Author: Timothy Donahue

  • Lawmakers File Amicus Brief in SCOTUS Vape Case

    Lawmakers File Amicus Brief in SCOTUS Vape Case

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    VV Archives

    A group of congressional lawmakers urged the Supreme Court of the United States to overturn a lower court ruling that blocked federal regulators from rejecting certain e-cigarette products. They argued that the move could hinder government efforts to keep illegal vaping products off store shelves.

    The Supreme Court is set to tackle the FDA’s power to regulate vape sales altogether this term, in FDA v. Wages and White Lion Investments, LLC. The forthcoming case challenges a January ruling from the Fifth Circuit, which found that the FDA overstepped its authority when it rejected marketing applications from two manufacturers looking to sell flavored liquids for e-cigarettes, according to Courthouse News.

    In an amicus brief filed with the Supreme Court Monday, the group of legislators — led by Senate Majority Whip Dick Durbin, Oregon Senator Jeff Merkley and New Jersey Representative Frank Pallone — argued that the FDA’s decision to reject these marketing applications was “carefully” reasoned.

    “Guided by Congress’ chief directive — to deny such authorization unless a product under review would be ‘appropriate for the protection of the public health’ … FDA has been appropriately mindful of children and teenagers, the most vulnerable pool of non-tobacco users,” the lawmakers wrote.

    They contended that judicial oversight of the agency’s authority had been “generally consistent” until the Fifth Circuit’s ruling and had not impeded it from accomplishing its regulatory responsibilities.

    The legislatures told the high court that allowing the lower court’s ruling to stand would not only force the FDA to waste resources reevaluating the rejected marketing applications but could also invite other manufacturers previously rejected by the FDA to relitigate their own marketing requests.

    “While those applications are once again pending FDA review, the tobacco products they cover would continue to be sold, despite the law’s clear pre-market authorization regime,” the lawmakers said. That provides a “powerful financial incentive” for manufacturers to reapply for FDA approval, even if they know the agency will ultimately deny their applications.

  • Supreme Court Urged to Overturn Triton Ruling

    Supreme Court Urged to Overturn Triton Ruling

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    Ten U.S. public health medical and community organizations have filed an amicus brief supporting the Food and Drug Administration in asking the U.S. Supreme Court to overturn a recent Fifth Circuit Court of Appeals decision forcing the FDA to reconsider several marketing denying orders (MDOs) issued vaping companies.

    In their brief, the groups explain why they believe that allowing the decision in Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution to stand would undermine the FDA’s ability to protect young people from the health harms of flavored e-cigarettes.

    In September 2020, the FDA denied Triton’s applications for approval of a variety of flavored e-liquids for use in e-cigarettes. Triton appealed to the Fifth Circuit, which struck down the FDA’s marketing denial orders. In July, the Supreme Court agreed to hear the FDA’s appeal of that decision.

    According to amici, “E-cigarettes pose unique health risks for youth, as adolescent brains are more susceptible to nicotine’s effects due to ongoing neural development” and “[t]he tobacco industry has long known that flavors are important to its ability to successfully market its products to young people.”

    The groups argue that, contrary to the vaping companies’ protestations, the FDA’s decision to issue MDOs in this case was not arbitrary or capricious, because the applicants did not present evidence that their products would benefit the public health

    The brief cites notes that over 2.1 million U.S. youth, including 10 percent of high schoolers, reported current e-cigarette use in 2023, and nearly 30 percent of high school users reported daily use.

    The brief was submitted by the American Academy of Family Physicians, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the American Medical Association, the American Thoracic Society, the Campaign for Tobacco-Free Kids, the Louisiana State Medical Society, Parents Against Vaping E-cigarettes and the  Truth Initiative.

  • Study: Troubled Teens Likely to Start Vaping

    Study: Troubled Teens Likely to Start Vaping

    A new study has found that Australian high school students with symptoms of severe depression or poor well-being are twice as likely to have tried vaping.

    The study also found one-fifth of students in 7th and 8th grade had moderate to severe depression symptoms and demonstrated the need for early intervention targeting both mental health and vaping, experts said.

    In 2023, more than 5,000 students aged 12 to 14 were surveyed for the study as part of the OurFutures vaping prevention program led by the University of Sydney’s Matilda Centre, according to media reports.

    The results, published in the Australian and New Zealand Journal of Psychiatry, showed one-third of the cohort reported poor well-being, another third had high stress, and one-fifth had high anxiety.

    Students who reported moderate or high stress levels were 74% or 64% more likely to have tried vaping, respectively, than those who reported low levels of stress, though anxiety levels seemed to have little relationship with vape use.

    According to Michelle Jongenelis, an associate professor at the University of Melbourne, the results demonstrated the importance of early effective mental health support for young teenagers.

    The study added to previous research suggesting a connection between nicotine use and mental health issues but could not offer an explanation as data was drawn from a single point in time.

  • Durbin Blames Police for Illegal Flavored Vape Surge

    Durbin Blames Police for Illegal Flavored Vape Surge

    VV Archives

    Illinois Senator Dick Durbin strongly condemned top health and law enforcement officials for their inadequate efforts in combating the surge of illegal disposable e-cigarettes among young people in the U.S.

    Industry analysts estimate disposable vapes make up 30 percent to 40 percent of the roughly $7 billion vaping market. The two best-selling disposables—Breeze and Elf Bar—generated more than $500 million in sales last year, according to Nielsen retail sales data analyzed by Goldman Sachs, according to media reports.

    Both brands have been sanctioned by FDA regulators but remain widely available, in some cases with new names, logos, and flavors. More than half of the 2.8 million U.S. teens who vaped last year said they used Elf Bar.

    Overall, teen vaping has fallen 60 percent since its all-time high in 2019, following the COVID-19 pandemic and new age restrictions and flavor bans on e-cigarettes and other tobacco products.

    “Nearly all e-cigarettes are sold in violation of federal law, yet 2 million kids report vaping,” Durbin tweeted.

    Using its own authorities, the FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years. But the letters have done little to dissuade companies from flouting FDA rules and introducing new vapes.

  • South Africa Tobacco Control Bill Not Up in Smoke

    South Africa Tobacco Control Bill Not Up in Smoke

    Credit: Pavlo Fox

    A leftover bill from the previous administration seeking to tighten tobacco and vaping product regulations is back before South Africa’s Parliament’s health committee.

    However, the business community believes it needs to be properly consulted on its potential impact, media outlets have reported.

    Minister of Health Aaron Motsoaledi is set to reintroduce the Tobacco Control & Electronic Delivery Systems Control Bill to the portfolio committee on health on Wednesday.

    The government is pressing on in its efforts to align South Africa’s smoking restrictions with World Health Organisation (WHO) standards.

    Vaping advocates previously said the bill would destroy the vapor industry if it became law.

    The Vapour Products Association of South Africa (VPASA) warned that, among other provisions, the Tobacco Products and Electronic Delivery Systems Control Bill opens an avenue for the government to ban the sale of flavored e-liquids, which tobacco harm advocates insist are key to entice smokers away from cigarettes.

  • PMI Lobbies Nevada Lawmakers for Lower IQOS Tax

    PMI Lobbies Nevada Lawmakers for Lower IQOS Tax

    Credit: Aidman

    Representatives from Philip Morris International (PMI) have begun pitching the benefits of its IQOS heated tobacco device to Nevada state lawmakers. The cigarette maker hopes Silver State legislators will pass a bill next year to tax heated tobacco at a lower rate than traditional cigarettes.

    PMI is preparing to launch IQOS in the United States. As part of those efforts, PMI has hired lobbyists in multiple states, including Nevada, according to media reports. The company has postponed the test launch of IQOS in the U.S. to the fourth quarter. The company declined to say why. The pilot was earlier scheduled to run in Austin, Texas, in the second quarter.

    Anti-tobacco activists have been seeking to derail the U.S. introduction of IQOS, arguing among other things that PMI exaggerates the number of people who have quit smoking regulator cigarettes using IQOS.

    PMI director of Scientific Engagement Brian Erkkila explained how IQOS works in a presentation on Tuesday to Nevada’s Joint Interim Standing Committee on Revenue. While no specific legislative asks were made Tuesday, Eddie Ableser of Tri-Strategies — the Nevada-based government affairs firm working with PMI — told lawmakers the company is looking to start a conversation about how the product should be taxed.

    “The intent is not a complete absolution of harm,” he told the lawmakers. “It’s harm reduction. How do we move and target the current cigarette smokers in Nevada? How can we move them onto a harm reduction product that helps them?”

    He added, “We develop tax policy generally to motivate consumers one way or the other.”

    Nevada tax policy does not consider heated tobacco products such as IQOS as other tobacco products (OTPs), which includes vaping devices, and they are taxed at 30 percent of the wholesale price. However, most tax codes generally consider heated tobacco products to be traditional cigarettes.

    In Nevada, cigarettes are taxed the equivalent of $1.80 per pack. According to the anti-nicotine nonprofit Truth Initiative, Nevada is in the middle of the pack (25th highest) when it comes to tax rates for cigarettes.

    According to the Organized Crime and Corruption Reporting Project, PMI has successfully lobbied at least 10 countries to tax heated tobacco products at a lower rate than traditional cigarettes, using the argument that the product is far less harmful and less worthy of any kind of  “sin tax.”

    PMI launched IQOS in Japan a decade ago and has since expanded into dozens of other countries. According to Alexandra Wich, a senior manager of state regulatory and public policy at PMI, intellectual property litigation has kept the product out of the U.S. market, but those issues have been resolved.

    The U.S. Food and Drug Administration gave PMI permission to market their products as reducing exposure to the harmful chemicals produced by combustible cigarettes, concluding that “the net population-level benefits to adult smokers outweigh the risks to youth.”

  • Texas Police ‘Traumatize’ Store Staff in Hemp Raids

    Texas Police ‘Traumatize’ Store Staff in Hemp Raids

    Credit: Ongala

    Police in Allen, Texas, secured up evidence and marched out business owners in handcuffs for selling what attorneys for the vape shops say are legal products. In a coordinated raid, police invaded nine locations simultaneously.

    Allen police chief Steve Dye told media that the stores involved, more than a third of the vape shops within Allen city limits, were all caught marketing and selling products with illegal levels of THC. The THC compound can be derived from marijuana and hemp (both members of the cannabis family).

    “We did multiple rounds of undercover operations, including sending minors in, and many of them were able to buy the THC underage. And then we started testing those products and we found that the vast majority of those products were well over the .3 percent,” he said.

    Early Wednesday morning, an attorney representing some of the vape shops in a federal lawsuit against the DEA called the raids “legally questionable.”

    “These local, family-owned businesses are operating legally. The Allen, Texas Police Department and the DEA overstepped their authority by destroying products, taking point-of-sale systems and records, and confiscating personal computers belonging to employees,” said David Sergi of San Marcos-based Sergi & Associates.

    Pictures provided by the U.S. Drug Enforcement Administration, which assisted with the raid, show a bag of chips labeled “Doweedos”, cookies labeled “Trips Ahoy” and candy labeled “Medicated Skittles.”

    “We’ve seen percentages of THC in the high teens, upwards of 60, 65 percent. That is almost toxic levels of THC when you think about it. And is that what somebody is expecting to get?” asked DEA Special Agent In Charge Eduardo Chavez.

    The raids left owners and employees “traumatized,” according to Sergi, who also represents the Allen Hemp Coalition as well as eight of the nine shop owners. “We think it’s absolutely horrendous,” he told a media oulet.

    Sergi said that when police sent a letter to businesses in May raising concerns, the stores voluntarily removed the products mentioned from their shelves. This time, he said, police chose a different approach.

    “Rather than getting guidance and partnership from the Allen Police Department, we have gotten arrested, we have had clients whose stores have been destroyed, we have employees whose computers have been taken,” he said.

    Sergi said that while there’s no law against selling hemp products to minors, many shops voluntarily choose not to.

    When asked about the attorney’s comments, a spokesperson for Allen police said the department tried working with store owners, offering to provide advice about which products might pose a problem. Not all, he said, took them up on it.

  • Minnesota Attorney General Warns Illegal Vape Sellers

    Minnesota Attorney General Warns Illegal Vape Sellers

    Credit: Chris Titze Imaging

    The Minnesota Attorney General’s Office is sending thousands of letters to smoke shop retailers warning them to cease selling deceptive vaping products.

    Attorney General Keith Ellison states that some of the products are indistinguishable from everyday highlighters and other school supplies.

    Ellison states that once the rules are known, retailers will be fined up to $25,000 per device sold for violating them.

    State law prohibits tobacco products from being advertised to children; however, new products like “highlight” disguise themselves as everyday school supplies. And that makes it easier for students to smuggle devices into school, according to media reports.

    Ellison stated that the objective is to encourage voluntary compliance, but he also emphasized that his office will take legal action against businesses that choose to violate the law.

  • New Jersey Fines 19 Retailers for Illegal Vape Sales

    New Jersey Fines 19 Retailers for Illegal Vape Sales

    Credit: VetKit

    Sellers were allegedly violating the state’s consumer protection laws and were fined $4,500 each.

    New Jersey Attorney General Matthew Platkin and the state’s division of consumer affairs told media that 19 New Jersey retailers were issued notices of violation and assessed civil penalties of $4,500 each. The retailers were allegedly violating the state’s consumer protection laws by offering and selling flavored vapor products that are banned for sale in New Jersey, according to the attorney general’s office.

    The enforcement actions are the result of an investigation launched in June 2024 into the unlawful offer and sale of flavored vaping products, which research has shown to be appealing to teens and children, the attorney general’s office said.

    Through undercover buys and in-store inspections, investigators identified smoke shops, convenience stores, and gift and novelty retailers in five counties offering and selling the banned products. The attorney general said that “many” of these retailers were close to schools and parks or on or near shore town boardwalks.

    “As students across the state head back to school, we’re sending a message of deterrence to retailers. If you are caught selling these dangerous, banned products, you will be held accountable,” Platkin said.

    In 2020, New Jersey Gov. Phil Murphy signed legislation prohibiting the sale and distribution of all vapor products with a flavor, taste, or aroma other than tobacco.

    “The ban on flavor vaping devices is in place to protect New Jersey consumers—especially our youth—from the harmful effects of electronic cigarettes, nicotine, and tobacco,” said Cari Fais, acting director of the division of consumer affairs. “By identifying and taking enforcement action against merchants who illegally sell these products, we are protecting public health and fulfilling our responsibility to safeguard consumers from unlawful business practices.”

  • FDA Issues Final Rule to Raise Minimum Sales Age

    FDA Issues Final Rule to Raise Minimum Sales Age

    Credit: Onticello

    The U.S. Food and Drug Administration announced a final rule raising the minimum age for certain restrictions on tobacco product sales. The requirements are in line with legislation signed in December 2019, which immediately raised the federal minimum age for the sale of tobacco products in the United States from 18 to 21.

    Once implemented, the requirements are expected to help decrease underage tobacco sales.  

    Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone. 

    Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machines in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time.

    These changes, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation, according to an agency press release.

    “Today’s rule is another key step toward protecting our nation’s youth from the health risks of tobacco products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Decades of science have shown that keeping tobacco products away from youth is critical to reducing the number of people who ultimately become addicted to these products and suffer from tobacco-related disease and death.”

    The Further Consolidated Appropriations Act, signed into law on Dec. 20, 2019, increased the federal minimum age for selling tobacco products from 18 to 21 across the United States. Since then, it has been illegal to sell tobacco products, including e-cigarettes, to anyone under 21. The law also directed the FDA to take action today, increasing the age of certain requirements for tobacco product sales, as explained above.

    The agency also continues to provide retailers with resources to improve compliance with tobacco laws and regulations, including age of sale restrictions. For example, the FDA has developed a voluntary education program, “This is Our Watch,” which offers free resources to assist retailers in calculating the age of customers, including a digital age verification calendar and an age calculator app. Retailers can also find information on tobacco products that may be legally marketed in the United States through the Searchable Tobacco Products Database. Updated resources, including further information on these latest requirements, will be made available on the FDA’s website in the near future.