Category: Regulation

FDA Cracks Down on Illegal Disposables

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The U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022. The Puff products include Puff Bar.
“Protecting our nation’s youth from tobacco products—including disposable e-cigarettes—is a top priority for the FDA,” said FDA Commissioner Robert M. Califf. “We’re committed to holding all players in the supply chain—not just manufacturers but also retailers and distributors—accountable to the law.”
According to the FDA, the warning letters are part of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth—specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes, which are the most commonly used e-cigarette product type among youth. Puff Bar and Hyde were the first and third most popular brands used by youth who reported using e-cigarettes, according to the 2022 National Youth Tobacco Survey. Among youth e-cigarette users, about 20 percent reported usually using Puff Bar or Hyde brand products in 2022.
“Since becoming director of CTP [Center for Tobacco Products], I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well known to appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action.
June 1, 2023
FDA Commissioner Laments Lawsuits

Image: Tobacco Reporter archive
U.S. Food and Drug Administration Commissioner Robert Califf has lamented the FDA’s ongoing tobacco industry litigation following the agency’s attempt to regulate e-cigarettes, according to Politico. The FDA is facing over 40 lawsuits from companies whose premarket tobacco product applications have been denied.
“We are in a legal battle every single day, and it’s draining on the agency,” Califf said at the annual public meeting of the Reagan-Udall Foundation. “It has a big impact and a much bigger impact than I thought.”
“None of us expected 27 million applications for vaping,” he said.
Califf also noted that enforcement is difficult when it comes to illegal product. “I find myself in the midst of really an epic struggle … when I think of how to enforce when you have an industry that is amazingly creative.”
Califf hinted that the FDA would meet with the Department of Justice soon to discuss enforcement but declined to say more: “Stay tuned on that one.”
May 31, 2023
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

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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

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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