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Tag: Puff Bar

  • NY AG Files Lawsuit Against 12 Vape Companies

    NY AG Files Lawsuit Against 12 Vape Companies

    New York Attorney General Letitia James announced a lawsuit against 12 e-cigarette manufacturers, distributors, and retailers for “their role in fueling the youth vaping epidemic.” Those named in the lawsuit are Puff Bar, MYLE Vape, Pod Juice, Mi-One Brands, Happy Distro, Demand Vape, EVO Brands, PVG2, Magellan Technology, Midwest Goods, Safa Goods, and Price Point Distributors, as well as Price Point principals Weis Khwaja, Hamza Jalili, and Mohammad Jalili.

    “These companies are responsible for illegally distributing, marketing, and selling flavored disposable vapes, which have become extraordinarily popular among minors,” James said in a statement. “The vaping industry is taking a page out of Big Tobacco’s playbook: they’re making nicotine seem cool, getting kids hooked, and creating a massive public health crisis in the process.”

    In 2020, New York banned the sale of flavored vapor products, however, the products exploded in popularity globally in the past decade and are readily available at numerous outlets. The lawsuit seeks a “disgorgement of all revenues earned as a result of illegal activity” which would translate to hundreds of millions of dollars, as well as a permanent ban on flavored vapes in New York.

    “This punitive approach undermines American entrepreneurship and ignores the public health benefits of vaping as a smoking cessation tool,” Allison Boughner, the vice president of American Vapor Manufacturers, a trade group that represents vape makers and retailers, said in a statement. “This misguided action unfairly targets legitimate American businesses that employ thousands and contribute to local economies. Our members are dedicated to offering adult smokers safer alternatives to combustible cigarettes, supporting a mission of harm reduction backed by science and millions of successful former smokers.”

    Matthew Glauser, the chief strategy officer and a co-founder of Demand Vape, one of the companies named in the lawsuit, said in a statement that the suit was “wasting New York taxpayers’ money and federal court time, which desperately need to be focused on substantive issues that truly impact our communities.”

    According to the New York Times, Tony Abboud, the executive director of another industry group, Vapor Technology Association, disputed the suit’s claim that there was a youth vaping epidemic and called on President Trump “to take bold and decisive action to end the government lawfare against the flavored vaping industry.”

  • 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.

  • Flavors Detected in ‘Tobacco’ Liquids

    Flavors Detected in ‘Tobacco’ Liquids

    Photo: laboko

    E-liquids marketed as tobacco-flavored contain higher levels of sweet and fruit-flavored chemicals today than they did a decade ago, according to a new study published on Nov. 3 in a special supplement to Tobacco Control.

    This recent development coincides with the U.S. Food and Drug Administration’s ban on the sale of flavors other than menthol and tobacco in cartridge-based e-cigarettes.

    To find out if e-cigarettes marketed as “tobacco-flavored” contained sweet and fruit flavor chemicals, researchers drew on an extensive database of e-liquid and aerosol flavor chemicals to identify any trends and changes in chemical composition and levels since 2010–2011.

    They compared the number and amount of flavor chemicals in 63 “tobacco-flavored” e-cigarette refill fluids purchased between 2011 and 2019 and two popular pod-style e-cigarette brands—Juul and Puff.

    They found that tobacco-flavored products purchased in 2010 and 2011 had very few flavor chemicals; overall, the levels of which were generally very low.

    Nearly two-thirds (63 percent) of the refill fluids bought before 2019 had levels of flavor chemicals below 2 mg/mL, and most (84 percent) were below 5 mg/mL.

    But the total number and level of flavor chemicals in “tobacco-flavored” refill fluids purchased in 2019 and in Puff Bar tobacco e-cigarettes were higher than expected.

    Among the 13 refill products bought in 2019, more than half (54 percent) had total flavor chemical levels above 10 mg/mL. Products with total flavor chemicals of more than 10 mg/mL contained one to five dominant flavor chemicals (each more than 1 mg/mL). 

    The five most frequently used flavor chemicals in “tobacco-flavored” e-liquids were fruity and caramellic: ethyl maltol (sweet or caramel, 60 percent); corylone (caramellic, maple, 44 percent); menthol (33 percent); vanillin (25 percent); maltol and triacetin (fruity, creamy, 24 percent).

    Nine sweet and fruit flavor chemicals, used mainly in products bought in 2016 and 2019, were at levels above 2 mg/mL. 

    The flavor chemical levels for Juul Classic and Juul Virginia were below 0.35 mg/mL while levels of the individual chemicals were, in most cases, equal to, or less than, 0.05 mg/mL.

    Different flavor chemicals were used in the classic and Virginia products, suggesting these were added intentionally to create distinct tastes for each product, according to the researchers.

    Puff “Tobacco,” on the other hand, had 27 different flavor chemicals adding up to a total of 34.3 mg/mL. Individual chemicals ranged from 0.03 mg/mL to 15 mg/mL.

    Four flavor chemicals (vanillin, ethyl maltol, ethyl vanillin and corylone), which were the highest (range 2.07 mg/mL to 15 mg/mL), are typically used in sweet-flavored e-cigarette products, such as Dewberry Cream, which is popular with young vapers, noted the researchers.

    For the dominant flavor chemicals found in both brands, levels of vanillin were 300 times higher in Puff than in Juul while ethyl maltol was 239 times higher and corylone was 41 times higher.

    The total number of flavor chemicals used in Puff Bar tobacco was greater than those found in nearly all (94 percent) the refill fluids evaluated.

    “Concern has been raised previously about the safety of flavor chemicals when inhaled at these high concentrations,” the researchers noted.

    “Although these particular flavors are generally regarded as safe by the Flavor Extract Manufacturers Association (FEMA) for ingestion, FEMA has not evaluated them for inhalation toxicity.”

    In a press note, the researchers said there were two reasons for the FDA to identify and quantify flavor chemicals before authorizing premarket tobacco product applications (PMTAs). “First, flavor chemicals are often used in e-liquids without safety data at concentrations much higher than those found in other consumer products,” they wrote. “Second, our data show that e-cigarette manufacturers are manipulating e-liquid formulations apparently to circumvent flavor chemical regulations.”

  • FDA Issues Warning to Puff Bar, MDOs to Hyde

    FDA Issues Warning to Puff Bar, MDOs to Hyde

    Credit: Puff Bar

    New data from the 2022 National Youth Tobacco Survey (NYTS) shows that 2.5 million U.S. youth use e-cigarettes, according to the published findings in the Morbidity & Mortality Weekly Report released by the U.S. Food and Drug Administration in conjunction with the Centers for Disease Control and Prevention.

    “The FDA remains deeply concerned about e-cigarette use among our nation’s youth. It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use,” said FDA Commissioner Robert M. Califf. “We cannot and will not let our guard down on this issue. The FDA remains steadfast in its commitment to using the full range of our authorities to address youth e-cigarette use head-on.”

    The study shows that about one in 10 middle school (3.3 percent) and high school (14.1 percent) students reported current e-cigarette use; current use is defined as use within the past 30 days. About 85 percent of surveyed students reported using flavored e-cigarettes while 27.6 percent reported daily use. Respondents most commonly used disposables, with Puff Bar being most common (14.5 percent) followed by Vuse (12.5 percent) and Hyde (5.5 percent). Puff Bar and Vuse were pre-specified options on the survey, but Hyde was written in by students as their preferred brand.

    Since methodology changes occurred, including in survey administration and data collection procedures due to the Covid-19 pandemic, comparisons between the 2022 NYTS and previous years is limited.

    Following the release of this data, the FDA has issued a warning letter to Puff Bar for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA has requested a response within 15 working days of receiving the letter, detailing how the company intends to address the FDA’s concerns, including the dates on which they discontinued the sale and/or distribution of these tobacco products and plans for maintaining compliance with the Federal Food, Drug and Cosmetic Act. Failure to address the violations puts the manufacturer at risk of regulatory action, such as a civil money penalty, product seizure and/or injunction.

    The Puff products subject to this warning letter are nontobacco nicotine products.

    After reviewing premarket tobacco product applications for 32 Hyde e-cigarettes, the FDA issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology Inc. In conducting its scientific review, the FDA determined that the applications lacked sufficient evidence demonstrating that the products would provide a benefit to adult users that would be adequate to outweigh the risks to youth. No Hyde products have received marketing authorization orders from the FDA.

    “Congress gave the FDA authority to hold manufacturers and retailers who violate the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products. “FDA is actively working to identify violations and to swiftly seek corrective actions, particularly for products popular among youth. We will use all compliance and enforcement tools available to us, as appropriate, to protect our nation’s youth.”