Tag: e-cigarettes

Chemular Adds Carignan as Chief Commercial Officer

Jason Carignan
Jason Carignan has joined Chemular, an FDA regulatory consultancy group, as its chief commercial officer.
Carignan will lead the company’s revenue generation initiatives, strategic partnerships, and intellectual property monetization strategies across its diverse portfolio of business units, according to a press release.
“Carignan brings a wealth of experience and expertise to Chemular, having held various leadership positions in the tobacco and nicotine industry. He most recently served as president of Phillips & King and the Total Product Expo (TPE), both part of the Kretek International Inc. family of companies,” the release states. “Prior to that, he served as president of DRYFT Sciences, overseeing the successful development of the DRYFT line of nicotine pouches before selling the company to British American Tobacco in late-2020.”
With an impressive track record of driving growth and creating strategic alliances, Carignan is well-positioned to play a pivotal role in expanding Chemular’s market presence and further establishing the company as a leader in FDA regulatory matters.
Kevin Burd, CEO of Chemular. said he is thrilled to welcome Carignan to the Chemular team. “His deep industry knowledge and proven leadership in revenue generation and partnership strategies will be instrumental in driving our growth and expanding our client base,” said Burd. “We believe Jason’s appointment will advance our mission of providing comprehensive regulatory solutions to our clients and partners.”
Carignan will work closely with Chemular’s executive team to develop and execute business development strategies, identify new revenue opportunities, and forge strategic partnerships that enhance the company’s market position, according to the release.
Carignan said he was excited to join the Chemular team.
“Chemular has established itself as a trusted and innovative partner for clients navigating the complex landscape of FDA regulations,” Carignan said. “I look forward to leveraging my experience and expertise to drive revenue growth, establish impactful partnerships, and contribute to Chemular’s continued success.”
July 12, 2023
Korean Ministry Urges Group to Cancel Vape Show

Photo: Taco Tuinstra
South Korea’s Ministry of Health and Welfare (MOHW) has urged events organizer The Fairs to cancel its Korea Vape Show 2023, reports Korea Biomedical Review.
The exhibition is scheduled to take place July 21-23 in Goyang, Gyeonggi Province.
“We sent a letter asking for the event to be canceled because we had concerns from a health promotion perspective,” a MOHW official was quoted by Yonhap News as saying. “We are also concerned that adolescents may visit the show if access to the convention is not properly controlled.”
The ministry also expressed worries about advertised vaping contests that it said would violate indoor smoking restrictions. South Korea allows indoor smoking only in separate, fully enclosed areas.
The MOHW said it plans to inspect the venue on the day of the event and impose penalties if the organizers fail to create a fully enclosed smoking room inside the venue.
The organizers said they had submitted plans to resolve the issues raised by critics and said it would not cancel the convention.
The official also stressed that previous conventions had been held without problems. “During the past three conventions, officials from the local public health center visited the convention and found no wrongdoings,” she said.
July 12, 2023
New Report Urges Ban on Disposable Vape Products

Credit: Iama Sing
The only solution to curb the plastic and battery waste created by disposable vaping products is to ban the products entirely, according to a report released Tuesday from the U.S. Public Interest Research Group (PIRG) Education Fund.
“It doesn’t make any sense to manufacture electronics with rechargeable batteries, ship them across the world, and throw them out within a few days,” the report states.
The report explores the environmental impacts of disposable products and found that the devices are difficult to recycle properly due to a lack of infrastructure and regulation around e-waste recycling.
Disposable vaping devices also contain lithium-ion batteries as well as small plastic parts. They also contain nicotine, which is considered a toxic chemical.
“According to CDC Foundation sales estimates, lining up the disposable vapes sold in a year would stretch for 7,000 miles—long enough to span the continental U.S. twice,” a PIRG report states. “This vape waste is becoming more common while cigarette butts become less common as the trash that litters our beaches and waterways.”
The report advocates for federal and state legislation banning or restricting disposable vapes to keep them out of landfills and waterways and prevent fires.
It also calls for the U.S. Food and Drug Administration to make enforcement of vape marketing restrictions a priority, particularly for disposable products.
July 12, 2023
Broughton Grows into Extractables and Leachables

Photo courtesy of Broughton
Broughton has launched a new extractables and leachables (E&L) testing service for the reduced-risk nicotine industry. The new service will offer tailored E&L studies for products aimed at the premarket tobacco product application (PMTA) and the marketing authorization application (MAA) pathways.
According to Broughton, regulatory bodies increasingly focus on the interactions between manufacturing components, nicotine delivery devices and container-closure systems, and the final product formulation. Producers must identify and assess any toxicological risks that could arise via such interactions via E&L studies.
Aimed at supporting reduced-risk nicotine product categories such as electronic nicotine delivery systems, Modern Oral nicotine pouches and nicotine replacement therapy, the service is available across all stages of the product development lifecycle.
The new testing service includes study design, extractables studies, extractables toxicology assessments, leachables method development and validation, leachables shelf-life studies and leachable toxicology evaluation.
“Extractable and leachable studies are essential to the PMTA and MAA regulatory pathways for reduced-risk nicotine products to ensure their safety and demonstrate evidence of mitigating risk. Even in emerging categories, where regulations may not exist, such as nicotine pouches, they should be adopted as a best practice approach to product understanding and stewardship,” said Chris Allen, CEO of Broughton.
“Our scientific experts and toxicologists have years of combined experience conducting E&L studies across a range of reduced-risk nicotine product and device categories. By offering a one-stop solution for E&L studies, we can ensure a fully integrated approach across study design, extractables study delivery, leachables method development and toxicology assessment with our specialized consultants available to troubleshoot, problem-solve and develop analytical solutions to issues that may arise.”
July 11, 2023
Germany Readies to Ban Flavored Vape Products

Image: Tobacco Reporter archive
The German Bundesrat approved a third amendment to the Tobacco Products Act, which would ban flavored heated-tobacco products, according to Dokumentations und Informationssytem fur Parlamentsmaterialien.
The amendment includes “alignment of EU rules banning flavorings and distinctive flavors in heated-tobacco products; definition of the heated-tobacco product and its classification as a smoking tobacco product or smokeless tobacco product, extended labeling requirements in the form of combined text and image warnings and an information message, extension of the ban on placing cigarettes and roll-your-own tobacco with a characteristic flavor on heated-tobacco products; [and] amendment of various sections of the Tobacco Products Act,” according to the German Bundestag website.
July 11, 2023
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