Author: Timothy Donahue

  • 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.

  • HEXA Disposable Vapes Growing in European Market

    HEXA Disposable Vapes Growing in European Market

    The No. 1 vaping brand in Belgium is HEXA, according to media reports. The company recently presented a number of its products at the InterTabac 2023 trade show in September. The company highlighted both its pod and disposable vaping systems.

    “Since securing the No.1 position in the Belgian market in both major categories of pod-system and disposable products, HEXA has been rapidly rolling out its products to the wider European market,” a press release states. “With the trend of disposable products gaining popularity in the European market, HEXA has created HEXA Go, which is now available in Belgium, Germany, the Netherlands and Estonia.

    FEELM, a leader in closed vape system solutions, is the technology supplier of HEXA’s pod and disposable products. Its new disposable products quickly passed the EU TPD directive along with its launch. It is one of the reasons why the product has been able to seize the opportunity to promote rapidly in the European market, according to the release.

    “In the U.S. market, FEELM’s parent company, SMOORE, has become the manufacturer that has helped the highest number of clients to [survive] the [U.S. Food and Drug Administration’s premarket tobacco product application (PMTA)] process, while in the European market, several FEELM customers, such as HEXA Go, have also quickly passed the TPD to complete their speedy rollout.”

    As of now, HEXA Go has reached more than 50 percent share in the disposable segment in Belgium. The product is equipped with the FEELM Max 800+ disposable solution, which can increase the number of TPD-compliant disposable product puffs from the common 600 puffs to more than 800 puffs, for the first time in the industry, according to the release.

    Since the FEELM Max solution adopts ceramic coil, it avoids the wastage of vaporized e-liquid, a common problem in traditional cotton coils. Previously, HEXA pod-system products used FEELM ceramic core solution, and with this differentiated technology HEXA quickly became the No.1 brand of pod-system vapes in Belgium.

    HEXA’s pod vapes have captured a share of more than 70 percent of the category’s market. The success of HEXA’s pod-system products is a testament that FEELM is a differentiated technology with significant market competitiveness, according to the release.

  • 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.

  • Latvia to Raise Tobacco Taxes Gradually for 3 Years

    Latvia to Raise Tobacco Taxes Gradually for 3 Years

    Credit: Eyeg Elb

    The Latvian government has amended its Excise Tax Law to include a gradual increase in excise taxes on e-liquids and other next-generation tobacco products.

    E-liquids other vaping products will see their excise tax rates increase by an average of 21 percent every year in 2024, 2025 and 2026. Other tobacco “substitute products” which include nicotine pouches, will rise by 10 percent.

    The amendments will negatively impact Latvia’s efforts to curb smoking by making options to switch less attractive, according to Alberto Gómez Hernández, Community Manager of the World Vapers’ Alliance.

    “Increasing the taxation of safer nicotine products will discourage smokers from switching and push users back to smoking,” Gómez Hernández said in a press release. “The international evidence has shown that increasing taxation of e-cigarettes and e-liquids has always led to an increase in smoking, particularly among young adults and low-income groups.

    “Latvia should follow the steps of countries that are successfully reducing smoking rates by encouraging smokers to switch, such as the United Kingdom and Sweden, instead of making it more costly for them.”

    The bill will also increase the excise tax rates of heated tobacco products and combustible cigarettes by 5 percent and 5.6 percent every year, respectively.

  • U.S. Supreme Court Declines to Hear Avail Vapor Case

    U.S. Supreme Court Declines to Hear Avail Vapor Case

    Credit: Avail Vapor

    The U.S. Supreme Court declined Tuesday to hear arguments against the Food and Drug Administration’s regulatory authorization process.

    The denial order comes in one of several cases questioning the FDA’s oversight of the vaping industry.

    The US Court of Appeals for the Fourth Circuit sided with the FDA, finding that Avail hadn’t shown that its products had benefits for adults that offset the risk to youth.

    The case is connected to the FDA’s 2021 determination to deny all of Avail Vapor’s requests to approve fruit and dessert-flavored e-cigarettes. The company claimed that the agency made the application process intentionally difficult, which led to mass denials of new product submissions.

    In a Supreme Court brief filed Aug. 3, the company claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco flavored ones as an aid in adult smoking cessation.

    Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.

    In its petition, known as a Writ of Certiorari, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.

    Among other things, Avail argues in its petition that the FDA’s decision making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.

  • Chill Brands to Sell CBD Vapes in WH Smith Stores

    Chill Brands to Sell CBD Vapes in WH Smith Stores

    Credit: William

    Chill Brands said it will sell its nicotine-free CBD vapor products in U.K.-based WH Smith stores.

    The cannabidiol-products company on Monday said a range will be for sale in an initial 150 of WH Smith’s 1,700 stores, according to a press release.

    “These first outlets are WH Smith U.K. travel stores located in airports, train stations and other high-traffic hubs including Heathrow, Gatwick and Kings Cross Station. These areas benefit from an estimated combined daily footfall of more than 500,000 passengers per day,” it said.

    Further to the agreement, it has now secured initial orders worth more than 350,000 Pounds ($428,365) from U.K. retailers, it added.

    Chill Brands said that it continues to work to expand its retail distribution network in the U.K. and the U.S.

  • Texas: Group Wants Dallas to Enact Public Vape Ban

    Texas: Group Wants Dallas to Enact Public Vape Ban

    Credit: Lucitanija

    A citizen advisory group has recommended that the City of Dallas follow other major Texas cities with a ban on vaping in public spaces in the name of public health.

    The city’s Environmental Commission has recommended adopting a policy restricting the use of e-cigarettes, citing a “correlation between vaping aerosol exposure and negative health effects for vulnerable populations,” said Candace Thompson, chair of the commission’s environmental health committee.

    In August, the commission unanimously approved a recommendation to expand the city’s 2016 smoking ban to include the prohibition of vaping of nicotine and non-nicotine products in most public spaces, with a few exceptions, including bars, restaurants and parks controlled by private partners, according to the Dallas News.

    Dallas City Councilwoman Kathy Stewart, who chairs the parks, trails and environment committee, said she saw the recommendation in a memo. But her committee has not discussed nor voted on the proposed ban, which would be required before City Council action.

    Vaping was banned in Austin in 2017 and in Houston in 2022.

  • Oct. 11: Netflix to Debut Documentary on Juul Labs

    Oct. 11: Netflix to Debut Documentary on Juul Labs

    The Netflix documentary Big Vape: The Rise and Fall of Juul will premiere on Oct. 11. Netflix states the docuseries is “a scrappy electronic cigarette startup becomes a multibillion-dollar company until an epidemic causes its success to go up in smoke.”

    Helen Redmond of Filter wrote that she was prepared to hate-watch the docuseries, directed by R.J. Cutler, in her review of the show.

    “The name alone pissed me off because of its implied conflation of Juul, which is not a tobacco company, with ‘Big Tobacco.’ The trailer is a feverish montage of talking heads and voiceover accusing the company of being ‘wildly irresponsible,’ photos of hospitalized patients with bloody chest tubes, and a clip of James Monsees, one of Juul’s founders, being called ‘a marketer of poison to young people’ at a congressional hearing,” she wrote.

    She also states that she “was happily shocked” when the series presented a alternate viewpoint.

    The docuseries is based on TIME journalist Jaime Ducharme’s book, Big Vape: The Incendiary Rise of Juul.