Tag: regulation

Distributors Accused of Racketeering

Credit: Vitalii Vodolazskyi
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, [flavored vaping device] 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 guidelines.
July 11, 2023
Flavored Vaping Ban Begins Tomorrow

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 Outlaws Vape Sales and Promotion

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
Ninth Circuit Denies Lotus 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)
The U.S. Court of Appeals for the 9th Circuit on June 30 declined to review a Food and Drug Administration marketing denial order for Lotus Vaping Technologies’ flavored e-liquid products.
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.
Lotus challenged the ruling in court, but the judges held that the text of the Family Smoking Prevention and Tobacco Control Act 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 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
Topower Brings More Puffs and Better Battery

A new disposable vape battery solution was showcased during the World Vape Show Dubai, held from June 21-23.
The pioneering power technology developed by FEELM, a subsidiary of the world’s largest atomization technology company Smoore, is intended for markets that allow higher puff counts and has been designed to increase the endurance of single-use devices.
When compared to mainstream batteries, the new Topower offers 30 percent more capacity with the battery size remaining unchanged and can deliver over 6,000 puffs without needing to be recharged.
Topower also provides a constant power output that reduces the loss of taste caused by voltage drop.
FEELM says the new innovation also boasts the “longest shelf life in the industry,” according to a press release, promising just 1 percent power attenuation over six months and 3 percent over a year – which the brand says is 1/10th the level seen in traditional batteries.
“This is our new battery technology customized for higher puff disposable vape, with large puff vaping without charging, ultimate-low discharge, ultimate-high energy density,” said Rex Zhang assistant president of FEELM. “The end goal for our industry is to create a smoke-free future and unburden adults from the harms of deadly cigarettes – technology is going to play a leading role in achieving this.”
Zhang said the no-charge element of Topower was beneficial not just for brands, but for consumers as well. He said the battery solution eradicates the need for additional charging cables, which eliminates the necessity for internal charging devices and consequently saves on production costs.
He also said consumers would no longer need to “worry about when and where they could next plug their disposable, which can reduce user anxieties and create a more convenient vaping experience,” according to the release.
Topower has been incorporated into two solutions – FEELM Max’s ceramic coil disposable solution and Power Alpha‘s mesh coil solution.
FEELM Max and Power Alpha have already been extensively commercialized and have achieved considerable success in multiple countries.
June 26, 2023
Max Ceramic Coil and Topower Show in Dubai

FEELM, the subsidiary of the world’s largest atomization technology company, Smoore, exhibited two innovations that have been developed to “raise product performance” across the disposable vape category during an industry event in Dubai.
The FEELM Max’s ceramic coil and Topower battery technology were created as part of a targeted effort to ‘level up the single-use sector’ and enhance consumer experience, according to a press release.
The pioneering advancements both earned attention from the industry and are already appearing in devices from globally recognized brands.
FEELM says each was designed to address a “pain point” of the industry.
FEELM Max’s ceramic coil has done away with super-absorbent cotton to reduce the amount of e-liquid that goes to waste and increase the puff count of TRPR- and TPD-compliant 2ml disposables in the UK by as much as 30 percent – a rise from 600 to at least 800 puffs.
It also reduces impurities by 78 percent during the heating process, produces air particles that are 55 percent smaller than mainstream solutions and uses a “constant power engine” that provides a vapor consistency of 95 percent and a 35 percent improvement in taste consistency.
The second notable innovation is FEELM’s Topower battery technology. This breakthrough increases the endurance of large e-liquid capacity vapes and can provide over 6,000 puffs without needing to recharge, which allows consumers to get rid of the hassle of charging.
Further, the compact power solution – which offers 30 percent more capacity – delivers a consistent output which FEELM says will counter the common issue of flavor reduction caused by voltage drop.
Topower also promises a longer shelf life, with 1 percent power attenuation over six months and 3 percent power attenuation over a year. This advancement effectively avoids the burning taste and assures a strong consistency of flavor.
Speaking on the developments, Rex Zhang, assistant president at FEELM, said the company prides itself on being the brand behind the brands and its technology has become to vaping what Intel Core processors are to laptops.
“We aim to elevate the disposable category to a whole new level through innovation– our ceramic coils and Topower battery solution represent two significant successes on this front,” he said, adding that technology will be a “critical metric” on which to measure the winners and losers of the industry moving forward. “The vape category is fuelled by the desire to help adult smokers switch away from cigarettes – but it is built on innovation.”

June 22, 2023
McKinney Hires Fearon as Chief Scientific Officer

McKinney Regulatory Science Advisors stated today that it has appointed Ian Fearon as its new Chief Scientific Officer.
Fearon will play a pivotal role in enhancing the regulatory science consulting firm’s capabilities and expanding its range of services to clients, according to a press release.
“Fearon brings over 15 years of invaluable experience in the field of Tobacco Harm Reduction, with a specific focus on clinical and behavioral studies of these products,” the release states. “His deep understanding of regulatory submissions in the United States and Europe will enable McKinney Regulatory Science Advisors to provide unparalleled support and guidance to clients navigating the complex regulatory landscape.”
Prior to joining McKinney, Fearon held key leadership positions at several industry organizations such as senior director of Clinical and Regulatory Affairs EMEA at Juul Labs, where he helped advance the scientific understanding of tobacco and nicotine products and supported the company’s premarket tobacco product application (PMTA) submission to the U.S. Food and Drug Administration.
Fearon also served as the director of Tobacco Research at Celerion, where he contributed to the development of clinical evidence to support regulatory filings, and as principal scientist and head of Clinical Research at British American Tobacco.
Fearon has published more than 60 papers, including more than 20 on tobacco/nicotine product assessment, which generated more than 3,200 citations, according to the release.
“We are thrilled to welcome Ian as our Chief Scientific Officer,” said company CEO Willie McKinney. “His extensive experience and deep knowledge of tobacco and nicotine science and worldwide regulations make him an invaluable asset to our team. With Ian’s guidance, we will continue to provide exceptional scientific and regulatory consulting services to our clients, facilitating their success in bringing innovative consumer products to market.”
As the Chief Scientific Officer at McKinney Regulatory Science Advisors, Fearon will oversee the company’s scientific operations, lead strategic initiatives, and drive innovation in the regulatory science domain, according to the release.
May 31, 2023
CTP Hires Health Equity Advisor
The U.S. Food and Drug Administration Center for Tobacco Products (CTP) has hired Charlene Le Fauve as its first senior advisor for health equity.
“Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research,” the CTP wrote on its website. “She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”
Most recently, Le Fauve served as the senior advisor to the chief officer for scientific workforce diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research.
Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of disparities research and global mental health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.
“Diversity, Equity, Inclusion, and Accessibility are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the CTP said.
“She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”
May 22, 2023
FDA to Seize Illegal Vapes

Photo: N Felix
The U.S. Food and Drug Administration has issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as ELFBAR, EBDESIGN, Eonsmoke, Esco Bar and Stik that are on the agency’s “Red List.”
The alert covers China, South Korea and the United States.
“Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP)” the alert states. “CTP concurrence is required to add a product to the Red List.”
In order to remove a firm’s product from the Red List, companies must provide information to the FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation.
“The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, ‘Detention without Physical Examination (DWPE),’” the alert states.
The FDA states that the import alert is to prevent the sale of potentially illegal goods in America; Releasing agency resources to inspect other goods; provide uniform coverage across the country; shift the blame back to the importer to ensure that products imported into the United States comply with FDA laws and regulations, according to the agency.
In June 2009, the Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate tobacco products, recognizing that it is the primary federal regulator for the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, and smokeless tobacco.
The designation rule, published in the Federal Register on May 10, 2016, and effective August 8, 2016, extends FDA’s authority to designated tobacco products, such as e-cigarettes, cigars, hookahs, and pipe tobacco, as well as their components and parts, but not their accessories.
May 18, 2023
Portugal Mulls New Rules for Tobacco

Credit: Sezerozger
New legislation aims to restrict the use and sale of all tobacco products in Portugal, including e-cigarettes and heated tobacco.
A new bill would ban smoking in outdoor spaces next to public buildings such as schools, colleges and hospitals. It will also tighten control over the sale and marketing of cigarettes and other tobacco products in the country.
The aim is that by 2025 tobacco products will only be available for purchase in tobacconists, petrol stations and airports, reports EuroNews.
If enacted, it will no longer be possible to sell tobacco directly or through vending machines in places such as restaurants, bars, concert halls and venues, casinos, fairs and exhibitions. The products will also be prohibited at music festivals.
Portugal is also complying with the European directive of June 29, 2022, which puts heated tobacco products on an equal footing with other tobacco products.
May 15, 2023