Tag: regulation

  • Netherlands Votes on Motion to Introduce Vape Tax

    Netherlands Votes on Motion to Introduce Vape Tax

    Photo: dbvirago

    Dutch lawmakers on Oct. 26 voted for a motion to introduce a tax on vapor products, reports Dutch News. The move follows earlier reports that the Netherlands would not impose such a levy prior to the elections scheduled for November.

    The government had been planning to wait until the introduction of Europe-wide legislation but given that is unlikely to happen before 2026, ministers agreed to take unilateral measures, if that is what MPs wanted.

    One in five Dutch youngsters under the age of 25 uses e-cigarettes, and 70 percent of vapers also smoke tobacco cigarettes, according to the Trimbos addiction institute.

    The 18 age limit for using vapes is also widely flouted and internet sales have flourished, De Telegraaf reported earlier this month.

     Vaping is cheaper than smoking in the Netherlands, where a pack of cigarettes now retails for around €11 ($11.64). An e-cigarette with the equivalent of two packets of cigarettes in terms of nicotine costs around €6.

  • Deadline is Nov. 1 for Louisiana Vape Product Registration

    Deadline is Nov. 1 for Louisiana Vape Product Registration

    Credit: VFHNB12

    A strict new vape law goes into effect on Nov. 1 in Louisiana. It will require every vapor product manufacturer to register their products with the Louisiana Alcohol and Tobacco Commission (ATC).

    Store owners say the impact could be devastating for sales since fewer vape products will occupy shelf space as products not approved by the ATC can not be legally sold in the state.

    “Every store will take about a 30, 40 percent hit. It will impact us not only through sales but also through payroll, keeping up with our expenses, different things like that will definitely affect business in a worse way than we could imagine,” Lit Vape and Smoke Owner Bilal Wardariya told KPLCTV.

    The legislation stemmed from a bill to increase the vape tax, which tripled this year, but Wardariya said limiting the usage of vapes is taking it too far.

    “I think this vape ban negatively impacts the state in many different ways, not just people, but the state itself because we give so much tax revenue. As a whole, I’d like to see this thing get resolved and hopefully, we can still sell and keep the same process we’ve been having for many many years,” he said.

    Other vape shops in the area agree that it will affect business but believe the state and customers will suffer as well.

    “We pay thousands of dollars in taxes between all of our stores, so they’re going to lose that, and it affects our customers because a lot of them genuinely need this to stop smoking cigarettes and stuff,” Smoke 360 Manager Joshua Snyder said.

    For the products to be considered by the ATC, a $100 application fee per product is required as well as approval by the FDA. A list of those approved will be released on Nov. 1.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. Many of those products are outdated and all are owned by major tobacco companies.

  • Altria Revenues Down 4.1 Percent, NJOY Growing

    Altria Revenues Down 4.1 Percent, NJOY Growing

    Photo: Phimwilai

    Altria Group reported net revenues of $6.28 billion in the third quarter of 2023, down 4.1 percent from the comparable 2022 quarter. The decrease was driven primarily by lower net revenues in the company’s smokeable products segment.

    Altria’s domestic cigarette shipment volume decreased 11.6 percent from quarter to quarter, driven by the industry’s overall decline rate, retail share losses, calendar differences and trade inventory movements, among other factors.

    Following the completion of its Njoy Holdings acquisition on June 1, 2023, Altria has been strengthening Njoy’s global supply chain to support the anticipated volume increase associated with its expansion plans for the Njoy Ace brand.

    The company shipped 7.5 million Ace pods during the quarter. The retail share of Ace pods in U.S. muti-outlet and convenience stores was essentially unchanged since the completion of the Njoy transaction.

    The U.S. cigarette retail share of Altria’s Marlboro brand dropped 0.3 points, to 42.3 percent versus the prior-year quarter, primary due to increased macroeconomic pressures on disposable income and increased competitive activity.

    Net revenues in the oral tobacco products segment increased 2.2 percent, driven by higher pricing and lower promotional investments.

    “Our highly profitable traditional tobacco businesses were resilient in a dynamic operating environment during the third quarter and first nine months, providing fuel for our business transformation and significant cash returns to our shareholders,” said Altria CEO Billy Gifford in a statement.

    “I believe we have the appropriate strategies and people in place to execute our growth plans. I continue to believe that we can achieve our vision and create long-term value for our shareholders.”

  • Vaping Banned in Half of Southeast Asian Countries

    Vaping Banned in Half of Southeast Asian Countries

    Photo: Aliaksandr Barouski

    Of the 10 countries in the Southeast Asian region, five have banned e-cigarettes and vaping products, reports Malaya Business Insight, citing an the assessment by the Southeast Asia Tobacco Control Alliance (SEATCA).

    The sale and use of vapes and e-cigarettes are already banned in Brunei, Cambodia, Laos, Singapore and Thailand, according to the SEATCA.

    There are no bans in Myanmar and Vietnam while Indonesia, Malaysia and the Philippines regulate vapes and e-cigarettes. The SEATCA has urged the countries to strictly regulate the products.

  • Brian King Speaks About CTP Priorities and Progress

    Brian King Speaks About CTP Priorities and Progress

    Brian King (Photo: FDA)

    Throughout his first year as director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), the agency has maintained a steadfast commitment to its core principles of sound science, strategic partnerships, health equity and transparency, CTP Director Brian King said in a recent interview.

    King underscored the enduring importance of these principles. He emphasized that the center’s recent decisions and enforcement efforts have been grounded in comprehensive scientific analysis. This approach, he noted, ensures that product marketing and regulatory actions are well-informed and evidence-based.

    Furthermore, the director highlighted the importance of teamwork, a skill honed through his background as a scientist. Scientific thinking, rooted in objective evidence evaluation, plays a pivotal role in CTP’s work. This scientific approach is instrumental in addressing the complexities of tobacco product regulation effectively, according to King, who also emphasized the importance of effective communication in conveying scientific findings and messages.

    A significant focus of CTP’s work is promoting health equity in tobacco product regulation. King discussed efforts to address disparities in tobacco use, especially among youth and young adults. Notably, the CTP is working on product standards that would prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. King views these standards as a major step toward reducing the appeal of these products, particularly among communities disproportionately affected, such as people of color, low-income populations and LGBTQ+ individuals.

    To further advance health equity, the CTP has undertaken initiatives like the “Next Legends” campaign to educate American Indian and Alaska Native youth about the harms of e-cigarettes and providing Spanish-language adult cessation education resources.

    During his tenure, the center welcomed Charlene Le Fauve as its first senior advisor for health equity, a crucial role in integrating health equity into the center’s programmatic plans and priorities, according to King.

    Looking ahead to the next three to five years, the director stressed the importance of having a clear vision. The CTP is in the process of creating a new strategic plan with the involvement of internal staff and external stakeholders to ensure the center’s continued growth and adaptation in a dynamic regulatory landscape. The plan, to be released by December 2023, will provide a roadmap for CTP’s future, aligning its actions with changing times and the goal of reducing tobacco-related diseases and deaths in the United States.

  • Czechia Bans Flavors for Heated Tobacco Products

    Czechia Bans Flavors for Heated Tobacco Products

    Photo: diy13

    The sale of flavored heated-tobacco products (HTPs) will be banned in the Czech Republic, effective today, reports Expats.cz. A European directive requires that EU member states incorporate the ban into their legal frameworks effective Oct. 23. The directive does not allow for a transitional period for sale of existing stock.

    Slightly more than half of HTP users prefer flavored tobacco, according to Jiri Sochor, spokesperson for JT International. Sochor noted that based on U.S. ban results, some people reverted to traditional combustible cigarettes.

    The ban will not take effect simultaneously in neighboring countries, Sochor said, noting that only Germany has introduced it. Due to this, people are likely to purchase flavored products abroad.

    Flavored heated-tobacco products generate about CZK2.9 billion ($125.16 million) in consumer taxes annually, according to Sochor.

    Companies are responding to HTP flavors ban by introducing new, tobacco-free products. British American Tobacco, for example, has begun selling heat sticks with nicotine-infused rooibos tea. Certain tobacco firms have also opposed the ban, and the legislation will be addressed by the EU Court of Justice due to complaints from Irish companies.  

  • FDA Defeats Logic in Menthol Marketing Order Suit

    FDA Defeats Logic in Menthol Marketing Order Suit

    The U.S. Food and Drug Administration has defeated Logic Technology Development after the e-cigarette manufacturer asked the courts to block the regulatory agency’s market ban on Logic’s menthol-flavored e-cigarette products, according to media reports.

    Logic filed a petition for review in the U.S. Court of Appeals for the Third Circuit, alleging the FDA violated the Administrative Procedure Act when it denied Logic’s premarket tobacco product application to market its menthol-flavored vaping products. The court denied that petition Thursday after concluding the FDA “based decisions on scientific judgments.”

    Logic alleged it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to remove fruit- and dessert-flavored e-cigarettes from commerce. The Third Circuit Court entered a stay on the FDA’s marketing denial orders (MDOs) in December 2022. The MDOs were the FDA’s first-ever MDOs directed at menthol e-cigarette products.

  • Altria’s NJOY Sues 34 Disposable Vape Companies

    Altria’s NJOY Sues 34 Disposable Vape Companies

    Credit: Kristina Blokhin

    Altria Group today said that its e-cigarette subsidiary NJOY, LLC has filed lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. If successful, the lawsuit could potentially decimate the flavored disposable vaping market.

    Altria joins its largest U.S. competitor, BAT-owned RJ Reynolds, in using the courts to remove unauthorized vaping products (and their competition) from the U.S. market.

    On Oct.13, Reynolds filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors, and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves. Several legal scholars have told Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without an FDA marketing authorization could be stopped at the border and prevented from entering the U.S. market.

    The NJOY suit alleges that the disposable products are unlawfully marketed and sold in the State of California and other U.S. states in violation of California’s flavor ban law and federal marketing rules.

    The products are illegal under federal law and subject to action by the U.S. Food and Drug Administration and illegally compete against companies that comply with state and federal laws, according to an Altria press release.

    The suit seeks a nationwide injunction against the import, marketing and sale of these illicit products and significant compensatory and punitive damages. If successful the lawsuit could lead to the removal of all disposable flavored vaping products without an FDA marketing order from the market.

    “These companies knowingly violate federal and state laws and need to be held accountable,” said Murray Garnick, Altria’s Executive Vice President and General Counsel. “Today there are two markets – one for those who play by the rules and one for those who flagrantly ignore them. We are taking this action because the current state of the illicit e-vapor market is intolerable, and we must see more action from FDA and others.”

    The litigation, filed in the United States District Court for the Central District of California, is brought under four claims: unfair competition, false advertising, false advertising in violation of the Lanham Act and violation of the Prevent All Cigarette Trafficking Act of 2009.

    Named Defendants in the suit manufacture and distribute illicit disposable e-vapor products which include, but are not limited to, brands including Breeze, Elf Bar, EB, EB Create, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar (many of these companies were also named in the Reynolds suit). Domestic Defendants include companies doing business in Arizona, California, Delaware, Florida, Michigan, Minnesota, New Jersey, New York and Texas. Foreign Defendants are all based in China.

    None of the Defendants has received premarket tobacco product authorization (PMTA) approval from the FDA. In many instances, Defendants also have not filed PMTA applications. Several of these Defendants have already received warning letters from the FDA stating that their products are adulterated and misbranded and cannot be sold without marketing authorization.

    Additionally, some of these Defendants are subject to an FDA-ordered import alert authorizing U.S. Customs and Border agents to seize their products. NJOY may add additional manufacturers, distributors and retailers to this complaint and will consider further litigation activity, the release states.

    Despite a ban on the sale of flavored tobacco products that went into effect in December 2022, flavored vapor products make up more than 97 percent of the California market according to a recent study commissioned by Altria. Conducted by an independent research firm WSPM Group, “the study collected 15,000 empty discarded cigarette packs and 4,529 e-vapor product packages” from May 1st through June 28th in 10 California cities.

  • Reynolds ITC Complaint Could Destroy Vape Industry

    Reynolds ITC Complaint Could Destroy Vape Industry

    The implications could be far-reaching. R.J. Reynolds has filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors, and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves.

    Reynolds is asking the ITC to investigate and issue an exclusion order preventing further U.S. imports of disposable vaping products. Several legal scholars have told Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without a U.S. Food and Drug Administration marketing authorization could be stopped at the border and prevented from entering the U.S. market.

    Reynolds wants the ITC to issue a permanent “cease and desist order” prohibiting any businesses from selling illegal vaping products. The move would push nearly the entire vaping industry underground, with the exception of products owned by major tobacco companies such as Reynolds that have received marketing orders from the FDA.

    Several businesses were named specifically as “peddlers of illegal disposable vapes” in the Reynolds complaint, including the manufacturers, importers, distributors and retailers of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposable vapes.

    Also named are several well-known U.S. wholesale and retailers of disposable vapes, including Element Vape, Flawless Vape, Magellan Technology, Mi-One Brands, Price Point Distributors, and Vape Sourcing.

    The ITC complaint accuses what amounts to the manufacturers of all unauthorized vaping products of importing “illegal disposable vapes” in violation of Section 337 of the Tariff Act of 1930. Specifically, Reynolds claims the named businesses either falsely advertised that their products are authorized for sale by the U.S. government, failed to comply with federal laws imposing registration and reporting requirements and limitations on sales, or violated customs laws and regulations.

    Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order (MDO), ordering Alto menthol refill pods off the market. The Alto device and tobacco-flavored pods are still under review by the agency. Two older Vuse vapes, the Solo and Vibe models (and their tobacco-flavored refills) are among the 23 products currently authorized by the FDA.

    Reynolds also states it has the capacity to fill any void in the market if the illegal products were removed. “Reynolds has the capacity to replace any increase in demand if the Accused Products were excluded from importation,” the complaint states. “Reynolds is willing to meet any increased demand and can do so in a commercially reasonable time, given that it already supplies the industry with significant quantities of ENDS products, as well as oral tobacco and nicotine products.”

    The ITC has not yet made a decision on the complaint that was filed on Oct. 13.

  • Elf Bar Changes its Name to Sidestep Import Ban

    Elf Bar Changes its Name to Sidestep Import Ban

    Elf Bar continues to defy a U.S. import ban thanks to a simple but effective tactic: changing its name.

    Imiracle, the China-based manufacturer of Elf Bar, Lost Mary and EB Design vaping products, had its products added to the U.S. Food and Drug Administration import red list four months ago.

    The company is now importing its disposable vaping devices under a different name, EBCreate, EBDesign and brands such as Airo Max. The rebranded products also list different Chinese manufacturers than those targeted by the FDA, such as iMiracle.

    Convenience stores in Washington D.C., Philadelphia, New York and other cities remain fully stocked with the brightly colored vapes, sold in fruity flavors like strawberry melon and claiming to contain 5,000 “puffs” per device, according to the AP.

    The makeover underscores the FDA’s inability to stanch the flow of unauthorized e-cigarettes into the U.S., mainly through large shipping hubs like Los Angeles and Houston.

    “E-cigarette manufacturers have proven themselves to not operate in good faith,” said Desmond Jenson, an attorney at the Public Health Law Center. “Until there’s something global that’s a deterrent to selling illegal products this is going to be the status quo.”

    Elf Bar generated U.S. sales of over $271 million in the past year, according to retail data tracker Nielsen. Separate data previously obtained by the AP shows the brand hit U.S. stores in November 2021, racking up hundreds of millions in sales over 18 months before being targeted by FDA regulators.

    Two weeks after the FDA notified Elf Bar of the import ban, a request to trademark EBCreate was filed with the U.S. Patent and Trademark Office. The filing was made by the same patent attorney who submitted Elf Bar’s previous applications. But unlike those filings, the paperwork doesn’t mention Elf Bar’s parent company, iMiracle Shenzhen Technology. Instead the application lists a Hong Kong company, Nevera HK Limited, the same company listed on new EBCreate e-cigarette packages.