Category: PMTA

  • Second Circuit Appeals Court Rules in Favor of FDA

    Second Circuit Appeals Court Rules in Favor of FDA

    Credit: Brian Kinney

    A federal appeals court has ruled that the U.S. Food and Drug Administration didn’t change its position on admissible evidence and the agency’s failure to consider a marketing plan didn’t impact the outcome.

    The FDA acted reasonably in denying vapor maker Magellan Technology Inc.’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the Second Circuit ruled Friday.

    The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

    The agency found Magellan’s evidence—four non-clinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine delivery systems (ENDS) in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberglaw.

    The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process which cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full Second Circuit) or could appeal to the Supreme Court of the United States. 

  • Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Credit: Adobe

    U.S. lawmakers are urging the Food and Drug Administration to wrap up its review of pending e-cigarette premarket tobacco product applications, reports Law360.

    In a letter to FDA Commissioner Robert Califf, 50 members of Congress requested the agency finalize its review of pending applications for e-cigarette products; deny applications for all nontobacco-flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.

    The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In its most recent filings with the court, the FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.

    “FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said Colorado Representative Diana DeGette in a statement. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”

    While the FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications—including those for popular products manufactured by Juul Labs, Reynolds Vapor Co. and Smok.

    The lawmakers urged the agency to complete its review of all its pending applications no later than Dec. 31, 2023.

  • Mother’s Milk Denied Marketing for More Than 250 E-Liquids

    Mother’s Milk Denied Marketing for More Than 250 E-Liquids

    Credit: Kraken Images.

    The U.S. Food and Drug Administration on May 18 issued marketing denial orders to Mother’s Milk WTA for more than 250 flavored and tobacco-flavored e-liquids.

    After completing an initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health.

    For example, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently.

    “One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products, in a statement. “We remain committed to evaluating these applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”

    The agency has received premarket tobacco applications for more than 26 million deemed products, most of which are e-cigarettes. The agency says it has made determinations on 99 percent of these applications. This includes more than 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine, after Congress clarified FDA’s authority to regulate these products in April 2022.

    Further, 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. FDA has also denied marketing applications for millions of products that did not meet the requirements in the law. 

  • U.S. FDA Issues 6,500 MDOs to Small Businesses

    U.S. FDA Issues 6,500 MDOs to Small Businesses

    Credit: Waldemarus

    On Friday, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies that collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products.

    The health regulator said these companies cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action.

    “Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”

    The companies that received MDOs include:

    • Imperial Vapors LLC
    • Savage Enterprises
    • Big Time Vapes
    • SWT Global Supply Inc.
    • Great Lakes Vapor
    • DNA Enterprise LLC dba Mech Sauce
    • Absolute Vapor Inc.
    • ECBlend LLC

    FDA is not disclosing the names of the other two companies that received MDOs to protect potential confidential commercial information (CCI).

    The FDA added the premarket tobacco product applications (PMTAs) submitted for a variety of flavored e-cigarette products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for public health.

    The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol.

    “It doesn’t really matter to the FDA what your scientific evidence is or anything else, they’re pretty much handing anyone out there an MDO,” said Char Owen, president of the American Vapor Manufacturers Association.

    She said some of the companies targeted Friday had just one or two storefronts and were genuinely trying to help adults stop smoking through the use of flavored products, according to the Washington Post.

    “It’s tough out here because you’re dealing with lives and businesses,” Owen said.

    Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.

    The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.

  • U.S. Supreme Court Asked to Review Avail Case

    U.S. Supreme Court Asked to Review Avail Case

    Avail Vapor has asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the Food and Drug Administration to Avail products.

    In its petition, known as a Writ of Certiorari, Avail asks the Supreme Court to consider the lower court’s legal reasoning and decision.

    Among other things, Avail argues in its petition that the FDA’s decisionmaking was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.

    The Supreme Court has not yet decided whether it will hear Avail’s case.

  • U.S. FDA on Track to Complete PMTAs by End of Year

    U.S. FDA on Track to Complete PMTAs by End of Year

    The U.S. Food and Drug Administration says it is on track to finish reviewing premarket tobacco product applications (PMTAs) for the most prevalent e-cigarettes by the end of the year, reports CSP.

    The FDA has reviewed 52 percent of covered applications as of March 31. Covered applications are for new tobacco products on the market as of Aug. 8, 2016, with a PMTA filed by Sept. 9, 2020, and sold under the brands Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar and reach 2 percent or more of total retail sales volume per NielsenIQ reports, according to CSP. 

    Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.  

    The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.

  • New Resources to Help Submit PMTA Amendments

    New Resources to Help Submit PMTA Amendments

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

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

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

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

  • Court: Reynolds Likely to Prevail in PMTA Lawsuit

    Court: Reynolds Likely to Prevail in PMTA Lawsuit

    scales of justice
    Credit: Sang Hyun Cho

    When the U.S. Court of Appeals for the 5th Circuit granted a stay to RJ Reynolds Vapor Co. (RJRV) of the U.S. Food and Drug Administration’s denial of its 150,000-page premarket tobacco product application (PMTA) for its menthol Vuse products, the judges indicated that the court believes RJRV is likely to prevail on the merits when the full review is heard. 

    Tobacco harm reduction expert Clive Bates, of Counterfactual, said the substantive decision rests on three main arguments, as outlined by the judges granting the stay. The order states:

    Specifically, RJRV demonstrates that the FDA failed to reasonably consider the company’s legitimate reliance interests concerning the need for longitudinal studies and marketing plans; failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes; and has created a de facto rule banning all non-tobacco-flavored e-cigarettes without following APA notice and comment requirements.

    The three main points argued by the court are outlined below:

    FDA changed the decision-making criteria after the application.

    1. Legitimate reliance interests

    “The FDA did not reasonably consider RJRV’s legitimate reliance interests before changing its position on the types of comparative studies and marketing plans critical to a compliant and complete PMTA.”

    Failure to consider Reynolds’ arguments adequately 

    2. Failure to consider relevant factors

    The FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall. For example, RJRV’s application contained studies that “switching from smoking to use of menthol Vuse Vibe substantially reduces toxicant exposure in a manner similar to smoking abstinence.” RJRV also submitted evidence of low popularity among youth relative to other flavored ENDS.

    Bates stated that at least one portion part of the court’s argument looks troubling for Brian King, the newly appointed director of FDA’s Center for Tobacco Products (CTP).

    Then in July 2022, a new CTP director appeared on the scene and told OS that “the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found [appropriate for the protection of the public health] only if the evidence showed that the benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.” OS then changed its position.

    FDA has been implementing a de facto tobacco product standard (a flavor ban) without using the rule-making process, public comment etc. 

    3. “Tobacco product standard”

    RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard, without affording affected persons any notice or the opportunity for public comment. There is no dispute that the TCA requires the FDA to abide by notice-and-comment rulemaking procedures before establishing a “tobacco product standard.”8 21 U.S.C. § 387g(c)–(d). Similarly, it is clear that a ban on all but tobacco-flavored e-cigarettes would constitute a “tobacco product standard.” 

    Bates explains that the court justifies its assertion that FDA is imposing a de facto standard with reference to the so-called “fatal flaw memo.” This was an expedited decision-making regime that stipulated that applications for non-tobacco-flavored products must be supported with controlled trials or longitudinal studies showing a quitting or switching advantage over a tobacco flavor. Otherwise, they would be automatically denied. 

    We conclude that the Fatal Flaw memo’s heightened evidentiary standard “bears all the hallmarks” of a substantive rule. City of Arlington, 668 F.3d at 242. First, the memo is binding on its face by mandating that applications contain “the necessary type of studies.” Second, it has been applied in a way that indicates it is binding; indeed, the subsequent, myriad Denial Orders refer to the same deficiencies identified as “fatal” in the memo. Third, it took away the FDA reviewers’ former discretion to consider individual PMTAs solely on their merits and instead requires a cursory, boxchecking review.

    Finally, it affected the rights of literally hundreds of thousands of applicants whose PMTAs were denied. This is not a close call.

    Bates stated that the third point the court makes is potentially “very” serious for the FDA and “not a close call,” as the court suggests. “A tobacco product standard under the TCA s.907 means that the burden is on FDA to show that its de facto standard is appropriate for the protection of public health – e.g. considering the impact of closing down all vape shops, likely impact on adults or youth who smoke, unintended consequences, illicit trade etc,” explains Bates. “It shifts the analysis from the individual applicant (PMTA) to the system-wide impact (Product Standard) – and FDA will find this difficult or impossible to meet, in my view.”

    Taking everything into account, the court weighs up its decision to grant the stay against four criteria, as Bates outlined: 

    Our judgment is “guided by sound legal principles” that “have been distilled into consideration of four factors: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.”

    Bates stated that the first of these four criteria reflects the courts’ view on the merits discussed in the three above-stated substantive arguments. In the fourth: (4) where the public interest lies, the court gives significant weight to the “highest public importance that federal agencies follow the law” and states: 

    In sum, “there is generally no public interest in the perpetuation of unlawful agency action,” Texas v. Biden, 10 F.4th at 560. And there is no evidence that “Congress’s policy choice” included an exemption from mandatory federal administrative procedures.

    No date has been set for the court to complete its full review.

  • Vuse Menthol Pods Granted Stay by Appeals Court

    Vuse Menthol Pods Granted Stay by Appeals Court

    Fifth Circuit Court of Appeals

    Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal Fifth Circuit Court of Appeals issued a stay Monday.

    On Friday, the U.S. Food and Drug Administration denied Reynolds Vapor’s premarket tobacco product applications (PMTAs) for the Vuse replacement cartridge Menthol 4.8% (nicotine level) G1 and the Vuse replacement cartridge Menthol 4.8% G2.

    As a result, Reynolds would be prohibited from marketing or distributing the products domestically, or risk FDA enforcement action. However, the appeals court’s decision allows the products to stay in the marketplace.

    In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA has issued MDOs for menthol products after receiving a scientific review.

    A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stayed the order.

  • U.S. FDA Issues Denial Orders for 2 Vuse Menthol Products

    U.S. FDA Issues Denial Orders for 2 Vuse Menthol Products

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.

    Reynolds is expected to challenge the order.

    The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. 

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.

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

    Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.

    In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA has issued MDOs for menthol products after receiving a scientific review.

    A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stayed the order.

    The case continues.