Author: Timothy Donahue

  • FDA Wants Tracking Numbers of Imported Vapes

    FDA Wants Tracking Numbers of Imported Vapes

    Credit: Eduardo Barraza

    The U.S. Food and Drug Administration and the Department of the Treasury have announced a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of electronic nicotine delivery system (ENDS) products into the electronic imports system operated by U.S. Customs and Border Protection.

    The new requirement will help streamline the process of reviewing the admissibility of ENDS products into the United States, according to the FDA’s website.

    After an applicant submits a marketing application for a new tobacco product, FDA assigns a unique identifier called an STN. Under the proposed rule, if finalized, any ENDS product, including e-cigarettes, for which the STN is not submitted may be denied entry into the U.S.

    An FDA-issued STN is one data element that is important to FDA’s admissibility review and determination, which also includes review of other information about the product as well as possible sampling and examination of the product, according to the agency.

    “Beginning tomorrow, the docket for the proposed rule, titled ‘Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products,’ will be open for public comment through October 15, 2024.

    Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.”Beginning tomorrow, the docket for the proposed rule … will be open for public comment through October 15, 2024.

    Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.

  • Federal Court Reverses ‘Elf’ Trademark Suit

    Federal Court Reverses ‘Elf’ Trademark Suit

    VV Archives

    A ban on a Chinese company selling “Elf Bar” vapes can’t stand because a district court failed to analyze whether the rightsholder’s use of “Elf” on an illegal product negated its trademark rights, the Federal Circuit court stated Wednesday.

    “Elf Bar” seller Shenzhen Weiboli Technology Co. Ltd. argued the “unlawful use doctrine” precluded a preliminary injunction as plaintiff VPR Brands LP failed to clear its “new tobacco product” with the government as required under federal law, according to media reports.

    The U.S. Court of Appeals stated in its opinion that the district court wrongly dismissed the defense without considering the propriety of the doctrine, a proper standard, or Weiboli’s evidence.

    The Federal Circuit ruled that the district judge who ordered the injunction “misread” precedent and relied on a “deficient” legal analysis.

    A U.S. federal judge on Feb. 23 ordered Shenzhen Weiboli Technology to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark, reports Law360.

    According to U.S. District Judge Aileen M. Cannon, VPR has shown there is a likelihood of confusion and the company stands to suffer harm if its Chinese competitor is allowed to keep selling the Elfbar vapes.

    In November, VPR asked for an injunction blocking Shenzhen Weiboli from continuing to use the Elfbar mark, arguing the alleged infringement is costing VPR about $100 million because of the effect on future sales.

    VPR claims Shenzhen Weiboli is not only infringing VPR’s Elf trademark but also its patent for its e-cigarette device.

  • Airbox Fined for Illegal ‘Distance Selling’ in Slovakia

    Airbox Fined for Illegal ‘Distance Selling’ in Slovakia

    Credit: Pavlofox

    Airbox of Slovakia has been fined HUF189 million ($527,283) for illegally selling electronic nicotine delivery devices online in Hungary, reports the Daily News Hungary. The Hungarian Competition Authority (GVH) has blocked the company’s website.

    The GVH started proceedings against Airbox in February after it found that the company was likely misleading customers on its Hungarian-language website about the legality of its products in Hungary.

    Hungary law prohibits the online marketing and distance selling of flavored tobacco products and electronic smoking devices. The GVH found that Airbox had engaged in unfair commercial practices.

    Earlier, the GVH acted against two Slovak companies for illegally selling Elf Bar and other vaping products in Hungary.

  • Bloom, Cresco Labs to Launch Products in Florida

    Bloom, Cresco Labs to Launch Products in Florida

    Credit: Aleksandr Kondratov

    Today, the Bloom brand announced a partnership with Cresco Labs to expand distribution across the state of Florida. Launching in November 2024, Bloom’s Surf all-in-one vape will be exclusively produced by Cresco Labs in Florida and available at all 33 Sunnyside dispensaries throughout the Sunshine State.

    Florida is the seventh state in which Bloom products will be available to consumers. Bloom is currently available in California, Illinois, Michigan, New Mexico, and New York, with New Jersey and Virginia also slated for launch in Q3 and Q4, respectively.

    “Cresco’s Sunnyside is hands-down the right retailer to bring Bloom to Florida. Bloom’s products were originally developed for medical markets, designed for patients who rely on cannabis as medicine with a focus on a consistent and accessible product experience,” said Casey Ly, co-founder and co-CEO of Bloom. “Sunnyside’s focus on product education, a welcoming shopping experience and convenient locations makes them the ideal partner. We look forward to introducing our top-selling classic strains at all 33 locations this fall.”

    According to BDSA analytics, Bloom is one of the top five fastest-growing cannabis brands in the U.S. Founded in 2014 and celebrating ten years of business this year, Bloom is still focused on its core mission: to provide consumers with a vaping experience that replicates flower consumption, according to a press release.

    “Our patients want high-quality cannabis products that are effective and easy to use, and Bloom’s innovative hardware design provides a precise, flavorful vaping experience that patients will love,” said Connie Woolsey, vice president of retail of Cresco Labs. “Sunnyside offers a wide variety of innovative and quality cannabis products in the Florida market and we are looking forward to expanding our line with Bloom products.”

    Bloom will launch its Classic line products in its proprietary Surf device in .5g and 1g formats. Bloom’s Live line will launch later, in Q4 2024.

  • New Data Highlights Cessation Potential of Vaping

    New Data Highlights Cessation Potential of Vaping

    Photo: Teo

    New data from Action on Smoking and Health UK (ASH UK) found more than half of ex-smokers in Great Britain who quit in the past five years—amounting to 2.7 million adults—used a vape in their last quit attempt.

    Further, it revealed the main motivations for vaping amongst current smokers included “cutting down on smoking,” “protect others from the risk of second-hand smoke” or “to help them quit.”

    ASH UK also reported that misperceptions around vaping are at an all-time high, with 50 percent of smokers wrongly believing vaping to be as or more harmful when compared with smoking.

    The new data also found that, while current and ever use of vaping amongst young people has decreased between 2023 and 2024, under 18s are still accessing these age-gated products.

    “The latest figures from ASH UK once again highlight the stop smoking credentials of vaping for adults and reinforce the instrumental role these products have and must continue to play in stubbing out the health burden of smoking for good,” said UKVIA Director General John Dunne in a statement.

    “That said, if vaping is to reach its full potential in supporting the smokefree ambition, action must be taken to address growing misperceptions about the less harmful alternative which are no doubt being exacerbated by mainstream media scare stories and some mixed messaging in the public health sphere. This could be achieved through the introduction of national public education campaigns which arm adults with the best, science-backed information to help them quit.

  • RICO-Based Hemp Case Headed for Supreme Court

    RICO-Based Hemp Case Headed for Supreme Court

    Credit: Adobe Stock

    For the first time since the 2018 Farm Bill became law, the Supreme Court of the United States will decide a case about hemp. The lawsuit, Medical Marijuana, Inc., et al. v. Douglas J. Horn, involves the Racketeer Influenced and Corrupt Organizations Act (RICO) and asks whether product manufacturers can be held responsible for a person’s lost earnings and other job benefits under that powerful statute.

    The plaintiff is a commercial truck driver who was fired for failing a random drug test after taking a CBD product that was marketed as THC-free. The plaintiff then filed a RICO claim and state law claims against the companies that marketed the CBD product. He asserted that his lost job earnings and benefits are “business or property” damages that are recoverable under RICO.

    The federal district court dismissed the plaintiff’s RICO claim, finding for the companies that RICO does not provide for personal injury losses. However, the Second Circuit Court of Appeals reversed the district court and reinstated the RICO claim. The Supreme Court agreed to take up the case. If the Supreme Court affirms the Second Circuit’s ruling, the plaintiff could recover up to three times his lost earnings, plus attorney’s fees.

    The U.S. Hemp Roundtable has filed a “friend of the court” brief supporting the defendants’ position that Congress did not intend RICO to apply to personal injury losses. As the brief argues, expanding RICO has major implications for the hemp products industry.

    Industry experts have stated that increased costs will be passed on to consumers, potentially making products unavailable to people who need them. Additionally, more liability may cause manufacturers, distributors, or retailers to exit the industry entirely, which will reduce economic opportunities for hemp farmers and businesses.

    The case is expected to be heard during the court’s next session, which begins in October.

  • Iowa City Seeking to Limit Tobacco, Vape Shops

    Iowa City Seeking to Limit Tobacco, Vape Shops

    Credit: Argus

    Iowa City Council is working to change some of the rules regarding the amount of tobacco and vape stores in town.

    In a work session on Tuesday, councilmembers discussed a 55 permit limit in the city (down from 62), a 500 ft. barrier from tobacco shops being near school or university property, and the ban of the sale of kratom, an herbal substance the gives stimulus effects, according to media reports.

    This is in addition to the moratorium on new tobacco permits that’s in place until December.

    Up in Smoke is among the tobacco and vape shops that sell kratom. While the owner is happy there won’t be as much competition in town, he said it is concerning that the city is looking to ban kratom, as the shop is already dealing with the aftermath of the new state law limiting THC in products.

  • Costa Rica Bans Vaping in Public Places

    Costa Rica Bans Vaping in Public Places

    Credit: Adobe Stock

    Costa Rica has banned vaping in public places such restaurants, offices and educational institutions, reports The Tico Times.

    The move follows a dramatic increase in vaping-related disorders. In 2023 alone, the Costa Rican Social Security Fund recorded 14 cases of vaping-related intoxication, including nine minors, with seven requiring hospitalization.

    Vaping has become increasingly popular among young people in recent years. Gabriela Rojas of the Institute on Alcoholism and Drug Dependence (IAFA) warned that electronic cigarettes contain harmful chemicals.

    “The tobacco industry has cleverly marketed these products, using technology, attractive colors, and various flavors to target underage individuals,” said Zeanne Gonzalez, another IAFA official.

  • Finnish Youth Drop Smoking, E-Cigarette Use Rising

    Finnish Youth Drop Smoking, E-Cigarette Use Rising

    Image: sezerozger

    Finnish teens are drinking and smoking less but using more e-cigarettes and nicotine pouches, reports the Helsinki Times, citing findings from a European survey

    The European School Survey Project on Alcohol and Other Drugs (ESPAD) has been monitoring substance use among European students since 1995.

    Conducted every four years, the survey includes 16-year-olds across 23 to 39 European countries.

    The proportion of ninth graders who have never consumed alcohol has increased dramatically from 10 percent in 1995 to 35 percent in 2024.

    Only 6 percent of boys and 4 percent of girls smoked daily in 2024, down from around 20 percent at the beginning of the decade. However, vaping has been rising, with 40 percent of teens having tried e-cigarettes, up from 34 percent in 2019. Daily use is reported by 9 percent of boys and 13 percent of girls.

    The use of snus, a form of smokeless tobacco, has also dropped. In 2024, 26 percent of boys and 13 percent of girls had tried snus, with daily use at 7 percent for boys and 3 percent for girls.

    Teen use of nicotine pouches increased after Finland permitted the sale of modern oral products in 2023. By 2024, 31 percent of boys and 17 percent of girls had tried nicotine pouches, with 11 percent of boys and 3 percent of girls using them daily.

    Cannabis experimentation decreased slightly during the period studied, particularly among boys, with 11 percent of boys and 9 percent of girls having tried it in 2024.

    The full ESPAD report will be published in 2025.

  • States 2.0 Act may Clarify State, Federal Pot Rules

    States 2.0 Act may Clarify State, Federal Pot Rules

    VV Archive Photo

    In light of the widespread nullification of federal marijuana prohibition, the rising public support for legalization, and the potential excise revenues, policymakers are compelled to seriously consider significant reforms to federal marijuana policy. Last December, members of Congress introduced the STATES 2.0 Act, which would remove marijuana from the Controlled Substances Act, federally legalize its sale and use, and allow for interstate commerce.

    A defederalized marijuana prohibition policy would allow states to decide for themselves whether cannabis would be legal within their borders—which they have already been doing for decades—and how that legal cannabis market would be taxed, writes the Tax Foundation.

    What legal markets already exist are burdened by federal prohibition and punitive taxation, which keeps prices substantially higher than illicit markets. Bolstering black markets is a common unintended consequence of prohibition, and marijuana has been no different—even with existing state legalization. Revisions to federal cannabis policies, such as those in the STATES 2.0 Act, would give much-needed reform to a market struggling with a messy policy landscape.

    Regulating Cannabis Markets

    Instead of enforcing marijuana prohibition through the Drug Enforcement Administration, the STATES 2.0 ACT would rely on the Food and Drug Administration to regulate marijuana products permissible in US markets and the Alcohol and Tobacco Tax and Trade Bureau (TTB) to track products and collect taxes. Federal and state law enforcement would be able to shift focus and budgets away from petty offenses for marijuana possession toward removing more dangerous substances from illicit markets and preventing violent and property crimes.

    The recent failings of the FDA to properly facilitate a legal vaping market may call into question its ability to do the same for cannabis, and there are more efficient ways to ensure product safety. However, the STATES 2.0 Act specifies that no premarket approval would be required, which would preclude the type of disaster inflicted on the vaping market.

    Allowing legitimate businesses to manufacture and sell cannabis products, as well as allowing banks to do business with a legal cannabis industry, would do much to enable a safe, legal market to undercut the existing black markets dominated by cartels.

    The STATES 2.0 Act would allow interstate commerce in cannabis and cannabis products when traveling between states that have provided for legalized cannabis within their borders, even if passing through states that have chosen to keep marijuana illegal.

    TTB would be responsible for administering a national track-and-trace system. Similar track-and-trace systems are already in place within states that have legalized recreational marijuana, allowing states to track marijuana plants from seed to consumer sale.

    A federal system administered by TTB could incorporate existing state systems into a national database. TTB would also enforce consistent and timely tax collections.