Health advocates are calling on South Korea to regulate e-cigarettes as tobacco products, reports the Maeil Business Newspaper
The current law does not classify vapes as cigarettes, which means they are exempt from many of the regulations that apply to tobacco products. For example, vaping companies do not have to print graphic health warnings on their products or charge their customers tobacco consumption tax.
Article 2 of the Tobacco Business Act, defines “cigarettes” as products suitable for smoking, sucking, inhaling, chewing or smelling.
The calls for expanding the legal definition come follow concern about the growth of unmanned e-cigarette stores in Seoul, which are said to have inadequate age-verification procedures.
A survey by the Seoul metropolitan government revealed that the number of unmanned e-cigarette stores has quadrupled since April.
According to data from the Korea Centers for Disease Control and Prevention, three out of 10 youth smokers started smoking e-cigarettes from 2019 to 2023. Six out of 10 teenagers who started with e-cigarettes are currently smoking regular cigarettes, the centers said.
Bills to regulate e-cigarettes were tabled in the 20th and 21st National Assembly, but failed to cross the plenary session threshold in each instance.
The U.S. Food and Drug Administration has issued six warning letters to manufacturers and retailers for selling or distributing unauthorized e-cigarette products promoted at an industry trade show.
After observations made by Center for Tobacco Products (CTP) staff attending the trade show, the FDA conducted investigations and issued warning letters to six retailers and manufacturers for selling or distributing unauthorized e-cigarette products.
Regulated entities must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act. Under these requirements, the sale and distribution of unauthorized tobacco products is illegal, including at industry events such as trade shows or expos, according to the FDA.
“Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We remain committed to identifying and taking action against those breaking the law, including at these events.”
FDA also announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz.
“Results from the recently released 2024 National Youth Tobacco Survey found that Breeze and Mr. Fog were among the top five most commonly used brands among youth who use e-cigarettes,” an FDA release states. “Additionally, Raz was identified as a popular brand through routine surveillance, with youth-appealing flavors such as sour mango pineapple and razzle-dazzle.”
The companies receiving these warning letters sold or distributed e-cigarette products without marketing authorization from the FDA. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violations cited in the warning letter and to prevent future violations.
Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
This week, Cabinet approved draft laws tabled by Health Minister Stephen Donnelly. Under the proposed laws, the sale, manufacture, and import of single-use or disposable vapes in Ireland will be completely banned.
The legislation will also introduce a ban on a multitude of flavors that the government believes often appeal to children – it is estimated that as many as 15,000 flavor combinations exist.
The laws will also introduce a ban on point-of-sale display or advertising in shops, other than specialist shops that only sell the products, reports the BBC.
Donnelly also wants to restrict the colors and imagery on packages and devices to prevent them from being aimed at youth.
Ireland has already banned the sale of all nicotine inhaling products to under 18s and a range of other curbs such as advertising, pop-up shop sales and a ban of sale from vending machines will commence next year.
The minister has said the plans to introduce a ban are on environmental and public health grounds.
The agency is struggling to justify the need for additional resources to combat illegal vape products.
A bipartisan group of powerful House lawmakers are doubtful of the Food and Drug Administration’s proposal to begin collecting fees from e-cigarette companies, akin to how the agency charges fees to tobacco firms.
FDA officials say that the fees would give regulators resources to tackle the thousands of illegal vapes lining store shelves.
Lawmakers on the House Energy & Commerce Committee questioned whether the FDA’s Center for Tobacco Products (CTP), which has struggled for years to police the vaping industry, is capable of effectively using allocated funds.
The agency is caught in a Catch-22 situation. Some lawmakers are demanding that the FDA crackdown on illegal e-cigarettes before receiving more funding, but the FDA argues that it needs additional funding to boost its enforcement efforts.
Brian King
CTP Director Brian King attempted to persuade lawmakers that the agency has taken significant action against vape companies selling illegal products. This includes imposing fines on retailers, seizing products at the border, and filing injunctions against manufacturers in federal courts. Lawmakers from both sides questioned if the agency was taking sufficient action.
New Jersey Rep. Frank Pallone said that while he hopes e-cigarette user fees would “make a difference,” he was skeptical of whether the FDA would be able to rein in the illegal vape market. “I hate to say it but you just make it seem hopeless to me,” he said.
Tony Abboud, executive director of the Vapor Technology Association (VTA), said the FDA’s Center for Tobacco Products (CTP) created a flawed and broken premarket tobacco product application (PMTA) process. He explained that the House committee hearing revealed that, under King’s leadership, CTP continues to approve combustible cigarettes while also denying millions of e-cigarette PMTAs at a 91:1 ratio.
“Director King’s statement that there is ‘no safe harbor’ for companies with pending applications clearly demonstrates that CTP continues to move the scientific goalpost and is not truly committed to harm reduction for Americans who smoke,” said Abboud. “Cigarette smoking continues to be the leading cause of preventable death and disease in the U.S., yet Director King calls for more money to remove less harmful products from the market.
“The CTP must acknowledge the undisputed smoking cessation benefits of e-cigarettes, authorize a diverse marketplace of flavored nicotine alternatives to cigarettes, and stop approving new cigarettes.”
House Energy and Commerce Committee Chair Cathy McMorris Rodgers said that out of more than 26 million applications for electronic nicotine delivery systems (ENDS) products and has authorized fewer than 50 products.
“However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is with keeping up with the demand,” she said. “The lack of clear enforcement policy and authorized products leaves tobacco users, distributors, and convenience stores in the dark on what products they can use and sell to those that are looking for alternatives to traditional cigarettes.
“Companies need clear guidelines on what is required to meet the standard for authorization and what changes to products require new applications.”
The CTP currently collects user fees from cigarette and cigar companies. However, it requires Congressional approval to begin collecting user fees from vaping product manufacturers. The agency has been advocating for this change for some time. This change is estimated to increase CTP’s budget by approximately $114 million from its current budget of over $700 million.
Half of this additional funding would be allocated to increasing enforcement efforts, according to STAT News.
The hearing, titled “Evaluating FDA Human Foods and Tobacco Programs,” was House lawmakers’ first chance to question both King and Jim Jones, the FDA’s deputy commissioner for Human Foods. King joined the agency in July 2022. Jones joined last September.
U.S. lawmakers and advocacy groups expressed concern about the Food and Drug Administration’s regulation of smokefree products during a Sept. 10 House of Representatives’ Energy and Commerce Subcommittee hearing.
Health Subcommittee Chair Brett Guthrie criticized FDA delays and what he viewed as a lack of transparency. “Manufacturers filing premarket tobacco product applications [PMTAs] with the goal of meeting the standard of an ‘appropriate protection of public health,’ still have no clear guidance and are waiting for hundreds of days for outreach on their applications,” he said.
“More importantly, these products pending at FDA could present an opportunity to improve public health by providing less harmful alternatives to traditional cigarettes. This lack of transparency has consequences.”
Full Committee Chair Cathy McMorris Rodgers highlighted the massive backlog of product applications at the FDA’s Center for Tobacco Products (CTP). “Out of the over 26 million applications for electronic nicotine delivery systems, or ENDS products, the center has authorized fewer than 50 products,” he said.
“However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is in keeping up with demand.”
Representative Richard Hudson blamed the CTP for the increase in illegal products on the U.S. market from abroad. “Millions of illegal products are on the market targeting our youth while some legitimate companies have been waiting for years for review or even hear a word from FDA about their application,” he said.
“The illicit market has been enabled by the Center for Tobacco Products’ lack of action … the fact is, the inefficiency of CTP has driven an illicit market that has been filled by China.”
In a separate statement, Philip Morris said the hearing put a bright bi-partisan spotlight on the fact that the agency is neglecting millions of adult smokers by failing to authorize scientifically-substantiated, smoke-free nicotine products that are better alternatives to combustible cigarettes.
“More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized only several dozens of those applications, and none within the 180-day deadline set by Congress,” said PMI Director for Regulatory Communications Matthew Sheaff.
“FDA’s goal to strike ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes’ is far from the reality of its actions. It is our hope the FDA will fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act and more importantly provide the millions of adult smokers in the United States access to better alternatives to combustible cigarettes.”
The Taxpayers Protection Alliance (TPA) criticized the FDA’s authorization process and noted the low rate of youth e-cigarette use. “The PMTA costs to manufacturers are astronomical, while the regulatory requirements are obscure at best,” Lindsey Stroud wrote on the TPA’s website.
“To date, the FDA has only authorized 56 products under the PMTA pathway. Given the current low rate of youth e-cigarette use and the high number of adults using novel tobacco products, there is a pressing need for the FDA to adapt its authorization strategies to better serve adults seeking to quit smoking through these alternatives. Lawmakers are urged to advocate for this necessary shift in FDA policy.”
Americans For Tax Reform (ATR) called on the FDA to educate the public about the continuum of risk for nicotine products. “The agency’s failures to educate the public about the continuum of risk in nicotine products—despite their own internal documents demanding the need to do so—has meant that 75 percent of Americans inaccurately believe vaping is equal to or worse than smoking,” Tim Andrews wrote on ATR’s website.
“The fact that the agency’s leadership continues to ignore its own comprehensive plan for tobacco and nicotine, where harm reduction is supposed to play a central role in the FDA’s tobacco control plan, is a downright scandal.”
Earlier this year, The Vapor Chef informed its customers of ongoing difficulties with federal regulators. The company has been a stalwart in the e-liquid manufacturing segment.
In a recent update, the business has confirmed that it will no longer be able to continue operations following extensive discussions with the U.S. Food and Drug Administration.
As a result, The Vapor Chef has decided to liquidate its remaining inventory, offering a 50 percent automatic discount on all products on its website. As supplies dwindle, specific flavors will be removed from the online store.
The company has assured customers that any outstanding orders they cannot fulfill will be refunded.
Operations are expected to cease entirely by Sept. 30th, and the website will be taken down on that date or sooner if stock runs out.
Customers are encouraged to take advantage of the discounted sale before the business is closed.
The R Street Institute, a U.S. think tank promoting free markets and limited government, has published the first of three papers on tobacco issues and policy. Authored by Resident Senior Fellow Jeffrey Smith, the first installment addresses the health risks of smoking through the lens of preserving individual liberty.
According to the R Street Institute, new reduced-risk products, such as e-cigarettes, oral nicotine and heat-not-burn products, offer smokers an unprecedented opportunity to reduce their health risks by transitioning to less harmful methods of nicotine consumption.
However, the U.S. regulatory environment makes it nearly impossible for such products to enter the market. In addition, consumers must contend with considerable volumes of misinformation. As a result, too many Americans continue to die and suffer from smoking-related diseases.
The R Street Institute urges industry stakeholders, regulatory bodies and public health experts to work together—instead of in opposition—to reduce smoking-related death rates and provide smokers with safer options.
The proposed legislation tightens restrictions on where people can smoke, with hefty fines and even potential jail time for those who break the rules.
It also introduces stringent regulations for vaping and electronic nicotine delivery systems (ENDS), which are currently not addressed by existing laws, according to media reports.
There is significant opposition from the business and labor sectors.
Critics argue that the new restrictions could adversely affect the tobacco industry, including farmers and retailers.
This move is part of South Africa’s broader effort to align its tobacco policies with international standards, particularly those set by the World Health Organization’s (WHO) Framework Convention on Tobacco Control.
The Center of Excellence for the acceleration of Harm Reduction (CoEHAR) at the University of Catania, Italy, signed a letter of intent with the Universitas Padjadjaran to create a new CoEHAR branch in Indonesia. The branch will serve as a regional center for research, outreach and education on smoking harm reduction in the Asia-Pacific region.
According to statistics from the World Health Organization and other groups, Indonesia had nearly 80 million smokers aged 15 and older in 2022. This places the country third in the world in terms of the number of tobacco users. Conventional cigarette smoking remains the second-highest risk factor in Indonesia.
“The research conducted by the CoEHAR team at the University of Catania is changing the world, contributing to the revolution of policies aimed at protecting public health in many countries,” said CoEHAR founder Riccardo Polosa in a statement. “Supporting the CoEHAR efforts in Indonesia is a great source of pride for us but also a promise of further commitment to change the fate of a country plagued by unhealthy habits and lifestyles.”
“Low[-income] and middle-income countries in the Asian region represent a different and multifaceted field of investigation and activity,” said CoEHAR Director Giovanni Li Volti. “Our goal is to enhance research activities by developing joint projects that can fully utilize both the human and technological resources of all the universities and institutions involved, which will contribute to change and the exchange of knowledge and skills.”
Previously, the universities had already agreed to promote joint research, mobility and training in the field of smoking harm reduction.
Irish Health Minister Stephen Donnelly proposed bans on non-tobacco vape flavors and advertising in non-specialized shops, reports The Irish Times. He tabled the suggestions as Ireland’s cabinet approved restrictions on disposable vapes on Sept. 9.
Donnelly said the proposals are aimed at protecting children, who he believed were “very cynically” targeting children. The proposed legislation, he said, would see just one flavor, tobacco, being sold.
“We live in a country where around 13 percent of people between the ages of 12 and 17 have vaped in the last 30 days,” said Taoiseach Simon Harris, who described vaping as “the revenge of the tobacco industry.”
Minister of State for Public Health Colm Burke said the regulations are necessary because “many people who used vaping products subsequently moved on to smoking.”
