Category: Regulation

  • 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. 

  • Group Blasts Quebec Flavor Ban Proposal

    Group Blasts Quebec Flavor Ban Proposal

    Photo: vmargineanu

    A proposal by the government of Quebec to ban nontobacco-flavored nicotine vaping products will have negative consequences for public health if enacted, according to the Canadian Vaping Association (CVA).

    In addition to the flavor restrictions, the recently released draft legislation proposes a volume limit of 2 mL on prefilled devices and a limit of 30 mL on refill containers. Additionally, the regulations would restrict nicotine concentrations to 20 mg/mL and prohibit the use of any form, appearance or function that may be attractive to minors, both of which have already been regulated by the federal government.

    If the draft rules are implemented, Quebec, with its population of 8.5 million, will become the largest Canadian province to prohibit flavors, according to Vaping360. Quebec is the country’s second-most populous province. According to the Alliance of Vape Shops in Quebec, there are over 400 independent vape shops in the province, employing over 2,200 people and generating more than $300 million in economic activity. The trade group predicts the shops will all close.

    Quebec’s decision to ban flavors is a major win for tobacco companies, out-of-province vendors and contraband sellers.

    Darryl Tempest, government relations counsel to the CVA board

    In 2021, federal health agency Health Canada proposed a flavor ban that was scheduled to take effect in early 2022, but that plan seems to have been abandoned or postponed indefinitely without explanation. Health Canada’s updated vaping products regulations page makes no mention of the flavor restrictions.

    The CVA says Quebec proposed its rules despite warnings by the industry about their negative impacts. Vaping is proven to be significantly less harmful than smoking, according to the CVA, which says there is substantial evidence from jurisdictions that have already implemented flavor bans that the public health outcome is negative, as many vapers will return to smoking and fewer smokers will switch to vaping.

    “Quebec’s decision to ban flavors is a major win for tobacco companies, out-of-province vendors and contraband sellers,” said Darryl Tempest, government relations counsel to the CVA board, in a statement. “What Quebec has done is shift demand to tobacco owned products, retailers outside of Quebec and criminals. Quebec’s small businesses and domestic industry will be irreparably harmed in favor of multinational corporations,” said Tempest.

  • New Resources to Help Amend PMTAs

    New Resources to Help Amend PMTAs

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has created two new resources to help applicants prepare and submit amendments to their premarket tobacco product applications (PMTAs): Fact Sheet—Amendment Tips: Completing Form FDA 4057a and Video—Using the CTP Portal.

    The fact sheet provides quick tips for completing Form FDA 4057a—Premarket Tobacco Product Application Amendment and General Correspondence Submission. In most circumstances, the CTP can only accept PMTA amendments for review that include Form FDA 4057a. In general, when submitting amendments for a PMTA, the FDA will review the required Form FDA 4057a first. If required content is missing from the form, the FDA may not continue reviewing the amendment.

    The video provides an overview of the CTP Portal and how to use it, including how to find application submission tracking numbers online.

    Recently, CTP Director Brian King outlined several new actions to enhance the center’s efficiency, effectiveness and transparency. These activities include enhanced communication on scientific issues and practices. By providing these new resources, the CTP is aiming to better support applicants navigating the PMTA process.

  • CTP Held Public Hearing on Manufacturing Rules

    CTP Held Public Hearing on Manufacturing Rules

    Image: Tobacco Reporter archive

    On April 12, 2023, the Food and Drug Administration’s Center for Tobacco Products (CTP) held an online public hearing regarding its recently released proposed rule on “Requirements for Tobacco Product Manufacturing Practice.” This public hearing was scheduled when the CTP issued the proposed rule on March 10.

    The hearing began with introductory comments by CTP Director Brian King. In addition to welcoming the participants and audience to the hearing, King noted that the CTP has been designing this proposed rule since 2011. Following King was Matthew Brenner, CTP senior regulatory counsel. Brenner summarized the proposed rule and highlighted the definitions of a “finished tobacco product” and a “bulk tobacco product” with regard to the rule. Emil Wang, senior advisor for manufacturing and regulatory policy at the CTP’s Office of Compliance, concluded the introductory session by detailing the timeline of the proposed rule. The proposed rule’s 180-day public comment period is between March 10 and Sept. 6, 2023. The effective date for the regulation would be two years after the final rule is published in the Federal Register. For small manufacturers (those manufacturers with fewer than 350 employees), the effective date for the regulation would be six years after the final rule is published in the Federal Register.

    The public comment session featured the following scheduled participants (in order):

    • James O’Reilly—professor of public health policy at the University of Cincinnati. O’Reilly called the proposed rule “comprehensive” and noted that the CTP needs to add another $100 million in additional staff to properly enforce this rule. O’Reilly also called on the CTP to coordinate with other federal agencies, such as the Environmental Protection Agency, to handle foreign chemical imports that relate to this rule.
    • Drew Newman—JC Newman. The premium cigar maker representative highlighted four items: flexibility is required as each tobacco product differs from one another; recordkeeping is lengthy and costly; qualifying suppliers such as tobacco leaf growers will be difficult; and batch coding for final products will prove very difficult for the premium cigar industry.
    • Hiuyu Shi—e-cigarette manufacturer from Shenzhen, China. Shi noted that foreign components will be very difficult to regulate and monitor. One example was the difference in water quality between nations.
    • Laura Searcy—National Association of Pediatric Nurse Practitioners. Searcy supports the proposed rule.
    • Gabby Kaife—Boutique Cigar Association. Kaife is against the proposed rule.
    • Jason Hodge—former smoker and current vaper. Hodge is against the proposed rule.
    • Joshua Habursky—deputy executive director of the Cigar Association. Habursky is against the proposed rule.
    • Meredith Berkman—Parents Against Vaping. Berkman supports the proposed rule.
    • Maham Akbar—The Truth Initiative. Akbar supports the proposed rule.
    • Connor Fuchs—Campaign for Tobacco-Free Kids. Fuchs supports the proposed rule and notes that the timeline is too long and should be shortened.
    • Mark Anton—e-cigarette/vapor product manufacturer. Anton believes that sections of the proposed rule conflict with previous statements by the CTP. Also, he believes that the burden has been shifted from the regulator to the manufacturer.
    • Patrick Murphy—vice president of scientific and regulatory affairs at Reynolds American Inc. (RAI). Murphy calls for further refinement and guidance to the proposed rule. He calls for more clarity in several sections and better processes that are product dependent. RAI will forward its notes in a written comment.
    • Michelle Paige—tobacco chemist. Paige discussed storage conditions and stability issues regarding electronic nicotine-delivery system liquids. Further product standards are needed in this area.
    • Sammy Hamdouche—Lucy, manufacturer of oral nicotine products. Hamdouche called the regulation onerous for small manufacturers such as his company. Further labor for his company and their suppliers could eliminate parts or potentially all of their business. Costs could be 10-fold for these processes for his company. Predetermined acceptance criteria could be one solution. The CTP has wide latitude to make this rule more flexible, but Hamdouche is not optimistic.
    • Ron Tully—tobacco industry consultant. Tully believes that the proposed rule should recognize manufacturers of different products and sizes. Small manufacturers could face financial disaster with this rule.
    • Pamela Ling—professor at the University of California at San Francisco. Ling supports the proposed rule. She also calls to strengthen the section of the rule regarding storage procedures and shelf life.
    • Pamela Granger—anti-tobacco activist. Granger supports the proposed rule.

    The public comment session featured the following unscheduled participants (in order):

    • Jason Hodge concluded his earlier
    • Delores Orlando—Florida Smoke-Free Organization, nicotine product manufacturer. Orlando is against the proposed rule.

    On May 18, 2023, the CTP’s Tobacco Product Scientific Advisory Committee will meet the discuss the proposed rule on “Requirements for Tobacco Product Manufacturing Practice.”

  • Public Hearing for Manufacturing Rules

    Public Hearing for Manufacturing Rules

    Credit: Monticello

    The U.S. Food and Drug Administration will hold a public hearing tomorrow, April 12, concerning its proposed guidelines for vaping product manufacturers. When finalizing its rules, the agency weighs the public’s perspective and the perspectives of stakeholders like the vapor manufacturing companies that produce the products.

    The FDA will also bring together its Tobacco Products Scientific Advisory Committee on May 18 to get the opinions of those independent experts. The proposed rules would apply to all FDA-regulated bulk and finished tobacco products, including cigarettes, cigars, chewing tobacco and e-cigarettes.

    The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” The FDA is proposing new requirements for vaping and other tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.

    Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.

    When announcing the hearing, the FDA said speaking spots were limited, and the agency could not guarantee that it would be able to accommodate all requests. The agency asked groups and organizations to select a single spokesperson to help the agency hear as many different perspectives as possible.

    Registration to provide oral comments closed on March 31, 2023. The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.

  • Palau Makes Sale and Use of Vapes Illegal

    Palau Makes Sale and Use of Vapes Illegal

    Image: robodread | Adobe Stock

    The island nation of Palau has outlawed e-cigarettes and other vaping products after President Surangel Whipps signed a law for “a total ban on the import, advertising, sale and use of e-cigarettes,” reports the NZ Herald.

    The law—RPPL 11-27—has expanded the country’s Tobacco Control Act to include e-cigarettes and will come into effect 60 days after being enacted.

    Beginning May 29, businesses and individuals can be prosecuted if found with e-cigarette products.

    Individuals who are caught violating the law could face a $1,000 fine, and businesses or persons importing, distributing and/or selling the product could face a $20,000 fine.

    The initial bill was introduced in the Palau National Congress in July last year.