Category: Regulation

  • UK Motor Group Calling for Ban on Vaping While Driving

    UK Motor Group Calling for Ban on Vaping While Driving

    Credit: Monkey Business

    A motoring group in the United Kingdom is calling for the government to change laws on vaping and driving. With vaping at record levels, motoring experts at LeaseCar.uk are calling for an urgent ban on smoking e-cigarette devices when behind the wheel, according to an emailed press release.

    In the UK, it is a legal requirement to drive with due care and attention, and the experts at LeaseCar.uk say there is no way people can adhere to this standard of driving while vaping. Aside from causing drowsiness and dizziness, the devices emit vast clouds of smoke, which restricts vision, making it impossible to be aware of surroundings, the release states.

    “Drivers not in complete control of their vehicle could receive penalties such as an unlimited fine, 9 points and a discretionary disqualification,” the release states. “In extreme cases, if someone is injured or killed due to careless driving, they could be jailed.”

    In the UK, the only current law around smoking and driving is that it is illegal to smoke with someone under 18, but this doesn’t apply to vaping. Tim Alcock from LeaseCar.uk said that it is only a matter of time before there are more fatalities on the road due to vaping.

    “There has been growing concern over the effects of vaping, but we do know that there are high levels of nicotine in the devices, which is highly concerning from a driving point of view,” he said. “E-cigarettes that contain nicotine cause dizziness and lightheadedness, which is highly dangerous, putting both the driver and other road users at risk.

    “It is appalling that drivers are still allowed to vape with children in the car given the immediate dangers on the road and long-term medical side effects which are still being researched. Not only that, as people puff at the devices, the vast clouds of smoke create a massive hazard as it blocks and restricts vision. We are calling for the government to make urgent changes to current motoring offenses and consider just how dangerous vaping at the wheel is.”

  • Zanzibar to Ban Import and Consumption of Vape Products

    Zanzibar to Ban Import and Consumption of Vape Products

    Zanzibar authorities plan to impose a ban on import and consumption of shisha and e-cigarettes, according to The Citizen.

    “We are all witnesses—the consumption of shisha and e-cigarettes has become commonplace, and we shall come up with a special regulatory law to govern those who will have special permits to import and sell shisha or electric cigarettes,” said Masoud Ali Mohammed, Zanzibar’s minister of state, office of the president, regional administrations, local governments and SMZ departments.

    Current importers have been advised not to restock products but rather to reach out to authorities for new directives. “Do not order more products after your current stock is depleted,” said the minister. “You will have to follow the new laws that the government is going to issue.”

  • U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

    U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

    Credit: Pastel Cartel

    The U.S. Food and Drug Administration is continuing its crackdown on illegal disposable vape devices. The regulatory agency has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. 

    “The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.” 

    The warning letters are the result of a nationwide retailer inspection blitz over the past several weeks cracking down on the sale of these unauthorized e-cigarettes.

    The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people, according to an FDA release. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.

    “All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

    Last month, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on the red list, which makes them subject to Detention Without Physical Examination and allows the FDA to detain a product without physically examining it at the time of entry.

    Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA.

  • Second Circuit Appeals Court Rules in Favor of FDA

    Second Circuit Appeals Court Rules in Favor of FDA

    Credit: Brian Kinney

    A federal appeals court has ruled that the U.S. Food and Drug Administration didn’t change its position on admissible evidence and the agency’s failure to consider a marketing plan didn’t impact the outcome.

    The FDA acted reasonably in denying vapor maker Magellan Technology Inc.’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the Second Circuit ruled Friday.

    The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

    The agency found Magellan’s evidence—four non-clinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine delivery systems (ENDS) in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberglaw.

    The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process which cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full Second Circuit) or could appeal to the Supreme Court of the United States. 

  • Malaysia MPs Want Liquid Nicotine Back on Poisons List

    Malaysia MPs Want Liquid Nicotine Back on Poisons List

    Credit: Adobe Stock

    Opposition MPs in Malaysia are amplifying calls for the reintroduction of liquid nicotine into the Poisons Act 1952.

    Kuala Langat MP Ahmad Yunus Hairi, who heads Perikatan Nasional’s (PN) health portfolio, said the absence of regulations on vape has led to a proliferation in the number of teens using e-cigarettes or vaping products.

    “By excluding liquid nicotine from the Poisons Act, we have inadvertently created loopholes that undermine our efforts to combat the use of vaping among our youth.

    “I hope liquid nicotine can be reinstated into the Poisons Act, given the Health Minister’s authority over the matter, so that, at the very least, before we proceed with the Control of Smoking Products for Public Health Bill 2023, we can have some control over these e-cigarette devices,” Dr Ahmad Yunus said in his debate on the Health White Paper (HWP) tabled in Parliament, reports CodeBlue.

    Both the Malaysian Medical Association (MMA) and the Malaysian Pharmacists Society (MPS) have previously urged the government to bring liquid nicotine back under the control of the Poisons Act 1952, particularly in light of the uncertain status of the tobacco bill.

    The Control of Smoking Products for Public Health Bill, which regulates tobacco and vape products, remains in limbo after it was referred to the Health parliamentary special select committee (PSSC) – chaired by former Health Minister Dzulkefly Ahmad – immediately after first reading at the Dewan Rakyat on Monday.

    This means that vapes and e-cigarettes will remain legally available for sale to minors aged under 18 for at least another four months until the Lower House meets in October.

  • Clearwater, Florida Bans Vaping at Beach, Parks

    Clearwater, Florida Bans Vaping at Beach, Parks

    The city of Clearwater in the U.S. state of Florida approved a ban on vaping and smoking on city-owned public parks and beaches.

    The city council unanimously approved the new ordinance and it goes into effect immediately.

    It includes combustible cigarettes, vapes and e-cigarettes, but does not include unfiltered cigars, according to WFLA.

    City council members said the ultimate goal is to reduce the environmental impacts on the community.

    The city said the ban would protect beachgoers and marine life.

    This comes a year after Gov. Ron DeSantis signed a law that allows cities and counties to decide if they want to enforce a smoking ban.

    The city of St. Petersburg has already implemented a similar smoking ban.

  • Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Credit: Adobe

    U.S. lawmakers are urging the Food and Drug Administration to wrap up its review of pending e-cigarette premarket tobacco product applications, reports Law360.

    In a letter to FDA Commissioner Robert Califf, 50 members of Congress requested the agency finalize its review of pending applications for e-cigarette products; deny applications for all nontobacco-flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.

    The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In its most recent filings with the court, the FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.

    “FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said Colorado Representative Diana DeGette in a statement. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”

    While the FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications—including those for popular products manufactured by Juul Labs, Reynolds Vapor Co. and Smok.

    The lawmakers urged the agency to complete its review of all its pending applications no later than Dec. 31, 2023.

  • Group: Debt Ceiling Could Limit U.S. FDA’s Budget

    Group: Debt Ceiling Could Limit U.S. FDA’s Budget

    Image: Tobacco Reporter archive

    The proposed debt ceiling budget could stress the U.S. Food and Drug Administration’s budget, according to Inside Health Policy.

    The legislation’s nondefense federal funding cap makes it harder for programs like the FDA’s budget to get funding increases, and it could threaten some agencies’ existing funds, according to Steven Grossman, director of the Alliance for a Stronger FDA. “This is never a good situation for agencies whose mission and responsibilities keep expanding each year, as is the case with FDA,” he wrote.

    The Fiscal Responsibility Act of 2023 caps nondefense federal spending at $704 billion for the next two years. According to Grossman, after taking out funding for Veterans Affairs medical care and appropriations adjustments, the remaining nondefense funds are about $637 billion, which is roughly unchanged from fiscal 2023.

    There is still room to determine how much funding can be specifically allocated to the FDA, though, according to Grossman, despite the FDA’s funding being limited by the macro-budgetary levels determined by the debt ceiling.

    “FDA’s mission and responsibilities are incredibly consequential and visible,” he wrote. “It needs resources to protect public health and safety and to set standards for products that encompass 20 percent of all consumer spending (about $2.7 trillion).”

    The House GOP’s FDA funding bill cleared the Appropriations FDA-agriculture subcommittee last month; it would provide $6.6 billion in total funding with $3.5 billion in flat discretionary funding.

  • WHO: Uganda Holding Firm on Vaping Product Ban

    WHO: Uganda Holding Firm on Vaping Product Ban

    Credit: ATDR

    Uganda is standing firm on its eight-year-long ban on the sale of electronic cigarettes according to the World Health Organization (WHO) Country Representative Yonas Tegegn Woldemariam.

    The Tobacco Control Act 2015 sought to effectively remove vaping products from the Uganda market.

    “Despite Uganda’s high and increasing burden of non-communicable diseases morbidity and mortality rates, one in ten people still smoke cigarettes daily, making the practice an ongoing and dire public health threat. This justifies the Tobacco Control Act and all the other government initiatives to regulate products, including e-cigarettes,” said Yonas.

    Uganda is one of the 35 countries globally where e-cigarettes are banned. The law bans the importation, manufacture, distribution, processing, sale, or offer for sale of e-cigarettes, including nicotine- and non-nicotine-containing e-liquids.

    The WHO agent also cited a retracted 2016 study reported in the Lancet journal that found that people who use or have used e-cigarettes are less likely to stop smoking.

    Even though legal consequences aren’t optimally enforced, it is encouraging to see that there are now comparatively fewer people smoking in public, according to the statement.

    Uganda is a signatory to the WHO Framework Convention on Tobacco Control, which provides countries with evidence-based strategies to address the tobacco epidemic in their national contexts.

    WHO continues to support the Ministry of Health Tobacco control initiatives, including sensitizing communities about the negative impacts of tobacco consumption on health and the environment, and encouraging local farmers to plant food rather than tobacco.

  • Shipping Vapes to Hawaii Could End in Jail Sentence

    Shipping Vapes to Hawaii Could End in Jail Sentence

    Credit: Lost in Midwest

    Shipping e-cigarettes or other tobacco products in Hawaii can land you in jail after Governor Josh Green signed new measures into law today.

    Under the new legislation, a person who knowingly and unlawfully ships vaping and other tobacco products valued at less than $10,000 could face misdemeanor charges.

    Anything valued above $10,000 would be classified as a class C felony.

    The governor said this change will help to better regulate smoking products that enter the state.

    “Tobacco is poison ok and tobacco use continues to be the single most preventable cause of disease that we could deal with, that we can affect when we make good decisions as policymakers, it causes death in the united states, so this is a monumental first step in protecting our keiki from big tobacco,” he said.

    Any business selling vaping products must have a retail tobacco permit from the state. The new law takes effect on July 1st.