Tag: PMTA

  • Look Back: Vapor in 2022

    Look Back: Vapor in 2022

    It was more adversity for the vapor industry as many companies are still waiting on PMTA results.

    By VV Staff

    The year 2022 was tough on the vaping industry. While several countries banned or began heavily regulating vaping products, the United States banning most premarket tobacco product applications (PMTAs) probably had the greatest impact on the industry. Industry analysts estimate that 50 percent to 60 percent of vaping-related businesses in the U.S. had closed by late 2022 after the Food and Drug Administration began issuing mass marketing denial orders (MDOs) for nearly all the 6.5 million PMTAs submitted by 500 companies in 2021.

    Companies had until May 14 to submit a PMTA to the FDA to keep their synthetic nicotine products on the market. Companies that failed to secure authorization were supposed to pull their products from the market by July 13. However, the regulatory agency has been using some discretion in its enforcement of synthetic nicotine products as it continues to review both tobacco and nontobacco PMTAs.

    One of the biggest stories of the year is the rise of R.J. Reynolds Vapor Co.’s Vuse e-cigarettes, which took over as U.S. market leader from Juul in 2022. Juul’s fall came after the FDA issued an MDO for Juul Labs’ PMTAs on June 23. On July 5, the FDA stayed the MDO, announcing that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.” By October, Vuse had expanded its market share lead over Juul to 12 percent in the Nielsen analysis of convenience store data.

    January

    Credit: Selen Geren

    Thirty U.S. states plus the District of Columbia kick off the new year on Jan. 1 with taxes on vaping products. Filipino vapers appeal to Duterte to sign a bill that would legalize vaping. The U.S. Congress begins review the Clarifying Authority Over Nicotine Act of 2021—a bipartisan bill designed to give the FDA the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. South Africa begins considering taxes on hardware and e-liquids, with high-nicotine products getting higher rates. Malaysia postpones implementing a tax that would have more than doubled the retail prices of e-liquid bottles for open systems. FEELM Air launches in the U.K.

    February

    Credit: Timon

    Triton Distribution makes opening arguments in its battle with the FDA over how the regulatory agency conducted its PMTA reviews. A court of appeals stays Bidi Vapor’s MDO. Judges grant stays to Diamond Vapor, Johnny Copper and Vapor Unlimited in MDO lawsuits. The U.S. Senate confirms FDA Commissioner Robert Califf. Philip Morris International announces its plans to bypass an import ban by manufacturing IQOS in U.S. The FDA posts its first warning letter for vaping hardware products. The letter is issued to China-based Sigelei Vapor for two coil brands. The U.S. International Trade Commission (ITC) issues a general exclusion order that bans the importation of any unauthorized cartridges compatible with the Juul vaping system that infringe Juul Labs’ patents. The FDA submits its proposal to ban menthol to the Office of Management and Budget for review.

    March

    Credit: V. Chalup

    The Swedish government proposes a ban on nontobacco-flavored vaping devices, including menthol. The National Youth Tobacco Survey (NYTS) 2021 finds youth cigarette smoking rates in the U.S. at historically low levels, with just 1.9 percent of high school students reporting current use of cigarettes. U.S. President Joe Biden signs a bill giving the FDA power over synthetic nicotine. Companies have 60 days to file PMTAs. China announces e-cigarette regulations, including flavor bans and compliance of all products produced for export with the regulations and laws in the destination country. If a country does not regulate e-cigarettes, China’s rules for vaping products would apply to those exports, including bans on flavors and synthetic nicotine. Myth of a gateway from vaping to smoking is debunked … again. FDA issues marketing orders to eight Logic brand vaping products.

    April

    Credit: Jarretera

    Mitch Zeller retires as director of the FDA’s Center for Tobacco Products (CTP). Vuse surpassed Juul to become the No. 1 e-cigarette brand in the U.S., according to Nielsen. Smoore International, the largest vaping company in the world, reports 2021 annual revenue of $2.16 billion. Canada proposes the first federal nicotine-only vape tax. China releases its rules listing the requirements for design, chemical compounds and the mechanics for manufacturing e-cigarettes. New York Stock Exchange rules force RLX Technology co-founder Kate Wang to resign from RLX committees. Fontem Ventures, a subsidiary of Imperial Brands, receives an MDO for its MyBlu products. Judge orders the FDA to give PMTA updates every 90 days for products with at least a 2 percent market share. Juul begins settling marketing lawsuits with several states. Hong Kong’s ban on vaping products makes it illegal to use or carry an activated vaping device in no-smoking areas. The FDA publishes rules for the menthol ban. Several Njoy vaping products receive marketing orders.

    May

    For the first time, the FDA issues warning letters for marketing products containing delta-8 THC. Several R.J. Reynolds Vapor Co. Vuse branded e-cigarette products receive marketing orders, including six new tobacco products, through the PMTA pathway. The San Diego City Council passes an ordinance for the second time banning vape flavors, and it’s effective Jan. 1, 2023. In its first status report, the FDA states that it expects to have resolved 63 percent of PMTAs set out in its original priority by June 30. Altria Client Services pays $100.5 million for assets and properties used in Poda Holdings’ business of developing, manufacturing and marketing multi-substrate heated capsule technology. FEELM wins four Red Dot Awards, an international competition for product, communication and concept design. Longtime Centers for Disease Control and Prevention alumnus Brian King succeeds Mitch Zeller at the FDA’s Center for Tobacco Products (CTP).

    June

    Credit: Premium Collection

    Mexico bans all vaping and heated-tobacco products. Mexican President Andres Manuel Lopez Obrador signs a decree that outlaws the sale of e-cigarettes in line with continuing the government’s ongoing anti-vaping policy. Heated-tobacco products are not exempt from the ban as previously reported that they would. Njoy Daily disposables get marketing orders; however, the FDA issued MDOs to Njoy for multiple other flavored Daily e-cigarette products. A study finds e-cigarette or vaping product use-associated lung injury (EVALI) and Covid-19 boosted misinformation on vaping. A federal court jury finds R.J. Reynolds’ Vuse Solo and Alto devices infringe two Philip Morris patents. Zinwi is among the first to get a green light to produce e-liquids under China’s new regulatory framework. Juul receives an MDO, which is subsequently stayed in court. The FDA places Juul’s application back under review. EU lawmakers propose a flavor ban for heated-tobacco products.

    July

    PMI opens its flagship IQOS store in South Africa. Confronted with rising prices for batteries, engineers in Ukraine begin using power cells from vapes to power drones. A U.S. administrative tribunal invalidates two claims in an R.J. Reynolds vaping patent. Panama bans the sale and import of vapes, joining more than a dozen Latin American and Caribbean countries with such restrictions. Brazil also maintains its ban on vaping products. The FDA issues first warning letters for synthetic products. Juul Labs begins exploring financing options to avoid bankruptcy. Juul quarterly revenues drop 23 percent. FDA Commissioner Robert Califf says the nonprofit Reagan-Udall Foundation—a nongovernmental research group created by Congress to support the FDA’s work—will convene experts to evaluate the CTP within 60 business days. Matt Holman, the director of the CTP’s Office of Science, announces he is stepping down. Altria reduces the value of its investment in Juul Labs to $1.3 billion, a nearly 70 percent loss of its original $12.8 billion evaluation. The Philippine president allows a bill that legalizes e-cigarettes to lapse into law.

    August

    Credit: Savvapanf Photo

    CTP Director Brian King states that the agency is “making significant progress” in reviewing synthetic nicotine applications. Chinese car maker BYD gets a vape production permit and its stock price soars. Monroe County becomes the first in New York state to accept e-cigarettes and e-liquids for safe disposal. VPR Brands receives an FDA warning letter for its nicotine gummies. FEELM, one of the largest and most influential e-cigarette brands, earns its production license in China. The U.S. Court of Appeals for the Eleventh Circuit grants petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications in a 2-1 decision. Great Britain reports record levels of vaping in a report that found 2.4 million vapers are ex-smokers. Vuse’s market grows from 37.4 percent to 39 percent, with Juul declining from 30.7 percent to 29.4 percent. A U.S. appeals court denies a petition to review the FDA’s marketing denial order to Illinois-based e-liquid manufacturer Gripum.

    September

    Credit: Kristina Blokhin

    Juul Labs agrees to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping. A jury in the U.S. District Court for the Middle District of North Carolina awards Altria Client Services more than $95 million after finding that Reynolds Vapor Co.’s Vuse Alto e-vapor product infringes three Altria patents. The FDA states it sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine. Alaska’s governor vetoes an age-to-vape bill because it also included the implementation of a tax on e-cigarettes. Nicaragua bans the import of e-cigarette products. Altria Group exercises its option to be released from its noncompete deal with Juul Labs. Maine backs out of a Juul settlement claiming it would cancel out school district suits.

    October

    Credit: Charlottes Web

    The Colorado Supreme Court rules that the Colorado attorney general’s office’s lawsuit against electronic cigarette manufacturer Juul Labs cannot include four of the company’s executives. The FDA announces that as of Oct. 7, it has issued refuse to accept (RTA) letters for more than 889,000 synthetic nicotine product applications that did not meet the criteria for acceptance. Magellan CEO Jon Glauser says the FDA acknowledged in writing that it had “erred in failing to inform the company” about its MDOs before announcing the move publicly. An analysis suggests that over 90 percent of FDA warning letters were sent to small online retailers. For the first time, the U.S. Department of Justice files requests for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. Charlotte’s Web signs the first CBD licensing deal with Major League Baseball. A health regulatory body for Mexico’s government says its scientists have developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems because “no one else has come up with one.” PMI reaches a deal with Altria Group to pay nearly $2.7 billion for exclusive U.S. commercialization rights to IQOS. FDA staff comments for the Reagan-Udall assessment of the performance of the CTP suggest the regulatory agency is in a state of disarray and being influenced by outside forces not scientific research. The FDA issues its first menthol MDOs for the Logic Pro Menthol E-Liquid Package and the Logic Power Menthol E-Liquid Package.

    November

    Credit: Vege Fox

    China’s Ministry of Finance imposes a consumption tax on e-cigarettes sold in China from Nov. 1. China bans celebrities from endorsing vaping products. Logic is granted a temporary stay of the FDA’s menthol MDO. The EU publishes a directive officially banning flavors in heated-tobacco products throughout the union. Magellan sues the FDA and the U.S. Department of Health and Human Services, claiming the agencies violated the Administrative Procedure Act in the PMTA reviews. Maryland and Missouri become the 20th and 21st states to legalize marijuana for adult recreational use, but cannabis reform efforts meet defeat in Arkansas, North Dakota and South Dakota. Vuse’s market share rises from 40 percent in the previous report to 40.4 percent compared with Juul declining from 28 percent to 27.6 percent in Nielson’s four-week period ending Nov. 5. The European Union proposes a bloc-wide vaping tax policy as part of a shake-up of levies on the tobacco industry.

    December

    Credit: Sharaf Maksumov

    Macau’s blanket ban on vaping products goes into effect. The rules prevent people from carrying e-cigarettes across the border with fines up to mop20,000 ($2,505). The Netherlands bans all e-cigarette flavors except tobacco effective Oct. 1, 2023. U.S. President Joe Biden officially signs the first piece of standalone federal cannabis reform. The Marijuana and Cannabidiol Research Expansion Act is aimed at providing federal support to facilitate research of cannabis and its potential health benefits. Juul Labs settles more than 5,000 lawsuits covering more than 10,000 individual plaintiffs. Financial terms of the deal were not disclosed. Costa Rica for the first time gives a company authorization to grow and process hemp. Canada’s Minister of Mental Health and Addictions and Associate Minister of Health released a report finding that vaping products offer the 3.8 million Canadians who smoke a less harmful source of nicotine than tobacco products, and do help people to stop smoking. The Reagan-Udall Foundation submitted its recommendations to the commissioner of the FDA. The report concludes that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the Center for Tobacco Products (CTP), particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process. A separate investigation, conducted by the U.S. Office of Special Counsel (OSC) after a whistleblower complaint, found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.

    Looking ahead

    It’s impossible to predict what the vaping industry will look like by the end of 2023. The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand, according to industry analysts. More importantly, innovation should continue to thrive outside the U.S.

    Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, said the global fight for fair and sensible regulation of vaping products will continue throughout 2023. “Regrettably, just like years prior, some battles will be lost, and the end result will be fewer adults who smoke fully switching to vaping,” he said. “However, the silver lining is that—as we see today in Australia and Thailand—even prohibitions with criminal sanctions are not enough to stop illicit markets from popping up. This industry will never be able to stop every attempt at prohibition, but it can continue to document and expose how black markets follow whenever these bans are implemented.”

    On the U.S. state level, Conley said his major concern is PMTA registry bills being put forth by the tobacco industry. He explained that these bills would devastate law-abiding vape shops and smoke shops by banning any vaping product that does not have a PMTA granted or explicit enforcement discretion from the FDA. “This means that synthetic nicotine, nicotine-free [products] and CBD/delta products would all become illegal to sell,” said Conley.

    Nationally in the U.S., Conley said the FDA’s policy on vaping products in 2023 is likely to still be characterized by regulatory paralysis and the eternal search for the least politically controversial regulatory option. “Despite declines in youth vaping and the admonishment of federal judges, leadership at FDA remains steadfastly committed to having more combustible cigarettes on the market than vaping products,” he said. “On the plus side, the pace of FDA review has been slow to say the least, so we won’t hear rulings on many applications until 2024 or later.”

  • Analytically Speaking

    Analytically Speaking

    Kim Hesse shares her insights into the comparatively new field of testing ENDS products.

    By Timothy S. Donahue

    In late October, a health regulatory body in Mexico said its scientists had developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems (ENDS) because “no one else has come up with one.” Cofepris chief Alejandro Svarch said that the final results of a new analysis of ENDS products using the new method will be published in scientific journals in the coming months. Svarch added that the “pioneering methodology” developed in Mexico will be of interest to health authorities in other countries.

    The situation is puzzling at best since researchers have had the ability to evaluate aerosols in ENDS products for some time. Additionally, the sale of ENDS products was banned in Mexico in June. This led to many in the vaping industry to wonder how the nation could justify an ENDS ban when it now claims it had no ability to test the safety of the products.

    Every country that regulates vaping products requires that the products be tested for various elements, such as harmful and potentially harmful constituents (HPHCs) and heavy metals. According to Kim Hesse, vice president of sales and marketing for McKinney Regulatory Science Advisors, researchers have used aerosol testing methodologies to evaluate air quality, combustible cigarette smoke and inhaled medical product aerosols for many years, and ENDS aerosol testing has existed for nearly 15 years.

    “This knowledge was then adapted to the ENDS industry. The earliest known third-party tobacco testing laboratory of ENDS products occurred in 2008 by one of the largest tobacco laboratories. Most other third-party labs began testing no later than 2015,” explained Hesse. “Coresta [Cooperation Centre for Scientific Research Relative to Tobacco, an organization that promotes international cooperation in scientific research relating to tobacco] has been working on validating methods for ENDS products for many years. The organization has validated method[s] for smoke collection and instrumentation while continuing to work on many more method needs for the ENDS category.”

    Hesse said that it is important to test ENDS products to ensure the general public is not inhaling unacceptable levels of potentially harmful compounds (e.g., heavy metals or diacetyl). By testing these products, the industry can ensure consistency and provide regulators, such as the U.S. Food and Drug Administration and other government agencies, the data needed to evaluate ENDS products. She sat down with Vapor Voice to answer several questions related to ENDS testing.

    Vapor Voice: What type of experience do you have in testing tobacco and ENDS products?

    Hesse: We published several scientific articles that demonstrate our knowledge, capabilities and experience testing tobacco and ENDS products. For example, we recently published an article that provides instructions on the importance of conventional toxicological metrics when generating and characterizing ENDS aerosols.

    How is testing e-cigarette vapor different from testing combustible cigarettes?

    It depends. Testing combustible cigarette smoke, which contains a particle and gas phase, is a bit more challenging than simply testing an ENDS aerosol.

    However, when you consider product variability, ENDS products present many challenges that cigarettes don’t. ENDS products come in all different shapes and sizes. Some have round mouthpieces while others have square. This alone poses a challenge in connecting the device to the smoking instruments, whose adaptors are round. Some devices have actuators, all of which are in different locations. Some vaping machines have push actuators that do not work well with the various actuator shapes and locations. Cigarettes, on the other hand, are standard size, and 20 cigarettes can be lit at one time with a standardized lighter that is built into the smoking machine.

    Combustible cigarettes are tested to completion, and e-cigs are only tested for a set number of puffs. After the aerosol or smoke collection is accomplished, the remainder of the testing for the various compounds proceeds in essentially the same fashion regardless of whether it is aerosol or smoke. The e-cigs and cigarettes are tested on essentially the same instruments, but the method regimes (number of puffs, interval between puffs and volume) are slightly different.

    Are there different standards for testing, and how does a company know which ones to use?

    Both combustible cigarettes and ENDS products have a standard Coresta regime for ambient (ISO) testing. The Health Canada (intense) method for e-cigarettes [is] determined by the manufacturer’s scientists and is established based on the limitations of the devices (some devices have puff duration limits).

    The analytical methods can also vary slightly between combustible cigarettes and vaping products due to the significant reduction of constituents in the e-cigarettes. The calibration curve is usually much lower in e-cigarette analysis. Other variabilities are the angle in which the e-cigarette devices are tested. The testing angle of the device is based on the model (tank, cigalike, etc.).

    Are there many challenges in e-cigarette testing, and how can those difficulties be overcome?

    You are required to share data with FDA even if the data is not favorable. Several companies simply have their products tested and then send the report to FDA without knowing if the data supports their product as appropriate for the protection of public health.

    There is always room for improvement. We find that most labs are always working on method improvement. As mentioned previously, the various sizes and shapes of the ENDS devices pose a challenge. The lack of standardized testing methods for all the HPHCs and lab variability pose opportunities for improvement.

    How accurate are the testing methods and the results that the tests provide?

    Currently, analytical methods can detect chemicals at extremely low levels. Chemicals are often detected at levels that do not pose a health risk to humans. Some in public health use detected levels of chemicals rather than the more important harmful level of chemicals to create a public panic and thereby negatively impact the goal of harm reduction.

    Coresta has a good working group for ENDS testing and analytical methods. We should focus on having more companies and laboratories actively participate in studies aimed at simplifying and reducing variability of existing methods.

    One area of a standardization focus should be on the creation of a reference ENDS device that may be used with any remaining e-liquids—similar to the reference cigarette (1R6F), which is used to compare combustible cigarette data generated by different labs.

    From your test results, would you say that vaping is less risky than combustible smoking?

    This isn’t about me. What I can say is that Brian King, the director of the FDA’s Center for Tobacco Products, said in the media that he understands that e-cigarettes have “markedly less risk” than a combustible cigarette product. He acknowledged the continuum of risk for tobacco products and where e-cigarettes fall on that continuum. During the recent GTNF 2022 I attended, he said that there are certain products that are lower risk than combustible cigarettes, and that is an important component of the dialogue for the FDA. The FDA acknowledging that e-cigarettes are less harmful than combustible cigarettes is significant.

    Do you have any recommendations for companies looking to have their products tested?

    First, simply sending samples to a lab without understanding the testing requirements or how to interpret the data is a waste of money. Make sure you are working with a credible group of scientists that guide you through the process of generating scientific data.

    I suggest the following: Ensure the laboratory you choose is ISO 17025 certified. It is advisable to use a laboratory the FDA is familiar with. This will make the data review process a bit better and will likely not result in denial of data submission due to laboratory insufficiencies. When choosing a lab, make sure they have filed a tobacco product master file (TPMF) with the FDA and that their methods are validated and validation reports are included in their TPMF.

  • FDA Accepts Bantam Vape Non-Tobacco PMTAs

    FDA Accepts Bantam Vape Non-Tobacco PMTAs

    Bantam Vape received acceptance of its premarket tobacco product application (PMTA) submission from the U.S. Food and Drug Administration for its non-tobacco nicotine e-liquids, according to a press release. Bantam’s application now moves to the next step in the PMTA process—a preliminary scientific review to confirm the application contains all required items to permit a substantive review by the FDA.

    Bantam submitted its application for its non-tobacco nicotine e-liquids to the FDA on May 13, 2022, and is seeking marketing orders from the agency.

    “The receipt of this acceptance letter reflects Bantam’s efforts to provide adult consumers with high-quality, science-based e-liquids while upholding our responsibility to restrict youth access and use of these products,” said Bantam spokesperson Anthony Dillon. “Bantam remains supportive of the need for science-based regulation in the e-liquids industry and is proud of the progress of our various PMTAs. We remain confident in the quality and consistency of our products and the science behind them.”

    Prior to its non-tobacco nicotine-focused submission, Bantam submitted a PMTA to the FDA in September 2020 for its tobacco-derived e-liquids. The application entered scientific review in August 2021, and, to date, remains under FDA review.

    Earlier this year, the -liquid manufacturer received an exemption from the United States Postal Service (USPS) that allows the company to ship its e-liquid products to select vape retailers and distributors throughout the United States.

  • Appeals Court Denies Avail Vapor’s MDO Petition

    Appeals Court Denies Avail Vapor’s MDO Petition

    A unanimous panel of the United States Court of Appeals for the Fourth Circuit on Monday denied Avail Vapor’s petition to have its marketing denial order (MDO) issued by the U.S. Food and Drug Administration for its e-liquid products invalidated.

    Circuit Judge J. Harvie Wilkinson wrote Monday that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate to protect public health. Wilkinson was joined by Circuit Judges Diana Gribbon Motz and Albert Diaz.

    The court rejected all of Avail’s arguments, including that the FDA’s review of its premarket tobacco product applications (PMTAs) was arbitrary and capricious, according to a copy of the ruling obtained by Vapor Voice.

    “We see no merit in Avail’s remaining arguments that FDA acted arbitrarily and capriciously in reviewing petitioners’ PMTAs,” the decision states. “FDA could not allow young adults to perceive e-cigarettes as another Baby Ruth or Milky Way, only to find themselves in the grip of a surreptitious nicotine addiction. This was hardly arbitrary.”

    Avail’s chief complaint is that the FDA arbitrarily imposed a new “comparative efficacy” standard, which asked applicants to demonstrate through certain long-term studies that their fruit and dessert-flavored products better promote smoking cessation than tobacco-flavored products.

    This standard, Avail complains, was adopted with no explanation to applicants and without consideration of their reliance interests. Avail also raises a substantive objection, arguing that FDA’s imposition of this comparative efficacy standard exceeded its statutory authority under the TCA.

    “First, Avail attempts to tie the hands of the FDA to certain forms of evidence and kinds of studies in what is a rapidly evolving field. Second, in focusing upon procedural points, Avail encourages us to neglect the forest for the trees,” the decision states. “Avail essentially argues that “the FDA’s willingness to consider some forms of evidence, explicitly phrased as such, required the FDA to accept that evidence as meeting a statutory requirement even where the FDA found the evidence unsatisfactory.”

    According to the decision, Avail also filed its marketing plan with its PMTAs, which outlined measures designed to prevent underage use. Such measures consisted of naming its flavored e-liquids with “non-descriptive and non-characterizing names” that do not identify the product flavor to prevent appealing to youth.

    “The agency denied Avail’s application for its flavored electronic cigarettes, chiefly on the grounds that its products posed a serious risk to youth without enough offsetting benefits to adults,” the decision states. “We now uphold that decision and deny Avail’s petition for review.”

    The judge also specifically stated that he did not agree with the U.S. Court of Appeals for the Eleventh Circuit’s decision to stay the MDO issued by the FDA to Bidi Vapor. Persons with knowledge of the Avail suit said that it was a good case to petition for certiorari, a review of the lower court’s decision, to the United States Supreme Court.

  • First Vapor Manufacturers Handed DOJ Injunctions

    First Vapor Manufacturers Handed DOJ Injunctions

    Credit: MQ Illustrations

    The United States filed complaints in December against six companies and related individuals to stop the illegal manufacture and sale of unauthorized vaping products. The charges were brought on behalf of the U.S. Food and Drug Administration.

    E-cigarette manufacturers Seditious Vapours LLC and Vapor Craft LLC, two of those six companies, must stop distributing and selling their products under two separate court orders granting the FDA-requested injunctions, according to Bloomberglaw.

    Judge Douglas L. Rayes of the U.S. District Court for the District of Arizona sided with the FDA’s argument that Seditious Vapours failed to submit premarket applications for the products, and subsequently manufactured, sold, and distributed the e-cigarettes illegally, according to a court order filed Friday.

    Two days earlier, Judge Clay D. Land of the US District Court for the Middle District of Georgia granted a permanent injunction against Vapor Craft.

    The FDA states that the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers after receiving warning letters from the agency. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.

    “These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”

    When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure.

    The six companies originally having injunctions filed were: 

    • Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
    • Soul Vapor LLC in the Southern District of West Virginia
    • Super Vape’z LLC in the Western District of Washington
    • Vapor Craft LLC in the Middle District of Georgia
    • Lucky’s Convenience & Tobacco LLC d/b/a Lucky’s Vape & Smoke Shop in the District of Kansas
    • Seditious Vapours LLC d/b/a Butt Out in the District of Arizona

    The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.

  • FDA Accepts Several Streamline Synthetic PMTAs

    FDA Accepts Several Streamline Synthetic PMTAs

    Streamline, parent to Juice Herad and several other e-liquid brands, announced that the U.S. Food and Drug Administration had accepted the company’s premarket tobacco product applications (PMTAs) for several of its synthetic products under the Juice Head brand.

    In an email, Streamline co-founder and CEO Patrick Mulcahy said that his staff and Accorto Regulatory Solutions were instrumental in preparing the PMTAs for submission.

    “With ample investment and focus on ensuring the quality and compliance of all Juice Head products, we are thrilled to be making progress and look forward to a positive response from the FDA.

    “Currently, our PMTAs for Juice Head 5Ks, Juice Head Bars, and Juice Head Pouches are still under review; however, we are confident that we will receive a positive response from the FDA soon,” Mulcahy said. “As always, we will maintain our commitment to transparency and communication throughout the process ahead.”

  • FDA Warns 5 Vapor Businesses for Illegal Marketing

    FDA Warns 5 Vapor Businesses for Illegal Marketing

    The U.S Food and Drug Administration issued warning letters to five firms on Wednesday for the illegal marketing of 15 different e-cigarette products.

    The letters were issued to Wizman Limited doing business as Wizvapor, Shenzhen Fumot Technology Co., doing business as R and M Vapes, Shenzhen Quawins Technology Co., Ruthless Vapor and Moti Global.

    According to the FDA, all 15 products are packaged to resemble toys, food or cartoon characters.

    “The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”

    None of the manufactures have submitted a premarket tobacco product application (PMTA) for the unauthorized products. The items described in the warning letter include e-cigarettes that are designed to look glow sticks, walkie talkies and Nintendo Game Boy game systems.

    “The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.”

    Additionally, the products feature characters from cartoons and media that are aimed at a youth and/or teen demographic including The Simpsons, Family Guy, Squid Game, Rick and Morty, Minions and Baby Bus, as well as imitate youth appealing foods such as popsicles.

    Last month, the U.S. Department of Justice (DOJ) filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.

    The FDA states that each of the defendants failed to submit PMTAs for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law.

  • Bidi Parent Inks Deal for Marketing, Sales Strategy

    Bidi Parent Inks Deal for Marketing, Sales Strategy

    Kaival Brands Innovation Group, parent to Bidi Stick vaping products, today announced it has reached a three-year extension agreement with QuikfillRx, the third party vendor responsible for executing Kaival Brands’ marketing and sales strategies.

    As part of the agreement, QuikfillRx will be rebranded as Kaival Marketing Services (KMS) to more properly reflect the commitment of KMS to the success of Kaival Brands, according to a press release.

    “We are happy to continue our service with Kaival Brands and its commitment to responsible marketing,” Russell Quick, president of KMS, stated in the release. “Our combined efforts at preventing underage use of vaping devices and focus on the needs of legal-age smokers looking for an alternative to combustible cigarettes, stands as a model for the industry.”

    In February 2022, the U.S. Court of Appeals for the Eleventh Circuit stayed a marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021 for its non-tobacco flavored Bidi Stick products. The FDA had previously issued an administrative stay to Bidi Vapor, however, the agency rescinded that stay in December 2021.

    Kaival Brands reported revenues of $3.8 million for the third quarter of fiscal year 2022, up from $3.2 million for the same period of 2021. Gross profit was $442,100 compared to a loss of $84,300 for comparable 2021 period.

    Kaival attributed its improved revenues in part to an August court ruling that set aside a marketing denial order issued by the U.S. Food and Drug Administration to the company’s nontobacco flavored Bidi Stick e-cigarettes.

    The three-year extension with KMS was executed in preparation to support the anticipated improved sales volumes arising from this decision and the increase of Bidi Stick sales and marketing activities.

    In addition to monthly cash payments, which will be lower than during the initial term of the agreement, and a one-time upfront vested common stock option award, KMS will be eligible to receive performance-based common stock option awards from Kaival Brands.

    Eric Mosser, president and chief operating officer of Kaival Brands, stated that KMS has been an integral part of the Kaival story since its inception.

    “Their industry knowledge and expertise, experience working with our team, and unmatched around-the-clock service is best in class,” he said. “As part of ongoing corporate efforts in anticipation of increasing sales activity following Bidi Vapor’s merits case win, it became clear that reaffirming our relationship with KMS was an important step to manage growth.”

  • Hyde Maker Files Suit Against FDA for PMTA Denials

    Hyde Maker Files Suit Against FDA for PMTA Denials

    The manufacturer of Hyde and Juno brand e-cigarettes is suing the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accuses the agencies of refusing to review company’s premarket tobacco product applications (PMTAs) for 12 products, a process which has cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications, according to law360.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    According to the suit, applications for Magellan’s products were submitted to the FDA on May 12 and 13 by a third-party company based in China, Skyte Testing Services Guangdong Co. Ltd., before the May 14 deadline.

    However leading up to the due date, the FDA made last-minute changes to what was required in an application, the suit claims. Specifically, on April 14, the agency used emergency powers to amend a document, Form 4057, which Magellan would need to include with its application.

    An amended version of this form wasn’t posted on the government’s website for almost two weeks, additionally, the FDA didn’t announce the change until May 16, two days after the applications were due.

    Magellan claims that at the time Skyte submitted the applications, the government’s website did not generate submission tracking numbers. Magellan claims didn’t learn those numbers until after the FDA issued its RTAs in October, according to the suit.

    Without the numbers, Magellan was not able to properly submit amendments to its application, specifically a new Form 4057. Skyte tried to submit updated documents on Aug. 18, explaining in the summary page that these documents were meant to be included with its May submissions, according to the suit.

    But the FDA later rejected these forms for not including the submission tracking number, the lawsuit claims. The agency specifically noted that “although you submitted additional submissions which may have been intended to amend your applications, [the submissions] did not specify the [tracking number] assigned to the original submission within FDA Form 4057,” according to the suit.

    Magellan claims the omission was not its fault.

    The FDA did not act “in accordance with law by failing to consider Magellan’s timely amendments submitted on Aug. 18, 2022, on the grounds that the amendments did not include or reference the submission tracking numbers assigned … when FDA itself failed to assign the original bundled applications corresponding submission tracking numbers,” the suit states.

  • USVA Sues FDA for PMTA Impact on Small Business

    USVA Sues FDA for PMTA Impact on Small Business

    Credit: Sergin

    The United States Vaping Association (USVA) is suing the U.S. Food and Drug Administration for its handling of the premarket tobacco product application (PMTA) and its impact on small businesses.

    The USAVA, a trade association that represents the small businesses, suit alleges that the FDA failed to properly consider the impact the “seemingly impossible and expensive” PMTA process would have on small businesses.

    “In the deeming rule, the FDA spoke as if vapor applicants would be able to substantially rely on public data, or on 70 studies the FDA itself was conducting at that time,” the USVA wrote in a statement. “In the end, the FDA wrote an impossibly burdensome PMTA rule that is putting a lot of people in this industry out of business. Yet, in fact the FDA claimed that there would be no significant impact on small businesses.”

    The lawsuit asks for relief for the businesses that are members of the USVA that includes:

    • Declare the PMTA Final Rule in violation of the Regulatory Flexibility Act; 
    • Remand the PMTA Final Rule to the FDA; and 
    • Enjoin the FDA from enforcing the PMTA Final Rule against any members of the USVA, and to take such actions as are necessary and proper to remedy their violations deriving from any such actual or attempted enforcement.

    The suit also criticizes the FDA prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies also were allowed to make changes to issues with their PMTA submissions where smaller companies with the same issues received marketing denial orders for those issues.