Tag: regulation

  • New Zealand Vape Group Says Government Supports Vaping

    New Zealand Vape Group Says Government Supports Vaping

    A New Zealand vaping advocacy group says that the government spending over $1.6 million on its Vape to QuitStrong campaign is proof New Zealand’s leaders believe vaping is the most effective smoking cessation tool. “It’s now urgent that belief is also reflected in the country’s final vaping regulations and smokefree action plan, says a leading tobacco harm reduction advocate,” the Aotearoa Vapers Community Advocacy (AVCA) states in a release. “Official information released shows the Ministry of Health has funded a budget of $1,670,000 for the Vape to QuitStrong campaign between the 2019/2020 and 2021/2022 financial years.”

    Credit: Stock Snap

    The total budget for the campaign includes strategy development, creative development, media placement, agency fees, and an allowance for operational costs. “After some delays while last year’s vaping legislation was passed, it’s great the Vape to QuitStrong campaign was launched a few weeks ago. It has made a good splash on the likes of primetime television and radio, with poster and bus shelter campaigns in communities with a high smoking prevalence,” says Nancy Loucas, co-director of AVCA.

    Available on its website, the Ministry’s business case for the current campaign puts a strong focus on young Māori women who remain disproportionately represented in New Zealand’s smoking rates. “The Ministry of Health makes it very clear that vaping products can make a real contribution to the Smokefree 2025 goal as well as disrupt significant inequities. Subsequently, the Ministry confirms that Vape to QuitStrong centres on a behavioural change campaign that will support young Māori women to successfully switch to vaping,” she says.

    As well as supporting smokers to switch to vaping and stop smoking completely, the business case says a successful campaign will be defined by ‘reducing inequalities in smoking prevalence, particularly between Māori and non-Māori… and enable health practitioners, smokers and the broader community to better understand that vaping is significantly less harmful than smoking.

    However, AVCA is concerned that despite over $1.6 million of taxpayers’ money being spent on the Vape to QuitStrong’ campaign, the Government’s latest Smokefree 2025 reboot and its pending vaping regulations will both overlook the key role vaping can play in getting more Kiwis off deadly cigarettes.

    “Good on the Ministry of Health and the Health Promotion Agency on its work with Māori to deliver a campaign that they all know will be effective. These same people now just need to feed their extensive knowledge into the Government’s proposals for the Smokefree Aotearoa 2025 Action Plan as well as the final vaping regulations which will be signed off by Cabinet by the end of June. Otherwise, the best opportunities we have to free our at-risk communities from tobacco will be squandered,” says Loucas.

    AVCA is encouraging smokefree supporters, as well as vape consumers and businesses, to review and submit on the Government’s smokefree discussion document, released by Associate Health Minister Dr Ayesha Verrall, before 31 May 2021 via: https://www.health.govt.nz/publication/proposals-smokefree-aotearoa-2025-action-plan

  • Florida Bill Banning Local Vape Laws Goes to Governor

    Florida Bill Banning Local Vape Laws Goes to Governor

    The governor of Florida is expected to sign a bill that would ban local communities from enacting laws regulating e-cigarettes. The Florida House on Wednesday gave its final approval with a 103-13 and sent the bill (SB 1080) to Governor Rick DeSantis for a signature. The bill passed the Senate on Monday.

    Credit: Aleksandr Kondratov

    House sponsor Jackie Toledo told the Tallahassee Democrat that the bill is aimed at preventing minors from using electronic cigarettes. “This bill is necessary to stop youth vaping,” Toledo said.

    The bill would raises the state’s legal age to smoke and vape to 21, a threshold already established in federal law. It also would create a state regulatory framework for the sale of vapor products. The bill would ban vaping or smoking tobacco within 1,000 feet of a school and makes it illegal for local communities to create any regulations impacting the “marketing, sale, or delivery of, tobacco products.” It would also require retailers to obtain a “tobacco” permit.

    “Years of continued inaction by the state to regulate tobacco products, including e-cigarettes, demands strong, local laws that truly protect our children from a lifetime of addiction,” the American Cancer Society Cancer Action Network said in a statement this week. “Florida kids deserve effective protections, not to be left even more vulnerable to the industry and its predatory practices. And our localities have the right, freedom and responsibility to protect them, especially when the state won’t.”

    Backers of the proposals, however, have said they would help with enforcement of tobacco and vaping laws and that preemption of local regulations is needed because retailers could have multiple stores in different areas, which would make it hard to follow varying regulations and do business.

  • Montana Passes Bill to Stop Local Flavored Vapor Bans

    Montana Passes Bill to Stop Local Flavored Vapor Bans

    The Montana legislature on Monday passed a bill that would block local governments from banning the sale of flavored vaping products. The legislation has been sent to the governor’s desk. Senate Bill 398 was carried by Sen. Jason Ellsworth, a Republican from Hamilton. It cleared a final vote in the House, 59-40.

    Credit: Katherine Welles

    The bill says local governments may not adopt or enforce any ordinances or resolution that prohibit the sale of vaping products. Under the bill, a local government could enact a “reasonable” ordinance or resolution related to the sale of vaping products, according to helenaire.com. While the bill does not define “reasonable,” Ellsworth said to his thinking that could mean something like keeping products out of reach of children in stores or not allowing vaping in restaurants.

    Carrying the bill in the House on Monday, Missoula Republican Rep. Mike Hopkins said local governments shouldn’t have the authority to ban the sale of a legal product. “What they seek to do is make illegal what is a completely legal (product) and in the process of doing so smash the economic and financial lives of Montanans who are running businesses,” Hopkins said.

    Rep. Mark Thane, a Missoula Democrat, said flavored vaping products are meant to entice youth to take up vaping and that local ordinances are essential to public health. “We have a choice with this bill. We can side with Montana communities and allow them to retain a tool which they can use to help tackle this epidemic or we can prohibit local communities from taking that initiative,” Thane said.

    The 2019 Montana Youth Risk Behavior Survey shows that 58.3% of students had vaped in the 30 days prior to the survey. At one point, Ellsworth’s bill was voted down in the Senate before being revived.

    Earlier this session, Rep. Ron Marshall, R-Hamilton, brought a bill that would have barred a local government or the state Department of Public Health and Human Services from creating or continuing a regulation, ordinance or restriction related to vaping products. That bill passed the House in February but later was voted down in the Senate Business, Labor and Economic Affairs Committee. Marshall is a co-owner of a vaping shop.

  • 25% Wholesale Vapor Tax Clears Indiana Senate Hurdle

    25% Wholesale Vapor Tax Clears Indiana Senate Hurdle

    A bill in Indiana that will bring new taxes on vaping as well as a broad framework for disbursing future opioid litigation settlement cash is expected to be signed into law by Governor Eric Holcomb, today. It’s Indiana’s first-ever tax on e-cigarettes.

    Credit: Adobe Stock / Luzitanija

     

    The tax, which will take effect July 1, 2022, is split between wholesale and retail, with closed-system products like prefilled pods assessed 25 percent of the wholesale cost, and open-system products like bottled e-liquid being taxed at 15 percent of the retail price (a sales tax).

    A previous version proposed a 10 cent-per-milliliter tax on vaping fluid and an additional 10 percent percent excise tax on e-cigarettes and vaping products.

    Health advocates say the plan meets their goal of a tax rate comparable to the rate on traditional
    cigarettes, according to wibc.com. Indiana State Medical Association president Roberto Darroca says doctors are
    particularly concerned about discouraging teenagers from taking up vaping so they don’t get a
    taste for nicotine and move on to traditional cigarettes.

  • Alaska Legislators try Again to Tax Vapor Same as Tobacco

    Alaska Legislators try Again to Tax Vapor Same as Tobacco

    Legislators in the U.S. state of Alaska are trying again this year to tax “electronic smoking products” the same as tobacco products. Bills to extend the state’s tobacco tax to electronic smoking products died last March as lawmakers rushed to close down the session amid the start of the pandemic. However, two lawmakers are trying again this year.

    alaska state house
    Credit: David Mark

    The bills, sponsored by Kodiak Sen. Gary Stevens and Juneau Rep. Sara Hannan, have each cleared their first committee and are both waiting for a hearing in their respective Finance Committee before either could move to the full body for a vote.

    Alaska has no statewide tax on vapor products, although the state taxes smokeless tobacco at 75 percent of wholesale. Cigarettes are taxed at $2 a pack. HB 110 would enact a 75 percent wholesale tax on e-liquids, vaping devices, and components (HB 110 is the House version of SB 45).

  • FDA Issues 6 More Warnings for Vapor Marketing Violations

    FDA Issues 6 More Warnings for Vapor Marketing Violations

    The U.S. Food and Drug Administration (FDA) has issued 6 more warning letters to vapor companies for failing to submit a premarket tobacco product application. Oregon Vapor, Northwest Vapors, Legend Vapor, Flavor Concepts, Hi Lyfe Vapors and LJ’s E-Smokes all received letters and April 9 and the FDA posted the letters on its website on April 13.

    Today’s postings bring the total number of warning letters issued by the FDA to vapor companies for violating marketing rules to 90 this year. Oregon Vapor has 100 products listed with the FDA, Northwest Vapor has 4,400 and Legend Vapor has 2,500, according to the FDA. Flavor Concepts has 300 products listed, Hi Lyfe Vapors has 100 and LJ’s E-Smokes has 280 products registered with the regulatory agency.

    The FDA states that the companies failed to submit PMTAs by the required Sept. 9, 2020 deadline. The FDA also states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter.

    In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

    Vapor Voice and TMA have created a PMTA tracking tool to help find legal vaping products.

  • Str8Vape and Xtreme Vapour Receive FDA Warning Letters

    Str8Vape and Xtreme Vapour Receive FDA Warning Letters

    The U.S. Food and Drug Administration (FDA) handed down two more warning letters for vapor companies violating marketing rules for tobacco products on Thursday. Str8Vape and Extreme Vapour received letters for selling products without submitting a premarket tobacco product applications (PMTA) to the regulatory agency by the Sept. 9, 2020 deadline.

    The total number of warning letters for the illegal sale of vapor products now stands at 84 in 2021. The letters were posted on the FDA’s website on April 8, the same day the businesses received the warnings.

    The FDA states that is had determined that Extreme Vapour did “manufacture, sell, and/or distribute to customers in the United States the following Xtreme Vapour Babylon Vape Juice Pineapple 30ml e-liquid product without a marketing authorization order.” The company manufacturers over 80 products registered with FDA.

    The FDA states that is has determined Str8Vape did “manufacture, sell, and/or distribute to customers in the United States the following STR8VAPE AMERICAN BLEND 3mg 70VG/30PG 30ML e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 27,400 products listed with FDA.

    The FDA states that the companies failed to submit PMTAs by the required Sept. 9, 2020 deadline. The FDA also states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter.

    In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • Vapor Products Total 46% of All 2021 FDA Warning Letters

    Vapor Products Total 46% of All 2021 FDA Warning Letters

    In the first quarter of 2021, from Jan. 1 to March 31, the U.S. Food and Drug Administration (FDA) issued and posted a total of 166 warning letters. Compared to the same time period in 2020, only 97 total warning letters were issued. In 2020, the 139 letters issued by the Center for Tobacco Products comprised 22 percent of all warning letters issued by the FDA.

    Credit: FDA

    In the first quarter of this year, 80 of the 166 letters [that number is now 82], or 46 percent of warning letters, were related to tobacco products. The vast majority of products at issue were e-cigarette or e-liquid products that violated the FDA’s requirements for premarket approval before sale in the U.S.

    In virtually every warning letter for a tobacco product issued during the period under consideration, the FDA cited the manufacturer because their e-liquid products were considered new tobacco products, and had not submitted a premarket tobacco product application (PMTA), and were not subject to an exemption from the rule, according to Katie Insogna, an analyst with law360.com.

    As a result, the products were considered adulterated under Section 902(6)(A) of the Food, Drug and Cosmetics Act (FDCA). The agency also flagged many of these products for being misbranded under Section 903(a)(6) of the FDCA, because a notice or other information respecting these products were not provided as required by Section 905(j) of the FDCA.

    Manufacturers are responsible for ensuring their tobacco products and all related labeling and/or advertising — including on websites, social media and search engines — comply with each applicable provision of the FDCA and the FDA’s implementing regulations. In many of the recent warning letters, the agency acknowledges that the recipient is a registered manufacturer with thousands of products already listed with the FDA.

    As is customary in the case of most FDA warning letters, the agency has typically provided 15 working days for companies respond. Failure to address any violations may lead to regulatory action — including, but not limited to, civil money penalties, seizure and/or injunction. Because many of these companies already maintain authorizations for other tobacco products, they run the risk of additional regulatory scrutiny and negative action when they are flagged for selling unauthorized products, writes Insogna.

    Many of the FDA’s warning letters centered on Covid-19-related products making false claims. Like Covid-19-related products, tobacco products — especially vaping products — are receiving exceptional regulatory scrutiny. Companies marketing products in both of these categories should be particularly cautious of applicable federal regulations, to avoid negative action.

  • FDA Cleaning House With 80 Vapor Warning Letters in 2021

    FDA Cleaning House With 80 Vapor Warning Letters in 2021

    The total number of warning letters issued by the U.S. Food and Drug Administration (FDA) to e-liquid manufacturers for illegally marketing vapor products now stands at 80 in 2021. The FDA issued four more warning letters for marketing illegal vapor products. Kidney Puncher, Vapor Gold, Violet Vapor and Voltage Vapor all received letters on March 26 and those letters were posted to the FDA’s website on April 1.

    The FDA states that the company’s failed to submit premarket tobacco product applications (PMTA) by the required Sept. 9, 2020 deadline. The FDA also states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter.

    Kidney Puncher has more than 1,000 products registered with the FDA; Vapors Gold has more than 500; Voltage Vapor has more than 1,500 products registered; and Violet Vapor has more than 4,900 products listed with the regulatory agency.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • Philippine Dept. of Education Supports Vapor Rules

    Philippine Dept. of Education Supports Vapor Rules

    Credit: GEO TV

    The Department of Education (DepEd) in the Philippines has expressed its support towards stricter measures on electronic nicotine delivery systems (ENDS) and electronic non-nicotine delivery systems (ENNDS), according to a statement penned by the agency’s leader.

    “On matters related to substance use prevention, education alone is not enough. In their classes, we teach our learners how to reject harmful substances. Outside these classes, we need policies and structures that will help reinforce our learners’ health-promoting choices, complementing what we teach them in school,” Secretary Leonor Magtolis Briones wrote in her support statement. The letter was released during a public hearing on the provisions of the Vaporized Nicotine Products Regulation Act, according to press note.

    The Senate hearing explored regulations on age restriction, online trade, product flavors, among other items. Currently, vaping products and heated tobacco products (HTPs) are already regulated under Republic Act 11467 (RA 11467), signed by President Rodrigo Roa Duterte in January 2020. Under RA 11467, selling vapor products and HTPs to persons below 21 years old is prohibited. However, the pending bills in the Senate, similar to the substitute bill at the House of Representatives, intend to reduce the minimum age of restriction to 18.

    “This a real concern for us in DepEd. Before the pandemic, the Philippine Pediatric Society (PPS) has coordinated with us to explore the determinants of e-cigarette use among [Grades 7 to 9] learners [and results showed] that 6.7 percent [of 11,500 learners surveyed] have tried and are using e-cigarettes,” Briones said.

    The PPS survey results showed that the top reasons for using vape among DepEd learners are online accessibility (32%), varied flavors (22%), and the belief that e-cigarettes are safer than tobacco (17%).

    “Especially now that we are in a pandemic, I appeal to our legislators to approach the issue from a health perspective. We are all first-hand witnesses of how any threat or attack to a country’s health system eventually affects every other sector of public life, from economics to education,” Briones noted in her statement.