Vapor Voice

Tag: U.S. Food and Drug Administration

  • More Penalties for Unauthorized Elf Bar Sales

    More Penalties for Unauthorized Elf Bar Sales

    Photo: mehaniq41

    On Feb. 26, the U.S. Food and Drug Administration announced the filing of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers for the sale of unauthorized Elf Bar e-cigarettes. The FDA previously issued each retailer a warning letter relating to their sale of unauthorized e-cigarettes. However, follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking the maximum penalty amount of $20,678 for a single violation from each retailer.

    Including these complaints, the FDA has filed more than 100 CMP complaints against retailers for the illegal sale of Elf Bar e-cigarettes. Data indicate these products are appealing to youth. According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among U.S. youth e-cigarette users; among middle and high school students who reported using e-cigarettes in the past 30 days, more than half said they used Elf Bar products during that period.

    “These retailers have not adequately addressed the violations noted in previous warnings from FDA regarding the sale of unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products. “Their continued failure to comply with the law is inexcusable, and as is evidenced by today’s actions, we’re committed to holding them accountable for it.”

    As of Feb. 15, the FDA has issued more than 440 warning letters to and filed 100 CMP actions against retailers, including brick-and-mortar and online retailers, for selling unauthorized tobacco products. In addition to actions involving retailers, the FDA has issued more than 660 warning letters to manufacturers, importers and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes. The agency has also filed CMP complaints against 50 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.

  • Warning Letters for Vapes Resembling Alcohol Products

    Warning Letters for Vapes Resembling Alcohol Products

    Image: FDA

    On Dec. 20, 2023, the U.S. Food and Drug Administration issued warning letters to three online retailers for selling and/or distributing unauthorized e-cigarettes that imitate packaging for bottles of alcohol. These retailers sold Luckee Vape Daniels brands, which are flavored disposable e-cigarette products that come in a variety of common alcoholic drink flavors that may be appealing to young people, including icy pina colada, frozen strawberry daiquiri, frozen mangorita and watermelon martini.

    Data from the 2023 National Youth Tobacco Survey indicate that disposable products are the most commonly used type of e-cigarettes among U.S. middle and high school students. Among current youth e-cigarette users, approximately nine in 10 reported using flavors, with fruit flavors being the most popular (63.4 percent) and about one in 14 (7.2 percent) reporting use of products with alcoholic drink flavors.

    “FDA is committed to taking action across the supply chain, including among retailers, to remove unauthorized tobacco products from the marketplace,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “This includes continued monitoring of the online marketplace to identify and combat against emerging products of concern.”

  • FDA: New 5-Year Strategic Plan Announced for CTP

    FDA: New 5-Year Strategic Plan Announced for CTP

    Image: Tada Images

    On Dec. 18, Brian King, director of the U.S. Food and Drug Administration Center for Tobacco Products, published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.

    The CTP’s strategic plan defines five goals, 10 outcomes and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products.

    King said the CTP will also continue to invest in its staff by advancing operational enhancements and supporting the further development of its workforce.

    In conjunction with the strategic plan, the CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. According to the agency, this policy agenda will create a more efficient approach to meeting the CTP’s strategic plan. The agenda will be updated annually.

  • More Warning Letters for Unauthorized Products

    More Warning Letters for Unauthorized Products

    Photo: Adobe

    On Dec. 13, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure and/or civil money penalties.

    “It is illegal to sell, import, distribute or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA,” said CTP Director Brian King in a statement. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”

    As of December 2023, the FDA has issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes and filed civil money penalty complaints against more than 65 retailers and manufacturers for the manufacture or sale of unauthorized products.

    To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.

  • King: Progress Implementing Reagan-Udall Suggestions

    King: Progress Implementing Reagan-Udall Suggestions

    Photo: GTNF

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has made significant progress in addressing the recommendations made by an expert panel facilitated by the Reagan-Udall Foundation, CTP Director Brian King said in a recent update.

    Key areas of focus include cross-cutting initiatives, science and application review, regulations and guidance, compliance and enforcement, public education campaigns, and resource development.

    According to King, the CTP is working on a new strategic plan set to be released by December 2023, which includes cross-cutting themes like science, transparency, stakeholder engagement and health equity. The center has solicited extensive feedback from both internal and external stakeholders, aiming to create a robust and inclusive plan.

    Regarding science and application review, the CTP has processed more than 26 million deemed products’ applications and is committed to addressing the remaining applications efficiently while ensuring scientific accuracy and legal compliance. It has also developed resources and engaged with stakeholders to enhance the premarket application review process.

    In the realm of compliance and enforcement, the CTP has taken various actions to curb the sale of illegal tobacco products, particularly those appealing to youth. They have issued warning letters and complaints for civil money penalties, demonstrating their commitment to enforcing the law.

    Public education campaigns continue to play a crucial role in preventing youth tobacco product use. The CTP is actively seeking input and aims to share updated campaign information soon.

    The CTP recognizes the importance of their staff and is working on enhancing their workforce development. They are also exploring options for securing user fees to support regulation efforts and requesting additional funding in the president’s fiscal year 2024 budget.

  • Brian King Speaks About CTP Priorities and Progress

    Brian King Speaks About CTP Priorities and Progress

    Brian King (Photo: FDA)

    Throughout his first year as director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), the agency has maintained a steadfast commitment to its core principles of sound science, strategic partnerships, health equity and transparency, CTP Director Brian King said in a recent interview.

    King underscored the enduring importance of these principles. He emphasized that the center’s recent decisions and enforcement efforts have been grounded in comprehensive scientific analysis. This approach, he noted, ensures that product marketing and regulatory actions are well-informed and evidence-based.

    Furthermore, the director highlighted the importance of teamwork, a skill honed through his background as a scientist. Scientific thinking, rooted in objective evidence evaluation, plays a pivotal role in CTP’s work. This scientific approach is instrumental in addressing the complexities of tobacco product regulation effectively, according to King, who also emphasized the importance of effective communication in conveying scientific findings and messages.

    A significant focus of CTP’s work is promoting health equity in tobacco product regulation. King discussed efforts to address disparities in tobacco use, especially among youth and young adults. Notably, the CTP is working on product standards that would prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. King views these standards as a major step toward reducing the appeal of these products, particularly among communities disproportionately affected, such as people of color, low-income populations and LGBTQ+ individuals.

    To further advance health equity, the CTP has undertaken initiatives like the “Next Legends” campaign to educate American Indian and Alaska Native youth about the harms of e-cigarettes and providing Spanish-language adult cessation education resources.

    During his tenure, the center welcomed Charlene Le Fauve as its first senior advisor for health equity, a crucial role in integrating health equity into the center’s programmatic plans and priorities, according to King.

    Looking ahead to the next three to five years, the director stressed the importance of having a clear vision. The CTP is in the process of creating a new strategic plan with the involvement of internal staff and external stakeholders to ensure the center’s continued growth and adaptation in a dynamic regulatory landscape. The plan, to be released by December 2023, will provide a roadmap for CTP’s future, aligning its actions with changing times and the goal of reducing tobacco-related diseases and deaths in the United States.

  • FDA Denies Marketing Order for Flavored Vuse Alto Pods

    FDA Denies Marketing Order for Flavored Vuse Alto Pods

    Image: Rangizz

    The U.S. Food and Drug Administration on Oct. 12 issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.

    After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

    Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth, according to the agency.

    “We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.” 

    Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.  

    These actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. The FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. Applications for six tobacco-flavored Vuse Alto products remain under FDA review.

  • Hearing Set for FDA Manufacturing Requirements

    Hearing Set for FDA Manufacturing Requirements

    Photo: Jon

    Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 am to 5 pm.

    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.

    Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.

    The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.

  • Vaping Industry Unimpressed by CTP ‘Reset’

    Vaping Industry Unimpressed by CTP ‘Reset’

    Photo: aleksandar kamasi

    Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.

    “While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.

    The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.

    To address such criticisms, FDA Commissioner Robert Califf in July 2022 ordered an independent investigation into the CTP’s operations.

    On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.

    In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.

    Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.

    Tony Abboud, executive director, Vapor Technology Association

    Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.

    “After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.

    “But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”

    Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.

  • Vaping Industry Unimpressed by CTP ‘Reset’

    Vaping Industry Unimpressed by CTP ‘Reset’

    Photo: aleksandar kamasi

    Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.

    “While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.

    The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.

    To address such criticisms, FDA Commissioner Robert Califf in July 2022 ordered an independent investigation into the CTP’s operations.

    On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.

    In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.

    Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.

    Tony Abboud, executive director, Vapor Technology Association

    Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.

    “After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.

    “But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”

    Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.

    While welcoming the CTP’s new commitment to transparency, the Premium Cigar Association (PCA) expressed concern that the CTP continues to view industry engagement as an afterthought rather than a means to better understand how its approach can be better designed in the developmental phase of regulations, guidance or strategic planning.

    The PCA also questioned the CTP’s desire to increase its workforce and raise more funds through user fees. “Until the systemic failures are addressed, growing an agency that already spans over 1100 employees will only complicate and compound its problems,” the PCA wrote in a statement. “Rather, CTP should embrace Congressional oversight, as does every other Federal Agency, to ensure that its ongoing efforts remain in-line with its statutory mission and public demands.