The U.S. Food and Drug Administration and the Department of the Treasury have announced a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of electronic nicotine delivery system (ENDS) products into the electronic imports system operated by U.S. Customs and Border Protection.
The new requirement will help streamline the process of reviewing the admissibility of ENDS products into the United States, according to the FDA’s website.
After an applicant submits a marketing application for a new tobacco product, FDA assigns a unique identifier called an STN. Under the proposed rule, if finalized, any ENDS product, including e-cigarettes, for which the STN is not submitted may be denied entry into the U.S.
An FDA-issued STN is one data element that is important to FDA’s admissibility review and determination, which also includes review of other information about the product as well as possible sampling and examination of the product, according to the agency.
“Beginning tomorrow, the docket for the proposed rule, titled ‘Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products,’ will be open for public comment through October 15, 2024.
Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.”Beginning tomorrow, the docket for the proposed rule … will be open for public comment through October 15, 2024.
Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.
The FDA’s first premarket approval of a mentholated vape product reflects poorly on the agency’s authorization process.
By Stefanie Rossel
Lindsay Stroud
On June 21, the U.S. Food and Drug Administration for the first time authorized nontobacco-flavored vape products through its premarket tobacco product application (PMTA) pathway. The agency issued marketing granted orders (MGO) for two Njoy Ace menthol flavor pods and two disposable e-cigarettes, Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 2.4 percent. The news was hailed as a “significant decision” and a “watershed moment for the sector” that will have a “huge and significant impact” on the global reduced-risk products market.
Upon closer inspection, however, the authorization is less of a breakthrough than these superlatives suggest. Instead, it again highlights the many problems with the agency’s authorization process for electronic nicotine-delivery systems (ENDS) and novel nicotine products.
Lindsey Stroud, senior fellow with the Taxpayers Protection Alliance, describes the recent FDA authorization as a small step in the right direction in what has otherwise been a regulatory nightmare. “While allowing the sale of a nontobacco-flavored ENDS, FDA seems to understand that adults who use menthol-flavored combustible cigarettes should have access to products which are significantly less harmful,” she says. “Unfortunately, the FDA still continues to deny the sale of all other flavored ENDS, despite their effectiveness in helping adults quit smoking and remain smoke-free.”
Stroud is also concerned about the informal market. “Despite FDA not having issued authorization orders for flavored ENDS, a large, unregulated marketplace exists in the United States—99.9 percent of which are nontobacco flavored,” she says. “FDA must recognize the role that other flavors play in tobacco harm reduction because denialism isn’t stopping the flourishing non-FDA-authorized ENDS marketplace.”
Jeffrey Smith
Jeffrey Smith, a senior fellow in harm reduction at the R Street Institute, says he welcomes any action by the FDA Center for Tobacco Products (CTP) that supports reduced-risk options for those who smoke. “Unfortunately, in the grand scheme of things, the awarding of an MGO to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP,” he says. “If the regulatory environment does not change through external pressures, it is unlikely that the actions of the CTP will evolve in a swift and effective manner.”
Gray Market to Persist
While optimists may detect a new willingness to approve reduced-risk products (RRPs) in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals.
“Since the awarding of the Njoy menthol products, there haven’t been any additional actions or signals that more may be coming,” says Smith. “The only additional communications I have seen from the CTP since the Njoy announcement was a letter from the FDA to the clerk of the Supreme Court informing the court that the CTP had granted a marketing order to four menthol-flavored e-cigarette products. The case is the Logic v. FDA, where Logic is arguing that the CTP had adopted a blanket policy of rejecting menthol-flavored products.”
Stroud says the menthol announcement is a positive development but notes that the FDA remains opposed to any flavors that don’t exist in traditional tobacco products. “Dr. Brian King, director for the Center for Tobacco Products, is very anti-flavor, if not anti-vape,” she says. “Going back to at least 2015 and his time at the CDC [Centers for Disease Control and Prevention], King has been first to tout the Bloomberg party line that ‘flavors hook kids.’ This is in direct contrast to U.S. youth survey data, which finds flavors as one of the least-cited reasons why youth vape. FDA must recognize the role of flavors, their appeal to adults who smoke and how flavors help to reinforce a negative taste—literally—associated with combustible cigarette smoke. Until FDA recognizes this, the U.S. ENDS market will remain a large gray market.”
Unlike most other vape products that have received FDA authorization to date, the Njoy menthol variants are technologically up to date and relatively popular with consumers. “According to Altria’s first-quarter 2024 report, Njoy made up 4.3 percent of the U.S. retail market, but this will likely grow as Njoy is now the only menthol-flavored—and nontobacco-flavored—ENDS product legally permitted to be for sale in the U.S.,” says Stroud.
She is undecided about the FDA decision’s potential impact on the global RRP landscape. “I would imagine that with FDA recognizing the importance of menthol, most countries would follow the agency’s findings,” she says. “Unfortunately, due to a de facto flavor ban in the U.S., there is precedent for countries to restrict flavors, despite them not experiencing a huge surge in youth vaping as the U.S. did in 2019.”
“The awarding of a marketing granted order to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP.”
Depressing Number
Nicotine companies have long lamented the FDA’s product authorization process, which they say is needlessly time-consuming and costly and favors deep-pocketed players over less generously resourced applicants. Stroud and Smith believe the process can be streamlined only through external interventions.
To illustrate the challenge, Stroud recalls the tremendous technological progress in ENDS products, which went from cigalikes to larger open systems, back to pods and then on to disposables. “The FDA’s draconian regulations don’t account for the technological improvement that has been applied to ENDS,” she says. “FDA and Congress could reform the Tobacco Control Act [TCA] in a huge way if they pushed the predicate date further ahead than February 2007. Requiring ENDS to undergo extensive testing and a massive bureaucratic application process is not only a farce to public health, but it restricts innovation and competition, which is very un-American.”
With Congressional assistance and a reworking of the TCA, the FDA could establish a notification process for new products and then focus on post-market surveillance to monitor the public health effects of the new products, according to Shroud.
“The FDA must also recognize what percentage of youth is permittable,” she says. “No other consumer good in America has been forced to deal with so much scrutiny that even one kid using the product is one kid too many. While youth vaping was a problem in 2019, it declined by more than 60 percent in the years since—all while the non-FDA-authorized ENDS market grew exponentially. FDA must recognize that adults are using these products and that their use is associated with a 10 percent decrease in cigarette units sold in America in 2023. That’s a win for public health. FDA must reform the process so we can accelerate even further declines in smoking.”
As of June 21, the FDA had authorized more than 16,000 tobacco products—mostly cigarettes and cigars, according to Stroud. “Twenty-seven MGOs for ENDS is a depressing number and makes up less than 1 percent of authorized products,” she says. “Worse, only 49 products have been authorized by FDA using the PMTA pathway. FDA’s own budget is problematic; it’s entirely funded by user fees paid for by only six classes of tobacco products and not from e-cigarettes. There is more of an incentive to authorize the products that are paying for a $275,000 annual salary, as made by the CTP director in 2023, than authorizing products that pay nothing. While FDA has been asking Congress for years to be able to collect user fees on products including e-cigarettes, they refuse to issue orders—and instead denied tens of millions of products. That could have been a lot of fees and would have funded a significant amount of surveillance while also recognizing tobacco harm reduction. It is something the agency must recognize if the mission is to reduce smoking.”
While optimists may detect a new willingness to approve reduced-risk products in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals. | Photo: Tada Images
Significant Ruling
Smith says it is important to educate those affected by the failing 99.999 percent of all PMTA applications about the recent changes in the regulatory landscape and how those changes may lay a foundation for the significant changes necessary at the CTP.
“The first is the recent announcement by the Supreme Court where the Chevron Deference has been overturned,” he says. “This action by the court will now require that regulatory agencies follow the letter of the law and that the regulators would now have little leeway in the interpretation of how to apply regulatory law.
“The Chevron Deference has allowed the CTP to define the meaning of ‘appropriate for the protection of public health’ when conducting a review of the PMTAs and MRTPAs [modified-risk tobacco product applications]. Now, post-Chevron, if the Tobacco Control Act does not clearly outline the actions and process of enforcement of regulatory oversight in a manner that allows for the regulatory agency to action the law, the law will have to be amended to clarify the process, so legislators will have to work to make the law actionable … not the regulators that monitor the marketplace.”
Second, according to Smith, the Supreme Court may review four relevant lawsuits—Triton, Magellan, Lotus and Logic. Such a review may trigger action to change the TCA. “If the court decides to hear at least one of these cases, then the likely outcome is a requirement that the TCA be clarified so that the CTP will only enforce actions defined in the TCA,” says Smith. “If the TCA isn’t clear as to how to enforce it, then the law should be amended. Depending on how the policies are modified by the legislative branch, we may see shifts in the way that CTP reviews all tobacco and nicotine products, leading to a more effective regulatory environment. However, how the legislators refine the TCA will determine if the regulatory environment improves in a manner that supports the reduced-risk product marketplace.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
The U.S. Supreme Court on June 28 overturned the “Chevron deference,” a doctrine that requires courts to defer to federal agencies when sorting out ambiguities in law. The 6-3 majority ruling could impact the U.S. Food and Drug Administration and its premarket tobacco product authorization process. According to critics, the Chevron deference often gives agencies leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.
Chris Howard, executive vice president, external affairs & new product compliance for Swisher, welcomed the ruling, saying that for decades federal agencies have had too much power. “That ended today with the Supreme Court’s decision overturning the long-standing Chevron Doctrine,” said Howard. “The decision marks a significant shift in the judicial landscape, correcting the balance of power between federal agencies and the judiciary. It fundamentally alters how courts rule on agency statutory interpretation. As the majority states, courts will no longer be restrained by the need to provide deference.
“Instead, ‘Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA requires.’ This transformation will likely lead to significantly less regulatory flexibility and increased judicial scrutiny. The implications of this decision will resonate across industries, including the tobacco industry, influencing regulatory practices and shaping the future of administrative law. Regulatory overreach will become the exception as opposed to the norm and enable courts to fulfill their duty to interpret the law.”
In the years since electronic nicotine delivery systems (ENDS) became subject to FDA regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard.
Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.
“For far too long, unelected bureaucrats at the FDA have been making up the law to suit their own ulterior agenda and Today, the Supreme Court has thankfully put a stop to it once and for all,” said Allison Boughner, vice president of the American Vapor Manufacturers Association. “No longer will it be good enough for prohibitionists in Congress to write vague, Crayola language and then connive behind closed doors with FDA to impose arbitrary policies on the American public that could never withstand the light of day.”
It has been nearly 40 years since the Supreme Court indicated in Chevron v. Natural Resources Defense Council that courts should defer to an agency’s reasonable interpretation of an ambiguous statute.
The court’s ruling could have ripple effects across the federal government, where agencies frequently use highly trained experts to interpret and implement federal laws, according to SCOTUSblog. Although the doctrine as relatively noncontroversial when it was first introduced in 1984, in recent years conservatives—including some members of the Supreme Court—have called for it to be overruled.
The plea to overturn the Chevron doctrine came to the court in two cases challenging a rule, issued by the National Marine Fisheries Service, that requires the herring industry to bear the costs of observers on fishing boats. Applying Chevron, both the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of Appeals for the 1st Circuit upheld the rule, finding it to be a reasonable interpretation of federal law.
The fishing companies came to the Supreme Court, asking the justices to weigh in on the rule itself but also to overrule Chevron. Roman Martinez, representing one group of fishing vessels, told the justices that the Chevron doctrine undermines the duty of courts to say what the law is and violates the federal law governing administrative agencies, which similarly requires courts to undertake a fresh review of legal questions.
Under the Chevron doctrine, he observed, even if all nine Supreme Court justices agree that the fishing vessels’ interpretation of federal fishing law is better than the NMFS’s interpretation, they would still be required to defer to the agency’s interpretation as long as it was reasonable. Such a result, Martinez concluded, is “not consistent with the rule of law.”
Vapes are a powerful tool for adult smokers making the transition from cigarettes to reduced-risk products (RRP). The category is governed by market-specific regulation, often influencing public perception and, therefore, uptake.
Last week, following an extensive scientific review, the U.S. Food and Drug Administration authorized the marketing of four menthol-flavored e-cigarette products for Altria-owned vaping company Njoy. This is a watershed moment for the sector and one which will have a huge and significant impact on the global RRP market.
This announcement signifies the FDA’s acknowledgment that menthol vaping products have the potential to be an important and effective tool for adult smokers looking for reduced-risk alternatives. This is significant for the wider sector in a number of ways; above all, it sets a precedent for other markets, paving the way for other regulators, particularly those looking at bans, to consider flavors in the context of public health.
Across the globe, we are seeing an increasing number of markets introduce bans on flavors on a precautionary basis in a bid to mitigate youth uptake. At Plxsur, we have long advocated against the ban of flavors on vape products, arguing that it has the potential to negatively impact those making the transition from conventional cigarettes, who often are drawn to vapes for their flavor, amongst other factors such as price and convenience. There are also arguments and emerging evidence that flavor bans drive the black market sale of unregulated, dangerous products.
There will be many that, understandably, say this decision is “too little, too late,” but it is nonetheless encouraging to see the FDA, with its extensive science and evidence-based review, validating that with effective regulation and enforcement, flavored vape products are “in the interest of public health.” Those countries that have considered flavor bans should look to the U.S. and conclude that it can’t be justified from a scientific review perspective.
While this is the first authorization of a “characterizing flavor” by the FDA for vaping products, two of the major regulatory influencing bodies, the FDA and the Medicines and Healthcare Products Regulatory Agency (MHRA), now acknowledge that there is value in non-tobacco-flavored vaping products.
This decision has the potential to impact the world. The U.S. has long influenced international markets, so it sets a benchmark that we expect other, less vape-supportive governments and regulatory bodies will follow.
Rob Burton
In Italy, tobacco-flavored vapes constitute 40% of the vape market, while menthol represents 21%.[1] This demonstrates the significance of flavored products in the market as a whole. If such flavors were to be banned, this would act as a barrier for smokers to move to reduced-risk alternatives and potentially lead vapers to return to cigarettes.
In some geographies, it is great to see that vapes are being accepted as an effective alternative to conventional cigarettes, even this week’s news from Australia announcing that vapes – which until now have only been available through prescription – will soon be available for sale within pharmacies without the need for a prescription, offering an effective pathway to end the smoking epidemic in the country.
As we anticipate the potential revision of the Tobacco Product Directive Review next year, the justification for banning flavors, from a scientific point of view, simply isn’t there. In the case of Njoy, this has been shown through closed-system pod-based devices, which offer a more cost-effective avenue for existing smokers and disposable systems while incorporating child lock systems that will restrict access to children, as is already applied by a Plxsur company, ProVape, in its SALT and KUBIK brands.
While the FDA’s authorization is specific to these four products made and sold by Njoy and does not apply to any other menthol-flavored e-cigarettes, our expectation is this will open a channel for other such products to achieve authorization by providing the necessary framework and the potential for knowledge-sharing and guidance. With the weight of data-led evidence, the category can advocate for the democratization of this framework, enabling further regulatory authorizations for products produced by responsible vaping companies in the interest of the adult smoker.
At Plxsur, we have a clear purpose – to facilitate adult smokers to make positive health decisions by transitioning away from cigarettes to reduced-risk products. Flavor is a key factor in supporting smokers moving completely to such alternatives, and we look forward to seeing a more science and data-led approach being adopted across all markets as we work to save the lives of those impacted by smoking, mitigate the risk of youth uptake, and do so sustainably and responsibly.
We view this FDA decision as a significant step forward in broadening the pathway for adult smokers, and previously lacking “off-ramp” for U.S. menthol smokers looking to make the switch, which, according to Public Health England, is 95% less harmful and, therefore, undeniably, “in the interest of public health.”[2]
Robert Burton is Group Scientific and Regulatory director for Plxsur.
The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration have established a federal task force to combat the distribution and sale of illegal vaping products.
“Enforcement against illegal e-cigarettes is a multipronged issue that necessitates a multipronged response,” said Brian King, director of the FDA’s Center for Tobacco Products.
In addition to the FDA and the DOJ, partners in the task force will include the Bureau of Alcohol, Tobacco, Firearms and Explosives; the U.S. Marshals Service; the U.S. Postal Inspection Service; and the Federal Trade Commission (FTC).
“Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans—particularly children and adolescents—across the country,” said acting Associate Attorney General Benjamin Mizer. “This interagency task force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this task force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority.”
The federal task force will focus on several topics, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions under the Prevent All Cigarette Trafficking Act; the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; and other authorities.
“The U.S. Marshals Service asset forfeiture division stands ready to work with our task force partners in the seizure of unauthorized e-cigarettes from domestic distributors seeking to sell them unlawfully,” said Ronald Davis, director of the U.S. Marshals Service.
“The Justice Department is committed to enforcing the laws that prevent the sale and distribution of unlawful e-cigarettes,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the DOJ’s civil division. “We will work closely with our task force partners to address this crisis with all of the enforcement tools available to us.”
The FTC, which releases reports about cigarette, smokeless tobacco and e-cigarette marketing and enforces various statutory and regulatory prohibitions on false and misleading advertising, will support the task force’s activities, including by sharing its knowledge about the marketplace for vaping products.
“We look forward to sharing our experience with this rapidly changing, multibillion-dollar market through this important task force,” said Samuel A.A. Levine, director of the FTC’s Bureau of Consumer Protection.
The Food and Drug Administration Thursday rescinded its 2022 ban on Juul Labs’ e-cigarette products. However, the agency has not yet made a final decision on whether Juul can remain on the U.S. market. The move does open the door for Juul to receive marketing authorization from the regulatory agency.
In 2022, the FDA ordered Juul to stop its sales, but later paused the order while the vaping company appealed. The agency announced that it would reinitiate a scientific review of Juul’s products, essentially returning them to their regulatory status before the initial ban.
In the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA stated in a release. “Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”
Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.
Juul Labs welcomed the move. “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products, the company wrote in a statement. “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”
Njoy, a subsidiary of Altria, submitted a supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device.
The new device includes access restriction technology designed to prevent underage use. This is achieved through Bluetooth connectivity, which authenticates the user before unlocking the device. The company has also re-submitted PMTAs for blueberry- and watermelon-flavored pod products, which are exclusively compatible with the Njoy ACE 2.0 device.
“Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products,” said Njoy President and CEO Shannon Leistra in a statement. “Njoy ACE 2.0 includes critical technology features to prevent underage access to flavored Njoy products while also responsibly providing flavored options for adult smokers and vapers.”
The Njoy ACE is the only pod-based vaping product currently with marketing authorization from the FDA. In the first quarter of 2024, Njoy announced it had broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end.
Njoy also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space.
“Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, senior vice president of regulatory affairs of Altria Client Services. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”
The Njoy had previously received marketing denial orders for its blueberry (2.4% and 5% nicotine strengths) and watermelon (2.4% and 5% nicotine strengths) pods.
Njoy believes its latest applications sufficiently address the FDA’s concerns regarding underage use by incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco-flavored vaping product.
The U.S. Food and Drug Administration announced on May 1 that it had sent warning letters to 14 online retailers. The reason for the warning letters was that these retailers were selling unauthorized e-cigarette products.
The warning letters specifically mentioned the sale of disposable e-cigarette products marketed under various brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary, according to press release.
The retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act.
Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
The agency announced on April 30 that the U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California.
The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.
Florida’s governor, Ron DeSantis, has signed legislation intended to crack down on the sale of unauthorized vapes that the state deems attractive to children.
The new law (HB 1007), however, only targets disposable vaping products not authorized by the U.S. Food and Drug Administration. The rules will be enforced beginning Oct. 1.
Unlike other state registry lists, Florida is the first state in the nation to include a carve-out for refillable pod systems and open-system vaping products, as well as bottled e-liquids.
Florida Smoke Free Association president and vape shop owner Nick Orlando was the driving force behind getting the open system exemption.
In its original form, the bill would have prohibited sales of any vape products that had not yet received FDA approval, according to media reports.
The law now directs the state’s Department of Legal Affairs to develop and maintain a directory listing all single-use nicotine vapes it deems attractive to minors. The department must make the list publicly available on Jan. 1, 2025, and regularly update it.
Once a product is added to the list, retailers and wholesalers in Florida have 60 days to sell or remove it from their inventory. Any products left in circulation will be subject to seizure and destruction.
Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors that ship products into Florida.
Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.
The U.S. Food and Drug Administration today announced the issuance of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers and two online retailers for selling unauthorized e-cigarettes, including Elf Bar, a popular youth-appealing brand.
The regulatory agency previously issued warning letters to these retailers for selling unauthorized tobacco products. However, according to an FDA release, follow-up inspections revealed that the retailers had failed to correct the violations.
Accordingly, the agency is now seeking a CMP of approximately $20,000 from each retailer.
The approximately $20,000 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including in Sept., Nov., Dec. and Feb.
The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.
