Tag: regulation

  • Louisiana 21-to-Vape Bill Heads to Governor’s Desk

    Louisiana 21-to-Vape Bill Heads to Governor’s Desk

    A bill proposing to raise the legal age for vaping in Louisiana from 18 to 21 cleared its last hurdle in the Louisiana Legislature. The House gave final passage to House Bill 473 authored by state Rep. Buddy Mincey by a vote of 91-0.

    Credit: Gustavo Frazao

    The bill now heads to the desk of Gov. John Bel Edwards. It is unclear if Edwards will sign the bill into law or veto it, according to The Advertiser.

    Mincey said he was asked by a high school administrator to bring the bill because of rampant vaping on the Denham Springs High School campus. “I really wasn’t sure I wanted to do it because a similar bill got killed in the House two years ago, but then I saw a survey showing kids are vaping 100 times a day,” Mincey said in an interview with USA Today Network. “The results made it really obvious we needed to do something.”

    Mincey said all but 17 states have already raised the age to 21 to comply with federal law. The bill makes it illegal for people younger than 21 to buy or use the products. “Vaping has become so prevalent among young people; my concern is on the long-term health impacts,” Mincey said. “It’s clear what smoking does to your health, but we don’t know all of the long-term impacts of vaping.”

  • Revised Philippines Vaping Rules Heads to Senate

    Revised Philippines Vaping Rules Heads to Senate

    The House of Representatives in Philippines today approved on final reading a proposal that would regulate the manufacture, use, sale, distribution, and promotion of electronic nicotine- and non-nicotine-delivery systems (ENDS/ENNDS), as well as heated tobacco products (HTPs), according to a government release.

    Credit: Craitza

    With 192 affirmative votes, 34 negative votes, and four abstentions, the chamber passed on third reading House Bill 9007, otherwise known as the “Non-Combustible Nicotine Delivery Systems Regulation Act.” Rep. Sharon Garin, principal sponsor of the measure, said the bill seeks to address the unintended or potential adverse consequences on the use of HTPs and vaping products among Filipino consumers.

    “We have included in this bill mechanisms on controlling safety risks and preventing youth uptake of all tobacco and nicotine products,” she said during the virtual session.

    • The bill provides protection to minors from accessing ENDS/ENNDS or HTPs by setting the minimum allowable age for the purchase, sale, and use of such products to 18 years old.
    • Retailers shall ensure that no individual purchasing these products are below 18 years old by verifying the age through presentation of any valid government-issued identification card exhibiting the buyer’s photograph and age or date of birth.
    • The sale and distribution of the products shall be prohibited within 100 meters from any point of the perimeter of a school, playground or other facility frequented by minors shall be prohibited.
    • Online trade through Internet websites or via e-commerce and other similar media shall be allowed provided that sellers ensure that access is restricted to persons 18 years old or older and that the internet website bears the signage required by the bill.
    • Advertisements of the products shall be allowed in retailer establishments, through direct marketing, and on the internet.

    “These shall not be aimed at or particularly appeal to persons under 18 years of age. These should not undermine quit-smoking messages and should not encourage non-tobacco and non-nicotine users to use ENDS/ENNDS and HTPs. These should not contain any information that is untrue in particular with regard to product characteristics, health effects, risks, or emissions,” the bill states.

    The use of ENDS/ENNDS or HTPs shall be prohibited in all enclosed public places, as well as in schools, hospitals, government offices, and facilities intended particularly for minors. However, there shall be designated vaping areas that should comply with standards specified in the proposed law.

    The Department of Trade and Industry, in consultation with the Food and Drug Administration, the National Tobacco Administration, and other concerned agencies shall promulgate rules, regulations, and standards on packaging, ingredients, graphic health warnings, detailed information on the allowable nicotine-containing e-liquid, the strength of e-liquids, compliance with applicable electrical standards as well as with applicable industry standards for batteries, according to the release.

    Existing industries and businesses affected by the implementation of the Act shall be given an 18-month transitory period from the effectivity of the implementing rules and regulations to comply with the requirements.

  • CAPHRA: Philippine’s 21 Age to Vape Rule ‘Nonsensical’

    CAPHRA: Philippine’s 21 Age to Vape Rule ‘Nonsensical’

    A new bill to regulate vaping products in the Philippines is supported by the region’s vapor advocacy groups. House Bill 9007, the proposed “Non-Combustible Nicotine Delivery Systems Regulation Act” is a “massive legislative achievement for tobacco harm reduction advocates” in the Philippines, says Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

    Clarisse Virgino and Peter Paul Dator of CAPHRA

    “Nearly 90,000 Filipinos die from smoking-related diseases every year. This legislation will not only save thousands of lives, but the Philippines is now leading the way in the Asia-Pacific region with reasonable, risk proportionate regulation which will be very effective in curbing smoking rates,” said Loucas.

    Consumer advocates in the Philippines promoted the regulation of e-cigarettes as a consumer product. They argued that the “age of majority” in the Philippines is 18 – they age to purchase combustible tobacco products, alcohol and get married – so the current age to purchase vaping products set at 21 was “nonsensical.” Supporting the minimum age for the purchase, sale and use of such products to 18 would bring vapor products in line with other “adult” activities and privileges.

    At the same time, the advocates argued adult smokers keen to quit tobacco need reasonable access to safer alternatives and restricted advertising should be permitted. Product safety standards were also critically important to the consumer advocates.

    Clarisse Virgino, the Philippine representative of CAPHRA, said she is “delighted that the country’s legislators have listened,” adding that the prospect of more Filipinos successfully quitting smoking is of historic significance given the country’s “stubbornly high” smoking rates for decades.

    “The proposed Act will legitimize the market of vaporized nicotine products which means that consumers will have better protection. We hope that the Senate will also support this bill to provide millions of Filipino smokers with less harmful alternatives to combustible cigarettes,” said Virgino.

    Consumer groups in the Asia-Pacific region have launched a petition that urges the World Health Organization (WHO) to respect consumer rights ahead of its next biennial meeting of the WHO Framework Convention of Tobacco Control (WHO FCTC) in November. They are asking for supporters to sign and share the petition at change.org/v4v-petition.

  • Lawmaker Brings Back Bill for Vapor Usage Reporting

    Lawmaker Brings Back Bill for Vapor Usage Reporting

    Utah Rep. Chris Stewart has joined two other members of U.S. Congress to reintroduce a bipartisan bill aimed at providing more accurate information regarding electronic cigarette use. Presently, electronic health records (EHRs) allow doctors to record whether a patient uses traditional cigarettes or cigars, however, there are no options for e-cigarette or other harm reduction products, according to a press release from Stewart’s office.

    Credit: Lazy Llama

    The bill, called the Accurate Reporting of Smoking Variants Act, would require the National Coordinator for Health Information Technology to ensure that the electronic health records include options for vapor products and other reduced harm variants, such as heat tobacco products.

    According to the press release, the change would allow for health care providers and researchers to better understand the prevalence of e-cigarette usage, understand the long-term health impacts of these products, and develop strategies to curb vaping among young people.

    “Young people in Utah and across the country are using e-cigs at alarming rates,” said Stewart. “I’m proud to reintroduce this bipartisan bill in an effort to take concrete steps to reverse this trend. There’s no denying it: This is a public health crisis that demands action. Let’s give health providers and researches the tools they need to ensure a healthier America for future generations.”

    Co-sponsoring the bill along with Stewart are Reps. David Trone of Maryland and Raja Krishnamoorthi of Illinois.

  • FDA to Discuss Scientific Review of PMTA Submissions

    FDA to Discuss Scientific Review of PMTA Submissions

    Photo: Grandbrothers

    The U.S. Food and Drug Administration Center for Tobacco Products (CTP) will host a virtual meeting June 11 from 13:00 to 15:30 Eastern Daylight Time. The meeting will discuss the scientific review of tobacco marketing applications received by Sept. 9, 2020. It will focus on the application intake process, review progress and allocation of review resources. There will be time allotted for audience questions as well.

    Matt Holman

    The meeting will feature a presentation from CTP Office of Science Director Matt Holman and include a question-and-answer session. Other Office of Science staff participating in the meeting include Todd L. Cecil, deputy director for regulatory management; Crystal Allard, director for the division of regulatory science and informatics; Joanna C. Randazzo, D.C., acting chief for the science policy branch; and Cristi Stark, director of the division of regulatory project management.

    The CTP Office of Science is responsible for identifying, developing and enhancing the science related to tobacco products, their use, and the resulting morbidity and mortality so that regulatory decisions will have the greatest impact on improving public health.

    The Office of Science provides the scientific support for regulations and guidance, reviews tobacco product applications, evaluates the knowledge basis for regulatory decisions and carries out research to fill the gaps in scientific knowledge related to tobacco product regulation.

    For more information, click here.

  • The Smoker’s Alternative Receives FDA Warning No. 104

    The Smoker’s Alternative Receives FDA Warning No. 104

    The agency isn’t slowing down. In the U.S. Food and Drug Administration’s (FDA) quest to relieve the market of illegal vapor products, the regulatory agency has issued 104 warning letters since Jan. 1, 2021. The latest recipient is Texas-based The Smoker’s Alternative. The letters were sent today May, 11, and posted the FDA’s website the same day.fda

    The FDA states that The Smoker’s Alternative did “manufacture, sell, and/or distribute to customers in the United States The Smoker’s Alternative Vanilla Custard 60 ml 3mg e-liquid product without a marketing authorization order.” In order to legally sell vaping products, a company must have submitted a premarket tobacco product authorization (PMTA) to the FDA’s Center for Tobacco Products by Sept. 9, 2020.

    The FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

    :Your firm is a registered manufacturer with over 1,800 products listed with FDA,” the FDA letter to The Smoker’s Alternative states. “It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”

    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.

  • The People’s House

    The People’s House

    Montana vape shop owner Ron Marshall is taking the right to vape to a whole new level.

    By Maria Verven

    Ron Marshall, who owns Freedom Vapes with three vape shops in Montana, is taking the right to vape to the people’s house. Marshall ran for election to the Montana House of Representatives and won in the general election last November. A Republican, Marshall assumed office in January and will represent District 87—a section in the far western region of the state—for the next two years.

    Even before he took office, Marshall worked on two pro-vaping bills—B106, which seeks to prohibit expansion of the Montana Clean Indoor Air Act, and HB137, which seeks to revise the laws around vaping and alternative nicotine products. “Writing laws should be done in this house—the people’s house,” Ron Marshall told members of the House Human Services Committee during a hearing at the state capitol in January.

    Making a Difference at the State Level

    Although the U.S. Food and Drug Administration classifies vapor devices as tobacco products, Marshall’s bill HB137 seeks to differentiate the two. If passed, the bill would cancel bans on indoor vaping and on the sale of flavored nicotine solutions as well as previous anti-vaping regulations enacted by various counties and cities in Montana.

    In short, the bill would prevent the state of Montana from regulating the sale, manufacture, flavoring, marketing, product display, public exposure and access to “alternative nicotine products or vapor products.” Opponents said the bill would prevent individual communities from deciding what is best for them and that enacting the legislation would result in increased use of the addictive flavored nicotine products by young people.

    Vapers and vape shop owners gave passionate testimony in favor of the bill, asserting that the state legislature should adopt rules for businesses that ensure reliable access to vapor devices, which are primarily used by smokers to help them quit combustible cigarettes. “Everyone that owns vape shops share the same mission as myself and my family—to help people whom everyone has forgot[ten] about—the daily smokers,” testified Keith Bowman, part owner and general manager of six e-cigarette vape stores in Montana. 

    Fighting an Uphill Battle

    In 2019, the Montana Department of Public Health and Human Services enacted an emergency rule prohibiting the sale of flavored e-cigarettes. Last November, the city of Missoula became the first in the state to permanently ban the sale of flavored e-cigarettes. The state health department also proposed a permanent statewide ban on flavors but ultimately backed down after facing pushback from legislators. Nearly a dozen counties in Montana prohibit indoor vaping.

    Ron Marshall / Credit: State of Montana

    These anti-vape policies have harmed vape businesses across the state, Marshall said. “During the 2019 session, we defended against eight anti-vaping bills around taxes and clean indoor air. It was out of control,” he said. “We have no problem with sales to customers 18 years or older. The shops had already been doing that without being told. We wrote our own bill to curb youth access through store purchases. It didn’t make it out of committee, but the seeds had been sown.

    “Our problem is being called a tobacco product. We are not. Our bill separates tobacco products from alternative nicotine products. We aren’t the same by law in Montana,” he said, explaining that they pay $5 each year to the Department of Revenue for a license to sell alternative nicotine products.

    Marshall finally decided to take the fight to the people’s house and ran for the House of Representatives in his district.

    “Our current representative termed out, and the seat was open. After a three-way primary and general election, we won! It was a great feeling and a sobering experience,” he said. “The experience you have in everyday life is transmitted to how I look at legislation. If it sounds fishy, it probably is. Ask tough questions. Every time you vote on a bill, it will change someone’s life.”

    The Joy of Helping Others Quit Smoking

    The Marshalls started their vape business in 2014 after Ron’s wife Deanna suffered from a bad respiratory infection. “She used a disposable V-2 device that someone had recommended, and it worked great for her. After about 10 days, the infection healed. She tried to smoke a cigarette, but it was so disgusting, she couldn’t do it.

    “Being a smoker myself, I gave it a try,” Marshall said. “It was good, but not great. Deanna searched the internet looking for something better and found it in the form of SMOK Ego pens. We gave them a try, and it was perfect for both of us. It took me about 10 days to quit smoking completely.

    “After that, several people asked us how we did it. The answer was simple. The hard part was accessibility. There were no vape shops in Montana.”

    So, in February 2014, the Marshalls opened their own vape shop. “It was slow at first. Deanna put all her time and energy into it. I was only able to be in the shop two days a week,” Marshall said. “But after it took off, it was great. The joy of helping others get away from smoking and improving their lives was a reward that cannot easily be explained.”

    Freedom Vapes now has 10 employees with stores in three locations—Hamilton, Missoula and Belgrade. The Marshalls said most of their customers vape as a way to wean themselves off combustible tobacco products. While they and other vape shops refuse to sell products to anyone under age 18, young people can still buy products online, Marshall said.

    And while all of Freedom Vape’s flavorings are water-based, online products can potentially contain harmful contaminants. Still, other vapers may resort to mixing their own vape juice if a ban goes into effect.

    “That’s very dangerous,” Marshall said. “If they don’t get the right flavoring or use oil-based materials, they can harm themselves. We tell our customers not to buy anything off the street or use any product if they don’t know its source. This ban won’t make the problem go away. It will make it more of a problem.”

    Perspective From the ‘Inside’

    Marshall said it’s totally different being on the “inside.” “It’s a whole different outlook. I spend lots of time in committee hearings on lots of issues. Plus, you need to draft your own legislation and get it through the system.”

    Marshall had worked on his bill HB137 even before he was elected. After the election, a legislative drafter contacted him to ask what section of the Montana code the bill dealt with. A rough draft was sent back to him for input and adjustments before going through legal and other reviews.

    “Once it was done, I signed the bill, and then it was off to committee assignments. The committee’s job is to look at the intent of the bill. The intent of HB137 is simply to prevent local cities, counties or state bureaucrats from banning a legal product. It defines and categorizes flavors and definitions of alternative nicotine products and vapor products.”

    HB137 then made its way out of committee and on to the floor of the House. When the hearing was held in the House Health and Human Services committee, it was loaded with all the ANTZ (anti-vaping) groups. “It was easier for them to load the hearing with opponents—most of whom were from out of state—because they had to use Zoom during this Covid stuff. We have heard this all before. Nothing new here,” Marshall said.

    Montana’s 100 lawmakers then debated it on the floor. “It was tough, but it made it,” Marshall said. The vote was 62 in favor and 37 opposed. “Some of the opposed injected their own personal beliefs into the vote. That is bad policy. You should not dictate your lifestyle on others.

    “As a representative of the people, it is their—the people you represent—decision. If HB137 makes it through the Senate and to the Governor’s desk, it will make sure that the people of Montana have access to a product they want.

    “It will ensure that small businesses won’t be shut down and closed. Montana will be a vape-friendly state for both consumers and business owners.”

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.

  • Governor Inks Bill to Regulate Vapor Products in Florida

    Governor Inks Bill to Regulate Vapor Products in Florida

    Florida lawmakers have overwhelmingly passed a bill signed by Governor Ron DeSantis Friday that will create a state regulatory framework for the sale of electronic cigarettes. The bill (SB 1080) will take effect Oct. 1. Among other things, the bill will raise the state’s legal age to vape and smoke tobacco to 21, a threshold already established in federal law.

    Credit: Giban

    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.

    House sponsor Jackie Toledo, R-Tampa, said before the bill passed that it is aimed at preventing minors from using electronic cigarettes. “This bill is necessary to stop youth vaping,” Toledo said.

     

  • FDA: 102 Warnings for Illegal E-liquid Sales so Far in 2021

    FDA: 102 Warnings for Illegal E-liquid Sales so Far in 2021

    It is now at 102 in 2021. Posting on its website on April 30 that it has issued six more warning letters to companies for marketing illegal e-liquids, the U.S. Food and Drug Administration (FDA) continues its blitz to pull any vaping products from the U.S. market that haven’t submitted a premarket tobacco product application (PMTA) to the FDA’s Center for Tobacco Products.

    Credit: Yuri Hoyda

    Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The companies receiving the letters on April 9, the products they were cited for and the number of products each has registered with the FDA include:

    • Smoking Fire Vapor: e-liquid products without a marketing authorization order including: Smokin’ Fire Vapor Captain Custard and Smokin’ Fire Vapor Wrecking Ball; registered manufacturer with over 180 products listed with FDA.
    • Simply E-Juice: e-liquid without a marketing authorization order including: Simply Bodacious Blueberry and Simply Glorious Grape; registered manufacturer with over 200 products listed with FDA.
    • Smokecignals: e-liquid products without a marketing authorization order including: Blue Puppet and Black Frost; registered manufacturer with over 100 products listed with FDA.
    • Rocky Top Vapor: e-liquid products without a marketing authorization order including: RTV LTD Berry Shake and RTV LTD Pink Lemonade;  registered manufacturer with over 470 products listed with FDA.
    • VaporBombCOM: e-liquid products without a marketing authorization order including VaporBomb.com: Cafe Mocha and Cinnamon Danish Swirl; a registered manufacturer with over 2,200 listed with FDA.
    • B-X Vapor: e-liquid products without a marketing authorization order including: B-X Vapor Dad’s Milk and B-X Vapor Watermelon Crack; registered manufacturer with over 1,100 products listed with FDA.

    The regulatory agency has now issued warning letters to 102 companies in 2021 for violating PMTA rules. 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.

    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.

  • 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