Smoke Shop Insider Magazine 2025 Q1 - Issue 4

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Vape Bans: E-Cigarette Restrictions in the U.S. and Worldwide

DoorDash Expands Offerings to Include Hemp-Derived THC and CBD Products Supreme Court Hears Triton and FDA Arguments; Offers Few Hints Vape Companies vs FDA: Appeals and Legal Actions 22 32 38 44

Press release:

Geekbar and Digiflavor

Make a Splash at the 2024 Miami Rolling Loud - A Cross-Industry Extravaganza of E-Cigarettes and Music Culture.

Miami, December 13-15, 2024 —

As one of the most influential hip hop music festivals globally, Rolling Loud this year attracted around 140,000 music fans to celebrate its 10th anniversary in Miami. On this vibrant and creative stage, Geekbar and Digiflavor made their joint appearance.

Whether sampling the latest flavors, experiencing hightech devices, or engaging in 360° selfies and live interactive games, every visitor could feel the excitement and immersion that the brands brought to the event.

Geekbar PulseX: Leading technology and unique style for an unmatched vaping experience

This time, Geekbar introduced the PulseX Meteor Edition, which quickly attracted a large following of enthusiasts. The sleek design, complemented by the trail of a meteor streaking across the night sky, uses a unique gradient gloss technique. Each device’s surface presents a different play of light and shadow, shining like a meteor in the hand.

In addition to its stunning design, PulseX also features AI Power Adjustment, Quick Charge (reaching 90% battery capacity in 30 minutes), and a High-Comfort, Bite-Friendly Mouthpiece for a better user experience.

With special pulse power and super boost, the pulse mode offers instant dual heating for a more impactful flavor experience, while the regular mode ensures a smooth and durable vapor experience.

Digiflavor BRK: Take a break, making vaping more pleasurable.

Alongside Geekbar, Digiflavor showcased its new electronic cigarette product, the BRK Series. The BRK series offers eight flavors, each carefully crafted based on extensive experience in the U.S. market and frontline market research. Every consumer is sure to find their favorite among them.

The available flavors are: Watermelon Ice, Amazon Lemonade, Strawberry B-POP, Cherry Strazz, Sour Apple Ice, Day Walker, Miami Mint, and Blue Razz Ice.To meet the varied needs of its customers, Digiflavor is dedicated to consistently developing new flavors in 2025.

What impressed customers most is its adaptive color and lighter solo. The UI shifts colors to match each pod’s flavor, providing a visually stunning and flavorful vaping experience that tantalizes all the senses. And you can use the pod solo for a light experience, or snap on the battery for instant power and a dreamy vape. This feature makes the product more creative and more personalized.

“Take a break” — this device, with its cuttingedge technology and unique design, makes personalized vaping possible anytime and anywhere.

The ultimate fusion of e-cigarettes and hip hop festival vibes

Innovation and actively embracing local markets and consumers, while integrating local cultures, have always been a focus for both Geekbar and Digiflavor.

Whether through interactive product displays or live tech elements, Geekbar and Digiflavor combine vaping culture with technological allure, offering audiences more opportunities for interaction and entertainment. This crossindustry fusion has turned the vaping culture into more than just a product experience; it has become a lifestyle that intertwines art and technology.

Innovation

and actively embracing local markets and consumers, while integrating local cultures,

have always been a focus for both Geekbar and Digiflavor.

Moving forward, Geekbar and Digiflavor will continue to uphold their core philosophy of technological innovation and openness, staying committed to the mission of “Being Healthier.” They will focus on creating tailor-made products and flavors for the local market, providing better service to consumers.

Government attitudes toward vaping and nicotine vary. In the United Kingdom, vaping has largely been encouraged by government health agencies. Because smoking creates a costly burden for the UK’s National Health Service, the country stands to save both lives and money if smokers switch to e-cigarettes.

Many other countries also allow a regulated vaping market, but are less enthusiastic about the practice. In the United States, the Food and Drug Administration (FDA) has had authority over vapor products since 2016, but has refused to create a plain system of standards for e-cigarettes and e-liquids. In recent years, some U.S. states have imposed flavor and online sales bans. Canada somewhat followed the U.K. model for a short time, but has recently imposed nicotine-strength limits and extreme flavor restrictions.

There are more than 40 countries that have some type of ban on vaping—either on possession and use, sales, importation, or a combination. What we have attempted is to list U.S. state flavor and online sales bans, and the sales and use bans imposed in other countries.

U.S. bans on flavored vapes and online sales

The FDA has federal authority to regulate vaping products. In September 2020 the agency began reviewing premarket tobacco applications (PMTAs), and has signaled it will not authorize flavored products without extraordinary evidence. Whether the agency will be successful creating an unwritten standard that eliminates legal flavored products (except tobacco) may be determined by federal courts.

Most vape bans in the U.S. happen at the state and local levels. And while a few California cities— notably San Francisco—have banned outright the sale of all vaping products, most American vape restrictions involve flavors and online sales. There are only a few of each, despite the large number of vaping bans that have been proposed in state legislatures in recent years—proof that grassroots opposition can stop bad legislation.

Arkansas - online sales ban

Tobacco permits issued to Arkansas businesses only allow face-to-face transactions, so online sales are prohibited.

California - flavor ban

California has banned in-store sales of flavored vapes---with or without nicotine--since 2022. As of Jan. 1, 2025, the state also prohibits online sales of flavored products, and includes all forms of nicotine and nicotine analogs in the ban.

District of Columbia (D.C.) - flavor ban

The D.C. city council passed a flavor ban on all vaping and tobacco products in 2021.

Georgia - online sales ban

Georgia allows only face-to-face retail transactions of vaping products, so online sales are prohibited.

Hawaii - online sales ban from out of state

Hawaii bans online sales from outside the state, except to licensed retailers.

Maine - online sales ban

Maine bans online sales, except between licensed businesses.

Massachusetts - flavor ban

The first statewide flavor ban was passed in late 2019 by Massachusetts. It includes all tobacco products, and prohibits sales of all vape flavors except tobacco.

Nebraska - online sales ban

Nebraska bans online sales, except between licensed businesses.

New Jersey - flavor ban

New Jersey’s ban covers all flavors except tobacco.

New York - flavor ban + online sales ban

The New York flavor ban, which covers all flavors except tobacco, was passed

in April 2020. The state also adopted an online sales ban (of all vaping products) at the same time.

Oregon - online sales ban

Oregon bans online sales, except between licensed businesses.

Rhode Island - flavor ban

In March 2020, then-governor Gina Raimondo bypassed the state legislature and used the Department of Health to create a permanent ban on all vape flavors except tobacco. In 2024, the legislature converted the ban from a health department rule to a law.

South Dakota - online sales ban

Shipping of all tobacco products (including vapes) is prohibited in South Dakota.

Utah - flavor ban + online sales ban

Utah bans online sales, except between licensed businesses. In March 2024, the state passed a ban on vape flavors (other than tobacco and menthol), which took effect Jan. 1, 2025.

Vermont - online sales ban

Vermont bans online sales, except between licensed businesses.

Major cities with flavor bans include Chicago, IL; Columbus, OH; and Denver, CO.

Complete bans on vaping product sales have been adopted by San Francisco and some smaller California cities. Brookline, Massachusetts has passed a so-called generational ban on tobacco and nicotine product sales (including vapes). The city increases the legal age to buy nicotine products by one year each year. No one born after Dec. 31, 1999, can ever buy nicotine products legally in Brookline.

The city increases the legal age to buy nicotine products by one year each year. No one born after Dec. 31, 1999, can ever buy nicotine products legally in Brookline.

Countries that ban vaping product sales

or use

In some nations, vaping is completely illegal, including both sales and possession. Prohibition is most common in Asia, the Middle East, and South America. Australia has a bizarre pharmacyonly sales model for vaping products, and unauthorized importation can result in huge fines and even jail time. In Japan, nicotine vaping products are illegal, but heated tobacco products like IQOS are completely legal and widely used.

Some countries have outright bans on both sales and possession, others just prohibit sales, and some ban only nicotine-containing products. In many countries, the laws are ignored and black markets flourish. In others, they’re enforced (but even those have black markets too). If a country is not listed, vaping is either allowed and regulated, or there is no specific law governing e-cigarettes (as of now anyway).

This isn’t meant as a definitive legal guide for traveling vapers. If you’re visiting an unfamiliar country you should first check with an up-todate official source like your country’s state department, or the travel bureau of the country you’re visiting.

Antigua and Barbuda

Legal to use, illegal to sell

Argentina

Legal to use, illegal to sell

Australia

Legal to use, illegal to sell (outside of pharmacies), illegal to possess more than nine products

Bangladesh

Bangladesh currently has no laws or regulations specific to vaping. However, in 2021 the government announced it would update the country’s tobacco control law with an outright ban on the sales of e-cigarettes

Bhutan

Legal to use, illegal to sell

Brazil

Legal to use, illegal to sell

Brunei Darussalam

Legal to use, illegal to sell

Cambodia

Banned: illegal to use, illegal to sell

Chile

Legal to use, illegal to sell

Colombia

Legal to use, illegal to sell

Cook Islands

Legal to use, illegal to sell

East Timor (Timor-Leste)

Banned: illegal to use, illegal to sell

Ethiopia

Believed to be legal to use, illegal to sell

Gambia

Believed to be illegal to use, illegal to sell

Ghana

Legal to use, illegal to sell (except when prescribed by a doctor)

Hong Kong (a Special Administrative Region of China)

Legal to use, illegal to sell

India

Legal to use, illegal to sell

Iran

Believed to be illegal to use, illegal to sell

Jamaica

Legal to use, illegal to sell nicotinecontaining products without a medical license

Japan

Legal to use, legal to sell devices and zeronicotine e-liquid, but illegal to sell nicotinecontaining liquid (although individuals can import nicotine-containing products with some restrictions). Heated tobacco products (HTPs) like IQOS are legal and extremely popular

Kazakhstan

Legal to use, illegal to sell. The law, which prohibits sale, manufacture and import, also bans imports for personal use

Kuwait

Believed to be legal to use, illegal to sell

Kyrgyzstan

Vapes are currently legal, but as of July 1, 2025, a complete ban, including sales and personal possession, will take effect

Lao People’s Democratic Republic (Laos)

Banned: illegal to use, illegal to sell

Lebanon

Legal to use, illegal to sell

Macau (a Special Administrative Region of China)

Possibly legal to use, illegal to sell. In late 2022 a law took effect that bans the manufacture, distribution, sale, import, export, and transport of all vaping products. While personal use may be technically legal, there seems to be no way to acquire products without violating the import or transport bans

Malaysia

Legal to use, illegal to sell nicotinecontaining products. Although consumer sales of nicotine-containing products are illegal, Malaysia has a thriving vaping market. Sales of all vaping products (even without nicotine) are banned outright in the states of Johor, Kedah, Kelantan, Penang and Terengganu

Nepal

Legal to use, possibly illegal to sell (although the government itself seems unsure)

Nicaragua

Believed to be illegal to use, illegal to sell

North Korea (Democratic People’s Republic of Korea)

Banned: illegal to use, illegal to sell

Oman

Believed to be legal to use, illegal to sell

Palau

Banned: illegal to use, illegal to sell

Maldives

Banned: illegal to use, illegal to sell

Mauritius

Legal to use, illegal to sell

Mexico

Legal to use, illegal to sell

Myanmar

Believed to be illegal to use, illegal to sell

Panama

Legal to use, illegal to sell

Qatar

Banned: illegal to use, illegal to sell

Seychelles

Legal to use, illegal to sell. However, the country announced in 2019 its intention to legalize and regulate e-cigarettes

Singapore

Banned: illegal to use, illegal to sell. As of 2018, possession of vapes is a crime, punishable by fines and even prison time. However, the threat of prosecution hasn’t prevented a thriving black market

Sri Lanka

Legal to use, illegal to sell

Suriname

Legal to use, illegal to sell

Syria

Banned: illegal to use, illegal to sell

Taiwan (Republic of China)

Banned: illegal to use, illegal to sell

Thailand

Believed to be legal to use, illegal to sell. Thailand has earned a reputation for enforcing its ban on importation and sales of vaping products with several high-profile incidents in recent years, including detaining and even deporting tourists caught vaping

Turkey

Legal to use, illegal to import. Turkey’s laws are conflicting, and there is a vaping market and a vaping community in Turkey

Turkmenistan

Believed to be legal to use, illegal to sell

Uganda

Legal to use, illegal to sell

Uruguay

Legal to use, illegal to sell

Vatican City

Believed to be illegal to use, illegal to sell

Venezuela

Banned: illegal to use, illegal to sell. In August 2023, the Venezuelan health ministry banned the sale and personal use of all vaping and heated tobacco products on order of President Maduro

DoorDash Expands Offerings to Include Hemp-Derived

THC and CBD Products

In a strategic move to diversify its services and meet shifting consumer demands, DoorDash has announced the addition of hemp-derived THC and CBD products to its delivery platform in select U.S. states, according to an official company statement. This expansion enables eligible customers to order a variety of products— including beverages, gummies, and topicals— directly to their doorsteps.

“...including beverages, gummies, and topicals— directly to their doorsteps...”

Growing Consumer Interest in Hemp-Derived Products

According to a Harris Poll survey commissioned by DoorDash, nearly 75% of U.S. adults aged 21-65 who are looking to de-stress in 2025 are considering incorporating THC/CBD products into their wellness routines. This data aligns with a broader industry trend of increased demand for alternative wellness solutions, particularly plant-based and natural options.

Seamless Integration into the DoorDash App

DoorDash has designed its platform to accommodate this new category by introducing a dedicated “CBD/THC” tab within the app. This feature allows users in eligible areas to browse and order from a curated selection of hemp-derived products. To ensure compliance with legal age restrictions, DoorDash has implemented multiple safeguards, including electronic ID verification at the time of delivery, similar to its existing alcohol delivery protocols.

“ 75% of U.S. adults aged 21-65 who are looking to de-stress in 2025 are considering incorporating THC/CBD products into their wellness routines...”

Strategic Partnerships to Enhance Availability

DoorDash has partnered with several key retailers, including DashMart (its own fulfillment platform), Total Wine & More, and ABC Fine Wine & Spirits, to provide customers with a variety of hemp-derived products. These partnerships aim to offer a diverse range of options while ensuring a seamless purchasing experience for consumers.

Promotional Offers to Boost Consumer Adoption

To mark the launch of this new category, DoorDash has collaborated with Cann, a leading brand in hemp-infused beverages, to offer a $2 discount on a multipack purchase. This promotional offer is available through January 31, 2025, at participating retailers. According to DoorDash, initiatives like this are aimed at encouraging customers—especially those new to hempderived products—to try them out in a low-risk way.

“DoorDash has collaborated with Cann, a leading brand in hemp-infused beverages, to offer a $2 discount on a multipack purchase...”

Legal Compliance and Consumer Safety Measures

All hemp-derived products available through DoorDash comply with the federal legal limit of no more than 0.3% Delta-9 THC on a dry weight basis, as outlined in the 2018 Farm Bill. DoorDash has emphasized that these products are intended for responsible adult use, and strict verification measures are in place to prevent underage access.

A Strategic Move in an Evolving Industry

The inclusion of hemp-derived products in DoorDash’s offerings signals a broader shift in the retail and delivery landscape, as more companies explore ways to integrate cannabisrelated products into mainstream commerce. As consumer interest in CBD and THC products continues to rise, DoorDash’s move positions it as an early adopter in this evolving market.

According to industry analysts, this shift could pave the way for other major retailers and delivery platforms to expand their cannabis-

related offerings, making these products more accessible to a wider audience. By leveraging its robust logistics network and partnerships with established retailers, DoorDash is wellpositioned to meet the growing demand for hemp-derived products while maintaining compliance with regulatory standards. In conclusion, DoorDash’s expansion into hemp-derived THC and CBD deliveries reflects the company’s commitment to evolving alongside consumer preferences. With strategic partnerships, compliance measures, and a growing interest in wellness-focused products, DoorDash is set to make hemp-derived products more accessible, convenient, and mainstream than ever before.

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Supreme Court Hears Triton and FDA Arguments; Offers

Few Hints

On Monday, lawyers representing the FDA and vape manufacturer Triton Distribution faced off in the Supreme Court, taking questions from the court’s nine justices. The FDA is seeking to overturn a Fifth Circuit Court of Appeals decision that found FDA marketing denial orders (MDOs) issued to Triton and Vapetasia were “arbitrary and capricious” and violated the Administrative Procedure Act (APA).

A full transcript of the proceedings is available on the Supreme Court website.

For just over an hour the opposing attorneys—Deputy Solicitor General Curtis Gannon

representing the FDA, and Eric Heyer on behalf of Triton— took turns fielding questions about whether the FDA had given clear requirements to manufacturers submitting premarket tobacco applications (PMTAs), and whether the agency had moved the goalposts after the fact when it denied millions of products without the individual assessments mandated in the Tobacco Control Act, which governs the FDA’s regulatory processes.

The Tobacco Control Act says the FDA must assess whether each product is “appropriate for the protection of public health”—a vague standard that

gives the agency wide latitude to interpret. Triton argued that one element of the FDA’s denials—a requirement to show that nontobacco-flavored vape products are comparatively more effective than tobacco-flavored ones—was introduced after the fact, as was a requirement that successful applications must include evidence from certain kinds of long-term studies.

The FDA had never said those studies were the only possible acceptable evidence, argued Gannon; it had merely said they would “likely” be needed.

Lawyers point out that the justices could assign more orlessweightto topics discussed in oralarguments--or not depend on them at all in theirdecision. Issues not discussed could even form a primary basis for the court’s final ruling.

The FDA, said Triton, had also claimed before applications were submitted that marketing plans (which would show how the company intended to avoid youth uptake) would be an important PMTA component. But the agency never even reviewed Triton’s plans before issuing an MDO. The FDA contended that, if ignoring marketing plans was an error at all, it was “harmless error” that could be either ignored or remedied by remanding the applications back to the agency to review marketing plans only.

The study requirement and marketing plan “switcheroos,” as one Fifth Circuit judge described them, were the major topic of discussion during the arguments. Justices Clarence Thomas and Samuel Alito seemed to lean into the argument that the FDA didn’t provide “fair notice,” with Thomas calling FDA guidance “a moving target.”

But overall, the justices seemed somewhat sympathetic to the FDA’s defense that it had not changed its position on required evidence. The agency had said such studies weren’t required, said Gannon, but made clear that some strong evidence would be needed to prove products would benefit the population as a whole.

The three liberal justices—Elena Kagan, Kentanji Brown Jackson, and Sonia Sotomayor—were clearly satisfied with the FDA’s actions, and even conservative Justices Kavanaugh and Gorsuch seemed to question whether Triton had made its fair notice case. Kavanaugh also suggested that applicants who

The Tobacco Control Act says the FDA must assess whether a product is “appropriate for the protection of public health”--a vague standard that gives the agency wide latitude to interpret.

receive MDOs can simply reapply. Triton attorney Heyer reminded him that waiting two or three more years for another FDA decision while unable to do business would mean bankruptcy for Triton and many other companies, who would no longer be protected from FDA enforcement until receiving FDA authorization.

Indeed this would be no problem for a company like Altria, which could sell cigarettes while it waits for an FDA authorization for its vaping products. But Triton doesn’t sell cigarettes. (Altria, by the way, helped write the Tobacco Control Act, which deliberately sets a high bar for approval of lowrisk cigarette alternatives.)

While it’s difficult to predict the outcome of the case from the arguments (especially for a nonlawyer like me), it must be noted that some major issues were not discussed much or at all, including the Tobacco Control Act itself and the “appropriate for the protection of public health” standard, whether the FDA’s new de

facto standards for flavored products should have been handled with APA-mandated notice-andcomment rulemaking, and how the Supreme Court’s recent Loper Bright Enterprises v. Raimondo decision---rejecting court deference to agencies making rules based on vague statutes--would apply to the Triton case.

Lawyers point out that the justices could assign more or less weight to topics discussed in oral arguments—or not depend on them at all---in their decision. Issues not discussed could even form a primary basis for the court’s final ruling.

Many vape industry and consumer advocates seemed mystified because the conservative justices did not—as they were led to expect by some—use the opportunity to rain down fire and brimstone on the FDA, but instead seemed rather bored and disinterested in the agency’s actions. Why? Nobody knows. At least four of the justices proactively chose to hear this case, so some members of the court clearly feel strongly

about it for some reason. It would be difficult to believe any of the six conservative justices would lobby for the chance to decide a case in favor of the hated administrative state—but stranger things have happened.

We’ll have to wait until next year—perhaps as late as June—to find out what the justices are thinking and what they decide. Meanwhile, a new administration will take over, and the FDA and Justice Department could be given new marching orders on vaping regulation and enforcement. President-elect Donald Trump promised during the election campaign that he would “save flavored vaping.” Now is his chance.

While most of the discussion Monday tackled technical legal points, there were also comments illustrating that some members of the court have no idea of what vaping products are or how they work—which is not at all comforting to consumers who depend on these products.

“Blueberry vapes are very appealing to 16-yearolds,” said Justice Kagan, “not to 40-year-olds.”

Vape Companies vs FDA: Appeals and Legal Actions

This article is an attempt to list all of the companies challenging the FDA’s Marketing Denial Orders (MDOs) in court, and to follow up on additional actions, including motions, stays, and decisions. We will also list administrative stays (or denials) issued by the FDA, based on MDO reviews conducted by the agency.

We’ve overhauled this article, making it easier to navigate. You can now view legal and administrative actions by date (with the newest events listed first) or by the companies involved (listed alphabetically). You can navigate to either

section, or to our list of Vaping360 articles about MDO events, using the table of contents at the top of the page.

The original article was posted Oct. 18, 2021, but some events predated the article. It is possible there are companies that have filed legal challenges to MDOs that we aren’t aware of. If you know of any, please comment or contact me. Likewise, if you’re aware of companies receiving denials of administrative review applications, please let us know.

Legal actions listed by date (newest first)

Dec. 2, 2024 - Lawyers for Triton Distribution and the FDA presented their arguments before the Supreme Court, and fielded questions from all nine justices. The court will render an opinion sometime this session, probably in the spring.

Nov. 19, 2024 - The Fifth Circuit granted VDX Distro a stay pending review of its MDO for menthol vaping products.

Oct. 25, 2024 - VDX Distro filed a motion for a stay pending review in the Fifth Circuit for an MDO issued Sept. 19 for menthol products. (VDX filed a petition for review Oct. 17.)

Oct. 18, 2024 - The Supreme Court has scheduled oral argument in the FDA’s Triton appeal for Dec. 2, 2024.

Oct. 17, 2024 - A three-judge panel of the Fifth Circuit has granted a stay pending review to Florida-based Lead by Sales LLC (doing business as White Cloud Cigarettes) for an MDO issued July 17, 2024.

Oct. 9, 2024 - Briefs have been filed by the FDA and Triton Distribution in the FDA’s Supreme Court appeal of Triton’s win in the Fifth Circuit. Additionally, multiple amicus curiae briefs have been filed by interested parties supporting both sides. All filings in the case docket can be seen on the Supreme Court website. The case will be heard in the court’s session that began this week, although no date for oral arguments has been set.

that the Fifth Circuit is an improper venue for the Washington State-based manufacturer’s appeal. Aug. 8, 2024 - A three-judge panel of the Fifth Circuit granted Ohio-based NicQuid’s motion for a stay pending review for an MDO issued by the FDA earlier this year.

July 31, 2024 - A three-judge panel of the Fifth Circuit has granted petitions by five companies challenging MDOs received in 2021, sending their PMTAs back to the agency for new reviews. The companies are Cloud House, LLC; Paradigm Distribution; SWT Global Supply, Inc.; Vaporized, Inc.; and SV Packaging, LLC.

July 2, 2024 - The Supreme Court has granted the FDA’s petition and agreed to hear the agency’s appeal of the Fifth Circuit’s ruling in favor of Triton Distribution. The case will be heard next term.

Aug. 16, 2024 - A Fifth Circuit panel granted a stay pending review to Vertigo Vapor (doing business as Baton Vapor), rejecting the FDA’s argument

June 28, 2024 - The Supreme Court has scheduled a second conference for July 1 to discuss the four pending petitions for review (Triton, Magellan, Lotus and Logic) of lower court decisions regarding FDA marketing denials.

June 28, 2024 - The Supreme Court has overturned a decades-old precedent, ruling that courts no longer need to defer to federal agencies’ judgment when interpreting ambiguous laws. The ending of “Chevron deference” could have a major impact on future challenges to FDA vaping regulations.

June 6, 2024 - The FDA rescinded its MDO of all Juul Labs products and placed Juul’s PMTA back into scientific review.

June 4, 2024 - The Supreme Court has scheduled a conference for June 20 to discuss the four pending petitions for review (Triton, Magellan, Lotus and Logic) of lower court decisions regarding FDA marketing denials.

May 2024 - The Supreme Court will conference later this month to consider whether to accept one or more of four pending petitions that could alter the way the FDA regulates vape products. Many observers say FDA v. Triton Distribution is the most likely candidate to be accepted for review by the high court. The FDA petitioned the Supreme Court to review the Fifth Circuit’s rulings that the Fifth Circuit is an appropriate venue for R.J. Reynolds’ appeals of Vuse menthol products.

April 15, 2024

- Logic Technology Development petitioned the Supreme Court to review the Third Circuit Court decision upholding the FDA’s MDO for Logic menthol refills.

- Bidi Vapor filed the first brief in its Eleventh Circuit challenge of the MDO issued in January for the Bidi Stick Classic.

March 19, 2024 - The FDA petitioned the Supreme Court to review the Fifth Circuit decision that nullified Triton Distribution’ MDOs and ordered the FDA to conduct a new PMTA review.

Feb. 27, 2024 - A Tenth Circuit Court threejudge panel ruled unanimously against Cloud Nine Vapor Products and Electric Clouds in their consolidated MDO appeal. The companies could now ask for an en banc rehearing with all active Tenth Circuit judges, or request a hearing by the Supreme Court.

Feb. 15, 2024 - The Fifth Circuit granted R.J. Reynolds’ motion to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution). The FDA may appeal its loss in Triton to the Supreme Court.

“R.J. Reynolds filed a motion asking the Fifth Circuit to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo and Alto)...”

- Bidi Vapor filed a motion asking the Eleventh Circuit Court to stay the MDO for its tobaccoflavored disposable Bidi Stick-Classic pending review. The company had filed a petition for review of the MDO on Jan. 26.

Feb. 1, 2024 - R.J. Reynolds filed a motion asking the Fifth Circuit to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution), “including before the Supreme Court of the United States.”

Feb. 14, 2024 - An Eighth Circuit Court panel heard oral arguments from SWT Global Supply and the FDA regarding SWT’s appeal of MDOs for menthol e-liquids. (SWT also has a pending appeal for non-menthol-flavored products in the Fifth Circuit.)

Feb. 9, 2024 - Lotus Vaping Technologies has petitioned the Supreme Court for review of the Ninth Circuit’s 2023 denial of the company’s petition for review of MDOs issued for over 200 flavored e-liquids.

Feb. 6, 2024 - The Fifth Circuit Court denied the FDA’s motion for an en banc rehearing of R.J. Reynolds’ motions for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo and Alto) pending review, which were granted by the court. The stay pending review for the now-consolidated petitions remains in place.

Feb. 2, 2024 - The Fifth Circuit Court issued two orders in R.J. Reynolds’ now-consolidated appeals of MDOs for menthol Vuse Vibe, Solo and Alto refills. The first order denied the FDA’s motion to dismiss the Alto appeal or transfer it to a different circuit. The second order granted Reynolds’ motion for a stay pending review for the Vuse Alto menthol refills, and denied the FDA’s motion to lift previous stays granted to Reynolds for the Vibe and Solo refills.

The court had previously ruled (on June 15, 2023) that the Vuse appeals should be held in abeyance (put on hold) pending the outcome of the Triton appeal, since both cases hinged on similar arguments. On Jan. 3, the Fifth Circuit decided in favor of Triton and against the FDA. That decision left a petition to the Supreme Court as the FDA’s only possibility for reversal of the Triton decision.

Jan. 22, 2024 - Magellan has petitioned the Supreme Court to review the Second Circuit’s denial of the company’s appeal of MDOs for Juno refill pods.

Jan. 18, 2024 - SMOK and a Texas-based distributor filed a petition for review in the Fifth Circuit of the FDA’s Jan. 16 MDO for 22 standalone SMOK hardware products.

Jan. 3, 2024 - The Fifth Circuit ruled 10-6 for Triton and Vapetasia, granting their consolidated appeal, and sending their PMTAs back to the FDA for review.

Nov. 14, 2023 - A Tenth Circuit Court panel heard oral arguments from Electric Clouds and Cloud Nine Vapor Products, and the FDA, in the companies’ appeal of FDA MDOs. The cases were previously consolidated (date unknown).

Oct. 19, 2023

- A Third Circuit Court panel decided 2-1 to deny Logic’s appeal of MDOs for Logic Power and Logic Pro menthol refills, issued a year ago. Judge David Porter dissented, noting that he believed the FDA’s sudden decision to treat menthol vapes like other flavors was a political rather than a scientific decision. Logic could now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court. - The Fifth Circuit consolidated R.J. Reynolds’ appeals of its Vuse Alto menthol pod MDO and Vuse Vibe menthol refill MDO, according to attorney Gregory Troutman. (The Vuse Solo menthol refill MDO appeal was previously consolidated with the Vibe appeal.)

Oct. 16, 2023 - The Fifth Circuit issued a temporary stay of the MDO issued to R.J. Reynolds for its Vuse Alto menthol pods on Oct. 13.

Oct. 10, 2023 - The Supreme Court refused to hear AVAIL Vapor’s appeal of its loss in the Fourth Circuit. The case was rejected without comment. According to legal expert Jonathan Adler, the Court may be waiting for a broader split of opinions among the circuit courts and a stronger case to hear.

Sept. 14, 2023 - Lotus Vaping Technologies’ motion for an en banc rehearing of its petition for review was denied by the Ninth Circuit.

Aug. 29, 2023 - A three-judge panel of the D.C. Circuit issued a divided decision in the Fontem US myblu appeal, granting Fontem’s petition for review of the MDOs for the myblu device and tobacco-flavored pods, and denying the company’s appeal of MDOs for most pods in flavors other than tobacco.

Aug. 21, 2023 - Lotus Vaping Technologies filed a motion in the Ninth Circuit for an en banc rehearing of its petition for review.

July 7, 2023 - A three-judge panel of the Ninth Circuit ruled unanimously to deny the consolidated Lotus Vaping Technologies/Nude Nicotine petition for review. The companies could now ask for an en banc rehearing with all active Ninth Circuit judges, or request a hearing by the Supreme Court.

June 27, 2023 - The Fifth Circuit denied a motion (filed earlier in June) by the FDA to transfer R.J. Reynolds’ Vuse menthol MDO appeal to the District of Columbia Circuit Court.

June 16, 2023 - A Second Circuit three-judge panel unanimously denied Magellan’s petition for review of its MDO for flavored Juno refill pods.

June 15, 2023 - The Fifth Circuit granted R.J. Reynolds’ motion (filed yesterday) to stay the merits briefing in its appeal of the MDO for menthol Vuse products until after the court decision in the Triton Distribution rehearing. (Reported by attorney Greg Troutman.)

June 14, 2023 - R.J. Reynolds filed a motion asking the Fifth Circuit to stay the merits briefing in its appeal of the MDO for menthol Vuse products until after the court decision in the Triton Distribution rehearing. (The Triton case covers many of the same issues.)

June 14, 2023 - An amicus brief was filed today by a group of experts including David Abrams, Clive Bates and David Sweanor in support of AVAIL Vapor’s Supreme Court appeal of the company’s loss in the Fourth Circuit. A separate amicus brief was filed today by the Vapor Technology Association (VTA).

May 31, 2023 - An amicus brief was filed today by the Washington Legal Foundation, supporting AVAIL Vapor’s Supreme Court appeal of its loss in the Fourth Circuit.

May 16, 2023 - Triton Distribution/Vapetasia and the FDA engaged in oral arguments before the full Fifth Circuit. Triton argued in favor of its petition for review, and the FDA defended its MDOs.

May 11, 2023 - AVAIL Vapor appealed the Fourth Circuit’s denial of its petition for review to the Supreme Court, asking for a writ of certiorari that would allow a fresh look at the deficiencies of the PMTA process by the high court.

May 9, 2023 - The Third Circuit heard oral arguments from Logic and the FDA supporting and opposing Logic’s petition for review of the MDOs for Logic’s menthol refills.

“Triton Distribution/Vapetasia and the FDA engaged in oral arguments before the full Fifth Circuit. Triton argued in favor of its petition for review, and the FDA defended its MDOs...”

April 7, 2023 - The FDA petitioned the Fifth Circuit to rehear its decision granting R.J. Reynolds a stay pending review of the FDA’s MDO of Vuse Vibe menthol refills. The FDA requests an en banc (full-court) review, to be heard in conjunction with the court’s en banc review of Triton Distribution’s MDO appeal (scheduled for oral arguments May 16). In addition to other grounds for granting a rehearing, the FDA petition challenges Reynolds’ right under the Tobacco Control Act to appeal the Vuse MDO in the Fifth Circuit, which is not, says the FDA, the circuit appeals court closest to Reynolds’ “principal place of business.”

March 29, 2023 - The Fifth Circuit granted a stay pending review of the MDO for the Vuse Solo menthol refill.

March 23, 2023 - The Fifth Circuit granted a stay pending review of the MDO for the Vuse Vibe menthol refill. (Reynolds dropped its appeal of the Vuse Ciro refills because it no longer sells that product).

March 20, 2023 - The Fifth Circuit granted R.J. Reynolds a temporary stay of the March 17 Vuse Solo menthol refill MDO. The temporary stay will be in effect pending a motion for a stay pending appeal.

Feb. 6, 2023 - The Second Circuit heard oral arguments in Magellan’s appeal of the MDO for its Juno-brand refill pods.

Jan. 25, 2023

- The Fifth Circuit granted R.J. Reynolds a temporary stay of the MDO issued yesterday for Vuse Vibe and Ciro menthol refills. The temporary stay will be in effect pending a motion for a stay pending appeal.

- The D.C. Circuit Court heard oral arguments from Fontem US and the FDA regarding MDOs issued for the myblu device and multiple flavored refill pods.

Jan. 19, 2023 - The Fifth Circuit Court granted Triton Distribution and Vapetasia a rare en banc rehearing of their MDO appeal, which a threejudge Fifth Circuit panel denied last year. In the en banc rehearing, all active judges on the Fifth Circuit will rehear the case.

Dec. 12, 2022 - A three-judge panel of the Fourth Circuit ruled unanimously to deny AVAIL Vapor’s petition for review of its MDO. The company could now ask for an en banc rehearing with all Fourth Circuit judges, or request a hearing by the Supreme Court.

Oct. 28, 2022 - The Third Circuit granted Logic LLC a temporary stay of two MDOs issued Oct. 26. The court set a seven-day deadline for a motion to stay the denials pending appeal.

Oct. 27, 2022

- A three-judge panel of the Third Circuit ruled unanimously to deny Liquid Labs’ petition for review of its MDO. The company could now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.

- Logic LLC filed a petition for review in the Third Circuit of the MDO issued Oct. 26 for its menthol-flavored refills. The company also filed an emergency motion for a temporary stay of the MDO.

Oct. 11, 2022 - Triton Distribution/Vapetasia filed a reply brief addressing the FDA’s Sept. 30 response to the Triton petition for en banc review in the Fifth Circuit.

Sept. 30, 2022 - The FDA filed its response to the Sept. 1 Triton Distribution/Vapetasia motion for en banc review in the Fifth Circuit.

Sept. 20, 2022 - Juul Labs sued the FDA in the U.S. District Court for D.C., charging the agency improperly withheld documents requested by Juul under the Freedom of Information Act (FOIA). The documents are related to the June 23 MDO issued to Juul.

Sept. 1, 2022 - Triton Distribution and Vapetasia petitioned the Fifth Circuit Court for both panel and en banc rehearings of their case (panel rehearing means a rehearing by the original three-judge panel that voted in the FDA’s favor; en banc is a full rehearing by the whole court). The petitions are based partly on the FDA not including its “bracketing and bundling” memo in the administrative record (thus hiding it from the vape company petitioners); and on the panel judges’ misunderstanding of the requirements the FDA imposed on manufacturers submitting PMTAs.

Aug. 29, 2022 - The Seventh Circuit Court of Appeals denied the petition for review filed by Gripum LLC. The company could now ask for an en banc rehearing with all Seventh Circuit judges, or request a hearing by the Supreme Court.

Aug. 23, 2022 - The Eleventh Circuit Court found in favor of six manufacturers—Bidi Vapor, Diamond Vapor, Johnny Copper, Pop Vapor Co., Union Street Brands, and Vapor Unlimited. The ruling vacates their MDOs and forces the FDA to conduct new reviews of the companies’ PMTAs.

Aug. 4, 2022 - The Ninth Circuit Court has consolidated appeals by Lotus Vaping Technologies and Nude Nicotine (date of action unknown). Oral arguments are scheduled for Aug. 11, according to attorney Lance Churchill.

They can be heard at 9:30 a.m. PDT at this site.

July 26, 2022 - The D.C. Circuit Court of Appeals denied petitions for review filed by four manufacturers—Prohibition Juice Co., Cool Breeze Vapor, Ecig Charleston, and Jay Shore Liquids. The cases had been consolidated by the court. The companies could now ask for an en banc rehearing with all D.C. Circuit judges, or request a hearing by the Supreme Court.

July 25, 2022 - The D.C. Circuit Court denied Fontem US’s emergency motion for a stay, leaving the myblu MDO in effect. The court set a schedule for briefs to be filed in the appeal, with the first brief from Fontem due by Aug. 10.

July 19, 2022 - In a Ninth Circuit Court filing, the FDA admitted it may not make a decision on MVO’s administrative appeal until January 2024.

July 18, 2022 - The Fifth Circuit ruled against Triton Distribution and Vapetasia in their appeal of MDOs issued last year. The vote was 2-1, with Judge Edith Jones issuing a blistering dissent. The companies say they will ask the court to grant an en banc rehearing of their petitions, with all active Fifth Circuit judges participating.

July 12, 2022 - In the D.C. Circuit Court, Fontem US filed an emergency motion for a stay of its MDO for the myblu device and refill pods.

July 6, 2022 - Juul Labs and the FDA filed a joint motion asking the D.C. Circuit Court to hold Juul’s legal challenge in abeyance (pausing the process) until the FDA has completed its administrative review. Juul also withdrew its emergency motion for a stay pending review (which can be refiled if the FDA denies Juul’s appeal).

July 5, 2022 - The FDA granted Juul an administrative stay of its MDO, agreeing not to take enforcement action while the FDA “supervisory review” is in progress.

June 27, 2022 - Juul filed an emergency motion in the D.C. Circuit for a stay pending review. FDA’s response is due July 7.

June 24, 2022 - Juul Labs filed a petition in the D.C. Circuit for review of its MDO, and asked the court to temporarily stay the MDO until Juul is able to file a motion for a full stay pending review. The temporary stay was granted later the same day.

May 17, 2022 - The Eleventh Circuit Court heard oral arguments from lawyers for the FDA and Bidi Vapor, Pop Vapor, and a consolidated case including Diamond Vapor, Johnny Copper, Union Street Brands, Vapornine and Vapor Unlimited. (The links are downloadable MP3s. You can also listen on the court’s website.)

April 22, 2022 - Vapor Voice reported on April 22 that Simple

Vapor had voluntarily withdrawn its petition for review in the Sixth Circuit. Date of action unknown.

April 20, 2022 - The Seventh Circuit heard oral arguments from lawyers for Gripum and the FDA.

March 14, 2022 - The Eleventh Circuit Court stayed enforcement of Pop Vapor’s MDO pending review, according to Vapor Voice.

March 1, 2022 - The FDA rescinded Al Khalifa Group’s MDO after an administrative review (according to the FDA’s official MDO list updated April 25). Date unknown: Al Khalifa voluntarily withdrew its petition to the Ninth Circuit Court, according to Vapor Voice.

Feb. 23, 2022 - AVAIL Vapor lost its FDA appeal. (The company is also appealing its MDO in the Fourth Circuit.)

Feb. 10, 2022 - Breeze Smoke voluntarily withdrew its MDO appeal to the Sixth Circuit (which had been scheduled for oral arguments Feb. 22), according to Vapor Voice.

Feb. 9, 2022 - The D.C. Circuit scheduled oral arguments in a consolidated case for April 21. The four petitioners—Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.—are all represented by the Texas-based Najvar Law Firm.

Feb. 2, 2022 - After FDA withdrew its MDO in October, Fumizer’s action against the FDA was dismissed by the Ninth Circuit for “failure to prosecute,” according to Vapor Voice.

Feb. 1, 2022 - MDOs for Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Unlimited MDOs were all stayed by the Eleventh Circuit pending review. The court ordered these four cases, and three others that did not receive stays—Pop Vapor Co., Union Street Brands, and Vapornine (New Leaf Vapor Co.)—to appear together for oral arguments on a date to be set later.

Jan. 31, 2022 - The Fifth Circuit heard oral arguments from attorneys for Triton Distribution and the FDA.

Jan. 28, 2022 - The Fifth Circuit issued a “stay of proceedings...for American Vapor, Inc.s petition pending a decision in [Triton Distribution’s review]” (reported in the FDA’s official MDO list updated Feb. 3). Vapor Voice reported later (April 22) that American Vapor had voluntarily withdrawn its petition for review.

Dec. 30, 2021 - An amicus brief in support of Gripum’s petition was filed in the Seventh Circuit by David Abrams, Clive Bates, and David Sweanor.

Dec. 10, 2021 - The Supreme Court denied Breeze Smoke’s emergency application for a stay of its MDO. The Sixth Circuit Court will now consider Breeze

Smoke’s petition for review, but the company will be subject to FDA enforcement if it continues selling the denied products during the appeal.

Dec. 7, 2021 - Breeze Smoke responded to the FDA’s brief filed yesterday opposing Breeze Smoke’s application to the Supreme Court for a stay of its MDO.

Dec. 6, 2021 - The FDA filed a memorandum in opposition to Breeze Smoke’s application for a stay of its MDO with the Supreme Court. In the brief, the agency claimed that Breeze Smoke’s products were introduced after Aug. 8, 2016— the cutoff date for products allowed to remain on the market (until Sept. 9, 2020) without first being authorized by the FDA.

Nov. 29, 2021

- Supreme Court Justice Brett Kavanaugh asked the FDA to respond to Breeze Smoke’s application for a stay by Monday, Dec. 6.

- The Fifth Circuit granted stays pending review to Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized, and consolidated the cases. The stay motions were unopposed by the FDA.

Nov. 24, 2021

- An amicus brief in support of Bidi Vapor’s petition for review was filed in the Eleventh Circuit by David Abrams, Clive Bates, and David Sweanor.

- An amicus brief in support of My Vape Order’s petition for review was filed in the Ninth Circuit by David Abrams, Clive Bates, and David Sweanor.

Nov. 23, 2021

- Breeze Smoke applied to the Supreme Court for an emergency stay pending circuit court review of its MDO.

- Pop Vapor Co.’s MDO was partially rescinded by the FDA (according to the FDA’s official MDO list updated Feb. 17).

Nov. 19, 2021 - Bidi Vapor filed its opening brief in the Eleventh Circuit, and requested the court allow oral argument.

Nov. 17, 2021 - An amicus brief in support of Triton

Distribution’s petition for review was filed in the Fifth Circuit by David Abrams, Clive Bates, and David Sweanor.

Nov. 12, 2021 - Breeze Smoke’s motion for a stay was denied by the Sixth Circuit.

Nov. 4, 2021 - Gripum’s MDO was stayed by the Seventh Circuit Court pending review.

Nov. 3, 2021 - Al Khalifa Group’s MDO was stayed by the FDA pending administrative review (according to the FDA’s official MDO list updated Feb. 17).

Nov. 2, 2021 - Humble Juice’s MDO was rescinded by the FDA (according to the FDA’s official MDO list updated Nov. 3), and the products were moved back into scientific review. Tobacco Reporter reported that Humble Juice withdrew its petition for review in the Ninth Circuit after the FDA recission of its MDO.

Nov. 1, 2021 - AVAIL Vapor’s MDO was stayed by the FDA pending administrative review.

Oct. 26, 2021

- ECS Global’s MDO was partially rescinded by the FDA (according to the FDA’s official MDO list updated Nov. 3) and the products were moved back into scientific review.

- The Triton Distribution and Vapetasia cases were consolidated by the Fifth Circuit, and both MDOs were stayed by the court pending review.

Oct. 25, 2021 - Bidi Vapor filed a motion for a stay in the Eleventh Circuit pending court review of its MDO.

Oct. 22, 2021

- Bidi Vapor’s MDO was stayed by the FDA pending administrative review.

- Fumizer’s MDO was rescinded by the FDA and the products moved back into scientific review.

- Gripum replied in a court filing to the FDA’s filing opposing a stay.

Oct. 19, 2021 - Gripum’s MDO was temporarily

stayed by the Seventh Circuit while the company’s motion for a stay is considered.

Oct. 18, 2021 - My Vape Order’s MDO was stayed by the FDA pending administrative review.

Oct. 17, 2021 - Gripum filed an emergency motion for a stay in the Seventh Circuit pending court review of the company’s MDO.

Oct. 14, 2021 - Triton Distribution responded to the FDA in a court filing.

Oct. 13, 2021 - Breeze Smoke filed an emergency motion for a stay in the Sixth Circuit pending court review of its MDO.

Oct. 12, 2021 - The FDA responded to Triton Distribution’s emergency motion for a stay.

Oct. 8, 2021 - Turning Point Brands withdrew its petition for review after the FDA’s rescission of Turning Point’s MDO.

Oct. 7, 2021 - The FDA rescinded Turning Point Brands’ MDO, claiming the agency missed evidence included in the company’s PMTA. Turning Point’s products were moved back into scientific review.

Oct. 6, 2021 - Triton Distribution filed an emergency motion for a stay in the Fifth Circuit pending court review of its MDO, and requested expedited consideration of the motion.

Sept. 30, 2021 - Turning Point Brands filed an emergency motion for a stay pending court review of its MDO, and requested expedited consideration of the motion.

Legal actions listed by company (alphabetical)

7 Daze LLC - Petition for review filed Oct. 7, 2021 – Ninth Circuit Court of Appeals

Al Khalifa Group LLC - Petition for review filed in 2021 (exact date unknown) - Ninth Circuit Court of Appeals

- Nov.3, 2021: Al Khalifa Group MDO stayed by FDA pending administrative review.

- March 1, 2022: FDA rescinded Al Khalifa Group’s MDO after administrative review.

- (date unknown): Al Khalifa voluntarily withdrew its petition for review, according to Vapor Voice.

American Vapor, Inc. - Petition for review filed in 2021 (exact date unknown)– Fifth Circuit Court of Appeals

- Jan. 28, 2022: Court “issued a stay of proceedings for American Vapor, Inc.s petition pending a decision in [Triton Distribution’s petition]” (according to FDA’s official MDO list updated Feb. 3).

- (2022 - date unknown): Vapor Voice reported April 22 that American Vapor withdrew its petition to the court.

AVAIL Vapor, LLC - Petition for review filed Sept. 30, 2021 – Fourth Circuit Court of Appeals

- Nov. 1, 2021: AVAIL MDO stayed by FDA pending administrative review.

- Feb. 23, 2022: FDA denied AVAIL’s appeal.

- Dec. 12, 2022: A three-judge Fourth Circuit panel decided unanimously to deny AVAIL’s petition for review of its MDO. The company could now ask for an en banc rehearing with all active Fourth Circuit judges, or request a hearing by the Supreme Court.

- May 11, 2023: AVAIL appealed the Fourth Circuit’s denial of its petition for review to the Supreme Court, asking for a writ of certiorari that would allow a fresh look at the deficiencies of the PMTA process by the high court.

- May 31, 2023: An amicus brief was filed today by the Washington Legal Foundation, supporting AVAIL’s Supreme Court appeal.

- June 14, 2023: An amicus brief was filed today

by a group of experts including David Abrams, Clive Bates and David Sweanor supporting AVAIL’s Supreme Court appeal. A separate brief was filed today by the Vapor Technology Association (VTA).

- Oct. 10, 2023: The Supreme Court refused to hear AVAIL’s appeal of its loss in the Fourth Circuit. The case was rejected without comment. According to legal expert Jonathan Adler, the Court may be waiting for a broader split of opinions among the circuit courts and a stronger case to hear.

Bad Modder Fogger (BMF Labs) - Petition for review filed Oct. 4, 2021 – Fourth Circuit Court of Appeals

Baton Vapor - see Vertigo Vapor

Bidi Vapor LLC (PMTAs for flavored Bidi Stick disposables) - Petition for review and motion for expedited review filed Sept. 29, 2021 – Eleventh Circuit Court of Appeals

- Oct. 22, 2021: Bidi Vapor’s MDO was stayed by FDA pending administrative review.

- Oct. 25, 2021: Bidi filed a motion for a stay pending court review of its MDO.

- Nov. 19, 2021: Bidi filed its opening brief and requested the court allow oral argument.

- Nov. 24, 2021: An amicus brief in support of Bidi Vapor’s petition was filed by David Abrams, Clive Bates and David Sweanor.

- Feb. 1, 2022: Bidi’s MDO was stayed by the court pending review.

- May 17, 2022: The court heard oral argument from Bidi Vapor and the FDA.

- Aug. 23, 2022: The court ruled in favor of Bidi Vapor and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA scientific review.

Bidi Vapor LLC (PMTA for tobacco-flavored Bidi Stick-Classic disposable) - Petition for review filed Jan. 26, 2024 – Eleventh Circuit Court of Appeals

- Feb. 2, 2024: Bidi Vapor filed a motion asking the Eleventh Circuit Court to stay the MDO for

its tobacco-flavored disposable Bidi Stick-Classic pending review.

- April 15, 2024: Bidi Vapor filed the first brief in its Eleventh Circuit challenge of the MDO issued in January for the Bidi Stick Classic.

Breeze Smoke, LLC - Petition for review filed Oct. 4, 2021 – Sixth Circuit Court of Appeals

- Oct. 13, 2021: Breeze Smoke files an emergency motion for a stay pending court review of its MDO.

- Nov. 12, 2021: Breeze Smoke’s motion for a stay was denied by the court.

- Nov. 23, 2021: Breeze Smoke applied to the Supreme Court for a stay pending review by the circuit court of its MDO.

- Nov. 29, 2021: Supreme Court Justice Brett Kavanaugh asks the FDA to respond to Breeze Smoke’s application for a stay by Monday, Dec. 6.

- Dec. 6, 2021: FDA files its memorandum in opposition to Breeze Smoke’s application for a stay of its MDO by the Supreme Court.

- Dec. 7, 2021: Breeze Smoke responded to the FDA brief filed yesterday opposing Breeze Smoke’s application to the Supreme Court for a stay of its MDO. Breeze Smoke also filed a supplemental declaration from employee Steven Haddad in which Haddad claims that Breeze Smoke “developed the ENDS products that are the subject of its September 3, 2020 PMTAs by building on the specifications of the Arctic

Smoke product, which had been on the market well before FDA ‘deemed’ e-cigarette products effective August 8, 2016.”

- Dec. 10, 2021: The Supreme Court denied Breeze Smoke’s emergency application for a stay of its MDO. The full review of Breeze Smoke’s MDO will now proceed in the Sixth Circuit, but the company will be subject to FDA enforcement if it continues selling the denied products during the court review.

- Feb. 10, 2022: Breeze Smoke voluntarily withdrew its petition to the Sixth Circuit (which had been scheduled for oral arguments Feb. 22), according to Vapor Voice.

Cloud House LLC - Petition for review filed Oct. 8, 2021 – Fifth Circuit Court of Appeals

- Nov. 29, 2021:The Fifth Circuit grants a stay of Cloud House’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

- July 31, 2024: A three-judge panel of the Fifth Circuit has granted consolidated petitions by five companies challenging MDOs received in 2021, sending their PMTAs back to the agency for new reviews.

Cloud Nine Vapor Products - Petition for review filed Oct. 8, 2021 – Tenth Circuit Court of Appeals

- Date unknown: consolidated with Electric Clouds appeal.

- Nov. 14, 2023: Tenth Circuit hears oral arguments.

- Feb. 27, 2024: A Tenth Circuit Court three-judge panel ruled unanimously against Cloud Nine and Electric Clouds in their consolidated MDO appeal. The companies could now ask for an en banc rehearing with all active Tenth Circuit judges, or request a hearing by the Supreme Court.

Cool Breeze Vapor LLC - Petition for review filed in 2021 (exact date unknown) - District of Columbia Circuit Court of Appeals

- (2021/22 - date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.

- Feb. 4, 2022: The FDA filed a brief supporting its MDOs.

- Feb. 9, 2022: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.

- July 26, 2022: The D.C. Circuit denied petitions for review filed by Cool Breeze Vapor and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

Diamond Vapor LLC - Petition for review filed Oct. 1, 2021 – Eleventh Circuit Court of Appeals - Feb. 1, 2022: Diamond Vapor’s MDO was stayed by the Eleventh Circuit pending review.

- May 17, 2022: The court heard oral arguments from the FDA and Diamond Vapor (and copetitioners).

- Aug. 23, 2022: The court ruled in favor of Diamond Vapor and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA scientific review.

E-Liquid Brands, LLC - Petition for review filed Oct. 7, 2021 – Fourth Circuit Court of Appeals

ECig Charleston LLC - Petition for review filed in 2021 (exact date unknown) - District of Columbia Circuit Court of Appeals

- (2021/22 - date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.

- Feb. 4, 2022: The FDA filed a brief supporting its MDOs.

- Feb. 9, 2022: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.

- July 26, 2022: The D.C. Circuit denied petitions for review filed by ECig Charleston and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

ECS Global LLC - Petition for review filed Oct. 12, 2021 – District of Columbia Circuit Court of Appeals. (ECS Global received MDOs for Phix pod-vape devices and prefilled Phix pods.)

- Oct. 26, 2021: ECS Global’s MDO was partially rescinded by the FDA (according to the FDA’s official MDO list updated Nov. 3) and products were moved back into scientific review.

Electric Clouds - Petition for review filed Oct. 8, 2021 – Tenth Circuit Court of Appeals

- Date unknown: consolidated with Cloud Nine Vapor Products appeal.

- Nov. 14, 2023: Tenth Circuit hears oral arguments.

- Feb. 27, 2024: A Tenth Circuit Court threejudge panel ruled unanimously against Electric Clouds and Cloud Nine Vapor Products in their consolidated MDO appeal. The companies could now ask for an en banc rehearing with all active

Tenth Circuit judges, or request a hearing by the Supreme Court.

Fontem US, LLC - Petition for review filed May 6, 2022 - District of Columbia Circuit Court of Appeals. (Fontem, a subsidiary of Imperial Brands, received MDOs for the myblu device and refill pods)

- July 12, 2022: Fontem filed an emergency motion for a stay of its MDO.

- July 25, 2022: The court denied Fontem’s emergency motion for a stay, leaving the myblu MDO in effect. The court set a schedule for briefs to be filed in the appeal, with the first brief from Fontem due Aug. 10.

– Jan. 25, 2023: The court heard oral arguments from Fontem and the FDA.

- Aug. 29, 2023: A three-judge panel of the D.C. Circuit issued a divided decision on the myblu appeal, granting Fontem’s petition for review of the MDOs for the myblu device and tobaccoflavored pods, and denying the company’s appeal of MDOs for most pods in flavors other than tobacco.

Fumizer, LLC - Petition for review filed Oct. 6, 2021 – Ninth Circuit Court of Appeals.

- Oct. 22, 2021: Fumizer’s MDO was rescinded by the FDA and the products were moved back into scientific review.

- Feb 2, 2022: The Ninth Circuit dismissed Fumizer’s appeal for “failure to prosecute,” according to Vapor Voice (which does not affect the FDA review already granted).

Gripum LLC - Petition for review filed Oct. 8, 2021 – Seventh Circuit Court of Appeals

- Oct. 17, 2021: Gripum filed an emergency motion for a stay pending court review of its MDO.

- Oct. 19, 2021: Gripum’s MDO was temporarily stayed by court while the motion is considered.

- Oct. 27, 2021: Gripum replied in a court filing to the FDA filing opposing a stay.

- Nov. 4, 2021: Gripum’s MDO was stayed by court pending review.

- Dec. 27, 2021: Gripum filed a brief preceding oral arguments.

- Dec. 30, 2021: An amicus brief in support of Gripum’s petition was filed by David Abrams,

Clive Bates, and David Sweanor.

- April 20, 2022: The court heard oral arguments from Gripum and the FDA.

- Aug. 29, 2022: The court denied Gripum’s petition for review. The company could now ask for an en banc rehearing with all active Seventh Circuit judges, or request a hearing by the Supreme Court.

Humble Juice Co., LLC - Petition for review filed in October 2021 (exact date unknown) –Ninth Circuit Court of Appeals

- Nov. 2, 2021: Humble Juice’s MDO was rescinded by the FDA (according to FDA’s official MDO list updated Nov. 3) and the products were moved back into scientific review. Tobacco Reporter reports that Humble Juice then withdrew its petition for review.

Jay Shore Liquids LLC - Petition for review filed in 2021 (exact date unknown) - District of Columbia Circuit Court of Appeals

- (2021/22 - date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.

- Feb. 4, 2022: The FDA filed a brief supporting its MDOs.

- Feb. 9, 2022: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.

- July 26, 2022: The D.C. Circuit denied petitions for review filed by Jay Shore Liquids and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

Johnny Copper LLC - Petition for review filed Oct. 7, 2021 – Eleventh Circuit Court of Appeals

- Feb. 1, 2022: Johnny Copper’s MDO was stayed by the court pending review.

- May 17, 2022: The court heard oral arguments from the FDA and Johnny Copper (and four copetitioners).

- Aug. 23, 2022: The court ruled in favor of Johnny Copper and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA scientific review.

Johnny Copper LLC - Petition for review filed Oct. 15, 2024 – Eleventh Circuit Court of Appeals

Juul Labs, Inc. - Petition for review filed June 24, 2022 - District of Columbia Circuit Court of Appeals

- June 24, 2022: Juul Labs filed a petition for review of its MDO, and asked the court to temporarily stay the MDO until Juul is able to file a motion for a full stay pending review. The temporary stay is granted later the same day.

- June 27, 2022: Juul filed an emergency motion for a stay pending review. The FDA’s response is due July 7.

- July 5, 2022: The FDA granted Juul an administrative stay of its MDO, agreeing not to take enforcement action while the FDA “supervisory review” is in progress.

- July 6, 2022: Juul Labs and the FDA filed a joint motion asking the court to hold Juul’s legal challenge in abeyance (pause the process) until the FDA has completed its administrative review. Juul also withdrew its pending emergency motion for a stay pending review in the D.C. Circuit (which can be refiled if FDA denies Juul’s appeal).

- Sept. 20, 2022: Juul Labs filed a lawsuit against the FDA in the U.S. District Court for D.C., charging the agency improperly withheld documents requested by Juul under the Freedom of Information

Act (FOIA). The documents are related to the MDO issued to Juul on June 23.

-June 6, 2024: The FDA rescinded its MDO and placed Juul’s PMTA back into scientific review.

Lead by Sales LLC - see White Cloud Cigarettes

Liquid Labs LLC - Petition for review filed Oct. 12, 2021 – Third Circuit Court of Appeals

- Oct. 27, 2022: A Third Circuit panel unanimously denied Liquid Labs’ petition for review of MDO. The company could now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.

Logic Technology Development (Logic LLC)

- Petition for review filed Oct. 27, 2022 – Third Circuit Court of Appeals

- Oct. 26, 2022: Logic received MDOs for two menthol-flavored refills.

- Oct. 27, 2022: Logic LLC filed a petition for review

of the MDO issued Oct. 26 for its menthol-flavored refills. The company also filed an emergency motion for a temporary stay of the MDO.

- Oct. 28, 2022: The Third Circuit granted Logic a temporary stay of its MDO, and set a sevenday deadline for a motion to stay the denials pending appeal.

- May 9, 2023: The Third Circuit heard oral arguments from Logic and the FDA supporting and opposing Logic’s petition for review of the FDA’s MDOs for Logic’s menthol refills.

- Oct. 19, 2023: A Third Circuit Court panel decided 2-1 to deny Logic’s appeal of MDOs for Logic Power and Logic Pro menthol refills, issued a year ago. Judge David Porter dissented, noting that he believed the FDA’s sudden decision to treat menthol vapes like other flavors was a political rather than a scientific decision. Logic could now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.

- April 15, 2024: Logic petitioned the Supreme Court to review the Third Circuit Court decision upholding the FDA’s MDO for Logic menthol refills.

Lotus Vaping Technologies, LLC - Petition for review filed Oct. 14, 2021 – Ninth Circuit Court of Appeals

- Aug. 4, 2022 update: The Ninth Circuit consolidated Lotus’s petition with Nude Nicotine’s (date unknown). According to attorney Lance Churchill, oral arguments are scheduled for Aug. 11.

- July 7, 2023: A three-judge panel of the Ninth Circuit ruled unanimously to deny the consolidated Lotus/Nude Nicotine petition for review. The companies could now ask for an en banc rehearing with all active Ninth Circuit judges, or request a hearing by the Supreme Court.

- Aug. 21, 2023: Lotus filed a motion with the Ninth Circuit, asking for an en banc rehearing.

- Sept. 14, 2023: Lotus’ motion for an en banc rehearing of its petition for review was denied by the Ninth Circuit.

- Feb. 9, 2024: Lotus has petitioned the Supreme Court for review of the Ninth Circuit’s 2023 denial of the company’s petition for review of MDOs issued for over 200 flavored e-liquids.

Magellan Technology, Inc. - Petition for review filed Sept. 24, 2021 – Second Circuit Court of Appeals

- Feb. 6, 2023: The Second Circuit heard oral arguments in Magellan’s appeal of the MDO for Juno-brand refill pods.

- June 16, 2023: A Second Circuit panel ruled unanimously to deny Magellan’s petition for review of the MDO for its flavored Juno refill pods. The company could now ask for an en banc rehearing with all active Second Circuit judges, or request a hearing by the Supreme Court.

- Jan. 22, 2024: Magellan has petitioned the Supreme Court to review the Second Circuit’s denial of the company’s appeal of MDOs for Juno refill pods.

My Vape Order, Inc. - Petition for review filed Sept. 30, 2021 – Ninth Circuit Court of Appeals

- Oct. 18, 2021: My Vape Order’s MDO was stayed

by the FDA pending administrative review.

– Nov. 24, 2021: An amicus brief in support of My Vape Order’s petition was filed by David Abrams, Clive Bates and David Sweanor.

- Jan. 5, 2022: The court agreed to hold MVO’s appeal in abeyance (put it on hold) pending the outcome of the FDA’s administrative appeals process.

- Jan. 19, 2022: The FDA “partially rescinded” MVO’s MDO “with respect to certain products.”

- July 19, 2022: In a court filing, the FDA admitted it may not make a decision on MVO’s appeal until January 2024.

New World Wholesale, Inc. & Shenzhen Goldreams Technology Co., Ltd. - Petition for review filed Oct. 11, 2021 – Fifth Circuit Court of Appeals

NicQuid, LLC - Petition for review filed May/ June 2024 (exact date unknown) - Fifth Circuit Court of Appeals

- Aug. 8, 2024: A three-judge panel of the Fifth Circuit granted Ohio-based NicQuid’s motion for a stay pending review for an MDO issued by the FDA on May 3 for menthol- and tobaccoflavored e-liquids.

Nude Nicotine, Inc. - Petition for review filed Oct. 6 – Ninth Circuit Court of Appeals

- Aug. 4, 2022 update: The Ninth Circuit consolidated Nude Nicotine’s appeal with Lotus Vaping Technologies’ (date unknown). According to attorney Lance Churchill, oral arguments are scheduled for Aug. 11.

- July 7, 2023: A three-judge panel of the Ninth Circuit ruled unanimously to deny the consolidated Lotus/Nude Nicotine petition for review. The companies could now ask for an en banc rehearing with all active Ninth Circuit judges, or request a hearing by the Supreme Court.

Paradigm Distribution - Petition for review filed Oct. 11, 2021 – Fifth Circuit Court of Appeals

- Nov. 29, 2021:The Fifth Circuit granted a stay of Paradigm’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

- July 31, 2024: A three-judge panel of the Fifth Circuit has granted consolidated petitions by five companies challenging MDOs received in 2021, sending their PMTAs back to the agency for new reviews.

Pop Vapor Co. LLC - Petition for review filed in 2021 (exact date unknown)– Eleventh Circuit Court of Appeals

- Nov. 23, 2021: Pop Vapor Co.’s MDO was partially rescinded (according to FDA’s official MDO list updated Feb. 17).

- March 14, 2022: The Eleventh Circuit stayed FDA enforcement of Pop Vapor’s MDO pending review, according to Vapor Voice.

- May 17, 2022: The court heard oral argument from Pop Vapor and FDA.

- Aug. 23, 2022: The court ruled in favor of Pop Vapor Co. and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review.

Prohibition Juice Co. - Petition for review filed Oct. 13, 2021 – District of Columbia Circuit Court of Appeals

- (2021/22 - date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.

- Feb. 4, 2022: The FDA filed a brief supporting its MDOs.

- Feb. 9, 2022: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.

- July 26, 2022: The D.C. Circuit denied petitions for review filed by Prohibition Juice Co. and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

R.J. Reynolds Vapor Co. (Vuse Alto menthol refills MDO) - Petition for review filed Oct. 13, 2023 – Fifth Circuit Court of Appeals

- Oct. 16, 2023: The Fifth Circuit issued a temporary stay of the MDO issued to R.J. Reynolds for its Vuse Alto menthol pods on Oct. 13.

- Oct. 19,2023: The Fifth Circuit consolidated R.J. Reynolds’ appeals of its Vuse Alto menthol

pod MDO and Vuse Vibe menthol refill MDO, according to attorney Gregory Troutman. (The Vuse Solo menthol refill MDO appeal may have been previously consolidated with the Vibe appeal.)

- Feb. 1, 2024: R.J. Reynolds filed a motion asking the Fifth Circuit to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (for Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in the Triton Distribution vs. FDA appeal, “including before the Supreme Court of the United States.”

- Feb. 2, 2024: The Fifth Circuit Court issued two orders in R.J. Reynolds’ now-consolidated appeals of MDOs for menthol Vuse Vibe, Solo and Alto refills. The first order denied the FDA’s motion to dismiss the Alto appeal or transfer it to a different circuit. The second order granted Reynolds’ motion for a stay pending review for the Vuse Alto menthol refills, and denied the FDA’s motion to lift previous stays granted to Reynolds for the Vibe and Solo refills.

- Feb. 6, 2024: The Fifth Circuit Court denied the FDA’s motion for an en banc rehearing of R.J. Reynolds’ motions for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo and Alto) pending review, which were granted by the court. The stay pending review for the now-consolidated petitions remains in place.

- Feb. 15, 2024: The Fifth Circuit granted R.J. Reynolds’ motion to stay proceedings in the consolidated appeal of MDOs for Vuse menthol

refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution). The FDA may appeal its loss in Triton to the Supreme Court.

R.J. Reynolds Vapor Co. (Vuse Ciro and Vibe menthol refills MDO) - Petition for review filed in January 2023 (exact date unknown) – Fifth Circuit Court of Appeals

- Jan. 25, 2023: The Fifth Circuit granted Reynolds a temporary stay pending a motion for a stay pending appeal.

- March 23, 2023: The Fifth Circuit granted a stay pending review of the MDO for the Vuse Vibe menthol refill. (Reynolds dropped its appeal of Vuse Ciro refills because it no longer sells that product).

- April 7, 2023: The FDA petitioned the Fifth Circuit to rehear its decision granting R.J. Reynolds a stay pending review of the FDA’s MDO of Vuse Vibe menthol refills. The FDA requested an en banc (full-court) review, to be heard in conjunction with the court’s en banc review of Triton Distribution’s MDO appeal (scheduled for oral arguments May 16). In addition to other grounds for granting a rehearing, the FDA petition challenges Reynolds’ right under the Tobacco Control Act to appeal the Vuse MDO in the Fifth Circuit, which is not, says the FDA, the circuit appeals court closest to Reynolds’ “principal place of business.”

- June 14, 2023: R.J. Reynolds filed a motion asking the Fifth Circuit to stay the merits briefing in its challenge to the FDA denial order for menthol Vuse products until after the court decision in the Triton rehearing. (The Triton case covers many of the same issues.)

- June 15, 2023: The Fifth Circuit granted R.J. Reynolds’ motion (filed yesterday) to stay the merits briefing in its challenge to the FDA denial order for menthol Vuse products until after the court decision in the Triton rehearing.

- June 27, 2023: The Fifth Circuit denied a motion (filed earlier in June) by the FDA to transfer R.J. Reynolds’ Vuse menthol MDO appeal to the D.C. Circuit Court.

- Oct. 19,2023: The Fifth Circuit consolidated R.J. Reynolds’ appeals of its Vuse Alto menthol pod MDO and Vuse Vibe menthol refill MDO, according to attorney Gregory Troutman. (The Vuse Solo menthol refill MDO appeal may have been previously consolidated with the Vibe appeal.)

- Feb. 1, 2024: R.J. Reynolds filed a motion asking the Fifth Circuit to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (for Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in the Triton Distribution vs. FDA appeal, “including before the Supreme Court of the United States.”

- Feb. 2, 2024: The Fifth Circuit Court issued two orders in R.J. Reynolds’ now-consolidated appeals of MDOs for menthol Vuse Vibe, Solo and Alto refills. The first order denied the FDA’s motion to dismiss the Alto appeal or transfer it to a different circuit. The second order granted Reynolds’ motion for a stay pending review for the Vuse Alto menthol refills, and denied the FDA’s motion to lift previous stays granted to Reynolds for the Vibe and Solo refills.

- Feb. 6, 2024: The Fifth Circuit Court denied the FDA’s motion for an en banc rehearing of R.J. Reynolds’ motions for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo and Alto) pending review, which were granted by the court. The stay pending review for the now-consolidated petitions remains in place.

- Feb. 15, 2024: The Fifth Circuit granted R.J. Reynolds’ motion to stay proceedings in the consolidated appeal of MDOs for Vuse menthol

refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution). The FDA may appeal its loss in Triton to the Supreme Court.

R.J. Reynolds Vapor Co. (Vuse Solo menthol refills MDO) - Petition for review filed in 2023 (exact date unknown)– Fifth Circuit Court of Appeals

- March 20, 2023: The Fifth Circuit granted Reynolds a temporary stay pending a motion for a stay pending appeal.

- March 29, 2023: The Fifth Circuit granted a stay pending review of the MDO for the Vuse Solo menthol refill.

- Oct. 19, 2023: The Fifth Circuit consolidated R.J. Reynolds’ appeals of its Vuse Alto menthol pod MDO and Vuse Vibe menthol refill MDO, according to attorney Gregory Troutman. (The Vuse Solo menthol refill MDO appeal was previously consolidated with the Vibe appeal.)

- Feb. 1, 2024: R.J. Reynolds filed a motion asking the Fifth Circuit to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (for Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in the Triton Distribution vs. FDA appeal, “including before the Supreme Court of the United States.”

- Feb. 2, 2024: The Fifth Circuit Court issued two orders in R.J. Reynolds’ now-consolidated appeals of MDOs for menthol Vuse Vibe, Solo and Alto refills. The first order denied the FDA’s motion to dismiss the Alto appeal or transfer it to a different circuit. The second order granted Reynolds’ motion for a stay pending review for the Vuse Alto menthol refills, and denied the FDA’s motion to lift previous stays granted to Reynolds for the Vibe and Solo refills.

- Feb. 6, 2024: The Fifth Circuit Court denied the FDA’s motion for an en banc rehearing of R.J. Reynolds’ motions for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo and Alto) pending review, which were granted by the court. The stay pending review for the now-consolidated petitions remains in place.

- Feb. 15, 2024: The Fifth Circuit granted R.J. Reynolds’ motion to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution). The FDA may appeal its loss in Triton to the Supreme Court.

Simple Vapor Company - Petition for review filed Oct. 12, 2021 – Sixth Circuit Court of Appeals

- (date unknown): Vapor Voice reported on April 22, 2022 that Simple Vapor had voluntarily withdrawn its petition to the court.

SMOK (Shenzhen IVPS Technology Co., Ltd.)

- Petition for review filed Jan. 18, 2024 - Fifth Circuit Court of Appeals

- Jan. 18, 2024: SMOK and a Texas-based distributor filed a petition for review in the Fifth Circuit of the FDA’s Jan. 16 MDO for 22 standalone SMOK hardware products.

SWT Global Supply, Inc. (incorrectly spelled “STW” on some legal documents) - Petition for review filed Oct. 1, 2021 – Fifth Circuit Court of Appeals

- Nov. 29, 2021: The Fifth Circuit granted a stay of SWT’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

- July 31, 2024: A three-judge panel of the Fifth Circuit has granted consolidated petitions by five companies challenging MDOs received in 2021, sending their PMTAs back to the agency for new reviews.

SWT Global Supply, Inc. (incorrectly spelled “STW” on some legal documents) - Petition for review filed June 12, 2023 - Eighth Circuit Court of Appeals

- Feb. 14, 2024: An Eighth Circuit Court panel heard oral arguments from SWT Global Supply and the FDA regarding SWT’s appeal of MDOs for menthol e-liquids. (SWT also has a pending appeal for non-menthol-flavored products in the Fifth Circuit.)

SV Packaging, LLC (SAVEURVAPE) - Petition for review filed in 2021 (exact date unknown) – Fifth Circuit Court of Appeals

- Nov. 29, 2021:The Fifth Circuit granted a stay of SV Packaging’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

- July 31, 2024: A three-judge panel of the Fifth Circuit has granted consolidated petitions by five companies challenging MDOs received in 2021, sending their PMTAs back to the agency for new reviews.

Triton Distribution (also known as Wages and White Lion Investments, LLC) - Petition for review filed Oct. 6, 2021 – Fifth Circuit Court of Appeals

- Oct. 6, 2021: Triton Distribution filed an emergency motion for a stay pending court review of its MDO and asked for expedited consideration of the motion.

- Oct. 12, 2021: The FDA responded to Triton’s emergency motion in a court filing.

- Oct. 14, 2021: Triton Distribution responded to the FDA’s opposition to a stay.

- Oct. 26, 2021: The Triton Distribution and Vapetasia cases were consolidated by the Fifth Circuit, and both MDOs were stayed pending review.

- Nov. 17, 2021: An amicus brief in support of Triton Distribution’s petition was filed by David Abrams, Clive Bates and David Sweanor.

- Jan. 31, 2022: The Fifth Circuit heard oral arguments from attorneys for Triton Distribution/ Vapetasia and the FDA.

- July 18, 2022: The Fifth Circuit ruled against Triton Distribution and Vapetasia, denying their appeals of MDOs issued last year. The vote was 2-1, with Judge Edith Jones issuing a blistering dissent. The companies announced they will ask the court to grant an en banc rehearing of their petitions for review with all active Fifth Circuit judges participating.

- Sept. 1, 2022: Triton Distribution and Vapetasia petitioned the court for both panel and en banc rehearings of their case (a panel rehearing is a rehearing by the original three-judge panel that voted in the FDA’s favor; an en banc review is a

full rehearing by the entire court). The petitions were based partly on the FDA not including its “bracketing and bundling” memo in the administrative record (thus hiding it from the vape company petitioners); and also on the panel judges’ misunderstanding of the requirements FDA imposed on manufacturers submitting PMTAs.

- Sept. 30, 2022: The FDA filed its response to the Triton/Vapetasia motion for en banc review.

- Oct. 11, 2022: Triton/Vapetasia filed a reply brief addressing the FDA’s Sept. 30 response.

- Jan. 19, 2023: The Fifth Circuit Court granted Triton Distribution and Vapetasia a rare en banc rehearing of their MDO appeal, which a threejudge panel from the same court denied last year.

In the en banc rehearing, all active judges on the Fifth Circuit will rehear the case. The decision to rehear the case nullifies the previous decision.

- May 16, 2023: Lawyers for Triton/Vapetasia and the FDA engaged in oral arguments before the full Fifth Circuit. Triton argued in favor of its petition for review of the agency’s MDOs, and the FDA defended its MDOs.

- Jan. 3, 2024: The Fifth Circuit ruled 10-6 for Triton and Vapetasia, granting their consolidated appeal, and sending their PMTAs back to the FDA for review.

- Feb. 15, 2024: The Fifth Circuit granted R.J. Reynolds’ motion to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution). The FDA may appeal its loss in Triton to the Supreme Court.

– March 19, 2024: The FDA petitioned the Supreme Court to review the Fifth Circuit decision that nullified Triton Distribution’ MDOs and ordered the FDA to conduct a new PMTA review.

-July 2, 2024: The Supreme Court has granted the FDA’s petition and agreed to hear the agency’s appeal of the Fifth Circuit’s ruling in favor of Triton Distribution. The case will be heard next term.

-Oct. 9, 2024: Briefs have been filed by the FDA and Triton Distribution in the FDA’s Supreme Court appeal of Triton’s win in the Fifth Circuit. Additionally, multiple amicus curiae briefs have been filed by interested parties supporting both sides. All filings in the case docket can be seen on the Supreme Court website. The case will be heard in the court’s session that began this week, although no date for oral arguments has been set.

-Oct. 18, 2024: The Supreme Court has scheduled oral argument in the FDA’s Triton appeal for Dec. 2, 2024.

-Dec. 2, 2024 - Lawyers for Triton Distribution and the FDA presented their arguments before the Supreme Court, and fielded questions from all nine justices. The court will render an opinion sometime this session, probably in the spring.

Turning Point Brands, Inc. - Petition for review filed Sept. 23, 2021 – Sixth Circuit Court of Appeals

- Sept. 30, 2021: Turning Point Brands filed an emergency motion for a stay pending court review of its MDO, and asked for expedited consideration of the motion.

- Oct. 7, 2021: The FDA rescinded Turning Point Brands’ MDO, claiming the agency missed evidence included in the company’s PMTA. TPB’s products are moved back into scientific review.

- Oct. 8, 2021: Turning Point Brands withdrew its petition for review after the FDA rescinded the company’s MDO.

Union Street Brands - Petition for review probably filed in 2021 (exact date unknown)–Eleventh Circuit Court of Appeals

- May 17, 2022: The court heard oral arguments from the FDA and Union Street Brands (and copetitioners).

- Aug. 23, 2022: The court ruled in favor of Union

Street Brands and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review.

Vapetasia LLC - Petition for review filed in 2021 (exact date unknown) – Fifth Circuit Court of Appeals

- Oct. 26, 2021: The Triton Distribution and Vapetasia cases were consolidated by the court, and both MDOs were stayed pending review. See the Triton Distribution entry for further developments.

Vapor Unlimited LLC - Petition for review filed Oct. 8, 2021 – Eleventh Circuit Court of Appeals

- Feb. 1, 2022: Vapor Unlimited’s MDO was stayed by the Eleventh Circuit pending review.

- May 17, 2022: The court heard oral arguments from the FDA and Vapor Unlimited (and copetitioners).

- Aug. 23, 2022: The Eleventh Circuit ruled in favor of Vapor Unlimited and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review.

Vaporized, Inc. - Petition for review filed Oct. 11, 2021 – Fifth Circuit Court of Appeals

- Nov. 29, 2021: The Fifth Circuit granted a stay of Vaporized’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

- July 31, 2024: A three-judge panel of the Fifth Circuit has granted consolidated petitions by five companies challenging MDOs received in 2021, sending their PMTAs back to the agency for new reviews.

Vapornine LLC (New Leaf Vapor Co.) - Petition for review probably filed in 2021 (exact date unknown)– Eleventh Circuit Court of Appeals

- May 17, 2022: The court heard oral arguments from the FDA and Vapornine (and four copetitioners).

- Aug. 23, 2022: Despite being consolidated for oral arguments with four of the companies that today had MDOs vacated in a favorable court decision, Vapornine was not included in that ruling. The status of Vapornine’s MDO appeal is unclear.

VDX Distribution (VDX Distro) - Petition for review filed Oct. 17, 2024 - Fifth Circuit Court of Appeals

- Oct. 25, 2024: VDX filed a motion for a stay pending review for an MDO issued Sept. 19 for menthol products.

- Nov. 19, 2024: The Fifth Circuit granted VDX Distro a stay pending review of its MDO for menthol vaping products.

Vertigo Vapor Inc. (Baton Vapor) - Petition for review filed 2024 (exact date unknown) - Fifth Circuit Court of Appeals

- Aug. 13, 2024: A Fifth Circuit panel granted a stay pending review to Vertigo Vapor (doing business as Baton Vapor), rejecting the FDA’s argument that the Fifth Circuit is an improper venue for the Washington State-based manufacturer’s appeal.

Wages and White Lion Investments, LLC - see Triton Distribution

White Cloud Cigarettes (also known as Lead By Sales LLC) - Petition for review filed 2024 (exact date unknown) - Fifth Circuit Court of Appeals

- Oct. 17, 2024: A three-judge panel of the Fifth Circuit has granted a stay pending review to Florida-based White Cloud for an MDO issued July 17, 2024.

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