Tag: FDA

Court Bans Soul Vapor From Selling Illegal Vapes

Credit: Yelp
The United States District Court for the Southern District of West Virginia enjoined Soul Vapor LLC, a West Virginia-based company, and the company’s owner, Aurelius Jeffrey, from “directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product” that has not received marketing authorization from FDA.
The court also ordered Soul Vapor and Jeffrey to destroy e-cigarette products that were manufactured by Soul Vapor and are in their custody, control, or possession.
“FDA vigorously enforces the law and will continue to work with the U.S. Department of Justice to take enforcement actions, such as pursuing permanent injunctions, against those who defy the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “This injunction is another reminder that FDA will use the full scope of its enforcement tools to protect public health.”
According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, the defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products by failing to first obtain marketing authorization from FDA. The complaint also alleged that the defendants submitted materially false information to FDA.
“The court’s order is yet another example of how FDA – in coordination with federal partners – is successfully ramping up enforcement to combat unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “We will continue to work with our federal partners to identify and bring enforcement actions against bad actors, while continuing to educate stakeholders about the need for additional resources to best support these efforts.”
CTP’s ability to pursue enforcement actions, including injunctions, is solely dependent on user fees. CTP is 100 percent funded by user fees, which the FD&C Act authorizes FDA to collect from manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. However, this authority has not been updated to reflect the realities of the tobacco product marketplace, including the emergence of e-cigarettes over a decade ago, according to a release.
As a result of this inequity, e-cigarette manufacturers are currently paying no fees while continuing to profit off unauthorized products. In order to enhance the CTP’s enforcement actions, including pursuit of injunctions, the agency has requested updated authority from Congress to modernize the tobacco user fee framework to apply to all tobacco products regulated by the agency.
The injunction against Soul Vapor highlights the successful cooperation between FDA and the DOJ to enjoin bad actors from manufacturing, selling, and distributing unauthorized e-cigarette products. FDA has taken numerous judicial enforcement actions as a part of its comprehensive approach to enforcing the law, including eight injunctions in coordination with DOJ since 2022, according to the FDA.
Additionally, on June 10, 2024, FDA and DOJ announced the creation of an interagency task force focused on using an all-government approach to combat the illegal distribution and sale of unauthorized e-cigarettes in the U.S.
July 16, 2024
FDA Issues Warning Letters for Delta-8 THC Foods

Credit: FDA
The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling copycat food products containing delta-8 THC and introducing them into the marketplace in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The warning letters were issued to: Hippy Mood, Earthly Hemps, Shamrockshrooms.com, Mary Janes Bakery Co. LLC and Life Leaf Medical CBD Center. The FDA also issued a warning letter independently to the company GrowGod LLC for the same FD&C Act violations.
These warnings are part of the FDA and FTC’s ongoing joint effort to take action against companies selling illegal copycat food products containing delta-8 THC. In June 2023, the two agencies worked together to warn six other companies about selling edible food products containing delta-8 THC in packaging that could easily be confused for foods sold by popular national brands.
All six of those companies no longer have such products in stock.
“Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” said FDA Principal Deputy Commissioner Namandjé Bumpus. “As accidental ingestion and/or overconsumption of delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.
“The FDA will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”
In June 2022, the FDA warned consumers about children accidentally ingesting food products containing delta-8 THC. From Jan. 1, 2021, to Dec. 31, 2023, the FDA received over 300 adverse event reports involving children and adults who consumed delta-8 THC products.
Nearly half of these reports involved hospitalization or emergency department visits, and approximately two-thirds of these adverse events followed ingestion of delta-8 THC-containing food products such as candy or brownies. Adverse events included, but were not limited to, hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness.
July 16, 2024
FDA Officially Issues Notice of Better Web Portal
Credit: Postmodern Studio
According to a release, today, FDA’s Center for Tobacco Products (CTP) issued two notices in the Federal Register regarding its intention to launch CTP Portal Next Generation—an improved web portal for the submission of applications for certain new tobacco products—next year.
The improvements are intended to:

Streamline electronic submission into one system for substantial equivalence (SE) reports and premarket tobacco product applications (PMTAs), amendments to previous submissions, and submission of general correspondence;
Introduce a more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, FDA’s eSubmitter Desktop Tool, and FDA’s CTP Portal Web application in one place;
Provide tools to expedite data entry, guide applicants to relevant sections, and verify that the applicant has provided all required data.
No action is needed from current users of any CTP systems regarding these planned improvements. Existing CTP Portal accounts, along with any pending or in-process applications, will be automatically migrated to the new CTP Portal Next Generation.
CTP is committed to ensuring a smooth transition to CTP Portal Next Generation and will provide additional communication and support, including resources on how to use the new system, leading up to the change.
July 15, 2024
CTP Brings Updates to Tobacco Compliance Website

The Food and Drug Administration’s Center for Tobacco Products (CTP) has announced an enhancement to its website, which will more easily present information about tobacco compliance check outcomes.
The agency noted in a statement that the database is designed to be a resource for various audiences, including the general public, public health groups, and the tobacco industry.
The new database offers the ability to search for various compliance and enforcement outcomes among brick-and-mortar and online retailers, including warning letters, civil money penalties, and no-tobacco-sale orders.
Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from the FDA’s compliance and enforcement efforts of retailers in one centralized location, according to reports.
This centralized database will be updated monthly with the latest compliance check outcomes. “The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.
To view the database, click here.
July 8, 2024
U.S. Supreme Court Overturns Chevron Deference

Credit: Sean Pavone Photo
On Friday, June 28, the Supreme Court of the United States ruled 6-3 in favor of overturning the “Chevron deference,” a backbone principle for how the federal government keeps corporations in check. Chevron is the practice by which federal courts defer to federal agencies when sorting out ambiguities in a law. Justices Breyer, Kagan, and Sotomayor dissented.
The ruling could impact the U.S. Food and Drug Administration and its process for authorizing vaping products through the premarket tobacco product authorization process. In practice, Chevron deference often gives agencies broad 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, said 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. The decision marks a significant shift in the judicial landscape, correcting the balance of power between federal agencies and the judiciary,” said Howard. “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 was 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 overturned.
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.”
June 28, 2024
US Customs Seizes 53,700 Illegal Flavored Vape Pens
U.S. Customs and Border Protection (CBP) officers in Chicago recently seized 53,700 electronic nicotine delivery systems (ENDS) for violating the U.S. Food and Drug Administration’s Federal Food, Drug, and Cosmetic Act (FD&C Act).
The shipment, originating from China, was destined for a wholesaler in Mississippi, according to a CBP release.
The vaping pens were inspected by CBP and the FDA, and it was determined that the shipment violated the FD&C Act as it consisted of adulterated consumer goods being imported by an unauthorized agent. On June 10, the FDA announced the establishment of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes.
“Our officers are dedicated to identifying and intercepting these types of shipments that could potentially harm the health and wellbeing of people within our communities,” said LaFonda Sutton-Burke, Direction Field Operations, Chicago Field Officer. “Customs and Border Protection’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers, and we will continue to work with our consumer product safety partners to identify and seize unsafe and illicit goods.”
The 179 boxes were mislabeled as electronic atomizers, a common practice used to smuggle unapproved goods into the U.S. CBP presumes the products were being sent to a wholesaler for wider distribution throughout the country. CBP continues to work diligently to stop non-legitimate products from entering the U.S. The ENDs had a combined Manufacturer’s Suggest Retail Price of over $1.08 million.
June 26, 2024
Burton: Menthol Marketing Orders a ‘Significant Step’

By Robert Burton
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.
[1] The Global Vaping Market: A Plxsur Snapshot
[2] E-cigarettes: an evidence update: A report commissioned by Public Health England
June 25, 2024
FDA Authorizes First Flavored Vape: NJOY Menthol

Image: Tada Images
The U.S. Food and Drug Administration today authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 2.4%.
The two authorized ACE pods are the NJOY ACE Pod Menthol 2.4% and the NJOY ACE Pod Menthol 5%. All four of the newly authorized products are pre-filled and non-refillable.
The decision is significant because it is the first non-tobacco flavored vapor product to be authorized by the FDA. In his TPL Review, Office of Science Director Matthew Farrelly said that NJOY had “demonstrated the potential for these new products to benefit adults who smoke [combustible cigarettes] as compared to those who continue to use [combustible cigarettes] exclusively,” and that the company had “also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization.” Farrelly also highlighted data from a longitudinal cohort study that NJOY submitted with its application, which pointed to “robust absolute switching rates” as well as a higher rate of complete switching than tobacco-flavored NJOY DAILY ENDS.
The FDA noted, however, that applications are reviewed on a case-by-case basis, and that this authorization of menthol products does not apply to any other menthol-flavored vaping products.
“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” said CTP Director Brian King in the agency’s press release. “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”
Altria welcomed the authorizations. “With the addition of NJOY menthol e-vapor products, we are now uniquely positioned with an FDA-authorized portfolio to support adult smokers in their transition to smoke-free alternatives. We believe these marketing orders are a testament to the quality of the NJOY products and the strength of evidence supporting the authorizations of the NJOY menthol e-vapor products,” said NJOY President and CEO Shannon Leistra in a statement.
“We believe that, for tobacco harm reduction to succeed, adult smokers must have access to a robust marketplace of FDA-authorized smoke-free alternatives,” said Paige Magness, senior vice president, regulatory affairs of Altria Client Services. “FDA authorization of NJOY menthol e-vapor products provides adult smokers and vapers with regulated alternatives to the illicit flavored disposable e-vapor products on the market today. We believe the NJOY menthol marketing orders are a positive outcome for public health.”
The FDA previously authorized the NJOY Ace and three of its tobacco-flavored pods on April 27, 2022. In March of 2023, Altria acquired NJOY for $2.75 billion cash. The acquisition was completed on June 1, 2023. However, the transaction terms included $500 million in additional cash payments contingent upon the product approvals received today, which would bring Altria’s total spend to $3.25 billion.
June 21, 2024
FDA Warns Sellers of ‘Drug Bottle’ Vaping Devices
The US Food and Drug Administration has sent warning letters to six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles.
The retailers were also warned for selling unauthorized flavored, disposable vaping products, including those under the brand names Funky Republic and HQD, according to an FDA release.
“It boggles the mind that someone thought it was a good idea to package a tobacco product to look like a prescription drug bottle,” said Brian King, director of FDA’s Center for Tobacco Products. “There’s no place for this gratuitous and blatantly dangerous packaging, and FDA is committed to taking action against the illegal sale of these products.”
In a Senate Judiciary meeting yesterday, King noted that products like Elf Bar cannot legally be sold in China because the government there has banned non-tobacco flavored e-cigarettes. Outraged that brands banned in China are sold in the U.S., Texas Senator John Cornyn vowed to introduce legislation to rectify that situation.
Jefferies analyst Owen Bennett said the Congressional testimony could spur the FDA to approve more products from British American Tobacco and Juul. “This hearing is another example of increasing political pressure for the FDA to act” against unauthorized products, he said in a research note quoted by Bloomberg.
June 13, 2024
FDA, DOJ Grilled for ‘Unserious’ Action on Illegal Vapes

Photo: Katherine Welles
U.S. Senators criticized top health and law enforcement officials for their failure to tame the rapidly growing illicit e-cigarette market, reports the Associated Press.
During a hearing on June 12, lawmakers on the Senate Judiciary Committee questioned officials from the Food and Drug Administration and Department of Justice (DOJ) about attempts to manage the vaping market, which has grown to include thousands of flavored, unauthorized e-cigarettes imported from in China.
To date, the agency has approved only a handful of e-cigarettes as alternatives for adult smokers. All other products on the market, including popular products like Juul, are pending review or considered illegal by regulators.
“I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application,” said the committee’s chairman, Dick Durbin.
Brian King, director of the FDA Center for Tobacco Products, said the agency has been slowed by a backlog of applications submitted by vape companies seeking approval to sell their products in the U.S. The FDA received millions of premarket tobacco product applications, each of which must be scientifically reviewed.
An industry lobbyist told the committee that the FDA has created an untenable marketplace by rejecting more than 99 percent of applications submitted by companies.

I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application.
Dick Durbin, chairman, Senate Judiciary Committee
Ahead of the congressional hearing, several government agencies, including the FDA and the DOJ established a task force to better coordinate the fight against illegal e-cigarettes. Republican Senator Thom Tillis called the timing of the announcement “a political stunt,” and criticized the absence of other federal agencies from the initiative, including Customs and Border Protection (CBP).
“If the timing of the task force formation wasn’t evidence of how unserious the FDA is about tackling the flood of illicit e-cigarettes, FDA’s exclusion of CBP from the task force makes it crystal clear,” said Tillis, who represents North Carolina, a major tobacco-producing state. He urged officials to concentrate enforcement on Chinese brands, rather than large domestic manufacturers like Reynolds American, which is based in North Carolina.
The FDA can conduct investigations and recommend cases, but only the Justice Department can bring lawsuits. The FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years. But the letters have done little to dissuade companies from flouting FDA rules and introducing new vapes.
Disposable vapes account for an estimated 30 percent to 40 percent of the roughly $7 billion-dollar U.S. vaping market. The two best-selling disposables—Breeze and Elf Bar—generated more than $500 million in sales last year, according to Nielsen retail sales data analyzed by Goldman Sachs.
Both brands have been sanctioned by FDA regulators but remain widely available, in some cases with new names, logos and flavors.
King noted that products like Elf Bar cannot legally be sold in China because the government there has banned non-tobacco flavored e-cigarettes. Outraged that brands banned in China are sold in the U.S., Texas Senator John Cornyn vowed to introduce legislation to rectify that situation.
Jefferies analyst Owen Bennett said the Congressional testimony could spur the FDA to approve more products from British American Tobacco and Juul. “This hearing is another example of increasing political pressure for the FDA to act” against unauthorized products, he said in a research note quoted by Bloomberg.
June 13, 2024