Tag: FDA

  • U.S. Supreme Court Overturns Chevron

    U.S. Supreme Court Overturns Chevron

    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.”

  • Menthol Marketing Orders ‘Significant Step’

    Menthol Marketing Orders ‘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

  • New U.S. Task Force to Combat Illegal Vapes

    New U.S. Task Force to Combat Illegal Vapes

    Photo: Orhan Çam

    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.

  • FDA Rescinds Juul Marketing Denial Order

    FDA Rescinds Juul Marketing Denial Order

    Photo: steheap

    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.”

     

  • PMTA Filed for Njoy ACE 2.0 With Age Check

    PMTA Filed for Njoy ACE 2.0 With Age Check

    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.

  • FDA Warns 14 Sellers of Illegal Flavored Vapes

    FDA Warns 14 Sellers of Illegal Flavored Vapes

    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 Passes First Disposables Registry

    Florida Passes First Disposables Registry

    Credit: Ajax9

    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.

  • Civil Money Penalties for 22 Elfbar Sellers

    Civil Money Penalties for 22 Elfbar Sellers

    Credit: Jeff McCollough

    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.

  • System Overload

    System Overload

    The broken U.S. new tobacco product application process revealed by the numbers

    By Steven McDonald

    “How long will it take?” is a question often raised by project managers and executives alike. Typically, a reasonable estimate can be generated, but when it comes to predicting the time it will take for a review of a tobacco product application with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), any time estimate is met with skepticism.

    The CTP provides performance metrics for new tobacco product applications, which were evaluated for this article to determine if the time an application meanders through the regulatory pathways could be deduced. The backlog of applications brings into question the agency’s capabilities of managing its processes and ability to conduct timely reviews. Unfortunately, the backlog distorts the CTP’s internal process data for reviews and obfuscates the time estimation for a submission. In addition, significant gaps in the data do not allow for robust deductions.

    Following is an overview of the steps for the different regulatory pathways, the collection and evaluation of the CTP’s (performance) metrics and reporting data, and the ramifications thereof for future submissions. Readers should be aware that the CTP’s past performance may not be an indicator of future results.

    Application Process and Performance Metrics

    In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA broad authority to regulate the manufacturing, distribution and marketing of tobacco products. This includes decisions on whether new tobacco products can be marketed and evaluation of new tobacco product applications.

    New tobacco products can be submitted for review through three pathways: substantial equivalence (SE), exempt from SE (EX), or premarket tobacco product application (PMTA). A fourth submission type, modified-risk tobacco product application, is not a pathway for new tobacco products but a pathway to obtain permission to make advertising “claims” specific to a particular product.

    Historically, the applications accepted through the SE and EX pathways have been for cigarettes, smokeless tobacco and roll-your-own products. In August 2016, the FDA’s tobacco authority was extended to all “deemed” tobacco products, including electronic nicotine-delivery systems (ENDS), cigars, hookah and pipe tobaccos. In addition, in 2022, Congress passed a law clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source (nontobacco-derived nicotine (NTN)). The vast majority of applications in the PMTA pathway have been for ENDS. Both the deeming rule and the NTN law led to a crushing number of new product applications submitted to the FDA in 2020 and 2022, respectively.

    The CTP posts the estimated number of submissions that are currently at each step on a somewhat regular basis and then publishes the totals for the fiscal year. Unfortunately, the level of detail provided and the frequency for the updates has not been consistent. However, by making use of the currently available information (through fiscal year 2023), annual values for the process steps can be estimated. The data and information, primarily gathered from the Tobacco Product Applications: Metrics and Reporting webpage was collected and compiled for SE, EX and PMTA submissions. For new tobacco product applications, the procedures for the SE and EX pathways are identical, and the PMTA pathway includes an additional step: acceptance review, filing review (PMTA only), scientific cycle reviews and determination.

    The enormous number of submissions from fiscal years 2020 and 2022 is working its way through the system, evident from the data, but the backlog indicates that the review process may have overwhelmed the CTP’s capabilities and distorts the internal process data.

    Substantial Equivalence

    The data for SE is provided in Table 1 for the calendar years 2013–2016 and the federal fiscal years (October to September) hence. It is assumed that these values for SE, in particular, marketing orders, Not Substantially Equivalent (NSE) Orders and Withdrawn, include the provisional SE report applications. Briefly, a “provisional tobacco product” is one that was introduced between Feb. 15, 2007, and March 22, 2011, and for which a provisional SE report had been submitted on or before March 23, 2011. The final three rows, Estimated Administrative (Admin) Backlog, Estimated Office of Science (OS) Backlog and Estimated Total Backlog, are calculated values derived from the data provided. Since there may be additional (unreported) applications, these estimates should be considered conservative.

    Table 1: Annual Data for Substantial Equivalence

    The metrics are divided into the different phases of the regulatory process: administrative review of the submissions (Accepted, Refuse-to-Accept, Total Received), determinations (Marketing Orders, NSE Orders, Withdrawns) and the calculated values (Total Final Actions, Estimated Admin Backlog, Estimated OS Backlog, Estimated Total Backlog).

    The calculated values for Total Final Actions are annual determinations: the sum of RTA, SE, NSE and Withdrawn. The remainder of the calculated values (Backlogs) should be considered estimates as the data missing from prior years may impact the accuracy of the results.

    The Estimated Administrative Backlog is a cumulative value, the difference between those applications received and those processed (Accepted or Refused). For example, the Estimated Administrative Backlog for fiscal year 2021 includes the values from fiscal years 2020 and 2021. The Estimated OS Backlog is calculated similarly, beginning in fiscal year 2020, as the difference between those applications accepted to be reviewed and those with determinations (SE, NSE or Withdrawn).

    Of note is the over 7,000 applications received by the CTP in 2020, which was likely due to the court-ordered submission deadline for newly deemed products such as cigars, pipe tobacco and waterpipe tobacco. Yet at the end of fiscal year 2021, the backlog of applications (neither accepted nor refused to accept) is less than 500. That number has since swelled to over 1,000, including over 100 submissions in fiscal year 2023 that remained unopened. In fact, during the October 2023 stakeholder engagement meeting, the CTP admitted that none of the SE reports submitted after Sept. 8, 2020, have undergone even an acceptance review.

    The thousands of applications from the Estimated OS Backlog and Estimated Total Backlog is staggering. This is in stark contrast to the few hundred Total Final Actions, interrupted only by a spike of Refuse-to-Accept determinations in fiscal year 2021.

    Using the historical CTP data and calculated estimates, projections for the CTP’s future throughput can be made. For example, it will take more than six years for the backlog of applications to work through the system with a 20 percent increase in staff and an insignificant number of future SE report submissions. In addition, if one considers a “first in, first out” application process, the time delay for a marketing order for any new SE report applications will be significant.

    Exempt from SE

    The annual data for Exempt from SE is provided in Table 2. The table structure and calculations are the same as Table 1. Similar to SE applications, the calculated Backlog values should be considered estimates as the data missing from prior years may impact the accuracy of the results.

    Table 2: Annual Data for Exempt from Substantial Equivalence (EX)

    The Estimated Administrative Backlog for fiscal year 2023 is less than 100 (during the October 2023 stakeholder engagement meeting, the CTP asserted that the EX backlog had been cleared). The Estimated OS Backlog and Total Backlog has been consistently over 1,000. This is in stark contrast to the few hundred Found Exempt Orders averaged annually.

    Calculated similarly as that of the SE report throughput (a 20 percent increase in staff and an insignificant number of future Exempt submissions), it will take 16 months for these applications to work through the system if the same rate for reviews is maintained. As with the SE applications, the large number from the Total Backlog suggests that the time delay for marketing orders for any new EX applications will be more than a year (but significantly less than an SE submission) if one considers a “first in, first out” application process.

    Premarket Tobacco Product Application

    The annual data for PMTAs is provided in Table 3. Again, the final three rows are estimates, calculated values derived from the data provided, and since there may be additional (unreported) applications, these estimates should be considered conservative.

    Table 3: Annual Data for Premarket Tobacco Product Application

    The metrics provided by the CTP are divided into the different phases of the regulatory process: administrative, filing and determination. A staggering number of applications were received in the fiscal year 2020 through 2022 time frame, and to date, nearly 25 million applications have been rejected without substantive review. The calculated values in the table are generated similarly as for the SE and EX tables.

    As the CTP has stated on several occasions (most recently on Jan. 22, 2024, in the press release announcing the marketing denial order (MDO) for flavored Blu e-cigarette products), the “FDA has received applications for more than 26 million deemed products and has made determinations on 99 percent of these applications.” The Estimated Admin Backlog at the end of fiscal year 2023 is over 60,000, and the Estimated OS Backlog is over 300,000. It is difficult to estimate the time for these applications to receive substantive review; however, if one considers the Marketing Granted Order (MGO) and MDO values from fiscal year 2022 as a guideline, values can be determined.

    Based on these estimated values, a modest 20 percent increase in staff, and a limited number of future PMTA submissions, it will take more than 16 years for the applications under scientific review (Estimated OS Backlog) to receive a determination. If one considers the Estimated Total Backlog of applications calculated with the same parameters, it will take nearly 30 years for all the currently submitted applications to receive a determination.

    Finally, the substantive review of the PMTAs for specific “covered applications” (brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar, and those that have a 2 percent or more sales volume as determined by Nielsen) is under a Maryland Federal District Court order (Am. Acad. of Pediatrics v. FDA (AAP), 379 F.Supp.3d 461, 492 (D. Md. 2019)). The original court-imposed deadline to complete the reviews was Sept. 9, 2021, which the agency was unable to meet. Based on the most recent (Jan. 24, 2024) status report filed with the district court, the CTP will take action on 100 percent of these applications by June 2024. This date has been pushed back on several occasions, indicating that even the CTP cannot predict how long it will take.

  • Ispire Technology Adds Partners

    Ispire Technology Adds Partners

    Image: kamiphotos

    Ispire Technology Inc. has partnered with Touchpoint World Wide Inc. dba Berify, a platform specializing in linking physical products to the digital world, digital engagement and brand protection, and Chemular International Inc., a multidisciplinary regulatory consulting firm, to form a joint venture.

    The joint venture will look to expedite innovation in the e-cigarette technology space, including the development of secure, user-friendly solutions for age verification and age-gating nicotine vapor devices.

    Leveraging Berify’s multi-patented technology, Chemular’s regulatory consulting and premarket tobacco product application (PMTA) knowhow and Ispire’s hardware expertise, the joint venture will introduce an industry-standard age verification solution for vapor devices as well as the submission of PMTAs that incorporate technologies across the U.S. e-cigarette market, such as: next-generation e-cigarette hardware with a user-friendly point-of-use age verification and geo fencing capability that eliminates use of hardware in certain designated areas such as schools and sensitive areas; e-cigarettes with end-to-end a range of dynamic features such as authentication, direct-to-consumer engagements and exclusive offerings built on the foundations of blockchain technology; and a real-time biometric identity platform for user access controls, creating added security and reliability that deters counterfeiting.

    “By combining our collective expertise in hardware, blockchain and regulatory consulting, we aim to set a new standard for age verification, security and overall quality in the e-cigarette space,” said Ispire Technology Co-CEO Michael Wang in a statement. “Our hope is that this JV [joint venture] will be a large step forward in innovative device control, safety, counterfeit prevention and enhanced user experiences that increase overall market and consumer satisfaction.”

    “The U.S. market is ripe for technological disruption that addresses age verification, safety and counterfeit issues,” said Berify founder and CEO Dan Kang. “Our mission is also to create smart products that generate a new level of consumer satisfaction. We plan to achieve this by leveraging our blockchain authentication, tokenized rewards and creating true decentralization while keeping companies in control of their products and data.”

    Kevin Burd, CEO of Chemular, added, “Our commitment is not only to create next-gen vapor devices but also to elevate market education. This venture includes additional partnerships that will bring together biometric identity and access control, ensure the solution is embedded into vapor devices during manufacturing and provide safety, security and privacy for consumers. It is also a testament to our dedication to positively shaping the future of vape hardware innovation.”