Tag: Puff Bar

  • 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.”

  • Puff Bar Owners on TV “to Build Trust”

    Puff Bar Owners on TV “to Build Trust”

    Puff Bar owners Nick Minas and Patrick Beltran appeared on CBS Mornings for their first television interview.

    Puff Bar rose to prominence in early 2020 after the Food and Drug Administration banned candy and fruit-flavored e-cigarettes because of their youth appeal but continued to permit the sale of flavored single-use devices like Puff Bar because they were not yet very popular.

    Today, Puff Bar is the most popular e-cigarette brand among high schoolers and middle schoolers. Nielsen reports that store sales of Puff Bar in the United States topped $150 million last fiscal year, but much of that is believed to be counterfeit product.

    Puff Bar has operated in the shadows for most of its existence. It listed its mailing address first to a shuttered storefront on skid row in Los Angeles and more recently to a P.O. box. The company appeared to relish its obscurity. Last year, its website read “Who makes Puff Bar? Everyone wants to know.” Minas and Beltran say the brand was originally developed in China, where it continues to be manufactured.

    In 2020, the FDA ordered Puff Bar off the market amid lawsuits and a widening public outcry about youth appeal. The company pulled its products but later reintroduced redesigned versions using synthetic nicotine, which some believe remains outside of the FDA’s remit.

    Four states have banned the product. It also faces a probe in the House of Representatives and lawsuits in at least three states. Recently, North Carolina’s attorney general launched an investigation.

    In early November, U.S. Representative Raja Krishnamoorthi, chair of the subcommittee on economic and consumer policy, wrote a letter to Minas and Beltran requesting information about its sale of synthetic nicotine products.

    Minas and Beltran, both 27, are childhood friends from Southern California who said they are now the sole owners and co-CEOs of Puff Bar. During the CBS interview, Beltran said they wanted to speak out to “build trust” with their consumers.

    “We’re aware that there is a lot of mystery, and there was a lot of shadowiness before. Us being here right now, talking with you guys [CBS News] is our first step in kind of really, like, building the trust with our consumers,” he said.

    The FDA declined to speak to CBS News about Puff Bar. In a statement, the agency said it was aware that companies have publicly announced strategies to switch to synthetic nicotine in an attempt to evade FDA jurisdiction, adding that it is investigating the issue.

  • Lawmaker Scrutinizes Synthetic Nicotine

    Lawmaker Scrutinizes Synthetic Nicotine

    Raja Krishnamoorthi

    U.S. Representative Raja Krishnamoorthi, chair of the subcommittee on economic and consumer policy, has sent letters to two companies that manufacture or sell synthetic nicotine products, requesting information about the companies and their sale of these products.

    One letter was addressed to Next Generation Labs, the self-declared market leader in the production and sale of synthetic nicotine. The company claims its unregulated synthetic nicotine is used in more than 60 products and projects its sales to increase by 1,800 percent this year.

    Synthetic nicotine has been gaining popularity among vapor companies after the FDA denied hundreds of thousands of marketing applications for products made with conventional nicotine.

    “In response, some e-cigarette and e-liquid manufacturers, banned from legally selling their products, reportedly plan to switch to synthetic nicotine in an effort to avoid FDA regulation,” Krishnamoorthi wrote in his letter to Next Generation Labs.

    “Next Generation Labs appears to support this approach, with its co-founder, Ron Tully, offering the following thoughts on the FDA laws and regulations governing nicotine: ‘If the statute has been ill-conceived, and the regulation has been ill-drafted, it is not the responsibility of the industry to conform to some kind of idea that you can’t innovate in those spaces where the legislation doesn’t occur.’”

    Krishnamoorthi also sent a letter to Puff Bar, whose products have replaced Juul as the vape of choice for many young people after Juul Labs discontinued certain flavored products. In 2020, the Food and Drug Administration ordered Puff Bar to pull its products from the market. Earlier this year, the company introduced new versions of its products using synthetic nicotine.

    In a recent profile by The Wall Street Journal, Puff Bar co-CEO Patrick Beltran described the Puff Bar ingredient change as “a forced innovation,” saying that the FDA gave the company no choice. Because the Tobacco Control Act specifically gives the FDA authority to regulate nicotine “made or derived from tobacco,” most people believe the agency’s Center for Tobacco Products cannot regulate products that use synthetic nicotine—at least not without serious legal challenges, according to Vaping360.

    “You have apparently made the vile decision to continue enriching yourselves by poisoning children,” Krishnamoorthi wrote in his letter to Puff Bar. “Puff Bar’s meteoric rise in popularity among kids resulted in $156 million in sales in 2020 alone. Puff Bar should not be allowed to continue harming children due to FDA’s failure to regulate synthetic nicotine, and I intend to put an end to your predatory practices.”

    In his letter to Next Generation Labs, Krishnamoorthi requested information regarding the company’s sales and new business. In his letter to Puff Bar, Krishnamoorthi requested information regarding the company’s ownership and operations as well as support for the company’s assertion that it is using synthetic nicotine and requested the company’s co-CEOs appear for transcribed interviews.

    Greg Conley, the president of the American Vaping Association, said Krishnamoorthi lacked evidence that the targets of his  investigation have broken any laws. “As per the usual, he is playing politics, and we are hopeful the demands specified in his letter will be resisted,” Conley told Filter.

    “With youth vaping numbers and the associated moral panic continuing to decline,” he continued, “it remains to be seen whether Representative Krishnamoorthi’s primary goal—getting media attention focused on Representative Krishnamoorthi—will actually be met with this campaign.”

  • Puff Bar CEOs Profiled

    Puff Bar CEOs Profiled

    Photo: Puff Bar

    The Wall Street Journal recently profiled Patrick Beltran and Nick Minas, co-CEOs of Puff Bar, a top-selling disposable e-cigarette brand in the United States.

    Puff Bar entered the U.S. market in 2019. At the time, it was owned by Cool Clouds Distribution of California. Cool Clouds sold the Puff Bar to the brand’s Chinese manufacturer, DS Technology Licensing, in early 2020.

    In February 2020, to curb youth vaping, the Food and Drug Administration implemented new restrictions excluding sweet and fruit flavors in reusable e-cigarettes such as those offered by Juul Labs. The restrictions did not apply to disposable devices such as Puff Bars.

    In the summer of 2020, however, the FDA ordered Puff Bar products off the market. Critics said the brand was replacing Juul as the vape of choice among young people as Juul discontinued certain flavored products. In February 2021 Puff Bar resumed sales with redesigned product containing synthetic nicotine, which remains outside the FDA’s purview.

    Minas and Beltran became executives of Puff Bar as CEO and CFO respectively in the spring of 2020, when the brand was taken over by two men and DS Technology as per company filings. The entrepreneurs owned and operated an online e-cigarette retailer called Eliquidstop.

    In the Wall Street Journal article, Beltran described the Puff Bar ingredient change as “a forced innovation,” saying that the FDA gave the company no choice.

    Puff Bar sales in retail stores tracked by Nielsen totaled $156 million for the year ended Sept. 25, according to Goldman Sachs, although it is unclear how many of those sales are counterfeit products. In a federal survey released in Sept., 26 percent of high-school vaporizers said they used Puff Bars. Among middle-school e-cigarette users, 30 percent reported that their generic brand was Puff Bars.

  • Relaunched Puff Bar Under Scrutiny

    Relaunched Puff Bar Under Scrutiny

    Photo: Tobacco Reporter archive

    The U.S. Food and Drug Administration (FDA) is investigating Puff Bar’s redesigned fruit-flavored disposable vaporizers, reports The Hill.

    In early 2020, the Trump administration banned fruity flavored e-cigarettes in reusable devices like Juul, the blockbuster brand that helped trigger the teen vaping craze in the U.S. Under that policy, only menthol and tobacco flavors were allowed for those devices. But the flavor ban did not apply to disposable vaping products like Puff Bar, which is offered in more than 20 flavors, including pina colada and pink lemonade.

    Following the ban, Puff Bar quickly emerged as the vape of choice among young people.

    In mid-2020, the FDA told Puff Bar to stop selling its fruity vaporizers as part of a broader crackdown on underage vaping. In a letter to Puff Bar, the FDA’s Center for Tobacco Products said Puff Bar products hadn’t been authorized for sale by the agency and that the company had made unauthorized claims on its website that its vaporizers were less harmful than traditional cigarettes. In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice.

    However, the brand resumed sales on its website last month with a changed product. To get around the ban, Puff Bar is now using tobacco-free nicotine, according to The Wall Street Journal.  

    The FDA said it was aware of Puff Bar’s move but would not say whether the agency’s ban was still applicable, citing the ongoing investigation.

    Puff Bar has fallen to No. 3 in the disposable category this year, after Bidi Stick and Blu, according to Nielsen data.

    It’s unclear who owns Puff Bar. Previous owners include Cool Clouds Distribution in California and DS Technology Licensing in China.

  • Puff Bar Owner Sues Over Fake Products

    Puff Bar Owner Sues Over Fake Products

    Photo: DS Technology Licensing

    DS Technology Licensing, the owner of registered trademarks associated with the Puff Bar vapor device, and Puff Inc., an authorized U.S. distributor, has filed a lawsuit in Los Angeles County Superior Court against over 20 Chinese and American companies accused of distributing counterfeit vaping devices.

    The defendants include international manufacturer and distributor CACUQ, U.S. distributors, e-commerce companies, and brick-and-mortar retail stores. Plaintiffs are represented by the law firm of Gallinger Law.

    The lawsuit addresses both counterfeit Puff Bar vapor devices as well as knockoff products identified as Puff Smart, Puff Mini, Puff Stig and Airis Puff and seeks $50 million in restitutionary damages and $25 million in punitive damages.

    “Defendants in the lawsuit have infringed on the famous Puff and Puff Bar marks by introducing competing devices which use the stylized “Puff” associated with Puff Bar Vapor Devices as well as by openly selling fake or counterfeit Puff Bar vapor devices,” DS Technology Licensing wrote in a statement.

    “Defendants are believed to be only a small number of the violators, as the anti-counterfeit verification system at puffbar.com has identified thousands of retail stores at which consumers bought devices which failed the check.”

    DS Technology Licensing promised award to those with information that leads to the seizure of counterfeit goods.

  • Puff Bar Sued for Online Vape Sales

    Puff Bar Sued for Online Vape Sales

    Massachusetts Attorney General Maura Healey is suing Puff Bar, alongside Cool Clouds Distribution, for allegedly selling its flavored vapor products online. The company is also being accused of failing to protect against delivery of their products to minors, in violation of state law, according to the suit.

    The complaint filed in Suffolk Superior Court on Wednesday also seeks a preliminary injunction to prevent Puff Bar and its distributor from selling its products in Massachusetts while the lawsuit is ongoing. Puff Bar has already suspended all US sales of its products.

    Last November, Massachusetts became the first state in the country to ban the sale of flavored vapor and tobacco products. The law also banned the sale of all menthol flavored tobacco products.

    Much remains unknown about Puff Bar. For example, it is unclear who owns the company, according to FairWarning. A document filed with the California Secretary of State lists Patrick Beltran as the chief financial officer and Nick Minas as the CEO, but both men have stated that despite their titles, they are in charge only of running the company’s website.

    “These products are dangerous, addictive and particularly appealing to young people, which is why Massachusetts moved quickly to regulate them. Companies that blatantly violate these laws will face legal action from my office,” Healey said in a statement.

  • Puff Bar Suspends Sales in the United States

    Puff Bar Suspends Sales in the United States

    Photo: Puff Bar

    Puff Bar has “ceased all online sales and distribution in the U.S. until further notice,” according to its website. International sales will continue for now.

    The California-based e-cigarette company has come under scrutiny lately for replacing Juul as the vape of choice among young people as Juul Labs discontinued some of its flavored products.

    Puff Bar comes in more than 20 flavors, including pina colada and pink lemonade. Although the Trump administration banned fruit, mint and dessert flavors in refillable cartridge-based e-cigarettes like Juul earlier this year, it exempted brands that are used once and thrown away.

    Launched last year, Puff Bar has been the key beneficiary of the decision to exempt disposables form the flavor ban. Juul’s business, by contrast, has shriveled since it restricted sales in the United States to tobacco and menthol varieties last fall.

    When the FDA started regulating e-cigarettes, it permitted the continued sale of products that were on the market as of Aug. 8, 2016, pending agency review. Because Puff Bar was introduced after that date, the agency should have the authority to remove it even though the product is disposable and even if the FDA cannot prove the company is targeting youths.

    The exception would be if Puff Bar had already been on the market before the 2016 deadline, under a different name or sold by another company.

    Much remains unknown about Puff Bar. For example, it is unclear who owns the company, according to FairWarning. A document filed with the California Secretary of State lists Patrick Beltran as the chief financial officer and Nick Minas as the CEO, but both men have stated that despite their titles, they are in charge only of running the company’s website.

    While online U.S. sales have been suspended for now, Puff Bar products are still available on other ecommerce sites, such as Eliquidstop, which is owned by Minas and Beltran. Puff Bars can also still be found at numerous convenience stores throughout the U.S.