.