Category: Regulation

  • Bantam Receives PMTA Acceptance Letter

    Bantam Receives PMTA Acceptance Letter

    Image: Tobacco Reporter archive

    Bantam Vape received acceptance of its premarket tobacco product application (PMTA) submission from the U.S. Food and Drug Administration for its nontobacco nicotine e-liquids, according to a press release. Bantam’s application now moves to the next step in the PMTA process—a preliminary scientific review to confirm the application contains all required items to permit a substantive review by the FDA.

    Bantam submitted its application for its nontobacco nicotine e-liquids to the FDA on May 13, 2022, and is seeking marketing orders from the agency.

    “The receipt of this acceptance letter reflects Bantam’s efforts to provide adult consumers with high-quality, science-based e-liquids while upholding our responsibility to restrict youth access and use of these products,” said Bantam spokesperson Anthony Dillon. “Bantam remains supportive of the need for science-based regulation in the e-liquids industry and is proud of the progress of our various PMTAs. We remain confident in the quality and consistency of our products and the science behind them.”

    Prior to its nontobacco nicotine-focused submission, Bantam submitted a PMTA to the FDA in September 2020 for its tobacco-derived e-liquids. The application entered scientific review in August 2021, and, to date, remains under FDA review.

  • California’s Flavored Tobacco Ban Begins

    California’s Flavored Tobacco Ban Begins

    Image: Tobacco Reporter archive

    California’s controversial ban on flavored tobacco begins today, reports ABC10. A week ago, the U.S. Supreme Court blocked R.J. Reynolds Tobacco Company’s contention that the new state law conflicted with federal law.

    Flavored tobacco products, such as e-cigarettes, menthol cigarettes, flavored cigars and more, can no longer be sold in stores.

    “If they wanted to ban flavored tobacco or regulate it, I feel they should have selected certain stores to be authorized to retail it. It’s saved so many lives, helped so many people get off cigarettes,” said Carlo Sharmoug, owner of Ziggy’s Smoke Shop in Stockton.

    Sharmoug says in his 14 years in business, his store has never once sold tobacco to a minor.

    Lindsey Freitas, an advocacy director representing California and Hawaii for the Campaign for Tobacco-Free Kids, says California’s tobacco rates among teens at one point began to decline until e-cigarettes appeared.

    “They started being sold in flavors like grape and cherry and gummy bear. And all of a sudden, we saw our youth tobacco rates increasing again,” said Freitas.

    Smoke shops like Ziggy’s say California will lose out on millions in tax revenue and believes product will be sold on the black market. However, Freitas disagrees, saying the savings in medical treatment in California alone will be huge.

  • OSC Letter Describes FDA’s ‘Public Failure’

    OSC Letter Describes FDA’s ‘Public Failure’

    Image: David Mark | Pixabay

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns, according to an investigation conducted by the U.S. Office of Special Counsel (OSC). The OSC sent a letter to President Joe Biden and Congress outlining the findings.

    The investigation began after a leading CTP toxicologist-turned-whistleblower disclosed to the OSC that a 2019 memorandum issued to the CTP’s scientists revised the process for evaluating potentially harmful ingredients in substantial equivalence applications used for certain tobacco products. According to the whistleblower, the memo directed scientists to stop using objective, quantitative data to evaluate applications and to instead use an approach that was more akin to “eyeballing it,” resulting in unclear review standards and less reliable decisions, according to the CTP.

    The whistleblower also alleged that flaws in the CTP’s internal scientific dispute resolution process effectively prevented the whistleblower and several other concerned scientists from raising these issues within the agency. “This internal dispute process is intended to safeguard the integrity of CTP’s scientific evaluations, including consideration of certain tobacco products to ensure those authorized for market meet the applicable health and safety standards,” the CTP stated.   

    The OSC referred the whistleblower’s allegations for investigation. In response, the FDA convened an independent panel of scientific experts to evaluate allegations concerning the allegedly flawed tobacco application review process. The panel largely agreed with the whistleblower’s concerns, finding that the process lacked “quantifiable standards or criteria.” The expert panel made six recommendations, including a new process for resolving scientific discrepancies, which the agency largely adopted.

    In response, the whistleblower acknowledged the CTP’s progress in giving scientists discretion to consider quantitative data in reviewing potentially harmful chemical compounds in substantial equivalence applications for new tobacco products. The CTP also revamped its scientific dispute procedures and created a mandatory training program for all CTP staff involved in scientific decision-making. While supportive of these steps, the whistleblower stated that FDA scientists will still need courage to challenge a system that “discourages dissenting voices.”

    “The public depends on the FDA to vigorously implement and enforce our nation’s health and safety laws, especially when new tobacco products are being brought to market,” said Special Counsel Henry J. Kerner. “I am deeply troubled that FDA’s own scientific dispute process failed our whistleblower and fellow concerned scientists, and as a result failed the public. I commend the whistleblower for persevering in the face of these unnecessary obstacles. I also thank the FDA for taking the allegations seriously by convening an independent expert panel and for taking positive steps to repair its review process.”

  • Belgium Bans Smoking at Train Stations

    Belgium Bans Smoking at Train Stations

    Image: Алексей Горелов | Adobe Stock

    Belgium has banned smoking and vaping at train stations, both indoor and outdoor, effective Jan. 1, 2023, according to The Brussels Times.

    The ban will apply to all 550 stations in Belgium, and those caught in violation will be fined. Ashtrays will be removed from platforms, and prohibition signs at visible places will indicate the ban.

    “Our children have the right to grow up in good health, including without exposure to tobacco. As children see fewer and fewer people smoking, the absence of tobacco is becoming the new norm for them,” said Marc Michils, Generation Smoke-Free spokesperson. “Generation Smoke-Free welcomes this measure that brings us closer to the first generation without tobacco.”

    “There are 14,000 victims of tobacco every year in Belgium—that should spur us into action,” said Federal Mobility Minister Georges Gilkinet. The ban will “ensure healthier air on the platforms and, above all, reduce the pressure for young people who have quit or want to quit smoking.”

  • Reagan-Udall Submits CTP Review to FDA

    Reagan-Udall Submits CTP Review to FDA

    The Reagan-Udall Foundation today submitted its recommendations to Robert Califf , commissioner of the U.S. Food and Drug Administration. The findings are what many in the industry are calling “meaningless” and “less than compelling.”

    The report concludes that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the Center for Tobacco Products (CTP), particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.

    The “Operational Evaluation of FDA’s Tobacco Program” was facilitated at Califf’s request. The announcement came as Califf attempted to push past several controversies that dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.

    The report did highlight several wide-ranging problems that the report states hinder its ability to regulate the industry and reduce tobacco-related disease and death. The report stated that the CTP should make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its program also has been affected by “changes in leadership and administrations.” In its first 13 years, CTP has operated under seven different commissioners in three different administrations, and recently hired a third CTP director, Brian King.

    “From the stakeholders’ perspective, policy shifts with broad impact on the industry occurred without notice. The Center has faced significant challenges in clearing its policies through the career and political infrastructure. It took years to establish requirements and standards governing application reviews, frustrating industry and creating problems for the Center itself when it received deficient applications,” the report states. “Issues in application reviews resulted in litigation necessitating re-review of some applications. The current environment reflects an unintended shift from what was structured by law as a pre-market authorization framework to the reality of a post-market regulatory environment, which is much more difficult to deal with given that there are few incentives for industry to come into compliance and many incentives for industry to delay the process.”

    The evaluation and resulting recommendations focused on four program areas: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders, according to the review. The review and recommendations are meant to assist the agency in making changes to better carry out its regulatory responsibilities; to strengthen its relationships with stakeholders

    The report identified several fundamental issues that the center needs to address and it states that the report offers “cross-cutting as well as program-specific recommendations to help CTP operate more effectively,” according to the authors of the review.

    The key points from the report can be summarized as follows:

    • The panel observes that CTP has been forced to operate primarily in a reactive mode, moving
      from one challenge to the next, mainly provoked by the outside forces. The Center should transition to becoming a more proactive and strategic program. With more substantial engagement with stakeholders and the public, CTP should take the time now to think strategically about where it is today and where it needs to go in the next several years.
    • Although CTP has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly, and transparently. This responsibility to function as an effective product regulator should be captured in the Center’s mission, vision, and goals and carried out to the best of the Center’s ability.
    • The panel recognizes that to improve the effectiveness of its application review, the Center should make process improvements and identify and address the policy and scientific questions that underpin its regulatory framework.
    • CTP needs to work with other entities on strategies to clear the market of illegal tobacco products more rapidly and provide more transparency to the public on its efforts to do so. This work is challenging but essential as CTP adopts a more strategic approach. While there is much the Center can do on its own, the panel notes that enforcement of the premarket requirements in the tobacco laws, particularly to help prevent youth use of tobacco products, requires the involvement and support of agencies other than FDA. The authors encourage the agency to elevate this issue and pursue a more comprehensive approach that leverages the resources of other agencies with a declared role in tobacco control.

    “Overall, the panel is confident that many of the concerns raised in this report can be addressed by CTP’s
    talented and dedicated staff, with the support of FDA leadership,” the report states.

    Numerous comments from purported staffers of the FDA for the Reagan Udall assessment claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research. One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs. The report fails to address these issues.

    The panel was comprised of former federal public health leaders, regulatory strategists, and process improvement specialists. Lauren Silvis, served as chair of the group, which included Jane Axelrad, Keith Flanagan, Charlene Frizzera, and Alberto Gutierrez.

    “The panel provided recommendations to help the Agency’s tobacco program strengthen its operations as it works to reduce the harm associated with tobacco use,” said Lauren Silvis. “The Center for Tobacco Products has made significant progress in establishing a regulatory program for tobacco products and our recommendations are intended to help the Center develop additional tools for achieving its public health objectives.”

    Through multiple listening sessions, interviews, and an online portal, the group received and carefully reviewed input from a range of stakeholders, including FDA staff and the public, according to the report. The author’s claim the report offers “cross-cutting and program-specific recommendations” for the FDA to consider, “focusing on regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders.”

    The report did not address tobacco policy issues, which are outside the scope of the evaluation, according to a Reagan-Udall Foundation.

    One industry stakeholder, who asked not to be named for fear of retribution from the FDA for its brands under PMTA review by the agency, said the report’s findings were “a joke” and “completely ignorant of the real problems at the CTP.”

    Califf said Monday he will review the recommendations with the aim of outlining the agency’s next steps by February.

    Earlier this month, Reagan-Udall delivered its food report that was commissioned at the same time as the tobacco report. The food response suggests the agency’s leadership be restructured to improve its response to emergencies, including the recent shortage of baby formula

    Reagan-Udall was created by Congress to help further FDA’s mission. The non-profit receives funding from both the FDA and the industries it regulates, including drugmakers.

    The report can be found at reaganudall.org.

  • Austria to Expand Smoking Ban

    Austria to Expand Smoking Ban

    Image: horst jürgen schunk | Adobe Stock

    The Austrian government plans to expand the country’s smoking ban to include “additional outdoor public places” in 2023, according to The Local.

    The new amendment to the Tobacco and Nonsmoker Protection Act would add public places, such as “children’s playgrounds and recreational areas for children and young people,” to the list of banned smoking areas. The amendment would also regulate nicotine pouches, which have become increasingly popular among young people.

    A ban on indoor smoking, including in bars and restaurants, was implemented in 2019.

    The new amendment will be reviewed at the beginning of 2023.

  • Governor to Veto ‘No Flavor Bans’ Bill

    Governor to Veto ‘No Flavor Bans’ Bill

    Image: Dmitry | Adobe Stock

    Ohio Governor Mike DeWine appears primed to veto a bill just passed by the state legislature that would prohibit cities like Columbus from regulating vaping and other tobacco products.

    DeWine told ABC 6 On Your Side he supports the Columbus ordinance passed Monday banning the sale of flavored vaping and other tobacco products.

    “Making a decision not to have flavored cigarettes is a logical decision that will save many, many lives and will save taxpayers a lot of money,” DeWine said. “Smoking costs the citizens of Ohio hundreds and hundreds of millions of dollars every single year.”

    The day after the Columbus tobacco ban passed, Republicans who control the legislature added a proposal to an unrelated bill mandating that only the state can regulate tobacco products in Ohio. The bill would wipe out attempts by local governments, such as that in Columbus, to rein in the use of tobacco products.

  • CTP Director Overruled Logic Approval

    CTP Director Overruled Logic Approval

    Photo: Araki Illustrations

    Memos recently submitted to the U.S. Court of Appeals for the 3rd Circuit show that the Food and Drug Administration’s Center for Tobacco Products (CTP) allowed its director, Brian King, to reverse a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.

    Attorneys for Logic, which is represented by Troutman Pepper, stated that the new documents reveal the “extraordinary fact that CTP’s Office of Science (OS) reversed its science-based recommendation to issue marketing granted orders for Logic’s premarket tobacco product applications (PMTAs) for its menthol-flavored electronic nicotine-delivery systems (ENDS) after receiving pressure from the new CTP director and his office, the Office of Center Director (OCD).”

    Logic attorneys claim the company is entitled to a stay of the agency’s MDO for the Logic menthol products because the OCD overruled the OS’ initial recommendations to approve Logic’s products based upon its “science-based evaluation” of Logic’s submission. However, because the OCD said in the memos that menthol as a category would be “treated disfavorably,” Logic is asking the court to recognize that the agency’s actions of “basing product-specific decisions” on “unpromulgated, across-the-board policies” that were never subject to notice-and-comment rulemaking is “arbitrary and capricious.”

    In the first memorandum, dated Oct. 25, the OS explains that it evaluated Logic’s PMTAs, including its product-specific evidence, and concluded that authorization of the marketing of Logic’s menthol-flavored ENDS was appropriate for the protection of public health. However, the memo shows that the OS changed course after the new CTP director and the OCD, to whom the OS reports, concluded that menthol-flavored ENDS should be treated as a “disfavored” product category despite the evidence to the contrary.

    The second memorandum reiterates the same policy shift and suggests that meetings were held to address the concerns of OS staff regarding the appropriateness of the decision-making process behind the denial of Logic’s menthol PMTAs. The OS also had concerns that the new OCD approach would eliminate all nontobacco-flavored ENDS products.

    Earlier this week, a unanimous panel of the United States Court of Appeals for the 4th Circuit denied Avail Vapor’s petition to have its MDO invalidated. Avail also argued that the FDA’s review process for PMTAs, although not specifically menthol, were arbitrary and capricious. 

    The U.S. Court of Appeals for the 11th Circuit stayed an MDO issued by the FDA to Bidi Vapor earlier this year, which also argued the agency’s rulemaking was arbitrary and capricious.

    These two rulings were all made before the release of the Logic documents. Industry experts suggest that this revelation of FDA memos could be “game changing” for industry lawsuits.

  • India Mulls Ban on Single Cigarette Sales

    India Mulls Ban on Single Cigarette Sales

    Photo: Africa Studio

    The Standing Committee of Parliament has proposed a ban on the sale of single cigarettes in India to help curb tobacco use, according to reports by DNA India and Latestly.

    The government should also implement a 75 percent goods and services tax (GST) on tobacco products in accordance with World Health Organization recommendations, according to DNA India. India currently imposes GSTs of 22 percent on bidis, 53 percent on cigarettes and 64 percent on smokeless tobacco. However, tax on tobacco goods has not increased significantly despite the GST, according to the committee.

    Smoking is prohibited in public places in the country, with those caught breaking the law facing a fine of up to INR200 ($2.41). Tobacco product advertisements are also banned.

  • FDA Fails in Enforcement: Report

    FDA Fails in Enforcement: Report

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration has failed to follow through after issuing warning letters to online tobacco products and vapor product sellers, according to a report by the Health and Human Services Office of the Inspector General (OIG).

    Between 2010 and 2020, the FDA issued warning letters to 899 online retailers but “took no enforcement actions,” according to the report.

    The FDA enforcement schedule, as of March 2022, calls for the following actions: first violation—warning letter; second violation within a 12-month period—fine of up to $320; third violation within a 24-month period—fine of up to $638; fourth violation within a 24-month period—fine of up to $2,559; fifth violation within a 36-month period—fine of up to $6,398; sixth violation within a 48-month period—fine of up to $12,794; and five or more repeated violations within 36 months—no-tobacco-sale order of 30 calendar days or six months or permanent.

    The OIG report criticizes the FDA’s lack of transparency, which it says makes it hard to track the FDA’s performance. The report suggests that the FDA collaborate with the Bureau of Alcohol, Tobacco, Firearms and Explosives on oversight of online tobacco retailers; complete its rulemaking on non-face-to-face sales of tobacco products as required by the Tobacco Control Act; collect data to support process and outcome measures for its oversight of online tobacco retailers; and publish information and performance data on its oversight of online tobacco retailers.

    In a response, the FDA did not dispute a lack of enforcement actions and agreed with the first and fourth suggestions, stating it is in the process of making those changes. The organization was noncommittal regarding the other two suggestions.

    The OIG report is separate from the Reagan-Udall Foundation review of the FDA’s Center for Tobacco Products.