Category: U.S. FDA

Durbin Disappointed in FDA for Menthol Vape Order

Credit: Dick Durbin
When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Sentor Dick Durbin was disappointed. He said the agency should have done better. The move marks the first non-tobacco flavored e-cigarette products to be authorized by FDA.
“Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”
Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a Committee hearing entitled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use, the role that flavors—such as menthol—play in youth use of tobacco products, and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.
Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s e-House cigarette hearing, said he applauds the FDA decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.
“The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern – the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.
“Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”
June 24, 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 Bans Boosted From Doing Vape Business in US

The United States District Court for the District of Colorado entered a consent decree of permanent injunction against Boosted (who also does business as Boosted E-Juice, Boosted and Live Boosted) and Cory Vigil, owner of Boosted LLC.
To avoid litigation, the defendants signed a consent decree, which is a written agreement signed by a federal judge and entered as a court order. Under the consent decree, the defendants have agreed not to manufacture, sell, or distribute any new tobacco products until they meet certain requirements.
These requirements include that the new tobacco products receive FDA marketing authorization, that FDA inspect the defendants’ facilities to determine compliance with the law, and that FDA notify defendants in writing that they appear to be in compliance with the law.
According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, defendants were previously warned that failing to obtain marketing authorization from FDA violated the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products.
The agency’s warnings noted that continued violations could lead to further action, including an injunction, according to a release.
“FDA remains steadfast in our work to enforce the law, especially after we’ve given a crystal-clear warning and explanation of what firms need to do to comply,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “Those who flout the law are responsible for the consequences, and we are committed to using the full force of our authorities to hold them accountable.”
This case represents the ongoing collaboration among federal partners—which will continue and expand under FDA and DOJ’s newly announced task force—to address unauthorized e-cigarettes in the United States. This is the eighth time FDA and DOJ have initiated injunction proceedings, the first of which occurred in October 2022, to enforce the FD&C Act’s premarket review requirements for new tobacco products.
DOJ institutes judicial enforcement actions under the FD&C Act in court. Accordingly, DOJ, on behalf of FDA, filed the consent decree of permanent injunction against the defendants in the District of Colorado, the manufacturer’s respective U.S. District Court.
“FDA has made clear it is committed to working with our federal partners, including the U.S. Department of Justice, to take enforcement actions, like seeking permanent injunctions, against those who violate the law,” said Jill Atencio, acting director of CTP’s Office of Compliance and Enforcement. “A coordinated, all government approach that brings together collective federal resources and experiences is critical to the success of these enforcement actions.”
The action is part of FDA’s comprehensive approach to enforcing the law in coordination with federal partners. Last year, FDA coordinated with U.S. Customs and Border Protection to seize more than $18 million in unauthorized e-cigarettes during a joint operation at LAX airport.
June 14, 2024
Reversal: FDA Rescinds Juul Marketing Denial Order

Credit: Jet City Image
The US FDA reversed a marketing denial order issued to Juul Labs for its vaping products.
By VV staff
Juul is allowed back on the market, but a final decision has yet to be made. On June 6, the U.S. Food and Drug Administration rescinded its 2022 ban on Juul Labs’ e-cigarette products, paving the way for the company to potentially receive marketing authorizations from the regulatory agency.
“The FDA rescinded its June 2022 marketing denial orders (MDOs) for the Juul system and placed our applications back into scientific review,” Juul Labs stated in a release. “We appreciate the FDA’s decision and now look forward to reengaging with the agency on a science[-based] and evidence-based process to pursue a marketing authorization for Juul products.
“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.
These products (the Juul device and Virginia tobacco and menthol Juul pods in 5 percent and 3 percent nicotine concentration) will remain on the market during this review.”
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.”
In the 2022 MDO, the FDA stated that Juul Labs’ premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products” and that some of the “study findings raised concerns due to insufficient and conflicting data.”
Soon after receiving its MDO in 2022, Juul Labs published its administrative appeal of the MDO, which explained the company’s position, “based on science and evidence,” that the MDO was substantively and procedurally flawed. The appeal, referred to as a 10.75 appeal, presumably led to the MDO being rescinded.
In late June 2022, the U.S. Court of Appeals for the D.C. Circuit told retailers they could continue to sell Juul products after it issued a stay of the MDO. In its 2022 court filing challenging the FDA ruling, Juul said the agency had overlooked more than 6,000 pages of data that the company had submitted on the aerosols that users inhale. Juul also suggested that the FDA’s decision was influenced by political pressure.
The American Lung Association stated in a release that it was “deeply troubled” by the FDA’s announcement and urged the agency to deny all Juul products. It cited Juul Labs’ role in the “youth e-cigarette epidemic” from 2017 to 2019. “These products and its manufacturer clearly do not meet the standard for protecting the public health,” Erika Sward, the association’s assistant vice president of nationwide advocacy, stated.
Anne Melzer, vice chair of the American Thoracic Society (ATS) Tobacco Action Committee, said she was disappointed with the decision. “FDA’s announcement that they are reconsidering the Juul application adds further delay and uncertainty to the already poorly regulated and chaotic e-cig market,” Melzer stated in a post on an X account for the ATS.
Elizabeth Hicks, U.S. policy analyst at the Consumer Choice Center, called the FDA’s reversal “a step in the right direction” for consumers who want more nicotine alternatives to combustible tobacco. “With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency,” said Hicks. “Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes.”
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, said the MDO reversal will have little impact since Juul products never actually left the market.
“A pause and a rescission of an MDO are differences without much distinction,” explained Conley. “Since the pause of the MDO enforcement, Juul has been able to market their products, and nothing about this move has made it harder or easier for them to continue to do so.”
At the end of last year, Juul Labs announced it was seeking FDA approval for new menthol-flavored pods, the Juul2 pods, which require age verification.
This announcement followed an announcement in July 2023 for a vaporizer with a unique pod ID chip to prevent the use of counterfeit cartridges and restrict underage access.
The July 2023 application included a proposal for tobacco-flavored pods.
The vaporizer is already on sale in the U.K. after its launch in 2021 as the Juul2 system. The menthol pod contains a secure microchip that requires age verification before use.
Users can lock the device at any time to prevent unauthorized usage.
So far, the FDA has authorized only 23 e-cigarette products for sale in the United States, all of them tobacco-flavored. The agency has denied menthol e-cigarette applications from several high-profile manufacturers, including BAT, which is appealing those decisions.
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, according to the FDA. Rescission of the MDOs returns the PMTAs 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.
Hicks said that she hopes that the move to rescind the Juul MDOs shows that the agency may be moving toward a more fair and logical approach to the PMTA review process.
“We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” she said.
June 6, 2024
PMTA Filed for Njoy ACE 2.0 With Age Verification

Credit: Kristina Blokhin
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 Shannon Leistra, president & CEO of Njoy. “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, according to a press release.
“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.”
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, noting that “…Rather, for flavored Electronic Nicotine Delivery System (ENDS), only the most stringent mitigation measures – specifically device access restrictions – have such mitigation potential.”
Njoy stated that it believes these 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.
May 20, 2024
Senator Demands FDA Testify Before Congress

Vapor Voice Archive
After months of pressure from lawmakers to prevent the unauthorized sale of vaping devices, federal regulators may soon have to explain themselves before Congress.
Senate Majority Whip Dick Durbin, who chairs the Senate Judiciary Committee, has long urged the U.S. Food and Drug Administration to follow through on a court-ordered review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers.
The U.S. Court for the District of Maryland mandated the survey, ruling in 2019 that the FDA had run afoul of federal law by allowing unauthorized vape sales. The review was supposed to have been completed in 2021, according to Court House News.
Durbin, in a January letter, accused the agency of “granting a free pass to scores of vaping products that are harming the health of children in our country.”
Now, Durbin is angling to haul FDA officials before Congress. He demanded in a letter Tuesday that Brian King, director of the agency’s Center for Tobacco Products, testify before the Senate Judiciary Committee.
Durbin extended a similar invite to Brian Boynton, principal deputy assistant attorney general for the Justice Department’s civil division. Federal law enforcement is tasked with assisting the FDA in bringing enforcement for violations of the Tobacco Control Act, which includes marketing authorizations for vape manufacturers.
Durbin met with Boynton and King in April during a private meeting to discuss the enforcement of unauthorized e-cigarettes. If the officials agree to testify publicly, the Judiciary Committee will hold a hearing in June.
A spokesperson for the FDA did not immediately respond to a request for comment on whether it would comply with the request.
May 8, 2024
FDA Updates Authorized Products Database

Photo: Andrey Kuzmin
The U.S. Food and Drug Administration has uploaded the first update to its recently created Searchable Tobacco Products Database, which provides an overview of tobacco products and vapor products that may be legally marketed in the United States.
Due to timing factors associated with the initial launch, the products included in this update cover a longer time period (January through mid-April 2024) than will typically be included in the future. The agency intends to update the database every month.
The current database updates include the addition of several tobacco products that were issued a substantial equivalence or exempt order, a number of tobacco products that were determined to be preexisting tobacco products through voluntary submissions, and links to redacted and 508-compliant order letters, decision summaries and other documents for various authorized products that were already in the database.
The database is available here.
May 6, 2024
FDA Denies Marketing of MNGO Disposable Vapes

Credit: Chase4Concept
The U.S. Food and Drug Administration on April 15 issued marketing denial orders (MDOs) to Shenzhen Yibo Technology Co. for 65 disposable e-cigarettes marketed as “MNGO Disposable Stick.”
The products involved include flavors such as tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze, iced banana, and others, with each flavor offered in a range of nicotine concentrations from 2 percent to 6 percent.
According to the 2023 National Youth Tobacco Survey (NYTS), disposable e-cigarettes were the most commonly used device among current e-cigarette users, and almost 9 out of 10 current e-cigarette users reported using flavored e-cigarettes with fruit flavors being the most popular.
The MDOs also include several “Clear” flavor products that were described by the applicant as flavorless or unflavored. However, data submitted in the company’s applications showed these products contained ingredients that are flavor enhancers or are known to impart a menthol or mint flavor, according to the FDA. Based on the entirety of evidence, the agency determined that the products have a characterizing flavor.
“The onus is on tobacco companies to provide the evidence demonstrating that the necessary public health standard has been met, and when they fail to do so, FDA will appropriately deny the marketing authorization of new tobacco products,” said Brian King, director of FDA’s Center for Tobacco Products, in a statement. “In this case, the applicant did not meet the necessary bar.”
April 15, 2024
Video: FDA Urged to Prioritize Access to Safer Alternatives
Consumer advocates were planning to speak out against what they describe as the U.S. Food and Drug Administration’s “alarming neglect” in facilitating access to safer nicotine alternatives for millions of adult consumers during a House Oversight hearing scheduled for 1 pm today.
“Despite the bipartisan mandate of the Tobacco Control Act of 2009, the FDA’s performance has fallen short of expectations, leaving countless individuals without viable options to effectively transition away from combustible cigarettes,” the Consumer Choice Center wrote in a press note.
“With over 26 million premarket tobacco product applications (PMTA) languishing in bureaucratic limbo, the FDA has only authorized fewer than 50 granted to just a handful of firms, completely disregarding the 180-day review deadline set imposed by Congress,” said Consumer Choice Center US Policy Analyst Elizabeth Hicks.
“Less than 10 unique devices are available on the regulated marketplace, all of which come from industry incumbents, not to mention the growing categories of nicotine alternatives such as heaters, pouches, toothpicks, and more.
“This blatant failure highlights a systemic issue within the agency, where regulatory inertia trumps the urgent need to provide consumers with safer nicotine alternatives such as e-cigarettes which studies have shown to be 95 percent less harmful than combustible cigarettes. As a result, consumers are being pushed towards the illicit market, which does not adhere to regulatory standards, to find their preferred nicotine alternative products,” said Hicks.
“Consumers are deeply troubled by the FDA’s abject failure to fulfill its obligations under the Tobacco Control Act. It is imperative that the FDA swiftly rectify this situation by implementing a transparent and expedited regulatory pathway that prioritizes access to scientifically validated, less harmful nicotine products,” she concluded.
April 11, 2024
Oversight Committee to Question FDA Commissioner
Robert Califf (Photo: FDA)
The U.S. House Oversight and Accountability Committee will question U.S. Food and Drug Administration Commissioner Robert Califf as part of an investigation into the agency’s handling of tobacco and nicotine products regulation, among other issues, according to a press release.
Last year, the committee announced an investigation into the FDA Center for Tobacco Products (CTP). “We have deep concerns that the CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Oversight Committee chairman James Comer in a letter for Califf. “Comments from FDA staff to RUF [the Reagan-Udall Foundation] … reflect such concerns.”
Other members of Congress have also questioned the FDA’s commitment to fair regulation, with a bipartisan group of senators asking Califf in 2023 to explain the FDA’s premarket tobacco product application process.
The hearing is scheduled for April 11 at 1 p.m. EDT. It will be live streamed on the committee website and on YouTube.
April 8, 2024