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Tag: U.S. Food and Drug Administration

  • Three Heating Products Authorized in the U.S.

    Three Heating Products Authorized in the U.S.

    Photo: Destina

    The U.S. Food and Drug Administration has authorized the marketing of three new tobacco-flavored heated-tobacco products included in Philip Morris Products’ supplemental premarket tobacco product applications (PMTAs). The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks and Marlboro Amber HeatSticks, each of which is used with the IQOS tobacco-heating device.

    Based on the FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth.

    In 2019, the FDA authorized the marketing of IQOS and several other Marlboro HeatSticks products through the PMTA pathway. Philip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product for which the company had previously received a marketing granted order. A supplemental PMTA can be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a marketing granted order. 

    Following the FDA’s rigorous scientific evaluation of the applications, the agency determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product. Like the previously authorized products, the FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.

  • Reynolds to Appeal Menthol MDOs

    Reynolds to Appeal Menthol MDOs

    Photo: BAT

    BAT will appeal the U.S. Food and Drug Administration’s marketing denial orders for its Vuse Vibe Tank Menthol 3.0 percent and Vuse Ciro Cartridge Menthol 1.5 percent, the company announced in a statement.

    On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.

    “Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21-plus without interruption,” the company said.

    “We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health.

    “We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”

    Anti-tobacco campaigners countered that menthol e-cigarettes appeal to underage consumers. “Existing evidence demonstrates that nontobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.

    Morgan Stanley said it expected the rejected products to remain on the U.S. market for the duration of BAT’s appeal, with minimal impact on the company’s operations. “Longer term, should today’s denial order reflect a broader effort by the FDA to ban menthol e-cigarettes, BAT’s U.S. cigarette business could benefit given its menthol mix as it might discourage some smokers from quitting or switching to reduced-risk products,” the bank wrote in a note to investors. Reynolds’ Newport brand represents about 40 percent of BAT’s U.S. cigarette dollar sales, according to Morgan Stanley.

    The Jan. 24  rejection of the Vuse refills underscores the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.

    However, the FDA has granted both a premarket tobacco product application and modified-risk tobacco product designation to IQOS’ menthol variant, which may eventually leave Philip Morris International’s heat-not-burn product as one of the few menthol reduced-risk alternatives on the market.

    The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.

  • FDA Denies Two Vuse Menthol Vapor Products

    FDA Denies Two Vuse Menthol Vapor Products

    Photo: rangizzz

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for R.J. Reynolds Vapor Co.’s Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent.

    “Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”

    “Existing evidence demonstrates that nontobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” the FDA wrote in a statement.

    “Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products. Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported ‘usually’ using.”

    “Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

    In assessing the implications of the most recent MDOs for RJRV’s parent company, BAT, Morgan Stanley noted that Vuse Vibe and Vuse Ciro represent only a small portion of BAT’s overall e-cigarette sales in the U.S.

    “Should it choose to appeal, we would expect its products to remain on the market as the appeal is ongoing, resulting in minimal/no operating impact,” the investment bank wrote in a note to investors.

    Morgan Stanley said the MDO provides another example of the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.

    The financial institution also noted that the FDA has granted both a premarket tobacco product application and modified-risk tobacco product designation to IQOS’ menthol variant, which may make it one of the few menthol reduced-risk alternatives on the market.

    The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.

  • 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.

  • 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.

  • Avail Loses MDO Case

    Avail Loses MDO Case

    Photo: Avail Vapor

    A U.S. court rebuffed Avail Vapor’s appeal of the Food and Drug Administration’s refusal to allow its products on the market, reports Reuters. The ruling is the latest in a series of court orders upholding the agency’s regulation of the e-cigarette industry.

    The 4th U.S. Circuit Court of Appeals on Dec. 12 found that the FDA had acted within its authority in rejecting Avail Vapor’s premarket tobacco product applications.

    In 2016, the FDA determined that e-cigarettes were subject to its regulation and gave manufacturers until 2020 to apply for approval of vapor products.

    Avail Vapor sought approval for its products in 2020, telling the FDA that they could help smokers quit by switching to e-cigarettes. The company said it had measures in place that would ensure that its liquids would not be sold to minors.

    The FDA denied the application in 2021, saying that the company had not presented long-term studies supporting its claim that its products, which included fruit flavors, were more effective at helping smokers quit than tobacco-flavored liquids, which the agency has said are less appealing to minors.

    Avail lost an administrative appeal and then petitioned the 4th Circuit to overrule the agency. The company argued that the FDA failed to inform applicants in 2019 that they would need long-term studies. It also said the agency was obligated to consider the sales plan.

    Circuit Judge J. Harvie Wilkinson wrote that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate to protect public health.

    The FDA has denied more than 55,000 applications from e-cigarette products. Those denials have been previously upheld by the D.C. Circuit, 3rd Circuit and 7th Circuit.

  • Vapor Firms Warned for Targeting Children

    Vapor Firms Warned for Targeting Children

    Photo: FDA warning letter to Wizman Limited

    The U.S. Food and Drug Administration on Nov. 16 sent warning letters to five e-cigarette companies for targeting children with products packaged to look like toys, food or cartoon characters. None of the manufacturers submitted a premarket application for any of the unauthorized products.

    The unauthorized products described in the warning letters include e-cigarettes that are designed to look like toys and electronics like glow sticks, Nintendo Game Boy and walkie-talkies. Some of the e-cigarettes feature youth-appealing characters from TV shows, movies and video game characters while others imitate foods like popsicles.

    “The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”

    Critics noted that four of the five companies targeted companies based in China, where the FDA has no jurisdiction.

    “Companies in China—like those cited today—manufacture products for sale around the world, not just in the United States,” wrote Jim McDonald on Vaping360. “The FDA cannot enforce its rules for U.S. manufacturers against Chinese companies or against retailers in other countries.”

    The recipients of the FDA letters are Wizman Limited doing business as Wizvapor, Shenzhen Fumot Technology Co., doing business as R and M Vapes, Shenzhen Quawins Technology Co., Ruthless Vapor and Moti Global.

  • ‘Implementation of Tobacco Act Flawed’

    ‘Implementation of Tobacco Act Flawed’

    Azim Chowdhury

    The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.

    Writing in Filter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.

    In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.

    For example, rather than conducting reviews in silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.    

    “It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.

    “Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”

  • Advocacy Group Suggests FDA Reforms

    Advocacy Group Suggests FDA Reforms

    Photo: Araki Illustrations

    The U.S. Food and Drug Administration has “significantly and substantially failed” to fulfill its congressional mandate to protect the public health, Americans for Tax Reform (ATR) told the Reagan-Udall Foundation in a letter.

    The Reagan-Udall Foundation is reviewing the FDA Center Tobacco Products’ (CTP’s) policies and procedures following months of criticism over its handling of e-cigarette reviews. As part of its assessment, the foundation offered stakeholders an opportunity to share their input.

    In its comment, the ATR suggested seven reforms to improve the agency’s performance:

    • FDA should introduce cross-disciplinary expert analysis factoring input from fields like psychology and behavioral economics to increase public awareness and engagement in the decision-making process.
    • FDA must provide an easy, streamlined PMTA pathway as initially promised.
    • FDA’s PMTA process should focus on product safety and individual risk, not behavioral and population assessments that are better gathered by a singular postmarket surveillance team.
    • FDA should be in regular, proactive contact with all PMTA applicants as opposed to merely issuing marketing denial orders after year-long periods of silence.
    • FDA should consider implementing product standards to assist in the streamlining process and look also to countries such as the United Kingdom as a model for a regulatory system that works.
    • FDA must urgently act to combat significant public misinformation that it admits exists in the community and is a barrier to smoking cessation.
    • FDA must reform its approach to youth risk behavior. FDA should accept that youth can benefit from harm reduction and properly evaluate the consequences of reduced vape access for both adults and youth.

    Tim Andrews, ATR’s director of consumer issues, wrote that the Reagan-Udall Foundation’s review could help the agency better the PMTA review process.

    “[The PMTA] process has created impossible administrative burdens on applicants,” he said. “When processes and requirements were changed, FDA failed to notify applicants and is alleged to have applied a new and different standard to certain applicants. FDA’s failures are structural. Our submission is cognizant of that and emphasizes that these issues can’t be solved with increased funding, especially not through user fees on small vape manufacturers.”

  • Comments in FDA Assessment Suggest Agency in Disarray

    Comments in FDA Assessment Suggest Agency in Disarray

    Photo: BillionPhotos.com

    The U.S. Food and Drug Administration is in disarray and influenced by outside forces rather than scientific research, according to several comments submitted to the Reagan-Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP).

    In July, the FDA commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of a baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the nonprofit Reagan-Udall Foundation, a nongovernmental research group created by Congress to support the FDA’s work, to perform the review.

    As part of its work, the Reagan-Udall Foundation has been soliciting feedback from stakeholders.

    Many of the comments paint a picture of an agency struggling to fulfill its mandate.

    One commenter said that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.

    “Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects and other opportunities that are needed for career development/promotion),” this person wrote.

    “In some divisions (e.g., Division of Nonclinical Science), leadership pushes a ‘gotta get ’em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”

    Another commenter claims that arbitrary and politically driven timelines set externally (by a judge for example) are driving reviews as opposed to allowing for a thorough scientific review. “When errors are found, the CTP reviewers are blamed when in fact the lack of adequate time to complete the reviews are at fault.

    “Staff are burned out and constantly told to do more in less time and blamed for not meeting insane deadlines,” the commenter wrote. “In cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.”

    To read all comments, please visit the Reagan-Udall Foundation’s stakeholder portal.