Author: Staff Writer

  • Companies File Suit Against California Flavor Ban

    Companies File Suit Against California Flavor Ban

    Credit: Niro World

    Vapor and other tobacco companies filed a lawsuit against California in federal court over the state’s ban on flavored products one day after voters backed the ban in a Nov. 8 referendum, reports the Courthouse News Service.  

    Though more than half the state’s ballots have yet to be counted, media outlets have declared that the referendum will pass. Unless a judge agrees to intervene, the ban is set to go into effect no later than Dec. 21, 2022.

    In their suit, the companies argue that the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 allows states and municipalities to regulate tobacco products, but not to ban their use or sale.

    “The ban falls under the TCA’s express preemption clause, ‘which preempts ‘any [state] requirement’ that is ‘different from, or in addition to,’  a federal requirement about a tobacco product standard,” the suit reads. “A flavor ban is a paradigmatic tobacco product standard.”

    In 2020, California lawmakers passed a ban on all flavored nicotine products except hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.

    Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.

    Vapor and tobacco companies already sued California over the flavor ban in 2021. But a federal judge dismissed the case, telling the plaintiffs to wait for the voters to weigh in before suing.

  • Juul Labs Secures Funding, Plans to Lay Off 400 Staff

    Juul Labs Secures Funding, Plans to Lay Off 400 Staff

    Credit: Piter2121

    Juul Labs Inc. said on Thursday that the company had secured an investment from some of its early investors that will keep the e-cigarette maker from filing bankruptcy.

    The company will also undertake job cuts as part of a reorganization, according to Reuters.

    Juul Labs also announced that it will lay off about 400 people and reduce its operating budget by 30 percent to 40 percent.

    The company said the investment would help Juul run its business operations, while it goes ahead with its administrative appeal of the U.S. Food and Drug Administration’s marketing denial order related to Juul its e-cigarettes.

    Juul Labs did not disclose the size of the investments.

  • Judge Orders Kentucky Sheriff to Return Delta-8

    Judge Orders Kentucky Sheriff to Return Delta-8

    A federal judge in Kentucky has ordered a Laurel County sheriff to return hemp products and derivatives that were seized from a pair of stores. The judge found that the store owner is likely to succeed on his claims that they were unlawfully taken.

    In an order filed last week, U.S. District Judge Claria Horn Boom said Joseph Bingham most likely has federal and state law on his side and his products were lawful, according to law360. She said Sheriff John Root must return what was seized in the February raid and is blocked from seizing similar products in the future.

    According to the suit, Bingham operates two CBD stores and on and Feb. 25, Root and others from the Laurel County Sheriff’s Department raided those businesses and seized products containing delta-8 THC without a warrant.

    While Root argued the products were in plain sight, Bingham alleged many of the products were in a back store room. There is also a dispute as to whether an employee at one of the stores consented to the search and seizure, according to the suit.

    In the order, Judge Boom noted that the 2018 Farm Bill exempts hemp and its derivatives from the definition of cannabis that is listed in Schedule I of the Controlled Substances Act, and the Farm Bill specifically excludes THC in hemp and its derivatives, with courts finding that this depends on the delta-9 THC concentration.

  • 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.

  • Total Geek Out

    Total Geek Out

    GeekVape’s new Aegis Max 2 retains all that made prior mods desirable and improves upon the nitpicks.

    By Mike Huml

    GeekVape is at it again with even more refinement and improvements to this latest version of the ever-popular Aegis series of mods. The Aegis Max 2 (also referred to as the GeekVape Max 100) is the king of intermediate mods, with a plethora of features for more advanced users and enough simplicity for the intermediate crowd. GeekVape took the already fantastic Aegis Max and somehow made it even better.

    The Aegis Max 2 is a single-battery mod that can fire atomizers from 0.1 ohm to 3 ohms up to 100 watts. By default, it requires a 21700 or 20700 battery, but an included adapter makes it possible to use an 18650 as well. Batteries can be swapped and charged via the screw-on battery door at the bottom of the device or charged internally through the use of a USB-C port.

    The traditional three-button setup is used here, with an additional slider on the side of the device to toggle the firing lock. The screen has been upgraded to color and displays the usual information at a glance: remaining battery life, resistance of the attached atomizer, power/temperature setting, amperage and voltage output, and a puff counter.

    The Aegis Max 2 is available in a variety of colors and comes as a standalone mod or in a kit with the latest GeekVape Z (Zeus) sub-ohm tank. The kit also includes a USB charging cable, replacement glass, too many O-rings to count, the 18650 battery adapter, a tool to help with coil removal, and a 0.2 ohm dual-coil replacement coil. The GeekVape Z also comes with a 0.2 ohm mesh coil preinstalled.

    What has always set GeekVape mods apart is the aesthetic and build quality. This masterpiece of leather, silicone and metal looks and feels rugged with a more streamlined, squared-off look compared to its predecessor. It’s also water resistant, impact resistant and dust resistant.

    The overall size has also been toned down slightly, which actually provides a more secure fit for the battery. The connection supports a flush fit for atomizers with diameters up to 25 mm, down from the oversized 30 mm connector featured in the previous generation. The matching tank tapers down to 24 mm at its base and looks fantastic atop the Max 2.

    In terms of features, the Aegis Max 2 is all encompassing. It has the capability to fire in power mode, with or without a custom power curve. It can make use of temperature-sensing wire such as nickel and stainless steel, again with custom TCR curves for other types of wire, from 100 degrees Celsius to 315 degrees Celsius or 200 degrees Fahrenheit to 600 degrees Fahrenheit.

    It also has the often-neglected bypass mode for users who want to use the natural battery voltage, similar to unregulated mods. Each of the aforementioned settings can be tweaked and customized using the in-mod menu and the three buttons. Many of these settings are for niche users with specific tastes, but the option is there for anyone to experiment with.

    For most users, they simply want to fill a tank, choose their wattage and vape. That’s definitely possible on the Max 2. For all the intricate settings available, they can all be ignored or utilized at the users’ leisure, conveniently hidden from anyone who simply doesn’t care. It’s the best of both worlds as the potentially confusing nature of menus and button combinations needn’t hinder the experience of those looking for something simple.

    There are three distinct ways to lock the device, thankfully none of them are redundant. As per usual, five clicks of the fire button will turn the device off (or on), preventing settings from being changed and the device from firing. By holding the plus and minus buttons simultaneously, the power setting becomes locked, allowing the device to fire but preventing accidental changes to the power or temperature settings.

    Lastly, the slider on the side will prevent the device from firing and the settings from being changed without powering down. It’s a most welcome addition, completely negating the frustrating experience of trying to click the fire button five times only to not have the command actually register. What’s more, the Max 2 powers itself back on once the battery has been replaced, so the generally horrible five-click on-off feature never needs to be used again if the user so wishes.

    The battery door has also been markedly improved over the original Aegis Max. Over time, that battery door could easily become cross-threaded. Due to the battery having more wiggle room, it could become difficult to determine when the battery door was adequately screwed in. With the Max 2, however, the battery door catches much more easily and has a distinct stopping point to prevent overtightening. Additionally, the battery door is recessed only by about half a millimeter to the point that it looks like a flush fit but doesn’t ever protrude past the base of the mod. The tighter tolerances have undoubtedly led to a more consistent and less fiddly experience.

    The charging port has also been redesigned. The Aegis Max 1 had a small silicone plug on the side of the device that could be difficult to remove, and once it was removed, it revealed a micro-USB port. Now with the Max 2, a USB-C charging port has replaced the obsolete micro-USB connector, and it’s been relocated to the top of the mod. A large silicone flap sits right above the fire button and is effortless to remove with the thumb that’s also used to fire the mod.

    Speaking of the fire button, it still retains a rocker shape but has been elongated to better fit the thumb and made to be more clicky and less mushy. The plus and minus buttons are also two parts of the same single button and sit side by side instead of over-under. Overall, the above changes not only improve the aesthetic of the Aegis Max 2 but also the functionality, ease of use and “feel.”

    The included tank, the GeekVape Z, is more or less the same as it’s ever been—fantastic. It’s top filling and top-down in terms of airflow and provides copious amounts of vapor and flavor for a wide range of power settings. Even upon the initial fill, it primes quickly, with zero break-in time. It holds a respectable 5.5 mL of e-liquid and is relatively compact given the amount of e-liquid that it holds.

    What’s especially nice is that the bubble glass doesn’t protrude very far, and the tank section is relatively lengthy. That means it has a higher chance of surviving if it tips over and doesn’t look ridiculous while still providing a substantial capacity. Being that the tank uses top-down airflow, it will never leak out the bottom and make a mess in the event of flooding.

    At worst, it will produce some spitback and need to be turned upside down and cleared to return it to full working order. It also means that the mod and hands are spared from condensation and spittle that tend to accumulate around the atomizer with tanks that opt for bottom-up airflow. Additionally, the airflow ring turns smoothly with hard stops on either end while providing a wide range of airflow options from restricted to wide open. Mouth-to-lung vaping is out of the question for all intents and purposes, but that’s why the mod is also available solo without the tank.

    All in all, the GeekVape Aegis Max 2 retains all the things that made prior mods desirable and improves upon all the small nitpicks. The improved charging port and its location, the tightened-up battery cap, the new slider lock, the much more reasonable 25 mm 510 connector base, the refined buttons—all these things come together to make the Aegis Max 2 a full-blown upgrade to the Aegis Max 1.

    Not to mention the general size and shape that favors lean, efficient functionality and appearance in lieu of girth and bulk. The Aegis Max 2 makes much better use of the space available, offering a 21700 mod that could pass for an 18650 device. The downside of that extra boost in power and battery life has always been size, but that downside is virtually nonexistent with the Aegis Max 2.

    The Aegis Max 2 can be purchased for $50 to $70 at retail, making it one of the best bangs for the buck out there. While at least one battery is required to be purchased separately, increasing the total investment, an external charger isn’t necessary.

    For anyone looking to upgrade to a proper mod or anyone looking for something that just looks and feels great with all the advanced features in a compact package that can be taken out for the day with minimal hassle, the Geekvape Aegis Max 2 is best-in-class. GeekVape retains its track record of offering top-quality products that look and perform like no other while keeping things affordable.

  • Quintessential Quality

    Quintessential Quality

    With top-of-the-line performance, there’s a wide potential market for Innokin’s new Klypse device.

    By Mike Huml

    Innokin is one of the most well-known and longstanding vapor product manufacturers in the industry. The company has long been adored by many vapers for its innovative products and level of quality, going all the way back to the original MVP. This latest offering, the Klypse, takes the slick, modern aesthetic that Innokin is known for along with solid build quality and puts it to good use in a simple, easy-to-use refillable pod system that anyone can pick up and use hassle-free.

    The Klypse is a mid-size pod system that’s mostly rounded but with two opposing flat corners for a better grip. It uses an internal 700 mAh battery that lasts all day with light vaping to moderate vaping. This battery can be charged quickly via the USB-C port and the included charging cable. The switch is draw activated, so there are no buttons, menus or settings to worry about.

    Each pod can hold up to 2 mL of e-liquid and is equipped with an integrated 0.8 ohm mesh coil. Once the performance begins to degrade, pod replacement is required since the coil cannot be removed or replaced. However, the pod is refillable. When the pod is removed from the device, a small silicone plug is revealed that can be popped open in order to fill it. It’s simple and effective. The translucent plastic informs the user as to the current e-liquid level, and there are clear markings on the side to indicate the minimum fill level to exceed for maximum flavor and performance.

    The pod is held in place with strong magnets and produces a satisfying click when installed. Additionally, the Klypse includes a snap-on magnetic cover that goes over the mouthpiece. This not only offers some protection if the Klypse is dropped but also eliminates contamination from dust and other impurities as a result of stowing the device in a pocket or bag. With the cap installed, the Klypse becomes very inconspicuous if not totally unrecognizable as a vaping device.

    The performance offered by the Klypse is top-notch and, perhaps more importantly, it’s consistent. The flavor is bold and accurate, and the volume of vapor is satisfying and easy to produce—it never feels as if it’s a struggle to get a good cloud, particularly for a mouth-to-lung device. Very restricted lung hits are technically possible but not recommended as there is no airflow adjustment, and the Klypse is intended solely for mouth-to-lung vaping. As such, e-liquids made with nicotine salts will provide the most satisfying experience.

    Throughout the life of the pod, there will not be any leaking, gurgling or dry hits (unless the pod is empty). Innokin’s commitment to quality has resulted in an extremely consistent vape experience, as mentioned above. However, the flavor produced by the Klypse is also nothing to scoff at. Fruits and menthols are crisp and fresh while dessert and tobacco flavors are deep and complex. The Klypse does a fantastic job of accurately representing all types of flavor profiles.

    The Klypse fills multiple roles. It’s very simple to use and would make for a fantastic starter kit for a new user. It’s a bit more “complicated” than a disposable or a device that utilizes pre-filled pods, but refilling is not a difficult process. On the positive side, this opens up the possibility of being able to use many more e-liquids and even taper down nicotine strength for someone looking to eventually quit altogether. It’s also potentially more cost-effective as bottled juice is generally less expensive than pre-filled pods or disposables. It strikes the ideal balance between simplicity and cost-efficiency.

    The Klypse could also serve as an upgrade for someone coming from a disposable or pre-filled pod system. It has longer battery life, better performance and again, gives the user many more options when it comes to e-liquid. For the most part, it boasts a longer battery life without adding too much in the way of size. Of course, there are exceptions, but the fast 1A charging and the option to vape while the Klypse is doing so mostly alleviates any inconvenience presented by the battery capacity coupled with heavy vaping.

    Lastly, and as with many other pod systems, the Klypse is a great choice for more experienced vapers who want something more portable and convenient. For enthusiasts, it won’t compete as a daily driver, but it’s a solid option to bring about during summer adventures. The sturdy build quality and the protective cap make the Klypse an attractive option for this purpose. It stands a good chance of surviving a day in the sand or a quick drop in the water if it’s recovered in a timely fashion.

    Innokin has always kept a finger on the pulse of the vaping community and is consistently able to produce some of the highest quality products without falling into the trap of over-engineering. The Klypse continues this legacy, and the value of simplicity can’t be overstated, especially for a pod system. For many years, the relative complexity, foundational knowledge and maintenance required even for starter kits was a huge barrier to entry for a lot of potential vapers.

    Today, many manufacturers have struck a good balance between quality and simplicity, but not like Innokin. When high-wattage, multi-battery mods were dominating the market, Innokin focused on simplicity, quality and safety, and those values carry into the modern era of vaping.

    What has changed about Innokin is the Klypse’s price point. Innokin products have historically been expensive compared to the competition, but it was usually justified due to the step up in quality. While Innokin certainly has not skimped in the quality arena, the entire Klypse kit can be had for approximately $16 retail. That’s cheaper than the bottle of e-liquid to go along with it or even some disposables.

    It’s a steal. The package includes the Klypse device itself, a single pod, a USB-C charging cable and the instruction manual. A three-pack of replacement pods hovers around $12, meaning the upkeep can be very inexpensive depending on the user’s choice of e-liquid. In any case, it’s undoubtedly cheaper than smoking.

    As advanced vapor devices become harder and harder to find, quality pod systems become invaluable, particularly for new vapers who want something simple. There’s also a huge potential market in those who want something that offers more than their disposable pod system but aren’t ready to make the jump to a proper mod.

    As with any product choice, generally price and quality have an inverse relationship, but the Klypse is one of the rare exceptions. Not only does the Klypse provide a great vape experience and a reliable quality product, but it does so while requiring minimal investment.

    With the Klypse refillable pod kit, Innokin has succeeded in creating a product that lives up to its reputation for producing quality vapor devices while also keeping it affordable. It does not lack in performance in any area and is simple enough for new users.

    It offers the choice of any e-liquid by nature of it being refillable but doesn’t get bogged down with features that aren’t necessary. While it’s perfect for newer vapers, it also has much to offer in the way of convenience, simplicity and portability that could potentially be attractive to advanced users and enthusiasts.

    As implied by its name, Innokin has always been at the forefront of innovation but in a different way. While other manufacturers were pumping out bigger and more powerful cheap devices, Innokin was focusing on quality and safety. It was one of the few manufacturers that never neglected their mouth-to-lung fans when sub-ohm vaping became all the rage.

    Now, that experience seems to have paid off as Innokin is several years ahead of many other manufacturers when it comes to a simple, refined product. They are also one of the few manufacturers to receive premarket tobacco product application acceptance for their products. Rest assured, the Klypse has the best shot at standing the test of time, meaning it will be supported by Innokin for the foreseeable future.

    The Klypse is a fantastic product all around and another notch in Innokin’s belt. It offers top-of-the-line performance in a simple package that won’t come anywhere close to breaking the bank. There’s a wide potential market for the Klypse, and it’s likely to stick around, meaning replacement pods should never be difficult to find. In a nutshell, the Innokin Klypse eclipses other products in its class and introduces quintessential Innokin to a new generation of vapers.

  • Maryland, Missouri Approve Recreational Marijuana

    Maryland, Missouri Approve Recreational Marijuana

    Several states had recreational marijuana on the ballot. Maryland and Missouri became the 20th and 21st states to legalize marijuana for adult recreational use on Tuesday, but cannabis reform efforts met defeat in Arkansas, North Dakota and South Dakota.

    Maryland voters approve a constitutional amendment that legalizes recreational marijuana for people 21 and older. It will go into effect on July 1, 2023, and allow possession of 1.5 ounces or two plants. Possession of small amounts of marijuana was already decriminalized in Maryland. Under the amendment, those previously convicted of cannabis possession and intent to distribute will be able to apply for record expungement, according to media reports.

    Missouri voters ended prohibitions on marijuana in the state and allow personal use for those over the age of 21. It will allow for personal possession up to three ounces and allow individuals with marijuana-related non-violent offenses to petition for release from prison or parole and probation and have their records expunged.

    North Dakota voters rejected a citizen-initiated ballot measure that aimed at allowing the use of marijuana in “various forms” for those who are at least 21 years-old. It would have allowed marijuana possession of up to an ounce and all marijuana to be tested in a facility “for the potency of products and the presence of pesticides” and subject to random inspection.

    South Dakotans rejected legalizing cannabis in the state, too. Legalization for recreational marijuana use had passed in South Dakota in 2020, but the results were nullified by state courts. According to the proposed 2022 ballot measure, marijuana possession of up to an ounce would have been legal. It also would have legalized possession of marijuana paraphernalia, use and distribution.

    Additionally, Arkansas voters rejected a constitutional amendment that would have allowed cannabis possession and recreational consumption by adults as well as the sale by licensed facilities. Had it passed, cannabis possession of up to an ounce would have been legal and some tax revenue from marijuana sales would have contributed to funding law enforcement.

  • California Bans Flavored Vaping, Tobacco Products

    California Bans Flavored Vaping, Tobacco Products

    Credit: Sharaf Maksumov

    Californians voted to uphold a state law ending the sale of most flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.

    Proposition 31, the ballot referendum to uphold the law, was ahead by a margin of 65 percent to 35 percent on Nov. 9. The Associated Press called the race, though official results will take longer to finalize. The state mailed ballots to all active voters. Ballots postmarked by election day have a week to arrive.

    In 2020, California lawmakers passed a ban on all flavored nicotine products except hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.

    “Proposition 31 is California’s antidote to the candy-flavored poison Big Tobacco has been peddling to our kids and communities of color,” said Fmr. Senator Jerry Hill, author of the original bill that became Prop. 31. “With the implementation of Prop. 31 comes a strong layer of protection against tobacco companies’ ability to lure kids into smoking and a lifetime of addiction to nicotine; and Californians will live longer, healthier lives as a result.”

    Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.

    Advocates for Proposition 31 argued the restrictions would deter tobacco use among kids by eliminating youth-friendly flavors such as bubblegum, cotton candy and cherry.

    Opponents said the ban would remove flavored electronic nicotine delivery systems as an effective tool to quit traditional cigarettes, and that some communities were unfairly targeted by the law. Black smokers, for example, are more likely to use menthol cigarettes.

    Supporters of the ban outspent opponents by a significant margin in the runup to the ballot. By mid-October, the billionaire anti-smoking and anti-vaping activist Michael Bloomberg had provided $15.3 million of the $17.3 million raised by the committee in favor of the ban, according to the San Francisco Chronicle. By contrast, the opposition had raised just over $2 million, almost entirely comprised of donations from Philip Morris USA ($1.2 million) and R.J. Reynolds ($743,000).

    California joins Massachusetts and the District of Columbia in ending the sale of flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars. Three other states—New JerseyNew York and Rhode Island—prohibit the sale of flavored e-cigarettes. With local laws included, 25 percent of the U.S. population will now be covered by laws ending the sale of flavored e-cigarettes.

  • 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.

  • Estonia Debates Ban on Disposable Vape Devices

    Estonia Debates Ban on Disposable Vape Devices

    Credit: Sharafmaksumov

    Estonia’s Minister of Labor and Health, Peep Peterson, says he will install measures to ensure that fewer novel tobacco products such as disposable, flavored e-cigarettes, fall into the hands of minors.

    Flavored e-liquids have been banned for purchase from outside Estonia since 2019, though initially it had not been clear whether the ban applied to flavored additives sold separately, according to ERR media reports.

    Peterson (SDE) says he has no leverage on e-cigarette paraphernalia entering the country, even in the case of banned items, telling ERR’s Madis Hindre that: “It is a classic role for customs to check and control commerce at the border.”

    Meanwhile Eerik Heldna, head of the Tax and Customs Board’s customs department said that the organization intercepts illicit tobacco products entering Estonia every day.

    Heldna said border checks: “Certainly do not comprehensively solve the social problem. Such a situation, where customs confiscates one hundred percent of illegal goods, no matter what the goods are, does not arise anywhere in the world,” adding that demand-side measures are key.

    Heldna said that the majority of illegal new tobacco products come to Estonia from another EU country, adding that for this reason, EU-level restrictions, such as those on heated tobacco products, will help.

    “Any such EU-level measures, which start to diminish this market, especially among young people would be very welcome. They will alter this picture significantly more than just one or another successful procedural action,” Heldna said.

    More legislation is likely to emanate from the social affairs ministry soon, to address the issue is single-use e-cigarettes, which have brought with them concern over their potential appeal to minors.

    “Hypothetically, a decision to ban disposable vapes, or e-cigarettes, is on the table,” the minister said, adding that retailers have not been at fault and are good at checking the age of customers where that would be appropriate.

    Measures might include retailers having to take back used-up e-cigarettes, though there are also environmental considerations regarding disposal.

    The disposable e-cigarette market is also booming, ERR reports, rising from 2.5 million sales of individual flavored e-cigarettes in 2020 in Estonia, to 35 million last year.