Author: Timothy Donahue

  • FDA Denies Marketing of Flavored Blu Products

    FDA Denies Marketing of Flavored Blu Products

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem U.S. for four Blu disposable products and one MyBlu e-cigarette product.

    The denied products include a closed menthol e-liquid and several flavored disposable e-cigarettes. As a result, the company may not legally market or distribute these products in the United States. However, the company may submit new applications for the products that are subject to these MDOs.

    The products that received MDOs are Blu Disposable Menthol 2.4 percent; Blu Disposable Vanilla 2.4 percent; Blu Disposable Polar Mint 2.4 percent; Blu Disposable Cherry 2.4 percent; and MyBlu Menthol 1.2 percent.

    After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. 

    More specifically, the FDA said the application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products. Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth, according to the agency.

  • FDA Warns More Sellers of Flavored Vapes

    FDA Warns More Sellers of Flavored Vapes

    The U.S. Food and Drug Administration has again issued warning letters to several small business owners for selling flavored disposable vaping products.

    The regulatory agency issued letters to 14 online businesses for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products marketed under brand names, including Elf Bar/EB Design, Lava Plus, Funky Republic/Funky Lands, Lost Mary, Cali Bars, Cali Plus, and Kangvape.

    “These warning letters were informed by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, an agency press release states. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the disposable e-cigarette brand Elf Bar; in 2023, the manufacturer of Elf Bar began marketing the product under the name EB Design.”

    In addition, the brands Lava Plus, Funky Republic/Funky Lands, Kangvape, Cali, and Breeze were identified as popular or youth-appealing by the agency following a review of retail sales data and emerging internal data from a survey among youth, according to the agency.

    Retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack marketing authorization from the FDA violate the Federal Food, Drug, and Cosmetic Act.

    Warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    As of Jan. 30, 2024, FDA issued more than 440 warning letters and 88 CMPs to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers, according to the release.

    Earlier this week, the FDA issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.

    In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency now seeks the maximum penalty of $20,678 from each retailer.

  • FEELM Launches Charge-Free Disposable

    FEELM Launches Charge-Free Disposable

    FEELM, a vaping industry leader in closed-system products, has launched the world’s first charge-free vaping system. The new Power Alpha 2.0 solves the problem of needing repeated charging in the large puff vapes currently popular on the market.

    FEELM started developing the charge-free battery technology that can empower large-puff vapes as early as 2022. The previous version of the company’s original Power Alpha technology could only support 6,000 puffs without charging.

    The upgrade more than doubles the count to 15,000 puffs, according to an emailed press release.

    FEELM states that the Power Alpha 2.0 also solves the issues of decaying tastes in cotton mesh coils, realizing consistently true flavors in every puff.

    The Power Alpha 2.0 is equipped with FEELM’s TopPower technology. “Relying on this technology, the energy density of Power Alpha 2.0’s battery cells is 40 percent higher than … products of the same size, making Power Alpha 2.0’s battery cells 40 percent smaller than … products with the same amount of power.

    “The extremely low self-discharge rate is another addition to benefits. A 700 percent lower self-discharge rate compared others on the market, which can lead to a longer shelf life and better support customers’ global market rollout.”

    The Power Alpha 2.0 also uses a unique Mesh constant power solution, leading to a taste that is 300 percent more consistent than other products on the market, according to FEELM.

    “With the substantial increase in the vapor volume and atomization efficiency, Power Alpha 2.0 supports the ability to fully vaporize the e-liquids for richer and fuller flavors, ” the release states. “Experiment data shows that the Power Alpha 2.0 solution’s atomization efficiency has increased by 200 percent along with an increased vapor volume of 49 percent compared to similar products from competitors. The numbers show a very evident advantage.”

  • Pax Labs Files Patent Suit Against Stiizy

    Pax Labs Files Patent Suit Against Stiizy

    Credit: Stiizy

    Pax Labs Inc. has filed a lawsuit against the vape brand Stiiizy Inc. and its manufacturer ALD Group Ltd. for allegedly infringing four patents with vape pens they make and sell.

    Stiiizy and Hong Kong-based ALD make vaporizing devices, including a cartridge and battery, that utilize methods similar to Pax Labs’ patents, according to separate complaints filed Monday in the US District Court for the Central District of California, according to media reports.

    Pax Labs said the companies infringed U.S. Patent Nos. 11,369,756, 11,369,757, 11,766,527, and 11,759,580, which deal with methods for leak-resistant vaporizer cartridges and apparatuses.

    The patents are all labeled as a “Leak-resistant vaporizer device.”

  • Luciano Cigars, Peter James Launch JV

    Luciano Cigars, Peter James Launch JV

    Luciano Cigars and Peter James Co. have announced the launch of Peter James Cigar Co., a new joint venture that will include cigars and accessories released in the near future.

    According to Luciano Meirelles, the new entity is a joint venture equally owned by Peter James Co. and Meirelles and his business partner, Tiago Splitter. The new company will hold the Peter James trademark in the U.S. as well as other trademarks for future products, according to Halfwheel.

    The two are working on a new cigar that will be launched in March, though details about its specifics have not been announced. However, the cigars will be produced at the Luciano Tabacos S.A. factory in Estelí, Nicaragua, and Luciano Cigars will distribute them.

    “This partnership is an extraordinary moment—a fusion of expertise and passion,” said Meirelles in a press release. “My love for the Peter James brand goes beyond their craft and luxury products.

    “There is an intentionality in everything they do: even the smallest details reveal beauty where most people won’t see it. That act of generosity carries beauty and passion into our world. We couldn’t be more excited for what’s to come.”

  • Registration Opens for 2024 Habano Festival

    Registration Opens for 2024 Habano Festival

    Registration for the 2024 Habano Festival is now available through an online accreditation system at https://registrations.habanos.com. Those hopeful to attend can review all activities and make a payment online with a credit card.

    Typically, registration for the event happens in November of the previous year. This year, registration was delayed by approximately two months. No reason was given by Habanos for the delay.

    The registration period for the Habano Festival will be open from January 30th to February 12th or until the slots available are exhausted.

    “Once payment has been made, you will receive an email with a QR code which you may present it per activity, either on your phone or printed, along with the physical invitation given to you at Palco Hotel, Convention Center, Havana,” the release states. “Thank you for your interest; we look forward to seeing you at the most important Premium tobacco event in the world: the Habano Festival.”

    The events and costs are:

    • Welcome Evening — €530 ($574) — Event commemorating the 30th anniversary of Habanos S.A. to be held at Club Havana;
    • Visit to Plantations in the Pinar del Río region — €170 ($184)
    • International Seminar — €425 ($460);
    • Mid-week Evening — €745 ($807)— Event celebrating 50th anniversary of Quai D’Orsay brand to be held at the El Laguito Protocol Room;
    • Visit to Habanos Factories — €200 ($216);
    • Gala Evening — €1,325 ($1,436) — Dedicated to the 55th anniversary of the Trinidad brand to be held at Pabexpo.

    The exclusive cigar event is to be held in Havana from Feb. 26 – to March 1, 2024.

    Payments in Cuba can also be placed through Havanatur, according to Habanos. For further information, email Havanatur at eventos@havanatur.cu

    Habanos, S.A., the state-run distributor of global Cuban cigars, said in a release that its annual event is “in an international and exclusive atmosphere,” and it will include a wide-ranging program of activities combining the knowledge of the Habano and the exciting culture, including the ending final evening gala dinner and famed humidor auction.

    “In this XXIV Edition, the best specialists, distributors and aficionados will enjoy all the activities that, along with the best gastronomy and music, have made this famous event: visits to renowned Habanos factories, plantations, seminars with interesting lectures, exclusives pairings, contests and three very special nights where they will get a sneak preview of the latest Habanos, S.A. novelties,” the release states.

    Habanos, S.A. is already “working to make this event memorable for the expectations of aficionados with the passion and magic they have come to expect from each new edition.”

  • Civil Money Penalties for 21 Vape Shops

    Civil Money Penalties for 21 Vape Shops

    The U.S. Food and Drug Administration has issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.

    In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency now seeks the maximum penalty of $20,678 from each retailer.

    The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. “These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”

    Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023.

    The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount, according to the release.

    “Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the release states. “As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.

    “In addition to actions involving retailers, FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.

    “The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.”

  • Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor will appeal the U.S. Food and Drug Administration’s January 2024 decision to deny the company’s premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick electronic nicotine-delivery system.

    Bidi Vapor has asked the U.S. Court of Appeals for the 11th Circuit to review the marketing denial order (MDO), which Bidi Vapor believes violates the Administrative Procedure Act. Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.

    “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Bidi Vapor founder and CEO Niraj Patel in a statement. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”

    With its recent legal challenge, Bidi Vapor hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 nontobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products. During this evaluation period, the 10 nontobacco-flavored products are still under FDA enforcement discretion.

  • Nicotine Pouch Sales Soar While Vapes Slow

    Nicotine Pouch Sales Soar While Vapes Slow

    Sales of cigarettes and e-cigarettes have declined in the last two weeks, while sales of oral nicotine pouches have seen significant growth, according to analysts at TD Cowen.

    They write in a research note that cigarette volumes across multiple channels were down 10 percent in the two weeks ending Jan. 13, a steeper decline than the trailing four weeks and 12 weeks.

    Bonnie Herzog, managing director at Goldman Sachs, remains cautious on the U.S. tobacco/nicotine industry in the near term as the tobacco consumer remains under substantial financial pressure.

    She stated in an emailed outlook that many consumers are being more selective in their purchases and turning to more affordable alternatives, such as 4th tier/deep discount cigarettes, modern oral tobacco and, increasingly, illicit or gray market disposable vapor products.

    “Shifts in category and consumer spending dynamics have been further exacerbated by flavor ban momentum at the state and federal level (with a final rule expected in March) and uncertainty with regard to the future of the e-cig category and category innovation (with FDA PMTA reviews still pending on big market brands such as JUUL and VUSE Alto, as well as menthol variants more broadly),” Herzog wrote.

    E-cigarette sales fell 11.3 percent in the two-week period and 10.7 percent in the four-week period, according to Barron’s.

    Sales of smokeless tobacco, including nicotine pouches, meanwhile grew 12.1 percent in the two-week period and 13 percent in the four-week period.

    The smokeless category continues to show strong dollar sales growth driven by the Zyn brand, the analysts say.

  • Court Dismisses Njoy Lawsuits, Allows Elf Bar

    Court Dismisses Njoy Lawsuits, Allows Elf Bar

    A U.S. District Court in California has dismissed a lawsuit filed by NJOY, the vape subsidiary of Altria Group, against multiple manufacturers, distributors, and retailers of disposable vapes. However, the case against IMiracle, the manufacturer of Elf Bar, has not been dismissed.

    NJOY filed the lawsuit last October. The company alleges that the companies named in the suit are selling products illegal in California and the United States. NJOY asked for a nationwide injunction that would prevent future importation and sale of the products, and compensatory and punitive damages paid to NJOY.

    Among the companies charged were manufacturers and distributors of Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar. Together the brands make up the majority of the U.S. disposable vape market.

    The dismissal order was entered on Jan. 18 by Judge Terry J. Hatter Jr. of the U.S. District Court for the Central District of California. The court found that the defendants did not participate in “the same transaction, occurrence, or series of transactions or occurrences,” and therefore were improperly joined in the lawsuit. Because of that, Judge Hatter dropped all parties from the suit except the first named defendant, IMiracle, according to media reports.

    The judge entered the orders “without prejudice” allowing NJOY to refile against the dismissed defendants individually or in smaller groups with demonstrable relationships. The court also dismissed NJOY’s claim of unfair competition and its motion for a preliminary injunction barring sales and distribution by the defendants.

    The court denied NJOY’s motion to serve IMiracle, the manufacturer of Elf Bar headquartered in Hong Kong, by email, citing an established international process, the Hague Convention, for serving legal notice to foreign defendants.

    NJOY’s lawsuit against IMiracle cannot proceed until the Chinese manufacturer is served notice.