Category: Regulation

Vaping to be Banned for Those Under 18

Image: Tobacco Reporter archive
Ireland will ban vaping for those under the age of 18, effective July, reports the Irish Times.
Minister for Health Stephen Donnelly will bring a memo to the Cabinet this week outlining the full legislation. The new law is expected to be enacted before the lower house of Parliament’s summer recess in mid-July.
The legislation includes restrictions on the types of retailers allowed to sell vapes or nicotine-inhaling products as well as measures to curb advertising of nicotine-inhaling products near schools and other locations frequented by kids and young adults.
Donnelly is expected to tell the Cabinet that there is “clear evidence” that nicotine exposure in young people has long-term effects on brain development, referencing recently published surveys of Irish school-aged kids. The surveys, including the Health Behaviour in School-Aged Children survey from 2018 and the European Schools Project on Alcohol and Other Drugs survey from 2019, showed that 9 percent of 12-year-olds to 17-year-olds and 15.5 percent of 15-year-olds and 16-year-olds used electronic cigarettes in the past 30 days. Donnelly is also expected to reference a Health Research Board review that found that kids who vaped were five times more likely to begin smoking.
The government is expected to prioritize passage of the bill through the Oireachtas to allow for full debate and discussion before sending the legislation to President Michael D. Higgins for his signature.
May 30, 2023
Innokin and Breeze Warned

The U.S. Food and Drug Administration has warned the manufacturers of two popular disposable e-cigarette brands that their products are unauthorized for sale in the United States.
The product involved are Esco Bars, which is manufactured by Shenzhen Innokin Technology Co., and Breeze, which is imported into the U.S. by Breeze Smoke. Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the country, according to the FDA.
“The science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action.”
The recent FDA actions could signal that the agency will no longer consider pending premarket tobacco product applications (PMTAs) when deciding which companies to enforce against. Esco Bar is believed to have a pending PMTA, according to Vaping360. Breeze Smoke reportedly received marketing denials orders for several products in 2021.
Thousands of other products remain on the market awaiting PMTAs without facing enforcement actions.
Innokin and Breeze Smoke have 15 days to dispute the allegations in the FDA’s warning letters.
May 26, 2023
Switzerland to Ban Youth Advertising

Photo: Taco Tuinstra
Switzerland will ban advertising of tobacco and vapor products to young people, the government announced on May 24, report Reuters and Swiss Info.
In February 2022, Swiss voters backed a proposal to limit tobacco promotions seen by minors. Following the referendum, the government had to adjust Switzerland’s tobacco product law to incorporate the proposal.
The new law will come into force from mid-2026 and will also strengthen restrictions on packaging and advertising on tobacco and e-cigarettes due to take effect from next year.
In the future, no advertising for tobacco products or e-cigarettes will be allowed in print media, shops or events that can be visited by minors. In addition, sponsorship of events that people under 18 attend will be banned. Online advertising will still be permitted provided that age control systems are in place.
The tobacco industry will also be made to collectively disclose its advertising expenditure, but companies will not be required to individually reveal this information. The government believes advertising plays an important role in the decision to start smoking.
Smoking remains relatively widespread in Switzerland with 9,500 people dying prematurely every year as a result of tobacco consumption, according to the government. In 2022, 6.9 percent of Swiss 11-year-olds to 15-year-olds had smoked cigarettes in the past 30 days while 5.7 percent of youths aged 15 to 24 had used electronic cigarettes at least once a month, the government said.
Switzerland is home to several tobacco multinationals, including Philip Morris International and Japan Tobacco International.
May 25, 2023
Bill Threatens Menthol and Nicotine Plans

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The U.S. House Committee on Appropriations may spoil the Food and Drug Administration’s plans to ban flavored cigars, ban menthol cigarettes and limit nicotine levels in cigarettes, reports Halfwheel.
On May 17, the committee, which is responsible for allocating funds to various government entities, including the FDA and the Department of Agriculture, unveiled the draft of the Agriculture, Rural Development, Food And Drug Administration, And Related Agencies Bill.
The proposed language says that FDA cannot use any of the money Congress allocates for it to ban menthol or set nicotine levels, effectively preventing the agency from carrying out the regulations.
The relevant passages are:
SEC 768. None of the funds provided by this Act or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, implement, administer, or enforce any rule, regulation, or order setting a tobacco product standard that mandates a maximum nicotine level for cigarettes.
And:
SEC 769. None of the funds provided by this Act, or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, or implement any rule, regulation, notice of proposed rule- making, or order setting any tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes or prohibit characterizing flavors in all cigars and their components and parts.
Anti-tobacco activists were aghast. “This bill is a special interest gift to the tobacco industry that would result in more kids addicted to tobacco and more lives lost, especially Black lives,” wrote Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement. “These shameful provisions give the tobacco industry everything it wants from Congress in exchange for its campaign contributions.”
The bill is in its early stages and is likely to undergo many modifications.
May 18, 2023
TPSAC to Discuss Proposed Manufacturing Rule

Photo: FEELM
The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice (TPMPs) proposed rule on May 18, 2023, from 9 a.m. to 2 p.m.
The proposed rule is open for public comment until Sept. 6, 2023.
The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting needed to be submitted by May 11 for consideration by the committee.
More information about the meeting is available at the FDA’s website.
May 17, 2023
Australia Cracks Down on Tobacco and Vapor

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The government of Australia plans to crack down on illicit tobacco trade and increase tobacco excise by 5 percent annually for three years from Sept. 1, reports The Guardian.
“These changes to tobacco excise are part of the government’s response to the National Tobacco Strategy and related initiatives on vaping and smoking prevention and cessation, and an enhanced regulatory approach to vaping,” the budget papers say.
In addition, Australia will ban the import of all vaping products sold without a prescription, including e-liquid and hardware that contains no nicotine, reports Vaping360.
In a recently published document, the government outlined its long-term vaping and tobacco plan.
The government’s plan comes in the wake of growing concern about disposable nicotine vapes sold in convenience stores. Its proposed measures, however, will also impact Australia’s specialized vape shops.
Rules for non-nicotine vapes will be tightened as well, with a ban on nontobacco flavors and a requirement to sell products in plain packaging.
The government says it will also reduce allowable nicotine strengths and ban disposable vapes outright.
Health Minister Mark Butler blames the tobacco industry—which sells no vaping products in Australia—for creating a “new generation of nicotine addicts.”
Critics say the plan will not benefit public health because it will continue to allow consumers to buy cigarettes—and without a prescription—at every corner store in Australia.
In its press release announcing the new measures, Butler says new tobacco taxes will raise an additional $3.3 billion over the next four years. Australia already has one of the highest cigarette tax rates in the world, which has led to a large illicit tobacco market.
Nicotine vaping products have been illegal in Australia without a prescription for many years, but the laws have been widely ignored by vapers, who imported nicotine from overseas and made their own e-liquid or bought zero-nicotine vape juice from vape shops and added nicotine, according to Vaping360.
In 2021, the previous Liberal coalition government launched a revised prescription-only model for nicotine vaping products and promised to ramp up border enforcement. However, few doctors chose to participate in the prescription program, and most consumers weren’t interested. Vape shops were allowed to continue selling zero-nicotine e-liquid and vaping hardware that contained no nicotine. Soon after, disposable vapes flooded Australia (and the rest of the world).
The current government says it will make it “easier to get a prescription for legitimate therapeutic use,” but it’s not clear that vaping consumers will be eager to jump through medical hoops to buy flavorless or tobacco-flavored, low-nicotine vape products.
May 15, 2023
FDA Rejects 6,500 Flavored Vape Products

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On May 12, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies, which collectively manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products. The companies may not market or distribute these products in the U.S., and retailers who sell these illegal products risk FDA enforcement action.
According to the FDA, the premarket tobacco product applications (PMTAs) provided insufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health. The flavor names of some of the products denied include Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.
Since the spring of 2020, the FDA has received applications for over 26 million new tobacco products, the majority of which were for e-cigarette products. To date, FDA has completed review and taken action on over 99 percent of these applications, according to the agency.
“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products in a statement. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”
The companies that received MDOs include Imperial Vapors, Savage Enterprises, Big Time Vapes, SWT Global Supply, Great Lakes Vapor, DNA Enterprise (“Mech Sauce”), Absolute Vapor and ECBlend.
FDA is withholding the names of the other two companies that received MDOs to protect potential confidential commercial information.
May 12, 2023
Vietnam Urges Stricter Control of New Products

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The Ministry of Health in Vietnam has called for stricter control of e-cigarettes and heated tobacco products that are not licensed in the country, reports VnExpress International.
In a recent document addressed to various government ministries and committees, the ministry asked for increased communication about the dangers of such products and for stronger measures to be taken against their purchase, sale, and trading.
Despite not being allowed in Vietnam, these products are becoming increasingly popular and are widely available on the internet. According to statistics from the World Health Organization, a growing number of Vietnamese students are using e-cigarettes, with 2.6 percent of those aged 15-17 vaping in 2019, and a 2022 survey revealing that 3.5 percent of those aged 13-15 use e-cigarettes.
There have been reports of students being poisoned by nicotine and liquids used in these products. The ministry also highlighted the risk of these products leading to social problems and addiction-related crime.
May 7, 2023
FDA to Finish Reviewing PMTAs by End of Year

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The U.S. Food and Drug Administration says it is on track to finish reviewing premarket tobacco product applications (PMTAs) for the most prevalent e-cigarettes by the end of the year, reports CSP.
The FDA has reviewed 52 percent of covered applications as of March 31. Covered applications are for new tobacco products on the market as of Aug. 8, 2016, with a PMTA filed by Sept. 9, 2020, and sold under the brands Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar and reach 2 percent or more of total retail sales volume per NielsenIQ reports, according to CSP.
Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.
The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.
May 3, 2023
Ban on Nonprescription Vape Imports

Image: Tobacco Reporter archive
The Australian government announced that it will ban the importation of all nonprescription vaping products—including those that do not contain nicotine. The new legislation is billed as containing the most significant tobacco and vaping control measures in the country in a decade.
The announcement today clarifies last week’s announcement of a crackdown on illegal vaping. This time, the government said it would now include a total ban on nonprescription vaping products.
To tackle youth vaping, minimum quality standards for vapes will be introduced, including restricting flavors, colors and other ingredients. Vape products will require pharmaceutical-like packaging, and the allowed nicotine concentrations and volumes will be reduced.
All single-use, disposable vapes will be banned, according to The Guardian.
Speaking on ABC’s Q&A on Monday night, Australia’s health minister, Mark Butler, said that the tobacco industry was trying to create a “new generation of nicotine addicts” through vaping and that he was “determined to stamp out this public health menace.”
The move follows an inquiry into vaping reforms led by the drugs regulator, the Therapeutic Goods Administration, with submissions from health professional bodies, public health associations, individual health professionals and university researchers that overwhelmingly support tightening border controls.
Many public health experts and bodies suggested to the inquiry that border controls should also be placed on non-nicotine vaping products to prevent mislabeling and exploitation of import loopholes. It follows manufacturers falsely labeling products containing nicotine as “nicotine-free” to get around import restrictions, leaving children easily able to buy vapes, often unknowingly inhaling nicotine and becoming addicted.
The government will also work with states and territories to end vape sales in convenience stores and other retailers. Prescriptions for nicotine vaping products for smokers trying to quit tobacco will be made easier to obtain, with stronger standards around the vaping products that can be bought in pharmacies so people can be assured of the content of the products.
Butler said he will expand on the reforms in a speech to the National Press Club on Tuesday, where he is expected to say vaping has become “the biggest loophole in Australian history” and announce that the following Tuesday’s federal budget will include AUD234 million ($156.22 million) in funding for tobacco and vaping reforms, the biggest since plain packaging of tobacco products was introduced.
May 2, 2023