Vapor Voice

Category: PMTA

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    FDA Warns Companies For Selling ‘Smart’ Vapes

    The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.

    The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.

    “These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of FDA’s Center for Tobacco Products. “They’re illegal to sell and a flagrant attempt to target kids.”

    The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers, or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.

    “The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug, and Cosmetic Act,” the release states.

    In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty.

    “FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”

  • CMSA Files Amicus Brief With SCOTUS in Triton Case

    CMSA Files Amicus Brief With SCOTUS in Triton Case

    This week, the Coalition of Manufacturers of Smoking Alternatives (CMSA), a trade coalition that represents a diverse array of members who manufacture and distribute smoking harm reduction products, filed an amicus curiae brief before the Supreme Court of the United States supporting White Lion Investments, dba as Triton Distribution, in its case against the U.S. Food and Drug Administration.

    In its brief, CMSA argues that FDA violated the Family Smoking Prevention and Tobacco Control Act (TCA) in its wholesale rejection of applications for flavored vaping products by applying a surprise and improperly adopted standard and foregoing the required notice-and-comment process. The brief emphasizes that the U.S. Congress specifically requires the FDA to undergo a transparent rulemaking process before imposing any restriction that amounts to a “tobacco product” standard.

    “Importantly, this process tasks FDA with considering the broader public health effects of any such standard, ‘such as creating demand for and increasing the use of unregulated black-market products,’ or other harmful consequences,” the CMSA states. “In its efforts to unilaterally reject flavored vapor product applications based on a new and heightened standard, FDA unlawfully sidestepped this critical regulatory check and operated outside the bounds of its authority.”

    The CMSA states that the FDA circumvented the very procedures Congress imposed to check the arbitrary or unreasonable exercise of such delegated power, and causes real harms as the FDA “misleads and whipsaws” manufacturers seeking to provide a robust set of options for consumers seeking to quit smoking,” the CMSA wrote in its brief. Further adding that “the long delays in FDA’s review of the many PMTAs (premarket tobacco product applications) it has received, coupled with the moving goal posts imposed via the review process, creates a level of uncertainty that severely deters investment and innovation in new products with harm-reduction potential.”

    Earlier this week, 13 members of Congress, including U.S. Senator Roger Marshall and U.S. Representative Andy Harris, filed an amicus brief supporting the position of Triton Distribution and CMSA. In their brief, the members of Congress write, “There is a clear lack of authority for such a ban. Congress has specifically prohibited the FDA from banning products. Despite this, the FDA imposed a categorical prohibition.”

    Also, the Global Action to End Smoking wrote in its amicus brief to SCOTUS that the FDA strayed from a “sensible, science-based harm-reduction approach, adopting an all-or-nothing stance that exalts outright cessation and all but ignores the harm-reduction strategy that Congress mandated…. [ignoring the] overwhelming scientific evidence that e-cigarettes containing flavor additives have an important role to play in moving adult smokers down the continuum of risk.”

    SCOTUS announced Dec. 2, 2024 as the date for the U.S. Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution hearing.

    Credit: Renas Child
  • Supreme Court to Hear Avail, Reynolds ‘Venue’ Case

    Supreme Court to Hear Avail, Reynolds ‘Venue’ Case

    The Supreme Court of the United States has agreed to consider another case involving federal approval of vapes at the request of the Biden administration on Friday.

    The case arose after the FDA denied R.J. Reynolds Vapor Company’s request to introduce three flavored vapes on the market. The FDA said the company failed to meet federal requirements concerning tobacco products’ marketing, but the company contends the decision was arbitrary and capricious.

    Reynolds is based in North Carolina, and the federal appeals courts located there and in D.C. already had precedent on the books unfavorable to the manufacturer.

    Under federal law, companies can challenge the U.S. Food and Drug Administration denying of a marketing order for a new tobacco product in Washington, D.C., or where the company’s principal place of business is located, reports The Hill.

    The 5th U.S. Circuit Court of Appeals has been more sympathetic to the industry, making it an attractive place for companies to contest their products being denied.

    The 5th Circuit’s rule effectively enables it to host any tobacco company’s challenge, so long as its lawsuit is joined by a convenience store or other retail seller within the 5th Circuit’s borders — which spans Louisiana, Mississippi and Texas.

    The companies instead filed its challenge in the 5th Circuit alongside Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association. The federal government attempted to move venues, but the 5th Circuit said the additional challengers meant the case was properly brought.

    No matter which way the justices rule, they are not expected to address the merits of the FDA’s denial. The Supreme Court only took up the question of whether the 5th Circuit was a proper venue.

    “There is no circuit conflict over the meaning of this venue provision. And other vehicle problems abound,” the company wrote in court filings urging the justices to turn away the appeal.

    The U.S. Supreme Court agreed in July to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

  • FDA Clears RespiRx IND Inhaler Application

    FDA Clears RespiRx IND Inhaler Application

    Image: Qnovia

    The U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for Qnovia’s RespiRx nicotine inhaler (QN-01).

    According to Qnovia, the RespiRx is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking.

    The company will initiate a Phase 1, randomized, crossover, open-label trial to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company,” said Qnovia CEO Brian Quigley in a statement.

    “Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies,”

    “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison. We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission [Marketing Authorization Application] to the MHRA [ Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to the company.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Mitch Zeller, Qnovia’s policy and regulatory strategy advisor.

    “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit,” Zeller added.

  • Penalties for U.S. Retailers Selling Illegal Vapes

    Penalties for U.S. Retailers Selling Illegal Vapes

    The U.S. Food and Drug Administration is seeking fines against two brick-and-mortar retailers and nine online retailers. The FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products, however, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking a civil money penalty of $20,678 from each retailer.

    To date, the FDA has filed civil money penalty complaints against 70 manufacturers and 160 retailers for distribution and/or sale of unauthorized tobacco products. These actions reflect the FDA’s continued dedication to bringing enforcement actions against entities along the supply chain who violate the law relating to tobacco products.

    The FDA has currently authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling or distributing e-cigarettes that lack the required premarket authorization risk enforcement actions.

     

  • FDA Warns 6 Companies for Trade Show Sales

    FDA Warns 6 Companies for Trade Show Sales

    Credit: Mr. Fog

    The U.S. Food and Drug Administration has issued six warning letters to manufacturers and retailers for selling or distributing unauthorized e-cigarette products promoted at an industry trade show.

    After observations made by Center for Tobacco Products (CTP) staff attending the trade show, the FDA conducted investigations and issued warning letters to six retailers and manufacturers for selling or distributing unauthorized e-cigarette products.

    Regulated entities must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act. Under these requirements, the sale and distribution of unauthorized tobacco products is illegal, including at industry events such as trade shows or expos, according to the FDA.

    “Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We remain committed to identifying and taking action against those breaking the law, including at these events.”

    FDA also announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz.

    “Results from the recently released 2024 National Youth Tobacco Survey found that Breeze and Mr. Fog were among the top five most commonly used brands among youth who use e-cigarettes,” an FDA release states. “Additionally, Raz was identified as a popular brand through routine surveillance, with youth-appealing flavors such as sour mango pineapple and razzle-dazzle.”

    The companies receiving these warning letters sold or distributed e-cigarette products without marketing authorization from the FDA. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violations cited in the warning letter and to prevent future violations.

    Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    The trade show was not named in the FDA release.

  • Mixed Feelings for Four-Year Anniversary of PMTAs

    Mixed Feelings for Four-Year Anniversary of PMTAs

    Credit: Asier Romero

    Representatives of the U.S. vapor industry expressed mixed feelings at the four-year anniversary of the filing of the first premarket tobacco product applications (PMTAs).

    Since the Sept. 9, 2020, deadline, the Food and Drug Administration’s Center for Tobacco Products (CTP) has received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes.

    However, despite its acknowledgement that e-cigarettes overall are less harmful and less toxic than combustible cigarettes, the agency has rejected more than 99 percent of PMTAs for these products.

    At the same time, the FDA has authorized 6,670 new combustible tobacco products to be sold in the U.S., including 3,232 new cigars, 1,291 new pipe tobacco products,1,073 new hookah tobacco products and 973 new cigarettes.

    According to the Vapor Technology Association (VTA), current CTP Director Brian King has authorized only four vaping devices as alternatives to cigarettes, compared with 1,270 combustible products.

    Director King has justified his refusal to authorize flavored e-cigarettes that are widely used by American adults with the need to protect youth. Yet the most recent National Youth Tobacco Survey revealed that the youth vaping rate—the share of users who say they’ve used an e-cigarettes at least once in the past 30 days—has declined to 5.9 percent, the lowest level in more than a decade.

    “Since Sep. 9, 2020, 1.93 million Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 million each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product,” the VTA wrote in a statement.

    “In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.”

  • FDA Posts 2 Regulatory Science Memos for Vapes

    FDA Posts 2 Regulatory Science Memos for Vapes

    Credit: Araki Illustrations

    FDA posted the following two regulatory science policy memos related to the agency’s review of premarket tobacco product applications (PMTAs) for new e-cigarette products: 

    • June 03, 2024: Genotoxicity Hazard Identification and Carcinogenicity Tiering of Constituents in ENDS Premarket Tobacco Product Applications
    • June 03, 2024: Calculating Excess Lifetime Cancer Risk in ENDS Premarket Tobacco Product Applications

    In general, the science policy memos provide a snapshot of FDA’s internal thinking on a specific topic at a certain point in time. Therefore, the information contained in the memos is subject to change, for example, based on changes in policy, the regulatory framework, or regulatory science, according to a press release.  

    FDA’s review of tobacco product applications is based on the specific facts presented in each application and is documented in reviews particular to each application. The memos posted today should not be used as a tool, guide, or manual for the preparation of applications or submissions to FDA.

    For applicants seeking to market new tobacco products, FDA has issued final regulations, such as the PMTA final rule that describes the required content, format, and review procedures for PMTAs, as well as guidance documents. FDA also regularly posts additional resources, such as webinars and application tips, on CTP’s website and social mediaExternal Link Disclaimer.  

    In April, FDA resumed the posting of regulatory science policy memos, with a subsequent release in May. The release of these latest memos reflects the CTP’s ongoing commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation.

  • Fifth Circuit Cites Triton to Vacate 5 Denial Orders

    Fifth Circuit Cites Triton to Vacate 5 Denial Orders

    Fifth Circuit Court of Appeals

    The 5th Circuit Court of Appeals granted petitions for review to five vaping companies, citing its own decision in the Triton Distribution case as precedent.

    The court sent the company’s marketing denial orders (MDOs) back to the U.S. Food and Drug Administration for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco applications (PMTAs), or until the Supreme Court takes action.

    “Specifically, the court determined that (1) FDA did not give e-cigarette manufacturers fair notice of the rule requiring long-term studies for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance,” the 5th Circuit wrote in its ruling.

    Five companies, Cloud House, Paradigm Distribution, SWT Global Supply, Vaporized and SV Packaging first challenged their MDOs in court in October 2021. The court consolidated the five cases, and in November 2021, all petitioners were granted stays pending review.

    In January, the 5th Circuit found in favor of Wages and White Lion Investments (doing business as Triton Distribution) in the e-liquid manufacturer’s appeal of an MDO. The FDA later petitioned the Supreme Court to review the 5th Circuit’s ruling, and last month the Supreme Court agreed to hear the agency’s appeal.

    The FDA challenged the Triton decision, and the U.S. Supreme Court agreed to hear that case. “But now another panel of the Fifth Circuit has applied the same rationale as in Triton to hold that these five, small-business manufacturers prevail for the same reason: FDA pulled a surprise switcheroo,” wrote the United States Vaping Association on X.

    The 5th Circuit found that the recent petitions posed the same issues as Triton’s. “Petitioners spent substantial time and resources preparing their PMTAs based on FDA guidance that they would not need to submit long-term clinical studies,” the court wrote.

    “Nevertheless, FDA rejected their PMTAs using the same boilerplate language it used for the Wages petitioners’ denials, as well as those of thousands of other e-cigarette manufacturers. Accordingly, for the reasons amply explained by the en banc court in Wages, we hold that FDA acted unlawfully here as well by denying Petitioners’ PMTAs based on the absence of long-term clinical studies.”

  • Warning Letters for 5 Online Illegal Vape Retailers

    Warning Letters for 5 Online Illegal Vape Retailers

    Credit: Marcus Krauss

    The U.S. Food and Drug Administration has again  issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products marketed under the brand names Geek Bar, Lost Mary, and Bang. It’s the second wave of warning letters issued in July.

    The retailers included Smoke and Vape Company, LLC d/b/a Smoke and Vape Co.; Smoking Vibes LLC d/b/a Smoking Vibes; Cavalry Industries d/b/a Select Vape; HTXW LLC d/b/a FOMO Culture; and Global Supply Allies Inc. d/b/a Vapor Grab.

    These warning letters were a result of FDA’s ongoing monitoring of multiple surveillance systems, including a review of various data, to identify emerging products of particular concern that are popular among youth or have youth appeal, according to an agency press release. For example, emerging data showed that Geek Bar – a Chinese-owned and manufactured brand – has recently seen an uptick in sales and can appeal to youth.  

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties. 

    FDA holds retailers accountable for selling unauthorized tobacco products, particularly those popular with youth. To date, FDA has issued over 680 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 690 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against 64 manufacturers and more than 140 retailers for distribution and/or sale of unauthorized tobacco products. 

    As of August 1, 2024, the FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products can be lawfully marketed and sold in the U.S. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement.