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Category: Global Regulation

  • Bill Threatens Menthol and Nicotine Plans

    Bill Threatens Menthol and Nicotine Plans

    Photo: Rechitan Sorin

    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.

  • TPSAC to Discuss Proposed Manufacturing Rule

    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.

  • Australia Cracks Down on Tobacco and Vapor

    Australia Cracks Down on Tobacco and Vapor

    Photo: Photo: nui7711

    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.

  • FDA Rejects 6,500 Flavored Vape Products

    FDA Rejects 6,500 Flavored Vape Products

    Photo: Surendra

    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.

  • Vietnam Urges Stricter Control of New Products

    Vietnam Urges Stricter Control of New Products

    Photo: efired

    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.

  • FDA to Finish Reviewing PMTAs by End of Year

    FDA to Finish Reviewing PMTAs by End of Year

    Credit: Monticello

    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.

  • Ban on Nonprescription Vape Imports

    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.

  • Tobacco Regulation Not Violation of Rights

    Tobacco Regulation Not Violation of Rights

    Image: Tobacco Reporter archive

    Malaysia’s anticipated tobacco control bill will not deprive citizens of personal liberties and equality, according to the Malaysian Council for Tobacco Control (MCTC), reports Malay Mail.

    The anti-smoking council found that the bill, which aims to end cigarette consumption for those born after 2007, is constitutional after former Chief Justice Tan Sri Zaki Azmi lobbied against the bill.  

    “Nicotine addiction is not distinguishable from addiction to other drugs,” the council said in a statement. “If the country can ban or regulate other drugs, it can also regulate nicotine. It must also be emphasized that nicotine is more addictive than opium; if we can stage a war on opium, why not on nicotine?

    “The main objection to the state initiative in this area is that the law will be difficult to enforce. That is indeed true. But admittedly, the challenges surrounding enforcement accompany all laws.”

    Azmi stated that the bill could infringe on constitutional freedoms, but the MCTC stated that Article 5(1) of the Constitution does not give an absolute right to liberty, which, according to the MCTC, can be deprived only in accordance with the law.  

    “As long as there is a valid law, and the executive acts under it, there is no unconstitutional violation of personal liberty,” the MCTC said after seeking advice from constitutional experts.

  • TPSAC to Discuss Proposed Rule

    TPSAC to Discuss Proposed Rule

    Image: Tobacco Reporter archive

    The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice 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 must be submitted by May 11 for consideration by the committee.

  • Taiwan E-Cig Investigations Increase

    Taiwan E-Cig Investigations Increase

    Image: Tobacco Reporter archive

    Taiwanese authorities are conducting more than 2,000 vaping-related investigations per month following amendments to the Tobacco Hazards Prevention Act that banned e-cigarettes and tightened heated-tobacco product restrictions, reports The Taipei Times.  

    Fines totaling TWD280,000 ($9,117) have been imposed in 18 cases, the Health Promotion Administration (HPA) said. 

    HPA data showed that about 67 percent of the 2,173 cases were for allegedly selling e-cigarettes, 477 were for advertising e-cigarettes, 40 were for displaying e-cigarettes, and 42 were for e-cigarettes or HTP use. 

    “What is worth noticing is that among the 42 cases of alleged illegal use, 41 involved people aged under 20,” HPA Tobacco Control Division head Chen Miao-hsin said.

    The amendments were implemented last month and also increased the age to buy cigarettes to 20, increased the size of required health warnings on cigarette cartons and expanded nonsmoking zones in public spaces.