Tag: FDA

  • Officials Urged to Fight Vaping Misinformation

    Officials Urged to Fight Vaping Misinformation

    Photo: Yeti Studio

    A group of public health experts along with the attorney general of Iowa have asked the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Surgeon General to correct misinformation overstating the dangers of e-cigarettes.

    In an editorial published Dec. 12 in Addiction, the authors cite the 2019 outbreak of EVALI and the Surgeon General’s 2016 youth vaping report, which claims that nicotine vaping is a gateway to smoking.

    The authors take issue with the CDC’s failure to amend the name EVALI (e-cigarette or vaping product use-associated lung injury) even after it became clear that the health problems were brought about by vitamin E acetate (mixed with cannabis oil by black market sellers) rather than nicotine vapes.

    “Smokers are still twice as likely to incorrectly identify e-cigarettes as the cause of a serious lung disease outbreak in 2019 than to correctly identify marijuana vape products contaminated by vitamin E acetate as the cause,” said lead author Michael Pesko of Georgia State University in a press note. “Because many smokers then falsely believe e-cigarettes to be as or more dangerous than cigarettes, the misinformation reduces smoking cessation that would otherwise occur. Population health suffers as a result.”

    The Surgeon General’s gateway claim, meanwhile, is simply untrue, according to the authors. “Significant evidence now exists that this association between vaping and smoking is not causal, which is a source of confusion for the lay public and healthcare professionals,” wrote Georgia State University health economist Pesko.

    “The lack of causation is underlined by real-life data collected since the SG report’s publication. Even as youth vaping hit its peak in 2019, youth smoking was sinking rapidly, and that decline has continued.”

  • Appeals Court Denies Avail Vapor’s MDO Petition

    Appeals Court Denies Avail Vapor’s MDO Petition

    A unanimous panel of the United States Court of Appeals for the Fourth Circuit on Monday denied Avail Vapor’s petition to have its marketing denial order (MDO) issued by the U.S. Food and Drug Administration for its e-liquid products invalidated.

    Circuit Judge J. Harvie Wilkinson wrote Monday that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate to protect public health. Wilkinson was joined by Circuit Judges Diana Gribbon Motz and Albert Diaz.

    The court rejected all of Avail’s arguments, including that the FDA’s review of its premarket tobacco product applications (PMTAs) was arbitrary and capricious, according to a copy of the ruling obtained by Vapor Voice.

    “We see no merit in Avail’s remaining arguments that FDA acted arbitrarily and capriciously in reviewing petitioners’ PMTAs,” the decision states. “FDA could not allow young adults to perceive e-cigarettes as another Baby Ruth or Milky Way, only to find themselves in the grip of a surreptitious nicotine addiction. This was hardly arbitrary.”

    Avail’s chief complaint is that the FDA arbitrarily imposed a new “comparative efficacy” standard, which asked applicants to demonstrate through certain long-term studies that their fruit and dessert-flavored products better promote smoking cessation than tobacco-flavored products.

    This standard, Avail complains, was adopted with no explanation to applicants and without consideration of their reliance interests. Avail also raises a substantive objection, arguing that FDA’s imposition of this comparative efficacy standard exceeded its statutory authority under the TCA.

    “First, Avail attempts to tie the hands of the FDA to certain forms of evidence and kinds of studies in what is a rapidly evolving field. Second, in focusing upon procedural points, Avail encourages us to neglect the forest for the trees,” the decision states. “Avail essentially argues that “the FDA’s willingness to consider some forms of evidence, explicitly phrased as such, required the FDA to accept that evidence as meeting a statutory requirement even where the FDA found the evidence unsatisfactory.”

    According to the decision, Avail also filed its marketing plan with its PMTAs, which outlined measures designed to prevent underage use. Such measures consisted of naming its flavored e-liquids with “non-descriptive and non-characterizing names” that do not identify the product flavor to prevent appealing to youth.

    “The agency denied Avail’s application for its flavored electronic cigarettes, chiefly on the grounds that its products posed a serious risk to youth without enough offsetting benefits to adults,” the decision states. “We now uphold that decision and deny Avail’s petition for review.”

    The judge also specifically stated that he did not agree with the U.S. Court of Appeals for the Eleventh Circuit’s decision to stay the MDO issued by the FDA to Bidi Vapor. Persons with knowledge of the Avail suit said that it was a good case to petition for certiorari, a review of the lower court’s decision, to the United States Supreme Court.

  • Supreme Court Paves Path for California Flavor Ban

    Supreme Court Paves Path for California Flavor Ban

    Credit: Niro World

    The Supreme Court of the United States on Monday rejected a last-minute plea from the tobacco industry and cleared the way for California to enforce a statewide ban on the sale of most flavored tobacco products, including menthol cigarettes.

    The court’s action has the effect of upholding a measure passed by the Legislature in 2020, which in turn was approved by 63 percent of voters in November. It is due to take effect next week, according to the Los Angeles Times.

    Washington attorney Noel Francisco, who served as U.S. solicitor general under then-President Trump, filed an emergency appeal with Justice Elena Kagan on Nov. 29, asking her and the high court to stop California’s statewide ban from taking effect.

    Kagan referred the appeal led by R.J. Reynolds to the full court, which issued a brief order denying it without comment and with no dissents.

    The outcome is a victory for anti-tobacco advocates who called for cracking down on e-cigarettes and eliminating youth-friendly flavors such as bubble gum, cotton candy and cherry.

    California joins Massachusetts and New York in prohibiting the sale of flavored tobacco.

  • First Vapor Manufacturers Handed DOJ Injunctions

    First Vapor Manufacturers Handed DOJ Injunctions

    Credit: MQ Illustrations

    The United States filed complaints in December against six companies and related individuals to stop the illegal manufacture and sale of unauthorized vaping products. The charges were brought on behalf of the U.S. Food and Drug Administration.

    E-cigarette manufacturers Seditious Vapours LLC and Vapor Craft LLC, two of those six companies, must stop distributing and selling their products under two separate court orders granting the FDA-requested injunctions, according to Bloomberglaw.

    Judge Douglas L. Rayes of the U.S. District Court for the District of Arizona sided with the FDA’s argument that Seditious Vapours failed to submit premarket applications for the products, and subsequently manufactured, sold, and distributed the e-cigarettes illegally, according to a court order filed Friday.

    Two days earlier, Judge Clay D. Land of the US District Court for the Middle District of Georgia granted a permanent injunction against Vapor Craft.

    The FDA states that the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers after receiving warning letters from the agency. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.

    “These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”

    When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure.

    The six companies originally having injunctions filed were: 

    • Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
    • Soul Vapor LLC in the Southern District of West Virginia
    • Super Vape’z LLC in the Western District of Washington
    • Vapor Craft LLC in the Middle District of Georgia
    • Lucky’s Convenience & Tobacco LLC d/b/a Lucky’s Vape & Smoke Shop in the District of Kansas
    • Seditious Vapours LLC d/b/a Butt Out in the District of Arizona

    The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.

  • FDA Accepts Several Streamline Synthetic PMTAs

    FDA Accepts Several Streamline Synthetic PMTAs

    Streamline, parent to Juice Herad and several other e-liquid brands, announced that the U.S. Food and Drug Administration had accepted the company’s premarket tobacco product applications (PMTAs) for several of its synthetic products under the Juice Head brand.

    In an email, Streamline co-founder and CEO Patrick Mulcahy said that his staff and Accorto Regulatory Solutions were instrumental in preparing the PMTAs for submission.

    “With ample investment and focus on ensuring the quality and compliance of all Juice Head products, we are thrilled to be making progress and look forward to a positive response from the FDA.

    “Currently, our PMTAs for Juice Head 5Ks, Juice Head Bars, and Juice Head Pouches are still under review; however, we are confident that we will receive a positive response from the FDA soon,” Mulcahy said. “As always, we will maintain our commitment to transparency and communication throughout the process ahead.”

  • Juul Labs Settles With More Than 10,000 Plaintiffs

    Juul Labs Settles With More Than 10,000 Plaintiffs

    Credit: Juul Labs

    Juul Labs has settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs, reports The Wall Street Journal. Financial terms of the deal were not disclosed. However, several media outlets are reporting the amount to be between $1.2 billion and $1.7 billion.

    The deal resolves much of the legal uncertainty that had driven the company close to bankruptcy.

    Juul announced on Dec. 6 it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout  that would cover legal liabilities.

    According to Juul CEO K.C. Crosthwaite, the settlement addresses the vast majority of outstanding litigation facing the company, including two pending bellwether trials that were set to go to court early next year, and four broad groups: personal-injury plaintiffs, Juul consumers, government entities such as school districts, and Native American tribes. Lawsuits brought by several attorneys general are pending. 

    A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.

    Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.

    Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.

    In September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products.

    Juul’s e-cigarettes were briefly banned in the U.S. in late June after the FDA concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.

    In October, Juul published the details of its MDO appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.

  • Flavor Ban has Little Impact on Consumer Vaping

    Flavor Ban has Little Impact on Consumer Vaping

    The U.S. Food and Drug Administration ban on flavored tobacco products, except for menthol and tobacco flavors, did not stop consumers from vaping, reports EurekAlert!, citing a study published in Tobacco Control.

    The study showed that less than 5 percent of the 3,500 adult e-cigarette users surveyed quit using e-cigarettes in response to the ban. The remaining respondents switched to other forms of tobacco products or flavors of e-cigarettes that are not covered by the ban. 

    “An increasing body of literature shows that e-cig flavors themselves cause damage when inhaled, so it makes sense to ban flavors,” said Deborah J. Ossip, a tobacco research expert and professor in the Department of Public Health Sciences and Center for Community Health and Prevention at the University of Rochester Medical Center (URMC) who co-authored the study. “But the ban doesn’t appear to be working. People—including youth—can still get flavored products and are still using them.”

    Lead study author Dongmei Li, associate professor of clinical and translational research, obstetrics and gynecology and public health sciences at URMC, stated that a big issue is that the ban did not cover products such as disposable e-cigarettes and e-cigarettes that use tanks rather than cartridges or pods.

    “Other forms of flavored e-cigs, especially disposable e-cigs, have become very popular after the FDA policy,” Li said. “The FDA policy also did not ban menthol[-flavored] or tobacco-flavored products—and our study shows many people switched to menthol-flavored e-cigs after the ban. It seems many people find menthol to be a nice flavor.”

    Of the survey respondents, nearly 30 percent switched to tank or disposable flavored e-cigarettes and another 30 percent switched to menthol-flavored or tobacco-flavored pods; 14 percent switched to combustible products, like cigarettes, and 5 percent switched to smokeless tobacco. Less than 5 percent quit using e-cigarettes following the ban.

  • ELFBAR Investigation: Warnings About Fake Vapes

    ELFBAR Investigation: Warnings About Fake Vapes

    Credit: Elfbar

    Potentially dangerous counterfeit disposable vaping products are flooding into the UK market, according to an investigation by ELFBAR, a Chinese manufacturer. Retailers and consumers are being warned that the illegal products are being produced in “squalid Chinese factories with no license for manufacturing and regard for product safety,” according to a press release.

    Since the launch of counterfeiting action by ELFBAR in June 2021, it has cracked down on more than 120 counterfeit production and sales targets, including factories, warehouses, logistics, and foreign trade companies, seizure of more than 2 million finished counterfeit ELFBAR products, millions of packaging boxes, anti-counterfeit codes, semi-finished vaping pipes and other accessories.

    Victor Xiao, the Chief Executive of ELFBAR, said consumers would be horrified if they saw the conditions in which these products are made. “The criminals behind these counterfeit products care nothing about product safety or the health of consumers and they cut every corner possible to maximize their profits,” he said. “Quite frankly, the conditions in these factories are absolutely squalid where workers man production lines in filthy conditions with no regard to hygiene at all.” 

    ELFBAR is clamping down hard on the illegal vape market and is building up an intelligence dossier on fake products as the counterfeiters get smarter and more efficient. While ELFBAR works hard to stop the fraudsters at source it realizes that it is impossible to stop all the fakes from getting through and is now warning retailers that they are the last line of defence to protect consumers.

    “While it can be hard to tell a fake product from the real thing just by looking at it, there is no excuse for any retailer to sell a counterfeit ELFBAR product. Retailers can scan a code on the packaging to check the authenticity of the product and we urge them to do this for every product they sell,” Xiao said. “Fighting fakes is a priority for ELFBAR and we remain  zero tolerance for these fake vapes right across the entire industry. The UK market is very important to us and we will continue to do all in our power to ensure that British consumers have confidence in their vapes.”

    John Dunne

    John Dunne, director general of the UK Vaping Industry Association (UKVIA), said he applauds ELFBAR for standing up against the counterfeiters.

    “They pose a significant risk to the harm reduction reputation of the global vaping industry. It’s why we have called for a retail licensing scheme here in the UK to prevent the sale of illicit products and much higher penalties of at least £10,000 per instance for retailers who break the law in this way,” he said. “Similarly, the counterfeiters and those who trade fake vapes along the supply chain need dealing with in a way by the relevant authorities that put them off from doing it ever again.”

  • Brussels to Propose First EU-Wide Vaping Levy

    Brussels to Propose First EU-Wide Vaping Levy

    In a long-anticipated move, the European Union is to propose a bloc-wide vaping tax policy as part of a shake-up of levies on the tobacco industry. The new rules would also double excise duties in member states with low cigarette taxes, according to a draft European Commission document.

    The update to the 2011 EU tobacco taxation directive will tax novel smoking products, such as e-cigarettes, vapes and heated tobacco, comparatively with combustible cigarettes as policymakers worldwide take an increasingly dim view of the new products’ popularity among young people.

    Products with a high nicotine content would have an excise duty of at least 40 percent applied to them, while lower-strength vapes will face a 20 percent duty. Heated tobacco products will also be hit by 55 percent duty, or a tax rate of €91 per 1,000 items sold.

    The changes to legislation, part of a push by Brussels to cut smoking rates, will increase the EU’s minimum excise duty on cigarettes from €1.80 to €3.60 per pack of 20, which would raise prices in eastern European nations where packs can sell for under €3.

    Alberto Alemanno, professor of EU law at HEC Paris business school, told the Financial Times that the absence of an EU-wide excise framework for vaping and heated tobacco products had been “weakening tobacco control efforts” across the bloc.

    Excise duties on cigarettes would also increase considerably in countries such as Austria and Luxembourg where prices are low relative to income. The tax rise on cigarettes is expected to generate an extra €9.3 billion for EU member states.

    The changes aim to speed up the EU’s push for a “tobacco-free generation” by 2040. As part of the EU’s Beating Cancer Plan, health officials want to drive tobacco use among EU citizens from the current level of about 25 percent down to 20 percent in 2025, and below 5 percent by 2040.

    The commission this month imposed a ban on flavored heated tobacco products to curtail a surge in demand among younger consumers. In the U.S., regulators at the Food and Drug Administration have moved to ban popular vaping products, such as Juul.

    Peter van der Mark, secretary-general of the European Smoking Tobacco Association, an industry body, warned that “if you have a sudden very steep increase, you can create a market for illicit trade.” Dustin Dahlmann, president of the Independent European Vape Alliance, added that imposing taxes on novel tobacco products could lead to “the much less harmful alternatives” to smoking being “taxed far too heavily in many countries.”

    A leaked impact assessment said that the increase in the minimum excise duty would have “a strong impact on consumers and economic operators” in EU states where cigarette prices were low, including Bulgaria, Slovakia, Poland and Hungary. The assessment also noted that the excise duty on novel tobacco products “which are particularly appealing to young people, who are at risk of developing addiction” would aid public health efforts to cut tobacco use.

    The proposal will have to be agreed by all EU member states before it is enshrined in law. British American Tobacco, one of the world’s biggest cigarette manufacturers, stressed this was “the beginning of a long legislative process.”

  • FDA Warns 5 Companies for Marketing CBD Edibles

    FDA Warns 5 Companies for Marketing CBD Edibles

    Credit: Simone

    The U.S. Food and Drug Administration today posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).

    These companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD. This could result in unintentional consumption or overconsumption of CBD.

    “CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,” the FDA stated in a release.

    Warning letters were sent to the following companies:

    The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm, according to the agency.

    “This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products,” the agency states.

    The warning letters also outline additional violations of the Food, Drug & Cosmetics Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

    “The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law,” the agency wrote. “Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”