Tag: regulation

New York City Accuses Vape Distributors of Racketeering

Credit: Maria Kray
New York City has filed a lawsuit in federal court charging four vaping product distributors and six persons associated with the companies for illegally selling flavored vaping products other than tobacco in the city. It is possible more companies will be added to the suit.
The civil lawsuit, filed Monday in the U.S. District Court for the Southern District of New York, claims the defendants violated “nearly every federal, New York State and New York City law applicable to the marketing, distribution, and sale of flavored e-cigarettes, the sales of which are prohibited under laws enacted by all three jurisdictions.”
Named in the suit are Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. Also named were Matthew Glauser, Donald Hashagen, Russell Rogers, Nikunj Patel, Devang Koya and Nabil Hassen. The suit also mentions Puff Bar, Elf Bar and Hyde products, however, those manufacturers were not named in the suit.
The lawsuit alleges the defendants committed mail and wire fraud, alongside violations of New York City’s Administrative Code, New York State Public Health Law, and the federal Tobacco Control Act. The city also accuses the companies of violating both the federal Racketeering Influenced Corrupt Organizations (RICO) Act and the Prevent All Cigarette Trafficking (PACT) Act.
The suit centers on disposable flavored vapes. However, the suit alleges that is seeking relief for any type of flavored e-cigarette product on the market. This would suggest the suit could grow into anyone entity that has sold flavored vaping products in the city.
“Although this action speaks principally about (flavored disposables), the favorite type of electronic
nicotine delivery system among youth and the most intentionally directed to that market, the City
seeks relief for defendants’ violation of laws applicable to e-cigarettes regardless of the type of
device with which the violation is committed,” the suit states. “Any non-FDA approved [the FDA authorizes for marketing; it does not approve products] e-cigarette containing a flavored e-liquid is governed by the laws under which the City’s claims are brought and the City seeks relief with respect to all such devices.”
The city says it “seeks to recover monetary damages and civil penalties from the defendants, potentially totaling millions,” according to a press release. The suit also alleges the sales of disposable flavored vapes created a youth use crisis. The suit alleges the largest increase in youth use ever. The claim is unsupported by any facts.
“By distributing devices that provide larger than normal doses of nicotine in a mild aerosol formulated to reduce or eliminate the harshness of burning tobacco and tasting pleasantly of fruit, candy or desserts, FDV manufacturers and distributors have triggered the largest increases in youth nicotine use ever seen,” the suit claims.
The lawsuit states the city will seek triple the damages awarded at trial under the RICO law guidelines.
July 11, 2023
U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for myblu Menthol 2.4%. Fontem US, a subsidiary of Imperial Brands, is banned from marketing or distributing the product in the United States, or they risk enforcement action by FDA.
The company may resubmit a new application to address the deficiencies of the product subject to this MDO, according to an FDA press release.
“Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks.”
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth).
“After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the release states. “For example, among other deficiencies, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”
The FDA has not authorized for sale of any flavored vaping product other than tobacco. Fontem is expected to challenge the denial order in court.
In April of last year, The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu.
July 10, 2023
Flavored Vape Ban in Ukraine Begins Tomorrow

Credit: Billion Photos
A ban on advertising e-cigarettes in Ukraine, including heated-tobacco products, goes into effect on July 11. Flavored electronic nicotine-delivery systems (ENDS) products are also banned.
The advertising rule applies to all types of media, including the Internet, social media, public transportation, and public events.
“The advertising, sales promotion and sponsorship of electronic cigarettes, liquids used in them, and devices for consumption of tobacco products without burning them (including IQOS and glo devices) will be prohibited from 11 July 2023,” according to the WHO Framework Convention on Tobacco Control (FCTC).
“Flavored cigarettes and flavored liquids for ENDS will also be banned at that date. Further, from 11 January 2024, the combined textual plus pictorial warnings will be required to cover 65 percent of both sides of the pack of smoking tobacco products (conventional cigarettes).”
The fine in the case of a violation is UAH30,000 ($812), and for each subsequent violation – UAH50,000. In addition, similar to the general smoking ban, the law prohibits the use of heated tobacco products in all public places and businesses.
In 2021, Ukrainian lawmakers passed the law prohibiting the use of ENDS in public places as well as advertising, sponsorship, and promotion of e-cigarettes. The law also bans the sale of flavored e-liquids other than tobacco flavors.
July 10, 2023
Ghana Makes Vape Sales and Advertisement Illegal

Credit: Adobe Stock
Ghana has banned all recreational use of vaping and e-cigarette products.
In a press release, the country’s Food and Drugs Authority (FDA) states that the “sale, advertisement and recreational use of electronic nicotine delivery systems (ENDS) such as vapes and other non-nicotine tobacco products by the public” is illegal.
However, ENDS can be registered as a prescription-only medicine for the purposes of cessation therapy.
The FDA claims it has sent notice to manufacturers, importers, wholesalers, and retailers to remove all advertisements on social media, billboards and neon signs immediately and refrain from the importation of the products.
The FDA states that there “will be repercussions including sanctions” for failure to adhere to the rules.
July 9, 2023
Germany: Minister Plans Ban on Vaping in Cars With Kids
Proposals by the Health Ministry would prohibit e-cigarettes in vehicles carrying children and pregnant women. The ban could also include traditional cigarettes, heated tobacco products and cannabis.
Credit: Tadeas
German Health Minister Karl Lauterbach is pushing for a ban to prevent smoking in cars where minors and pregnant women are passengers, German media group RedaktionsNetzwerk Deutschland (RND) reported on Friday.
RND, as well as other outlets, cited a draft by Lauterbach that will be coordinated with other ministries before he presents it to the Cabinet.
Smoking in cars is not currently illegal in Germany. The plan, which is part of Lauterbach’s draft proposal to legalize cannabis, aims to expand the existing Non-Smokers Protection Act.
The expansion of the smoking ban, which already applies in public transport, is intended to “ensure the necessary protection from passive smoking for this particularly vulnerable group of people,” according to the draft cited by RND.
Smoking in cars has been proven to pose higher risks due to the small space volume.
“According to confirmed studies, secondhand smoking also causes many serious illnesses and deaths, such as coronary heart disease, stroke, chronic obstructive pulmonary disease and sudden infant death syndrome,” the draft said.
Many studies have also established a link between secondhand smoking and lung cancer, Lauterbach said.
The draft also includes applying the ban to tobacco cigarettes, e-cigarettes, heated tobacco products and cannabis — although such details could be changed during discussions with ministers.
A government statement said a ban on smoking in cars with children would be “unconditionally welcomed.” But with cars representing private, personal space, it warned of constitutional concerns over any such ban.
July 8, 2023
U.K. Black Market for E-Cigarettes Continues to Grow

Credit: Yehuda
If you start to look for something, you will usually find more than when you weren’t looking. Seizures of illegal e-cigarettes in the UK in the first four months of the year were seven times as high as all of 2021.
Research found the UK has been flooded with two million illicit e-cigarettes since the beginning of last year, reports The Mirror.
Local leaders have called for a more vigorous crackdown on counterfeit vapes, with usage is said to be surging among children and adults.
London, the South East and North West were the top three regions for counterfeit vape seizures, according to the analysis.
The findings, uncovered through freedom of information requests sent to 167 local authorities by VapeClub, raise concerns about a booming black market selling products that do not comply with UK regulations and have not been through appropriate safety testing.
“Illicit vaping products have the potential to be dangerous to the user’s health. What’s needed is a licensing scheme so proper age verification tests can be applied to every retailer,” Dan Marchant, director of vaping and e-liquids retailer Vape Club, said.
“There must also be higher fines applied to every breach for the rogue sellers. The UK Vaping Industry Association is calling for the fines to be raised to at least £10,000 ($12,800), which would be a real deterrent.”
July 8, 2023
Ninth Circuit Denies Lotus Vaping MDO Review

Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)
A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit on Friday ruled 3-0 to deny Lotus Vaping Technologies’ petition for review of a marketing denial order (MDO) for its flavored e-liquid products. The company could now ask for an en banc rehearing with all Ninth Circuit judges
The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.
The panel held that the text of the Family Smoking Prevention and Tobacco Control Act (TCA) authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids, the judges wrote in the denial that is not considered an opinion.
The panel also held that the FDA did not arbitrarily or capriciously deny Lotuss’ applications and that “any error the agency committed by failing to comparisons of flavored e-liquids to tobacco-flavored e-liquids.” The panel also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless
July 8, 2023
New Virginia Hemp Law Forcing Some Shops to Close

Credit: RawF8
The U.S. state of Virginia recently enacted a law to curb kid-friendly packaging in cannabis products. That law is having hard effects on some local businesses.
Lawmakers have witnessed Delta-8 products sold in packaging that mimic foods that are enticing to kids, but those in the hemp industry say this new crackdown goes too far.
“Were one of hundreds that’s made the hard decision to just shut it down,” Reed Anderson said.
Anderson says he’s shutting down his Goochland hemp business, Kame Naturals, in the wake of a new state law cracking down on THC products like Delta-8.
It limits all hemp products to only two milligrams of THC per package. That’s far lower than most products in many smoke and vape shops. Hemp products must now have at least a 25-to-1 ratio of CBD to THC, according to media reports.
“25-to-1 ratio doesn’t do what we do justice right,” Anderson said. “We started our business as a solventless extraction company, and that over time kind of had to go to the wayside because of the different regulations coming through.”
Breaking the rules could mean fines of up to $10,000.
Anderson said it’s all too much and says lawmakers paid too much attention to the intoxicating effects of THC and very little to the health benefits THC may provide.
“Once you start getting into remediated product and trying to remediate THC out of a product, you lose a lot of the natural quality CBD products offer,” Anderson said.
However, Governor Glenn Youngkin and the law’s supporters said something needed to be done to stop the sale of Delta-8 products. Too many kids were getting sick.
A statement from Gov. Youngkin’s office said in part:
“SB 903 and HB 2294 took critical steps to strengthen consumer safety and regulations around edible and inhaled hemp-derived products as well as delta-8 THC products. Specifically, the amendment continued its efforts to crack down on dangerous THC intoxicants, including synthetic THC products. In addition to the ban on synthetic THC, the limited percentage of total THC allowed in hemp products, the packaging and labeling restrictions, the testing requirements, and the total per package limit for THC, the substitute also requires retailers to register with the Virginia Department of Agriculture and Consumer Services (VDACS) to sell any edible or inhaled hemp-derived product. Additionally, the General Assembly established the registration requirement and fees as a necessary operating cost and to create a database of all regulated hemp product retail stores.”
Anderson said while he’s no longer in the hemp business, he will become an advocate and plan to talk with politicians as often as he can to get these laws reformed.
July 6, 2023
Juul Labs Accuses NJOY Maker of Patent Violations

Juul Labs has asked the U.S. International Trade Commission (ITC) to block sales and imports of the NJOY Ace vapor device, claiming that the product infringes several Juul patents. It has also filed a complaint against NJOY with the U.S. District Court for the District of Arizona.
“Our technology, designed internally and in the U.S. and protected by our robust patent portfolio, has been the most effective product development to transition adult smokers from combustible cigarettes—switching over 2 million adult smokers in this country. Innovation is critical in this space to advance tobacco harm reduction,” said Juul Labs Chief Legal Officer Tyler Mace in a statement.
“When others infringe on our technology, we have no choice but to protect our intellectual property rights.”
This ITC complaint follows three prior successful actions from Juul Labs at the Commission, which all resulted in barring the importation and sale of infringing products, according to Juul Labs.
“Just like we have in three prior successful ITC actions that vindicated our company’s IP rights, we intend to reach the same result here,” said Mace.
The Juul Labs complaint also targets Altria Group, which agreed to acquire the NJOY in March after exchanging its minority investment in Juul for a heated tobacco product intellectual property license.
The NJOY Ace device received marketing authorization from the Food and Drug Administration in April 2022.
July 3, 2023
CTP Touts Progress Addressing Reagan-Udall Goals

Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.
At the request of FDA Commissioner Robert Califf, the Reagan-Udall Foundation evaluated the CTP’s operations. In December, the foundation submitted its report, which identified several problems hindering the agency’s ability to regulate the industry and reduce tobacco-related disease. Among other recommendations, the foundation urged the CTP to make process improvements and increase transparency.
According to King, the CTP has made significant strides in putting its plans for improvement into action. The agency, he said, is on track to issue proposed goals this summer, and to release the final plan by December 2023. The CTP intends to hold a public meeting in the summer of 2023 to seek stakeholder feedback about the strategic plan.
Meanwhile, said King, the CTP Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas, including establishing transparency liaisons. Externally, the center is planning for upcoming public meetings to gather stakeholder input. CTP also published a webpage of all the tobacco products-related citizen petitions received by the center to provide the public with information about such citizen petitions that is easy to access and user-friendly.
According to King, the center has reviewed 99 percent of tobacco product applications submitted over the past three years, authorizing 23 tobacco-flavored e-cigarette products and devices. The CTP is planning a public meeting in fall 2023 regarding the application review process.
Meanwhile, the center is in the process of finalizing rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.
CTP also recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.
King also highlighted the CTP Office of Science leadership’s participation in conferences and external meetings. For example, representatives from the Office of Science recently presented at the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the E-Cigarette Summit and the TMA annual meeting (see Todd Cecil’s TMA presentation here).
“I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future,” said King.
A comprehensive list of CTP status updates for each Reagan-Udall Foundation recommendation is available here.
June 29, 2023