The New Taipei City Council on Thursday approved an ordinance to ban the sale of e-cigarettes. If approved by the Executive Yuan, the legislation would make New Taipei the first of the nation’s six special municipalities to impose such a ban if it is approved.
Credit: Busara
The draft regulation prohibits manufacturing, importation, sale, display and advertising of vaping devices, and heated tobacco products and components without an individual drug or medical device license issued by the city government, according to the Taipei Times. Violators of the ban would be fined NT$10,000 to NT$100,000, and sales licenses of repeat offenders would be suspended, the draft regulation states.
It also prohibits people under the age of 18 to use smoking devices banned from sale in the city and violators of the rule must attend smoking cessation classes, and those who fail to attend the classes would be fined NT$2,000 to NT$10,000. New Taipei City Department of Health Director Chen Ran-chou said that the ordinance seeks to protect people from the health risks of e-cigarettes and safeguard public health.
The draft regulation was sent to the Executive Yuan and would take effect three months after it is approved, she said. The Taipei City Council is also reviewing a similar draft regulation, which is expected to clear the council next week.
On the national level, the Ministry of Health and Welfare has proposed an amendment to the Tobacco Hazards Prevention Act, seeking to raise the legal age for smoking from 18 to 20 and regulating e-cigarettes and related products. That amendment would move to the legislature for approval if approved by the Executive Yuan.
The U.S. Food and Drug Administration has stated its intent to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors (including menthol) in cigars. In a statement released today, the agency said it is working toward issuing proposed product standards within the next year. The plan does not include noncombustible products, such as e-cigarettes.
“This decision is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important previous actions that banned other flavored cigarettes in 2009,” the FDA wrote in its press release.
“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” said acting FDA Commissioner Janet Woodcock.
“With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers and address health disparities experienced by communities of color, low-income populations and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.”
According to the FDA, there is strong evidence that a menthol ban will help people quit. “Studies show that menthol increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults,” the agency stated. “Menthol masks unpleasant flavors and harshness of tobacco products, making them easier to start using. Tobacco products with menthol can also be more addictive and harder to quit by enhancing the effects of nicotine.”
One study cited by the FDA suggests that banning menthol cigarettes in the U.S. would lead an additional 923,000 smokers to quit, including 230,000 Black Americans in the first 13 to 17 months after a ban goes into effect. An earlier study projected that about 633,000 deaths would be averted, including about 237,000 deaths of Black Americans.
These flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities and promote health equity by addressing a significant and disparate source of harm.
“For far too long, certain populations, including African Americans, have been targeted and disproportionately impacted by tobacco use. Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
“These flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities and promote health equity by addressing a significant and disparate source of harm. Taken together, these policies will help save lives and improve the public health of our country as we confront the leading cause of preventable disease and death.”
The FDA stressed that, if implemented, enforcement of any ban on menthol cigarettes and all flavored cigars will address only manufacturers, distributors, wholesalers, importers and retailers. “The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product,” the agency stated.
Racial justice groups have expressed concern that by outlawing menthols, the FDA would set the stage for more negative interactions between law enforcement and people of color, who smoke a disproportionate share of menthol cigarettes.
Earlier this week, the National Newspaper Publishers Association (NNPA), representing more than 200 African American-owned community newspapers from around the United States, and leading Black and Hispanic law enforcement executives, too, sent a letter urging the FDA to keep menthol cigarettes legal.
In acting on menthol, the FDA granted a citizen’s petition requesting that the agency pursue rulemaking to prohibit menthol in cigarettes, affirming its commitment to proposing such a product standard.
The 2009 Tobacco Control Act (TCA) did not include menthol in its ban on characterizing flavors in cigarettes, leaving menthol cigarettes as the only flavored combusted cigarettes still marketed in the U.S. The law instructed the FDA to further consider the issue of menthol in cigarettes.
Since then, the FDA sought input from an independent advisory committee as required by the TCA, and further demonstrated its interest by issuing an Advance Notice of Proposed Rulemaking, undertaking an independent evaluation and supporting broader research efforts—all to better understand the differences between menthol and nonmenthol cigarettes and the impact of menthol on population health.
In the U.S., it is estimated that there are nearly 18.6 million current smokers of menthol cigarettes. But use of menthol cigarettes among smokers is not uniform: Out of all Black smokers, nearly 85 percent smoke menthol cigarettes compared to 30 percent of white smokers who smoke menthols. In addition, among youth, from 2011 to 2018, declines in menthol cigarette use were observed among non-Hispanic white youth but not among non-Hispanic Black or Hispanic youth.
After the 2009 statutory ban on flavors in cigarettes other than menthol, use of flavored cigars increased dramatically, suggesting that the public health goals of the flavored cigarette ban may have been undermined by continued availability of these flavored cigars, according to the FDA.
Flavored mass-produced cigars and cigarillos can closely resemble cigarettes, pose many of the same public health problems and are disproportionately popular among youth and other populations. In 2020, non-Hispanic Black high school students reported past 30-day cigar smoking at levels twice as high as their white counterparts.
Nearly 74 percent of youth aged 12 to 17 who use cigars say they smoke cigars because they come in flavors they enjoy, according to the FDA. Among youth who have ever tried a cigar, 68 percent of cigarillo users and 56 percent of filtered cigar users report that their first cigar was a flavored product. Moreover, in 2020, more young people tried a cigar every day than the number of young people who tried a cigarette.
Pamela Kaufman
Pamela Kaufman and Sanath Sudarsan of Morgan Stanley said that while the absence of a proposed rule in today’s statement was “somewhat better than the market had feared,” the FDA’s plan is likely to remain an overhang for the sector. They also noted the agency did not indicate plans to ban menthol in noncombustible products such as e-cigarettes, heat-not-burn products and nicotine pouches, which could help incentivize smokers to move away from cigarettes and toward reduced-risk alternatives.
Menthol regulation will have to follow the FDA’s multi-step/multi-year rulemaking process. The next step is a preliminary rule that would be subject to a comment and review period, typically lasting 90 days. The FDA would then review stakeholder responses and publish a final rule, which would require review from the Department of Health and Human Services and the Office of Management and Budget. Once a rule is finalized, the industry would have additional time to implement the change.
Kaufman and Sudarsan expect the tobacco industry to challenge a final rule, questioning its scientific basis and stressing the risk of creating an illicit market for menthol cigarettes.
The EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) final report on e-cigarettes is a step backwards for Europe, according to the World Vapers’ Alliance (WVA). Based on weak data, it ignores crucial scientific evidence, experience from consumers and the expert opinions received in the consultation period, the advocacy group said in a statement.
“This report is a tragedy for public health and will have dire consequences for smokers and vapers alike,” said Michael Landl, director of the WVA. “SCHEER ignores a large amount of scientific evidence on vaping, all of which was provided by experts and consumers to SCHEER during their consultation earlier this year. They chose to ignore it. This is a slap in the face of vapers and of common sense.”
According to the WVA, the report does not consider crucial independent evidence from Public Health England, which shows that e-cigarettes are 95 percent less harmful than smoking and recently found that vaping is the most used means to quit smoking.
“Countries like the U.K. and France are actively encouraging smokers to use vaping and switch to this less harmful alternative,” said Landl. “If the EU really wants to tackle smoking-related illnesses, it needs to look very carefully at all of the evidence. Unfortunately, the SCHEER report is biased against vaping, and its recommendations, if transposed into legislation, will damage public health.”
This report is a tragedy for public health and will have dire consequences for smokers and vapers alike.
The next few months will see further legislation updates in the EU as outlined in Europe’s Beating Cancer plan, including updates to the Tobacco Products Directive and the Tobacco Excise Directive. In this context, the findings of the SCHEER committee may ultimately be detrimental to the health of Europe’s citizens.
“It seems like the main objective has been overlooked: reducing the number of smokers and tackling smoking-induced illnesses,” said Landl. “Vaping is not smoking and must not be treated the same. Regulation must be drafted in a way that encourages current smokers to switch. The EU needs to focus on practical solutions to reduce harm and this major point is missing from the SCHEER analysis. Vaping can help smokers quit, but this report ignores that and compares vaping to non-smoking. So it is unsurprising that the results don’t echo reality.”
As part of a trial being led by the University of East Anglia, the U.K. National Health Service (NHS) will provide vaping devices and e-liquids to smokers coming to the emergency departments of five hospitals across the U.K. to help them quit.
Patients attending emergency departments in five hospitals in Norfolk, London, Leicester and Edinburgh will be offered a device, enough e-liquid supplies for a week and referral to local smoking-cessation services, alongside medical advice.
This will be followed up at one, three and six month intervals over a 30 month period, to monitor success rates for those introduced to vaping, compared to those only offered leaflets with details of local smoking-cessation services in the same trial.
“I welcome this trial being launched and the additional research, which will hopefully make it easier for people to quit smoking in the future.,” said Norman Lamb, former health minister and former chair of the House of Commons science and technology committee.
I welcome this trial being launched and the additional research, which will hopefully make it easier for people to quit smoking in the future
“I am particularly keen to ensure that vaping is made available to people with mental ill health given continuing high smoking rates. It is very positive to have such a prominent trial funded by the National Institute for Health Research (NIHR) including clinical trials. I await the results with interest.”
The U.K. Vaping Industry Association (UKVIA) heralded the NHS’ decision as a landmark moment. “This is a hugely significant moment in the history of vaping and harm reduction,” said John Dunne, director general of the UKVIA.
“For the first time, following years of research and campaigning, we are finally at the point where the NHS looks to be fully embracing vaping and acknowledging its important role as the number one quit method.”
Dunne renewed his call to government to give vaping more opportunity to promote itself as a harm reduction alternative to smoking when it is due to review the Tobacco Related Products Regulations in May.
“We have put forward the idea of using government-approved, expert health claims on vaping products to encourage the remaining six to seven million smokers in the U.K. to switch, as well as making sure that there are greater opportunities for the vaping industry to engage with smokers through marketing and advertising means, as current restrictions deter those who may have otherwise made the changeover,” he said.
“It is extremely important that hospital staff have the knowledge to advise smokers about vaping, including which devices to use, nicotine levels and flavors to opt for in order to support a successful quit.”
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.
The Biden administration is likely to announce its intention to ban menthol cigarettes tomorrow, people familiar with the plan told CBS News. It is unknown if the law would impact menthol and ice flavored e-liquids in vaping products.
Such a move would have considerable impact on the tobacco industry, however, because menthol cigarettes account for roughly one-third of the U.S. cigarette market. Approximately 20 million Americans smoke menthols, according to the Food and Drug Administration.
Mentholated cigarettes have been marketed in the U.S. since the 1920s. Critics want to see them banned because they believe that, by masking the harshness of tobacco smoke, menthol makes it easier to start smoking and harder to quit. While overall smoking has trended downward in recent years, menthol declines have dragged behind other products. The tobacco industry insists that menthol cigarettes are no more harmful to health than nonmenthol cigarettes.
Cigarette manufacturers have also come under fire for marketing menthol cigarettes disproportionately to Black Americans, highlighting racial inequities. More than 85 percent of Black smokers report using menthol products, as do more than half of all youth who smoke, according to government data.
The 2009 Family Smoking Prevention and Tobacco Control Act empowered the FDA to regulate cigarette ingredients. The agency duly banned characterizing flavors in cigarettes. However, it exempted mentholated cigarettes, citing concerns about illicit sales, among other considerations.
In 2011, the FDA’s Tobacco Products Scientific Advisory Committee concluded that “removal of menthol cigarettes from the marketplace would benefit public health in the United States,” but the additive remained on the market. In early 2020, the Trump administration again gave menthol a pass when it banned characterizing flavors in vapor products.
While the U.S. wavered, other jurisdictions charged ahead. Brazil outlawed menthol along with all flavored cigarettes in 2012, followed by Turkey in 2015 and the European Union and the United Kingdom in 2020.
Tired of what they perceived as FDA foot-dragging, anti-smoking and racial justice groups sued the agency. The judge in the case instructed the FDA to respond to this citizens’ petition by April 29.
There is no factual basis to assert that a menthol cigarette ban will stop people of color from smoking.
Advocates of the ban say the decision about whether to move ahead is ultimately President Biden’s. Banning menthol cigarettes has Democratic support in Congress too. Senator Dick Durbin, Representative Raja Krishnamoorthi and Representative Bobby Rush recently argued that the FDA has a “duty” to ban menthols. “These failures to protect children, particularly African American children, from a path to addiction are inexcusable,” they told the administration.
If enacted, a ban would not take effect overnight. Industry analysts expect the implementation of any plan to remove menthol cigarettes from the U.S. market to take years. The FDA, which does not yet have a permanent commissioner in place, would have to go through a lengthy rulemaking process, consider potential consequences, such as illegal sales and racial injustice, and solicit public input.
“In essence, such an announcement would simply be a way to tell the public, as well as the tobacco industry, that the agency intends to ban the flavoring in cigarettes,” Pebbles Fagan, the director of the Center for the Study of Tobacco at the University of Arkansas for Medical Sciences, told NBC News. “The rulemaking process would likely take several years to finalize and implement. That would provide time to boost smoking cessation programs targeting menthol smokers.”
The American Civil Liberties Union and dozens of other criminal justice groups warned the White House and Health and Human Services Secretary Xavier Becerra that a ban on menthol cigarettes would have “serious racial justice implications.”
The National Newspaper Publishers Association (NNPA), representing more than 200 African American-owned community newspapers from around the United States, and leading Black and Hispanic law enforcement executives, too, have urged the FDA to keep menthol cigarettes legal.
“It is clear that there is no factual basis to assert that a menthol cigarette ban will stop people of color from smoking,” says Benjamin Chavis, president and CEO of the NNPA. “In fact, the unintended consequences of such a racially discriminatory ban will set the stage for more negative and more likely counterproductive interactions between law enforcement and people of color.”
Supporters of barring menthol products say that a federal ban would focus on retailers selling products and would not criminalize personal use or possession. But critics say that it could be inevitable as a black market grows for illegal cigarettes.
Biden has pledged to address racial inequities in both criminal justice and healthcare, setting up for what could be an intense balancing act with critics arguing that a ban could increase police brutality and the incarceration of Black Americans.
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.
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.
Four more companies have received warning letters for violating marketing orders for the sale of e-liquids. The U.S. Food and Drug Administration (FDA) says the companies failed to submit a premarket tobacco product applications (PMTA) by the Sept. 9, 2020 deadline. The regulatory agency posted the letters to RP Vapor, DIY Vapor Supply, Electric Freedom (Crown7) and KV Liquids were received on April 23 and posted to the FDA website on April 27.
RP Vapor has over 4,600 products listed with the FDA. DIY Vapor Supply is the registered manufacturer for over 73,300 products listed with FDA. Electric Freedom has over 80 products listed with the FDA, while KV Liquids has more than 300. The FDA 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. This means that the company may or may not have submitted a PMTA for some of its registered products.
The regulatory agency has now issued warning letters to 96 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.
Beard Management announced that its premarket tobacco product application (PMTA) has advanced to the filing stage of the regulatory review process. Beard submitted 45 of its nicotine-based e-liquids to the U.S. Food and Drug Administration (FDA), including its The One and Beard Vape Co. brands. Blackbriar Regulatory Services (BRS), the company’s manufacturing partner and FDA agent of record, will be responsible for assisting Beard throughout the next steps of the FDA regulatory process.
“We are pleased to see our application moving through the PMTA process in order to scientifically demonstrate our products are appropriate for the protection of public health,” said Casey Bates, CFO at Beard, stated in a press release. “Partnering with BRS as our manufacturer gives us much broader access to a multitude of regulatory and scientific data that is critical to our ongoing PMTA work.”
BRS is providing Beard with cost-effective, turnkey solutions for manufacturing and regulatory needs, using a science-driven approach to testing for harmful and potentially harmful constituents, demonstrating good manufacturing practices, as well as providing additional analytical lab testing critical to the PMTA process, according to the release.
“We are very happy to be managing Beard’s PMTAs,” said Russ Rogers, CEO at BRS. “We have strong respect for the quality and brand marketing of their products, and we are confident that we can help Beard to achieve a marketing order from the FDA.”
The Artisan Vapor & CBD company announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). The company submitted 39 e-liquid products, seven of which are nicotine salt blends, according to its website.
Credit: Artisan Vapor & CBD
The company announced in a press release that its research included in the submission offered “detailed scientific research demonstrating that their products are appropriate for adult use.” No specific date was given for when Artisan received its acceptance letter, only that the letter was received in April.
Founded in Texas in 2013, Artisan Vapor & CBD has grown to become one of the largest vapor retailers in the world, with more than 70 stores operating across three continents, according to its website. The company now waits for a filing letter from the FDA. Artisan’s application would then move on to the Substantive Review phase where the scientific data is analyzed.
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
