Category: Regulation

  • Durbin Disappointed in FDA for Menthol Vape Order

    Durbin Disappointed in FDA for Menthol Vape Order

    Senator Dick Durbin
    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.”

  • Australia Softens Stance on Vaping Product Ban

    Australia Softens Stance on Vaping Product Ban

    Credit: Yavdat

    Australia will soften a proposed groundbreaking ban on vaping following opposition from the Greens party, leading the government to agree to revise a bill that would have limited vapes to those with a doctor’s prescription.

    The agreement between the ruling center-left Labor party and the Greens will lead to the passage of legislation later this week that restricts the sale of vapes to pharmacies and removes them from retail shelves. This move is aimed at curbing the rise in youth vaping.

    However, the bill falls short of the government’s initial ambition to restrict sales only to those with a doctor’s prescription, which would have been a world-first. The amended bill will take effect on 1 July, reports Reuters.

    Under the compromise deal, vapes will be moved “behind the counter” in October. Customers will need to have a conversation with the pharmacist before making a purchase, and under-18s will need a prescription.

    Health Minister Mark Butler said in a statement that the government “welcomed constructive engagement with the crossbench and secured the support of The Greens for our world-leading vaping laws.”

    The Labor party does not have a majority in the upper house and must negotiate with other parties and independent senators to pass legislation.

  • FDA Authorizes First Flavored Vape: NJOY Menthol

    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.

  • North Carolina to Vote on Vape Registry Law

    North Carolina to Vote on Vape Registry Law

    Credit: Katherine Welles

    A new bill in North Carolina, if passed, would require the state to certify vaping and other next-generation tobacco products for sale.

    The Senate Judiciary Committee approved the proposal Wednesday. It was slipped into HB 900, which deals with Wake County leadership academies and their ability to maintain state designations. The House passed it without objection.

    To become law, the bill would need to pass the Senate and then the House before the end of the session. Senate leaders have said they plan to complete their work by the end of the month, local media reports.

    The chambers, both controlled by Republicans, have been unable to come to an agreement on budget modifications for the fiscal year that begins July 1.

    A North Carolina lawmaker wrongly told others that the U.S. Food and Drug Administration regulates the products, but the regulatory agency does not have the ability to check which products are being sold.

    The bill would fine retailers who sell products that aren’t on the registry for initial violations. The legislation could also suspend or revoke the establishment’s license.

    Vaping industry representatives warned lawmakers that the bill will cost people jobs and money.

    PMTA registry laws are already being enforced in Alabama, Louisiana and Oklahoma. Wisconsin passed a registry law in December and will become effective July 1, 2025. 

    Utah also passed a registry bill that included a flavor ban that will become active on Jan. 1, 2025, and Florida has a unique registry that also begins Jan. 1, 2025.

  • Romania Bans Vape Product and Pouch Advertising

    Romania Bans Vape Product and Pouch Advertising

    Photo: xpable

    Romania’s Chamber of Deputies adopted a bill banning advertising of electronic cigarettes and nicotine pouches this week, reports Romania Insider.

    “It is prohibited to explicitly advertise tobacco products, electronic cigarettes, including vape types, products intended for inhalation without burning from tobacco substitutes, electronic devices for heating tobacco, and products intended for inhalation without burning from tobacco substitutes as well as nicotine pouches for oral use (pouches) broadcast within radio and television programs and on public transport tickets,” the bill states. 

    The bill also bans advertising for these products within educational institutions and healthcare facilities or within 200 meters of their entrances. Advertising is also banned in publications primarily intended for minors and in theaters before, during and after performances intended for minors. Ads are banned that target minors, depict minors consuming these products, suggest these products have therapeutic properties or have a stimulating, sedative effect or can solve personal problems, give a negative image of abstinence or do not contain warning inscriptions in Romanian.

  • FDA Bans Boosted From Doing Vape Business in US

    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.

  • Consumer Group Welcomes Juul Ban Rescission

    Consumer Group Welcomes Juul Ban Rescission

    Photo: Juul Labs

    The potential return of Juul to U.S. store shelves would represent a win for consumers and tobacco harm reduction, according to the Consumer Choice Center (CCC).

    On June 6, the U.S. Food and Drug Administration rescinded its 2022 marketing denial order. While the move it neither an authorization nor a denial, it places the company’s premarket tobacco product application back into scientific review, meaning it could potentially be authorized at some point.

    “This is a step in the right direction for consumers who want more nicotine alternatives to combustible tobacco,” said CCC U.S. Policy Analyst Elizabeth Hicks.

    The FDA said in its June 6 statement that it had “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology” and that their change of course is based on a “review of information provided by the applicant” plus new case law based on court decisions involving MDOs for e-cigarette products.

    “With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency. 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,” said Hicks.

    The FDA decision opens the door for Juul to return to the market in the future, and allow U.S. consumers the same choice as those in the U.K. and Canada.

    “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,” concluded Hicks.

  • Reversal: FDA Rescinds Juul Marketing Denial Order

    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.

  • New York Advances Bill to Ban Some Vape Products

    New York Advances Bill to Ban Some Vape Products

    Credit: Gary L Hider

    The New York Senate passed a bill last week that would ban the sale of vape products that resemble school supplies, children’s toys, or that use packaging and advertising with the intent of targeting children.

    If enacted, violators of Senate Bill S7882 could face a civil penalty of up to $1,500 for a first violation and $2,500 for each subsequent violation, according to media reports.

    Under the bill, businesses selling tobacco and related products would be prohibited from offering items that may include pictures, logos, symbols, mottos, selling messages or colors that specifically appeal to minors, as well as representations of cartoon, movie, or video game characters, toys, electronic devices and school supplies, including markers, highlighters, ballpoint pens and thumb drives.

    The bipartisan legislation must still be approved by the Assembly and signed by the governor before going into effect. A companion version of the proposal sponsored by is pending in that chamber.

  • Namibia Readies to Regulate Vaping Products

    Namibia Readies to Regulate Vaping Products

    Image: sezerozger

    Namibia plans to regulate vapor products and water pipes, reports the Windhoek Observer.

    The country’s Ministry of Health and Social Services wants to amend the Tobacco Act to include those products.

    The goal is to curb the growing use of electronic cigarettes and water pipes across the country. The amendment will also facilitate the development of a comprehensive tobacco strategic plan scheduled for launch later this month.

    Deputy Minister of Health and Social Services Ester Muinjangue stressed the urgency of regulating vaping products, despite existing legal frameworks to combat tobacco use in Namibia. “There is no safe form of tobacco smoke,” she said, rejecting suggestions that vaping and hookah smoking are safer alternatives to traditional cigarette smoking.

    Muinjangue encouraged smokers seeking to quit their habit to utilize existing resources and seek support from health professionals.