Category: Regulation

  • Oman Bans the Sale of Vaping and Shisha Products

    Oman Bans the Sale of Vaping and Shisha Products

    Credit: Fellow Neko

    The chairman of the Consumer Protection Authority states that a fine of up to OMR 2,000 ($5,196) for multiple violations will be imposed on anyone who trades in e-cigarettes, shisha, and their accessories in the Sultanate of Oman.

    His Excellency Sulayem bin Ali Al-Hakmani issued Ministerial decision No. 756/2023 on Sunday, January 7, 2024, creating the ban, according to media reports.

    Article One stipulates that the circulation of e-cigarettes, shisha, and their accessories is prohibited.

    Article Two states that, “without prejudice to the penal penalties stipulated in the aforementioned Consumer Protection Law, an administrative fine not exceeding OMR1,000 shall be imposed on anyone who violates the provisions of this decision, and the fine shall be doubled in the event of a repeat violation.

    “If this violation continues, an administrative fine of OMR 50 will be imposed for each day that the violation continues, provided that its total does not exceed OMR 2,000. The seized quantities of electronic cigarettes, shishas, ​​and their accessories will be destroyed in accordance with the controls in force at the Consumer Protection Authority.”

    The new bill also repealed an earlier Resolution (No. 698/2015), as well as any laws or rules that contravene the current resolution or conflict with its provisions.

    It also stipulates that the decision “shall be published in the Official Gazette, and shall be effective from the day following the date of its publication.”

  • Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

    Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

    Image: BCFC

    Two e-liquid companies will be able to resubmit their marketing applications to the U.S. Food and Drug Administration following a court ruling, reports Bloomberg Law.

    On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

    In a dissenting opinion, Judge Catharina Haynes stated that the agency “properly fulfilled its statutory mandate by considering the relevant portions of Petitioners’ PMTAs and coming to a reasonable conclusion that marketing Petitioners’ products is not appropriate for public health.”

    Oldham stated that the manufacturers dutifully spent untold millions “conforming their behavior and their applications to FDA’s say-so.”

    “Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans.”

    In an X post, Michael Siegel, a professor at Boston University School of Public Health, stated that the ruling “exposed” the FDA’s wrongful rejection of applications for flavored vapes, ultimately resulting in a “win for public health.”

    Eric Heyer, a lawyer for e-liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make “a significant course correction by communicating with specificity” what companies must do to get approval.

    “No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people,” Oldham wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. “And FDA’s regulatory switcheroos in this case bear no resemblance to square corners.”

    It is expected that the FDA will seek a review of the decision by the Supreme Court of the United States, however, the justice department hasn’t made an official announcement.

  • Norm Bour: Vape Laws Vary From Country to Country

    Norm Bour: Vape Laws Vary From Country to Country

    Genoa at Gaya Vapes in Bali

    By Norm Bour

    As I travel from one country to the next, everything changes: languages, currencies, foods—and also vape laws, which are so specific and seemingly random that it is challenging to keep them straight.

    Before I arrived in Indonesia, I was in New Zealand and Australia—both modern, contemporary, First World countries.

    New Zealand seemed comfortable with its vape laws, and shops were abundant. In Sydney and Canberra, Australia, vape shops were less common, and I had little success getting concrete feedback from shop owners and employees. There seemed to be paranoia there, and maybe there was just cause.

    With Health Minister Mark Butler having proudly stated on the record that Australia’s vape laws will be the “toughest in the world,” the vape shop owners’ fears may be justified. The government is lowering the hammer on disposables, and so far, more than A$11 million ($7.3 million) of nicotine-containing vape products—11 tons—have been seized this year.

    In November, Butler announced that Australia would ban all imports of disposable vapes beginning Jan. 1, 2024. The ban will be expanded in March 2024 to include all nontherapeutic vapes, including refillable devices, while importers of vapes for medical purposes will need a permit from the Office of Drug Control.

    Therapeutic vapes will be restricted from using flavors, have limited nicotine levels and be sold in pharmaceutical packaging under new rules to be introduced in 2024, with a transition period for manufacturers to comply.

    The legislative package will also include a total A$75 million in extra funding for the Australian Border Force and the Therapeutic Goods Administration to enforce the new rules. Additional legislation next year will apply the same prohibitions to domestic manufacturers.

    When it’s all said and done, it appears that no vape products will be sold without a prescription, and instead, they will be sold at pharmacies. Say goodbye to vape shops, and say, “welcome back, black market.”

    New Zealand may not be far behind.

    Currently, vaping laws are reasonable in Kiwi Country, and vape shops can operate independently but with significant government oversight. Age restrictions are huge, and to that end, disposables and flavoring (including “enticing names”) will be banned in the near future.

    In late 2022, the New Zealand Parliament adopted the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill, which regulators said would phase out combustible tobacco product use in the country. However, in November, New Zealand’s new coalition government announced its plans to scrap the generational tobacco ban, which would have prohibited tobacco products for people born after 2009.

    While ditching the generational tobacco ban, the new government vowed to get tough on vaping by banning disposable e-cigarettes and increasing penalties for illegal sales to those aged under 18.

    Meanwhile, 2,000 miles to the north is another world—“a newly industrialized country with a rapidly growing economy and political stability,” per the Indonesian press.

    Most shops are basic in their appearance, as is their product supply.

    The government has mostly ignored the vape market, and aside from an excise tax on e-liquids, there are few regulations on physical or online shops. For a decade, the government has stated its intention to address vape products, but for now, it has settled on a tax rate of 57 percent on vape products versus 40 percent on tobacco.

    In September, the Indonesian Parliament passed Health Law No. 17 of 2023, which categorizes e-cigarettes as addictive substances. Teguh Basuki A. Wibowo, chairman of the Indonesian Electronic Nicotine Industry Alliance, told the media that including e-cigarettes in the legal framework for solid and liquid tobacco products legalizes industry participants and allows smokers to find alternative products.

    The law puts Indonesia on equal footing with countries like the Philippines and the U.K., which have similar legislative frameworks for e-cigarettes, Wibowo said.

    With almost 65 million smokers, Indonesia trails only China and India in terms of prevalence. Tobacco is heavily advertised through television and other media, which has traditionally been one of the first targets of restrictions.

    In the city of Ubud, Bali, a favorite base for expats from all over the world, I visited Nyali Vapes, and the shop’s owners confirmed the same trends I heard about elsewhere: Disposables are the largest sellers. The people at Gaya Vapes, my next stop, said likewise, and when I asked about surprise visits from regulators, counterman Genoa admitted that these visits are frequent.

    He also spoke about the differences between the locals and the tourists: “Most of the tourists come in for refills and [fewer for] disposables,” he said. “They ask for their flavors, and we usually do not have their exact brand, but we do have a similar flavor, which they are fine with.”

    One of the largest groups of visitors to Indonesia, and Bali in particular, are Australians, home to the world’s most expensive cigarettes, at more than $25 a pack. Over the course of my time in Bali, I asked some Aussies if they stocked up on smokes while they were visiting, and unanimously, they all said, “hell, yes!”

    Even though all countries are different, some vapers’ patterns are standard, including that of Genoa, the front desk guy at Gaya Vapes, age 25, who stopped smoking in 2017 and started vaping instead. But he did confess that sometimes money is tight, in which case he goes with a cigarette instead of a vape.

    Vaping is much cheaper, but liquid prices can be off-putting for consumers with Indonesian wages. Regardless, Genoa’s passion for vaping is what motivated him to work at Gaya, one of several shops in the area with that same name.

    For those earning foreign salaries, life is cheap in Indonesia, a condition that also applies to tobacco and vape products. A standard pack of cigarettes costs about IDR24,000, which equates to just under $1.60. A name brand like Marlboro will set you back about $2.25 per pack, which is still a bargain for those accustomed to foreign prices. Indonesia is not the world’s cheapest country for smokers—that honor goes to Vietnam—but it is in the lowest percentile.

    My new friend William at Glory Vapes confessed that he was a dual user, and because vaping was so much cheaper (even at those insanely low cigarette prices), he was able to make his disposables last up to three weeks. Add in his love for all the fruit flavors, and he remains biased toward the liquids, so he smokes cigarettes only when socializing with friends.

    He also shared that local police officers regularly visit the shop, but he suspected they came in more to alleviate boredom than to look for anything illegal.

    Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.

  • January 1 Start to New York Vape Marketing Rules

    January 1 Start to New York Vape Marketing Rules

    Credit: Reuben Teo

    New York expanded its tobacco product marketing and event sponsorship laws to apply to vaping products in October. The new rules will begin on January 1st, 2024.

    The expanded law specifically prohibits:

    • E-cigarette manufacturers and distributors from selling or marketing e-cigarette branded items (other than actual e-cigarettes or accessories). The prohibition explicitly excludes retailer point-of-sale promotions.
    • Gifts in exchange for the purchase of e-cigarettes.
    • Sponsorship of athletic, musical, artistic, social, or cultural events or teams with branded e-cigarette images or logos. Sponsorships using corporation names are permitted.
  • Canton of Basel Bans Some Sales of Vaping Products

    Canton of Basel Bans Some Sales of Vaping Products

    Credit: Claude Wangen

    After testing 32 disposable e-cigarettes, the cantonal laboratory in Basel City, Switzerland, said it found problems with all of them and issued a sales ban on seven for containing toxic substances, reported SRF.

    The e-cigarettes were obtained from 12 sales outlets in the city. The problems detected include nicotine above the maximum legal limit, lead in metal joints, toxins linked to infertility and the presence of undisclosed additives.

    Smoking rates are high in Switzerland. An estimated 27 percent of the population 15 and over smokes, and 42 percent of men aged between 25 and 34 are smokers.

  • Under-18 Vape Product Sales Ban Begins in Ireland

    Under-18 Vape Product Sales Ban Begins in Ireland

    Photo: Timothy S. Donahue

    The Irish Government has announced that the ban on selling e-cigarettes or vapes to minors takes effect from tomorrow.

    Stephen Donnelly, the Minister for Health, obtained Cabinet approval for this measure earlier this year, which was signed into law by President Michael D. Higgins in August.

    The Public Health (Tobacco Products and Nicotine Inhaling Products) Bill comes into effect from Friday, December 21.

    From then on, it will be an offense to sell a nicotine inhaling product to someone under the age of 18. The offense will carry a penalty of a fine of up to €4,000 ($4408) and a prison sentence of up to six months.

    The new bill includes measures to address smoking and vaping among adults.

    Beginning today, the sale of tobacco products and nicotine inhaling products at events for children will also be prohibited, as will the self-service sale of such products.

    The bill prohibits the sale of certain items to minors and restricts their advertisement in schools and on public transport. It also provides for increased enforcement, according to media reports.

    The bill also allows for additional enforcement powers to the Environmental Health Service for measures in the bill and for all previous Tobacco Control Acts.

  • Singapore Cracking Down on Travelers With Vapes

    Singapore Cracking Down on Travelers With Vapes

    Image: monticellllo

    Singapore authorities will step up checks at air, land and sea checkpoints to prevent e-cigarettes from entering the city state, reports the South China Morning Post.

    “Incoming passengers may be screened for e-vaporizers and their components at the arrival halls, and those found with e-vaporizers or their components will be fined,” said the Ministry of Health and the Health Sciences Authority in a media release.

    Vaping is illegal in Singapore, and offenders can be fined up to SGD2,000 ($1,490). Those who import, distribute or sell such products face stiffer penalties, including a possible jail term.

    Despite the ban, the number of people caught using and possessing vapes has been rising, including among underage consumers.

    Apart from the border checkpoints, checks will be stepped up at places such as the central business district, shopping centers, parks and smoking areas as well as public entertainment outlets such as bars and clubs.

    Since Dec. 1, enforcement officers from the National Environment Agency have been empowered to take action against people who use or own vapes.

    Singapore authorities said that their multi-agency approach is aimed at protecting its population.

    The World Health Organization said last week that urgent action is needed to control e-cigarettes to protect children and nonsmokers.

  • Warning Letters for Vapes Resembling Alcohol Products

    Warning Letters for Vapes Resembling Alcohol Products

    Image: FDA

    On Dec. 20, 2023, the U.S. Food and Drug Administration issued warning letters to three online retailers for selling and/or distributing unauthorized e-cigarettes that imitate packaging for bottles of alcohol. These retailers sold Luckee Vape Daniels brands, which are flavored disposable e-cigarette products that come in a variety of common alcoholic drink flavors that may be appealing to young people, including icy pina colada, frozen strawberry daiquiri, frozen mangorita and watermelon martini.

    Data from the 2023 National Youth Tobacco Survey indicate that disposable products are the most commonly used type of e-cigarettes among U.S. middle and high school students. Among current youth e-cigarette users, approximately nine in 10 reported using flavors, with fruit flavors being the most popular (63.4 percent) and about one in 14 (7.2 percent) reporting use of products with alcoholic drink flavors.

    “FDA is committed to taking action across the supply chain, including among retailers, to remove unauthorized tobacco products from the marketplace,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “This includes continued monitoring of the online marketplace to identify and combat against emerging products of concern.”

  • Juul Labs Submits PMTA for JUUL2 Menthol Pods

    Juul Labs Submits PMTA for JUUL2 Menthol Pods

    Credit: Piter2121

    Juul Labs announced on Tuesday that it is seeking FDA approval for its new menthol-flavored pods. The JUUL2 pods require age verification and are designed to be used with Juul’s e-cigarette device, which is currently under regulatory review.

    The new menthol-flavored pods have a nicotine concentration of 18 mg/mL and are Juul’s latest premarket tobacco product application (PMTA) submission to the FDA, according to media reports.

    This follows a submission Juul Labs made in July for a vaporizer with a unique Pod ID chip to prevent the use of counterfeit cartridges and restrict underage access. The July application included a proposal for tobacco-flavored pods.

    The vaporizer is already on sale in the UK after its launch in 2021 as the JUUL2 System.

    The menthol pod contains a secure microchip that communicates a requirement for age verification to the device before use. The device can be locked by users at any time to prevent unauthorized usage.

    To mitigate the risk of social sourcing, Juul said it would limit not only the number of devices that can be purchased but also the number of new devices each unique age-verified user can activate and use with menthol-flavored pods.

    So far, the FDA has authorized only 23 e-cigarette products for sale in the United States, all of them tobacco-flavored. The agency has denied menthol e-cigarette applications from several high-profile manufacturers, including British American Tobacco, which is appealing those decisions.

    Juul Labs said in a statement it has submitted evidence showing its new menthol pods can help more cigarette smokers transition from smoking than tobacco-flavored e-cigarettes.

  • Illinois Public Vaping Ban Begins at Start of January

    Illinois Public Vaping Ban Begins at Start of January

    Credit: Karen Roach

    Starting next month, the use of vapes and other e-cigarette products will be prohibited in public places in Illinois.

    In 2007, the Smoke-Free Illinois Act was implemented to ban smoking of cigars and cigarettes indoors and within 15 feet of entrances. The law is now being strengthened and will take effect on Jan. 1st.

    “E-cigarettes, in all of their many forms, continue to be one of the most addictive products readily available for purchase in gas stations, vape shops and online,” State Senator Julie Morrison, who sponsored the bill in the Senate, said in a release. “We have made solid progress toward de-normalizing the perception of tobacco, and I am proud that on Jan. 1, e-cigarette usage will be banned indoors.”

    On the first offense, individuals caught smoking e-cigarettes in public places in the state will be fined $100.

    The governor signed the bill into law in July 2019, which also raised the legal age for purchasing tobacco products from 18 to 21 in Illinois.