Category: Regulation

  • Warning Letters for 5 Online Illegal Vape Retailers

    Warning Letters for 5 Online Illegal Vape Retailers

    Credit: Marcus Krauss

    The U.S. Food and Drug Administration has again  issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products marketed under the brand names Geek Bar, Lost Mary, and Bang. It’s the second wave of warning letters issued in July.

    The retailers included Smoke and Vape Company, LLC d/b/a Smoke and Vape Co.; Smoking Vibes LLC d/b/a Smoking Vibes; Cavalry Industries d/b/a Select Vape; HTXW LLC d/b/a FOMO Culture; and Global Supply Allies Inc. d/b/a Vapor Grab.

    These warning letters were a result of FDA’s ongoing monitoring of multiple surveillance systems, including a review of various data, to identify emerging products of particular concern that are popular among youth or have youth appeal, according to an agency press release. For example, emerging data showed that Geek Bar – a Chinese-owned and manufactured brand – has recently seen an uptick in sales and can appeal to youth.  

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties. 

    FDA holds retailers accountable for selling unauthorized tobacco products, particularly those popular with youth. To date, FDA has issued over 680 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 690 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against 64 manufacturers and more than 140 retailers for distribution and/or sale of unauthorized tobacco products. 

    As of August 1, 2024, the FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products can be lawfully marketed and sold in the U.S. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement.

  • Age to Purchase Nicotine Raised to 21 in Indonesia

    Age to Purchase Nicotine Raised to 21 in Indonesia

    Vapor Voice Archives

    Indonesia raised the minimum age limit for purchasing cigarettes and vaping products to 21 from 18 as part of a series of changes to health regulations intended to curb nicotine use in a country with one of the world’s highest smoking rates.

    A country of 270 million people, Indonesia is one of the world’s top producers of tobacco, and there are about 70 million adult smokers there, according to a 2021 World Health Organization survey, a media outlet states.

    In a government regulation signed by President Joko Widodo last week, Indonesia raised the minimum age for people wanting to buy cigarettes to 21. It also banned the sale of a single cigarette.

    The regulation is intended to “lower the prevalence of smokers and prevent early-age smokers.” Among the provisions is banning the sale of cigarettes within 200 meters (656 feet) of schools and playgrounds.

    The regulation took effect immediately.

    The new regulation also bans conventional and e-cigarette sales on “commercial electronic applications” and social media sites. It also bans advertising cigarettes on social media. Penalties for violations range from a written reprimand to a temporary ban on advertising cigarettes.

    The new provisions on advertising will come into force in two years.

  • Taiwan: No Approved Vape, Heated Tobacco Devices

    Taiwan: No Approved Vape, Heated Tobacco Devices

    Vapor Voice Archives

    Taiwan’s Health Promotion Administration (HPA) has reminded suppliers and consumers that it has not approved any e-cigarettes or tobacco heating products (HTPs), reports the Taipei Times.

    The warning came after security footage showed a lawmaker using a THP in the legislature’s corridors.

    Novel tobacco and nicotine products require government approval in Taiwan. To date, the HPA has received applications for authorization for HTPs from 12 companies. It has rejected the applications of eight, while two of the remaining four have been asked to furnish additional information.

    The HPA has a panel of toxicology, public health and addiction experts to assess requests for authorized use of THPs. The panel has so far convened 30 meetings.

    Taiwanese law punishes the manufacture, import, sale, supply, display or advertisement of unauthorized novel tobacco products by a maximum penalty of TWD5 million ($152,263), while users may be fined TWD10,000.

  • FDA Almost Finished Reviewing PMTA Products

    FDA Almost Finished Reviewing PMTA Products

    Photo: thodonal

    The U.S. Food and Drug Administration is almost done reviewing premarket tobacco product applications (PMTAs) for mass-market vaping products.

    In a July 22 progress report the agency said it had taken action on 185 of 186 marketing applications for e-cigarette products covered by a 2022 court order, which applied to products with significant market share that filed applications by Sep. 9, 2020.

    The manufacturers of those orders have received either a marketing denial order (MDO) or FDA authorization.

    Observers say the one application still under review is Juul. The FDA issued an MDO to Juul in 2022, but quickly stayed its order and agreed to further review the application. In June, the FDA rescinded the denial order, returning Juul’s products to full scientific review.

    In its report, the FDA says it has also issued more than 18 million refuse-to-accept decisions, over 67,000 refuse-to-file decisions, and approximately 46,000 MDOs—most of them for bottled e-liquid made by small- to medium-sized manufacturers.

    The new progress report is the most recent in a series of reports mandated by the U.S. District Court for Maryland as part of its decision that forced the FDA to move the PMTA submission deadline forward.

  • More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    Credit: Chris Titze Imaging

    The U.S. Food and Drug Administration announced on July 25 that it had issued warning letters to 80 brick-and-mortar retailers in 15 states for selling unauthorized e-cigarette products, including Elf Bar and Lost Mary. 

    The regulatory agency also filed complaints for civil money penalties (CMPs) against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.

    “These warning letters and CMPs are a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. The 2023 National Youth Tobacco Survey, according to an FDA release, found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.

    Additionally, the brand Lost Mary—manufactured by the same firm as Elf Bar—was identified as popular or youth-appealing following an agency review of retail sales data and emerging internal data from a youth-use survey. 

    The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. Warning letter recipients have 15 working days to respond with the steps they will take to correct current violations and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including CMPs.

    For the retailers receiving the eight CMPs, the FDA previously issued warning letters for to them for selling unauthorized tobacco products. Follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking $20,678 from each retailer.

    These actions are the latest in the FDA’s ongoing efforts to address the marketing and sale of unauthorized e-cigarettes that appeal to youth. Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes, including in May, March, and February. As a result of these actions, the FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.

    To date, the FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. Further information on tobacco products that may be legally marketed in the United States is available in the FDA’s Searchable Tobacco Products Database.

  • New Vaping Regulations Begin Across Nebraska

    New Vaping Regulations Begin Across Nebraska

    Credit: Adobe Stock

    Nebraska is taking on new statewide vape regulations with a registry law that went into effect on July 19.

    It’s a double-edged law: one side, trying to keep electronic nicotine devices out of the hands of children, another aiming at broader consumer protections. The law prohibits vapes with advertisements targeting kids, like those with cartoon characters or ones that look like school supplies.

    “When I went around the state and met with law enforcement, I would always ask, ‘What is the top issues you’re seeing?’” Nebraska Attorney General Mike Hilgers said. “And one of the top five issues I saw around the state and heard from them were vapes in the hands of children, hands of kids,” according to media reports.

    The other side of the law aims to protect consumers from potentially harmful chemicals. It will set up a registry through the Department of Revenue. Companies will have to pay $75 for each type or model of vape device to get on the registry. By October 2025, it will be against the law to sell any product not on that list.

    “I think that what it will do is weed out the good actors from the bad actors,” said Sarah Linden, owner of Generation V. Linden helped work on the regulations, aiming to destigmatize an industry she said is designed to help people stop smoking.

  • FDA OKs Vuse Alto Tobacco-Flavor Pods, Device

    FDA OKs Vuse Alto Tobacco-Flavor Pods, Device

    The U.S. Food and Drug Administration authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway.

    Following an extensive scientific review, FDA issued marketing granted orders to R.J. Reynolds Vapor Co. for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable:

    • Vuse Alto Pod Golden Tobacco 5%
    • Vuse Alto Pod Rich Tobacco 5%
    • Vuse Alto Pod Golden Tobacco 2.4%
    • Vuse Alto Pod Rich Tobacco 2.4%
    • Vuse Alto Pod Golden Tobacco 1.8%
    • Vuse Alto Pod Rich Tobacco 1.8%

    While the FDA says it remains concerned about the risk of youth use of all e-cigarettes, youth are less likely to use tobacco‐flavored e-cigarette products compared to other flavors.

    According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarettes.

    However, only 6.4 percent of students who currently used e-cigarettes reported using tobacco‐flavored products. To further mitigate youth use of these products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.

    The FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of those applications. To date, the agency has authorized 34 e-cigarette products and devices, including the seven authorized today.

    A list of all authorized e-cigarette products is available here.

  • Critics Blast UK’s Focus on Generational Tobacco Ban

    Critics Blast UK’s Focus on Generational Tobacco Ban

    Image: Benjaminet

    The new U.K. government’s intention to progressively increase the age at which people can buy cigarettes will not achieve its objectives, according to the smoker’s group Forest.

    Responding to an announcement in today’s King’s Speech, the annual ceremony in which the British monarch sets out the policies of and proposed legislation that the government plans to introduce, Forest Director Simon Clark said the measure would fail to stop people smoking. Instead, he warned, it would drive more people to the black market and make smoking cool again.

    SImon Clark

    Originally proposed by former Prime Minister Rishi Sunak, the generational tobacco ban would make it illegal for anyone born on or after Jan. 1, 2009, to ever legally buy cigarettes, effectively raising the legal age of purchase by one year, every year.

    The measure passed its first parliamentary hurdle in April but was put on hold after Sunak, a conservative, called a national election, which was won by the Labour party.

    While vowing to ditch many Tory policies, Labour reiterated its commitment to the generational tobacco ban, prompting criticism from smoker rights activists.

    “Labour, like the previous Conservative government, is addicted to the nanny state,” said Clark.

    “It’s ironic that Labour wants to reduce the voting age to 16 whilst denying adults the freedom to legally purchase cigarettes.

    “If you are old enough to drive a car, join the army and buy alcohol, you are old enough to buy cigarettes and other tobacco products.”

  • King Confirms UK Generational Ban Moving Ahead

    King Confirms UK Generational Ban Moving Ahead

    Credit: Michael

    The new Labour government will propose a bill to gradually raise the legal age for purchasing cigarettes and impose restrictions on the sales and promotion of vaping products, as confirmed by the UK’s King Charles III in a speech.

    Under the proposed Tobacco and Vapes bill, children born on or after Jan. 1, 2009 will never be able to legally be sold cigarettes.

    The bill will also stop vapes and other consumer nicotine products from being deliberately branded and advertised to appeal to children.

    The Tobacco and Vapes bill was proposed under the previous Conservative government and was voted through the House of Commons in April, according to media reports.

    It has also passed the Committee stage but must still pass a third reading in the House of Commons, three readings in the House of Lords, amendments, and Royal Assent before becoming legislation.

  • FDA Officially Issues Notice of Better Web Portal

    FDA Officially Issues Notice of Better Web Portal

    Credit: Postmodern Studio

    According to a release, today, FDA’s Center for Tobacco Products (CTP) issued two notices in the Federal Register regarding its intention to launch CTP Portal Next Generation—an improved web portal for the submission of applications for certain new tobacco products—next year.

    The improvements are intended to:

    • Streamline electronic submission into one system for substantial equivalence (SE) reports and premarket tobacco product applications (PMTAs), amendments to previous submissions, and submission of general correspondence;
    • Introduce a more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, FDA’s eSubmitter Desktop Tool, and FDA’s CTP Portal Web application in one place;
    • Provide tools to expedite data entry, guide applicants to relevant sections, and verify that the applicant has provided all required data.

    No action is needed from current users of any CTP systems regarding these planned improvements. Existing CTP Portal accounts, along with any pending or in-process applications, will be automatically migrated to the new CTP Portal Next Generation.

    CTP is committed to ensuring a smooth transition to CTP Portal Next Generation and will provide additional communication and support, including resources on how to use the new system, leading up to the change.