Category: Regulation

First Vapor Manufacturers Handed DOJ Injunctions
Credit: MQ Illustrations
The United States filed complaints in December against six companies and related individuals to stop the illegal manufacture and sale of unauthorized vaping products. The charges were brought on behalf of the U.S. Food and Drug Administration.
E-cigarette manufacturers Seditious Vapours LLC and Vapor Craft LLC, two of those six companies, must stop distributing and selling their products under two separate court orders granting the FDA-requested injunctions, according to Bloomberglaw.
Judge Douglas L. Rayes of the U.S. District Court for the District of Arizona sided with the FDA’s argument that Seditious Vapours failed to submit premarket applications for the products, and subsequently manufactured, sold, and distributed the e-cigarettes illegally, according to a court order filed Friday.
Two days earlier, Judge Clay D. Land of the US District Court for the Middle District of Georgia granted a permanent injunction against Vapor Craft.
The FDA states that the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers after receiving warning letters from the agency. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.
“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure.
The six companies originally having injunctions filed were:

Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota

Soul Vapor LLC in the Southern District of West Virginia

Super Vape’z LLC in the Western District of Washington

Vapor Craft LLC in the Middle District of Georgia

Lucky’s Convenience & Tobacco LLC d/b/a Lucky’s Vape & Smoke Shop in the District of Kansas

Seditious Vapours LLC d/b/a Butt Out in the District of Arizona
The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.
December 12, 2022
FDA Accepts Several Streamline Synthetic PMTAs
Streamline, parent to Juice Herad and several other e-liquid brands, announced that the U.S. Food and Drug Administration had accepted the company’s premarket tobacco product applications (PMTAs) for several of its synthetic products under the Juice Head brand.
In an email, Streamline co-founder and CEO Patrick Mulcahy said that his staff and Accorto Regulatory Solutions were instrumental in preparing the PMTAs for submission.
“With ample investment and focus on ensuring the quality and compliance of all Juice Head products, we are thrilled to be making progress and look forward to a positive response from the FDA.
“Currently, our PMTAs for Juice Head 5Ks, Juice Head Bars, and Juice Head Pouches are still under review; however, we are confident that we will receive a positive response from the FDA soon,” Mulcahy said. “As always, we will maintain our commitment to transparency and communication throughout the process ahead.”
December 12, 2022
Ireland’s Government Approves E-cigarette Rules
Credit: Schankz
The Minister for Health Stephen Donnelly and the Minister for Public Health, Frank Feighan, received government approval to introduce additional restrictions on the sale and advertising of nicotine inhaling products such as e-cigarettes.
Under the new proposals, the sale of e-cigarettes and related vaping products will be prohibited from self-service vending machines, from temporary or mobile premises and at places or events for children, according to a press release. In addition, advertisements for e-cigarettes will be prohibited on public transport, in cinemas and near schools.
“These measures are designed to protect our children and young people from starting to vape,” said Donnelly. “We recognize that nicotine is a highly addictive drug, and we are acting today to make these products less accessible to our young people and to remove the advertising for these products from our children’s everyday lives.”
The proposals will be incorporated into the Public Health (Tobacco and Nicotine Inhaling Products) Bill which is currently being drafted. The Bill is expected to be finalised and published by year-end. The legislation will be designed to regulate any product that can be used for the consumption of nicotine-containing vapour or any component of that product.
The Bill already contains measures to ban the sale of nicotine inhaling products to those under the age of 18 and to introduce a licensing system for the retail sale of tobacco products and nicotine inhaling products. Other measures contained in the Bill include:
prohibiting the sale of tobacco products and nicotine inhaling products by persons under 18 years of age
prohibiting the sale of tobacco products from self-service vending machines, from temporary or mobile units and at events or locations for children
introducing minimum suspension periods for retailers convicted of offences
introducing fixed penalty notices for offences
The Minister of State with responsibility for Public Health, Well Being and the National Drugs Strategy, Frank Feighan, welcomed the government’s approval of the measures.
“Tobacco smoking continues to kill approximately 4,500 people in our country each year,” he said. “We recognize that nicotine inhaling products are used by some adult smokers to assist them to quit tobacco smoking. However, we are clear that these products are of no benefit to our children and young people or to non-smokers and that is why we are taking this action today.”
November 26, 2022
FDA Warns 5 Vapor Businesses for Illegal Marketing

The U.S Food and Drug Administration issued warning letters to five firms on Wednesday for the illegal marketing of 15 different e-cigarette products.
The letters were issued to Wizman Limited doing business as Wizvapor, Shenzhen Fumot Technology Co., doing business as R and M Vapes, Shenzhen Quawins Technology Co., Ruthless Vapor and Moti Global.
According to the FDA, all 15 products are packaged to resemble toys, food or cartoon characters.
“The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”
None of the manufactures have submitted a premarket tobacco product application (PMTA) for the unauthorized products. The items described in the warning letter include e-cigarettes that are designed to look glow sticks, walkie talkies and Nintendo Game Boy game systems.
“The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.”
Additionally, the products feature characters from cartoons and media that are aimed at a youth and/or teen demographic including The Simpsons, Family Guy, Squid Game, Rick and Morty, Minions and Baby Bus, as well as imitate youth appealing foods such as popsicles.
Last month, the U.S. Department of Justice (DOJ) filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
The FDA states that each of the defendants failed to submit PMTAs for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law.
November 17, 2022
Chowdhury: Implementation of Tobacco Control Act Flawed
Azim Chowdhury
The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.
Writing in Filter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.
In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.
For example, rather than conducting reviews in a silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.
“It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.
“Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”
November 16, 2022
Ireland Considering Vape Ban for Under-18 Youth

Credit: Promesa Art Studio
The sale of e-cigarettes and vaping products to under-18s is set to be banned in Ireland.
Health Minister Stephen Donnelly is to seek Cabinet approval to ban the sale of “nicotine inhaling products” to those aged under 18 from early in the new year, according to Irish media.
Legislation is at an advanced stage and the minister will seek Cabinet approval to introduce a ban on the sale of vaping products to under-18s early next year.
Ireland has the highest rate of people who use e-cigarettes in the European Union at 7 percent, while the EU average is 2 percent.
Donnelly will also restrict the types of retailers that can sell vaping products, reducing the number of vape shops.
He also intends to curb the advertising of nicotine-inhaling products near schools. This will also apply to a number of other settings frequented by children and young teenagers.
A ban on advertisements for vaping instruments and CBD oils will also apply on public transport.
The intention is to limit children’s exposure to commercial messages “normalizing or glamourizing” the purchase and use of e-cigarettes, a source said.
November 15, 2022
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.
November 10, 2022
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.
November 8, 2022
ATR Submits Comment to Reagan-Udall FDA Review
Credit: Araki Illustrations
Americans for Tax Reform (ATR) has submitted a comment to the Reagan-Udall Foundation as the Foundation continues its external review of the U.S. Food and Drug Administration‘s Center for Tobacco Products (CTP)’s policies and procedures.
The ATR states that the FDA has “significantly and substantially failed” to fulfill the regulatory agency’s congressional mandate to act on behalf of the protection of public health.
Tim Andrews, ATR’s director of Consumer Issues, wrote that his organization is hopeful that the Reagan-Udall Foundation’s review could help the agency better the PMTA review process.
“[The PMTA] process has created impossible administrative burdens on applicants. When processes and requirements were changed, FDA failed to notify applicants and is alleged to have applied a new and different standard to certain applicants,” said Andrews. “FDA’s failures are structural. Our submission is cognizant of that and emphasizes that these issues can’t be solved with increased funding, especially not through user fees on small vape manufacturers.”
In its comment, the ATR also offered seven FDA reforms that the ATR hopes the Reagan-Udall Foundation would consider:
FDA should introduce cross-disciplinary expert analysis factoring input from fields like psychology and behavioral economics, to increase public awareness and engagement in the decision-making process.
FDA must provide an easy, streamlined, PMTA pathway, as initially promised.
FDA’s PMTA process should focus on product safety and individual risk, not behavioral and population assessments that are better gathered by a singular post-market surveillance team.
FDA should be in regular, proactive contact with all PMTA applicants, as opposed to merely issuing MDO’s after year long periods of silence.
FDA should consider implementing product standards, to assist in the streamlining process, and look also to countries such as the United Kingdom as a model for a regulatory system that works.
FDA must urgently act to combat significant public misinformation that it admits exists in the community and is a barrier to smoking cessation.
FDA must reform its approach to youth risk behavior. FDA should accept that youth can benefit from harm reduction and properly evaluate the consequences of reduced vape access for both adults and youth.
The ATR also complained about stringent rules vape manufacturers and retailers are forced to follow, such as being forbidden by law from sharing scientific studies about their products with consumers. The responsibility for correcting the public’s perception of reduced-risk products “lies at the feet” of the CTP.
“There is a desperate need for widespread public messaging that vaping is safer than smoking and can save lives,” Andrews stated. “[The] FDA should be the agency that educates the public about the safer nicotine products that exist to help adults who smoke quit the deadly habit of cigarettes.”
The ATR comment also mentions significant and fundamental structural problems at the agency. After numerous purported FDA staffers have revealed that FDA’s tobacco program “has a toxic internal culture, rife with racism, sexism, and unconscious bias. FDA employees have shared concerns that [the] FDA allows political pressure to influence scientific decisions and that scientific staff feel intimidated in the workplace.”
November 8, 2022
Logic Granted Temporary Stay of FDA’s Menthol MDO

Credit: Sundry Photography
In an expected move, Logic Technology Development obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stays the U.S. Food and Drug Administration’s marketing denial order (MDO).
The temporary stay issued by the circuit court means that both the Logic Pro Menthol e-Liquid package and the Logic Power Menthol e-Liquid package products can be sold by retailers and wholesalers in the United States while the stay is in place.
The Third Circuit will now consider a further motion from Logic regarding the MDO that the company has seven days to file, according to media reports.
“The foregoing motion for a partial administrative stay is GRANTED as follows. The FDA’s marketing-denial order is TEMPORARILY STAYED as to the Logic Pro Menthol e-Liquid Package and the Logic Power Menthol e-Liquid Package products. Within seven days of this order, the petitioner must file its motion for a stay pending the petition,” the order states. “The FDA’s response must be filed within ten days thereafter.
“The panel considering the stay motion may decide it without waiting for a reply […] so any reply must be filed as quickly as possible (and no later than three days after the response).”
The temporary administrative stay will remain in effect until a panel of the court decides on Logic’s new stay motion. If no timely stay motion is filed, the clerk is authorized and directed to vacate the temporary administrative stay.
October 31, 2022