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Tag: Supreme Court

  • Supreme Court Told Cannabis Ban is Outdated

    Supreme Court Told Cannabis Ban is Outdated

    Two libertarian advocacy groups — the Cato Institute and Pacific Legal Foundation — filed amicus briefs supporting a petition in Canna Provisions Inc. v. Bondi/Garland, which asks the U.S. Supreme Court to reconsider the federal marijuana ban under the Controlled Substances Act (CSA). They argue that the Court’s 2005 ruling in Gonzales v. Raich, which upheld federal authority over intrastate cannabis activity, is outdated given widespread state legalization and shifting federal enforcement.

    A third group, the Americans for Prosperity Foundation, has also filed a brief urging the Court to take the case, claiming the CSA’s application to state-regulated, intrastate marijuana markets exceeds Congress’s commerce-clause powers.

    A recent federal appeals court decision rejecting a similar challenge reaffirmed that Raich remains controlling — underscoring that only the Supreme Court can revisit the precedent.

    The justices will consider the petition at their December 12 conference and announce on December 15 whether they will hear the case. A ruling limiting federal authority over intrastate cannabis activity could have broader implications for federal-state regulatory power, potentially affecting future oversight of nicotine products, heated tobacco, and other controlled substances.

  • Massachusetts Weighs Philip Morris Punitive Damages Appeal

    Massachusetts Weighs Philip Morris Punitive Damages Appeal

    The Massachusetts Supreme Judicial Court is reviewing Armand Fontaine v. Philip Morris USA Inc. (Docket No. SJC-13778), a case that in 2022 produced one of the largest tobacco verdicts in state history after a Middlesex County jury awarded $8 million in compensatory damages and $1 billion in punitive damages. The trial court later reduced the punitive award to $56 million.

    Philip Morris appealed, saying the massive award showed the jury was “inflamed beyond reason,” that punitive damages should require a clear and convincing evidence standard or a separate (bifurcated) trial phase, and that guardrails should be enacted to prevent “nuclear verdicts” (awards of more than $10 million).

    Law360’s Chris Villani wrote that the “court appeared unreceptive to arguments” for imposing new procedural rules, noting existing safeguards such as judicial review and remittitur already limit excessive awards. A decision is expected to clarify how Massachusetts courts handle punitive damages going forward.

  • Supreme Court Grants Extension in Cannabis Industry Challenge to Federal Ban

    Supreme Court Grants Extension in Cannabis Industry Challenge to Federal Ban

    The U.S. Supreme Court gave marijuana companies more time to file their appeal challenging federal cannabis prohibition, extending the deadline from August 25 to October 24. Justice Ketanji Brown Jackson approved the 60-day extension request filed by Boies Schiller Flexner LLP, which represents Canna Provisions, Gyasi Sellers, Wiseacre Farm, and Verano Holdings.

    Attorneys said the additional time is necessary due to the “significant and complex constitutional issues” involved and to allow state governments, law professors, and advocacy groups to prepare supporting amicus briefs. The Justice Department did not oppose the extension.

    The case seeks to overturn the landmark 2005 ruling Gonzales v. Raich, which upheld Congress’s authority to enforce federal prohibition even against state-legal cannabis activity. Plaintiffs argue that modern developments, including state legalization and shifting federal enforcement policies, have undermined the ruling. While lower courts dismissed the challenge, industry advocates see the appeal as a potential vehicle for the Supreme Court to revisit the federal government’s stance on marijuana. Justice Clarence Thomas previously suggested that Raich should be reconsidered, criticizing the government’s “half-in, half-out” approach to cannabis enforcement.

    The petition would need support from at least four justices for the Court to hear the case.

  • Tariffs, Executive Orders and Cuts: The Trump Administration’s First Six Months

    Tariffs, Executive Orders and Cuts: The Trump Administration’s First Six Months

    By Freddie Dawson, Senior editor, Tamarind Intelligence

    The first six months of the second Trump administration can be defined by tariffs, executive orders and no further action on reforming the issues facing the American vaping market.

    President Donald Trump embarked on his second term as president having promised to “save flavored vaping” in the U.S. in the lead up to the election. This has not yet happened despite a flurry of executive orders – at least 157 that have been published in the U.S. Federal Register as of May 23. (More have been announced but that was the date of the last one published at the time of writing.)

    Many vaping advocates had hoped he might use an executive order to reset or reassess the U.S. Food and Drug Administration (FDA) Pre-Market Tobacco Application (PMTA) process. Thus far this has not happened and, instead, there have been some comments that could be construed as concerning.

    There was the U.S. Supreme Court decision in the long-running case with the vaping company Wages and White Lion Investments – doing business as Triton Distribution – and the vaping company Vapetasia. The Supreme Court unanimously decided to vacate and remand the appealed Fifth Circuit Court decision that had been in favor of the companies over whether the FDA had been right to issue market denial orders (MDOs) to the them.

    This was a disappointment for vaping advocates. The companies had argued the FDA had been arbitrary and capricious in the changes it made to PMTA requirements while also being unclear about those changes and what minimum requisites would need to be included to successfully be granted a market authorization and be considered a legal product able to be sold in the American market. Advocates hoped a decision in favor of the vaping companies would confirm the FDA approach had been wrong and pave the way for the new administration to implement a new policy.

    Instead, the Supreme Court mostly rejected the vaping companies’ arguments. It did not arbitrate on all issues presented and returned the case to the lower court for further work, making the decision not a total defeat. However, it was a pretty galling blow for those wanting to see a change. Many of them hoped the Department for Health and Human Services (HHS) – now under new management – would even decline to continue to argue the case following the change in leadership.

    Instead, they appeared to fully embrace the prior approach. A HHS spokesperson welcomed the Supreme Court decision. They said it represented confirmation that the approach taken by the FDA – including under the administration of former Democratic president Joe Biden – was the correct one. “The recent Supreme Court ruling supports the FDA’s efforts to regulate e-cigarette products in line with the standards outlined in the Tobacco Control Act,” a spokesperson said.

    Beyond this, comments by the new HHS secretary – Robert Kennedy Jr and head of the FDA – Marty Makary could also be construed to be viewed as negative takes on vaping from major administration figures.

    Both have been questioned by Florida Republican Senator Ashley Moody on what they will do to combat Chinese vaping products illicitly on the U.S. market. Makary told Moody he agreed that vaping products were proliferating on the American market and that this was due to the Chinese flooding it with cheap supplies.

    He said public health research would never be able to properly study them as the market moved faster than the science could but that the FDA could collaborate with other U.S. government departments to increase enforcement actions. “The Office of Inspections and Investigations has a lot of people with guns, and they do enforcement and raids,” he said.

    Several vaping commentators did not react well to this – particularly on the semi-serious threat of armed enforcement raids. However, it could also be theoretically read that Makary was implying the enforcement action would be directed at imported Chinese vaping products and that emphasis was placed on revamping the FDA’s approach to PMTAs.

    Kennedy Jr’s later comments in answer to questions from Senator Moody could potentially support such a reading. He told her that the FDA had created its own backlog and had deliberately dragged its feet on approvals for American vaping companies, which had been acting responsibly by putting age verification chips in vaping devices, providing information on addiction and were making labels not attractive to children.

    Chinese products had flooded the opening in the market provided by them obeying the law and that these were the products that were responsible for youth attraction issues with flavors, colors and youth-aimed enticements such as cartoon like imagery as well as features such as gaming capabilities on devices. He told Senator Moody that he promised to “wipe them out”.

    Despite being a complete misreading of the nicotine alternatives history – and almost certainly being a ‘barn door shut after the horse has already bolted’ sort of promise, it does at least show some favor for American vaping companies and a potential desire to address issues facing it in the future.

    That marks something of a change from Kennedy Jr’s initial nomination hearings where vaping did not come directly come up. However, his potential use of an Alp nicotine pouch during the sessions did draw a few headlines and suggested the new secretary may have a sympathetic stance on nicotine alternatives.

    But although the administration has not addressed the U.S. vaping regulatory situation through any means – such as the use of executive orders – it has taken other actions through those means that have had an impact on the industry.

    This includes several orders trimming resources for government entities that have some impact on vaping and other nicotine alternatives – including the HHS, the Center for Tobacco Products (CTP) itself and aspects of the Centers for Disease Control (CDC) such as the Office on Smoking and Health (OSH). This has resulted in redundancy or resignation for myriad groups of former federal employees in these organizations up to and including the former head of the CTP, Brian King and – allegedly – the entirety of the OSH.

    The impact of these actions will likely take some time to properly be felt. In the short term it presumably has increased the disorder and delay already present in organizations such as CTP that would have had primary responsibility for PMTA assessment. Further in the future the decisions could potentially benefit vaping and other nicotine alternatives – depending how important intervening steps turn out.

    For example, significantly more will be revealed on the future direction of PMTA assessment by who becomes the next head of CTP. A new head and new staff could perhaps be more efficient in assessing and processing PMTAs – though it is hard to see where new staff with the requisite expertise will suddenly materialize from. Similarly, much will be implied about the administration’s opinion of, and the potential future of, nicotine alternatives by what is done with the former activities of the OSH. For example, maintaining the collection and publication of smoking-related datasets but dropping things like preferential access to data or provision of OSH opinions on issues could create a more vaping-amenable atmosphere in the U.S..

    Setting that aside, more immediately, the action taken through executive orders that has had the most impact on vaping and other nicotine alternatives has been the imposition of tariffs on goods imported into the U.S. from China. Primarily this has affected vaping hardware – though has also had an impact on other product which rely on specialist or mass-produced items that are hard to find from other sources at economically viable prices.

    Theoretically this activity could be considered taking action against the proliferation of illicit Chinese vaping products on the market – as promised by Kennedy Jr and Makary. There is some evidence this is happening with reports of limits placed on maximum purchase numbers for disposable vaping products from wholesalers and decreases in registered imports of vaping products from China.

    Data from the FDA showed only 71 shipments this May, compared to 996 in January 2025, before the additional new Trump tariffs started to be announced. It also compares to the 1158 shipments recorded last May.

    But without a viable domestic vaping manufacturing sector in the U.S., the move risks worsening public health. There previously was little evidence of other nicotine alternatives leaching numbers away from vaping. There is perhaps a little more of that – primarily through dual use driven by situational advantages. This, for example, could be using pouches in scenarios where more discretion is required. But primarily the trend appears to still be for dual or poly use of products rather than switching entirely.

    If vaping products continue to be limited by supply constraints brought about by tariffs, this trend may increase, or people may instead choose to move back to conventional cigarettes. There is little evidence domestic vaping will be able to spring up to fulfil the need. A couple of companies have announced they were transferring manufacturing capacity to the U.S. Many more are moving capacity out of China to third-party countries partly at least to get around U.S. tariffs.

    But there will be no major transference of vaping capacity to the US simply because of the continuing PMTA situation. No company will take the time, effort, and capital it would require setting up manufacturing in the U.S. with no guarantee the product would ever be approved to be sold on the domestic market.

    Meanwhile it is also unclear whether there has definitely been a reduction in Chinese vaping imports. Several manufacturers were already in the process of moving vaping manufacturing capacity out of the Shenzhen region in China due to rising costs driven by competition. Tariffs will have accelerated that trend – though President Trump’s “Liberation Day” spread of tariffs will have gone some way to reducing the advantage such a move would gain in terms of exports to the USA.

    But it has been noted that imports of vaping products from countries such as Indonesia have already outstripped their totals for the entirety of last year (3,139 thus far this year compared to 3,102 for all of 2024). And there remains significant speculation that the vast majority of Chinese vaping imports – particularly for disposable vaping products – do not enter the U.S. under the proper registration. U.S. officials have alleged that they are often deliberately labelled as products such as shoes to get around restraints. Though this claim has been repeated many more times than evidence backing it has been produced.

    One potential support of vaping products entering the U.S. market through some means aside from in registered shipments is the 90% discrepancy between the reported value of Chinese vaping exports to the U.S. ($3.6bn for 2024) and Chinese vaping imports registered with U.S. authorities ($333m for the same time period).

    So thus far there has not been much help for vaping in the first six months of the second Trump administration. But there is the potential of future promise. Appointments and reassignments for the OSH and – primarily – the CTP could theoretically change the approach to vaping regulation in America. Further policing of illicit vaping products entering the market could lead to domestic uptake – if PMTA conditions were first sorted. So not much for vaping or wider nicotine alternatives in the first six months. But perhaps the groundwork for something more to be built later.

  • U.S. Supreme Court Backs RJR, Broader Legal Challenges to FDA

    U.S. Supreme Court Backs RJR, Broader Legal Challenges to FDA

    The U.S. Supreme Court ruled 7–2 in favor of R.J. Reynolds Vapor Company, allowing it to challenge FDA denials of e-cigarette marketing applications in the Fifth Circuit, even though the company is based in North Carolina.

    The decision effectively expands who can file lawsuits under the 2009 Family Smoking Prevention and Tobacco Control Act, now including retailers and trade groups affected by product bans, not just manufacturers. This enables tobacco companies to approach conservative-leaning courts like the Fifth Circuit, which has frequently ruled against FDA vaping restrictions.

    The FDA argued that retailers were never meant to be included under the legislation, and that 75% of e-cigarette appeals were being filed in the Fifth Circuit through strategic partnerships with local vape shops and trade groups, undermining consistent enforcement.

    Justice Amy Coney Barrett, writing for the majority, said that retailers are “adversely affected” because they lose potential sales or risk penalties by selling unapproved products. Justice Ketanji Brown Jackson, in dissent, warned the ruling contradicts Congress’s intent, allowing companies to bypass venue restrictions meant to streamline regulation.

    The case specifically involved menthol-flavored Vuse vapes, which the FDA had denied for failing to meet public health standards. The ruling now returns the case to the Fifth Circuit for further review.

  • FDA Scores Win, but Industry Eyes PMTA Denial Challenge

    FDA Scores Win, but Industry Eyes PMTA Denial Challenge

    On April 2, 2025, the U.S. Supreme Court issued its decision in the Wages and White Lion Investments (d/b/a Triton Distribution) Premarket Tobacco Product Application (PMTA) Marketing Denial Order (MDO) challenge. In a 9-0 unanimous ruling, the Supreme Court held that the FDA did not act arbitrarily and capriciously when it denied the PMTA for Triton’s flavored electronic nicotine delivery systems (ENDS) under the “fatal flaw” review standard. While the decision reaffirmed the deference owed to FDA under the Administrative Procedure Act (APA), at least with respect to the agency’s ability to change its position on PMTA requirements, the Court left open several critical issues, including whether the agency committed a potentially prejudicial error by failing to consider applicants’ marketing plans, according to an article published by Keller and Heckman LLP.

    “As previously reported, Triton’s MDO challenge in the U.S. Court of Appeals for the Fifth Circuit attracted significant attention within the vaping industry’s broader efforts to secure market access for flavored ENDS products,” Keller and Heckman wrote. “In the lead-up to the Supreme Court’s review, numerous manufacturers had filed petitions in circuit courts across the country challenging FDA’s issuance of boilerplate MDOs for millions of flavored ENDS products. To date, FDA has denied or refused virtually all (>99%) of applications for flavored ENDS products and has only authorized two menthol-flavored products. The MDO appeals yielded conflicting outcomes: the Fifth and Eleventh Circuit held that certain MDOs were arbitrary and capricious under the APA, while the D.C., Second, Third, Fourth, Ninth, and Tenth Circuits upheld the denials. The Supreme Court’s decision to review Triton’s case was widely regarded as pivotal for the regulated industry, public health stakeholders, and FDA, as it promised to resolve the circuit split.”

    Justice Samuel Alito’s narrowly focused 46-page opinion ultimately fell short of the broader expectations many in the industry had for the Court’s review. Rather than addressing the full range of legal and regulatory questions raised by the parties, the Supreme Court confined its analysis to the APA’s “change-in-position” doctrine—specifically, whether FDA had assured applicants like Triton, through its guidance documents and other public statements, that it would apply one evidentiary standard, only to apply a different one during PMTA review. As Justice Alito framed it, the question was whether FDA “told [Triton] in guidance documents that it would do one thing and then turned around and did something different.” While the ruling provided clarity on this narrow issue, it left several critical questions unresolved.

    “Although the ruling was unanimous for FDA with respect to whether the agency arbitrarily changed its position on the PMTA requirements for flavored products, the Supreme Court avoided addressing several significant APA and constitutional issues raised in both the parties’ and amici briefs,” Keller and Heckman wrote. “The Court did not address, for example, the constitutional right to due process or the applicability of the major questions doctrine. Nor did it engage in a deeper examination of FDA’s PMTA review process, sidestepping key concerns such as the absence of appropriate tobacco-flavored comparators for companies like Triton, or the lack of clarity regarding the level of benefit required to satisfy the agency’s comparative efficacy standard. Although it vacated the en banc decision, the Supreme Court has remanded the case back to the Fifth Circuit, specifically to consider whether FDA’s refusal to consider Triton’s marketing plans during the application review process was a harmless error, especially given FDA’s prior characterization of such marketing plans as being ‘critical’ to the PMTA.

    “The remand focusing on FDA’s failure to consider Triton’s marketing plans takes on added weight in light of the Eleventh Circuit’s 2022 decision in Bidi Vapor LLC v. FDA, where the court held that a similar omission by the agency rendered the MDO arbitrary and capricious. Furthermore, the Supreme Court declined to reach (and expressed no view on) Triton’s argument that FDA erred in evaluating its PMTA under standards developed in adjudication rather than standards promulgated in notice-and-comment rulemaking. The Fifth Circuit’s resolution of these issues could have sweeping implications for how FDA must evaluate future PMTAs and respond to procedural challenges under the APA. The remand also presents the vaping industry with a renewed opportunity to advance alternative administrative law claims in a court that has historically viewed FDA’s approach to flavored ENDS products with skepticism.”

    Whether these challenges move forward, however, may ultimately depend on FDA’s litigation strategy under a new Administration that has forced out many of the leaders and staff at the FDA Center for Tobacco Products, and previously signaled support for flavored vaping products. All eyes now turn to the Fifth Circuit, as both sides consider their next moves in this closely watched case.

  • Supreme Court Favors FDA in Flavor Battle

    Supreme Court Favors FDA in Flavor Battle

    Today (April 2), the Supreme Court unanimously overturned a lower court’s decision that the U.S. Food and Drug Administration incorrectly blocked flavored nicotine e-liquids, rejecting e-cigarette makers that were challenging regulatory hurdles on tobacco products.

    E-liquid companies Triton Distribution and Vapetasia LLC claimed the FDA unlawfully denied the marketing authorization for flavored vape products and disputed that the products appealed to children, arguing that the government was harming nicotine-addicted adults by keeping a cigarette alternative off the market.

    The vape companies argued the FDA failed to review the company’s own scientific evidence, which demonstrates its flavored products were crucial to getting smokers to switch from combustible cigarettes to e-cigarettes. The Fifth Circuit Court agreed with the e-cigarette maker, ruling that “the agency’s rejection was arbitrary and capricious because the FDA relied on conflicting evidence requirements.” The court also faulted the FDA for dismissing “out-of-hand companies’ strategies to keep their products away from minors.” The agency said such efforts haven’t proven to be effective.

    Public health groups had already sued the FDA for not moving fast enough to review the products after the agency, in 2016, finalized rules for regulating them under the 2009 Family Smoking Prevention and Tobacco Control Act. Under the Act, vape companies were forced to submit applications to the FDA in order to bring new vape flavors to market, and the FDA was to assess the public health effects of those products. A rift, however, emerged over the agency’s criteria for approving or denying those applications, which culminated in the Fifth Circuit.

    The fight was brought to the Supreme Court in November with the FDA contending it correctly applied the Tobacco Control Act, saying it considered both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”

    Oral arguments in front of the Supreme Court centered on whether the FDA standards are a policy position or a substantive rule imposed without notice and comment. The Biden administration argued the standards fell into the policy bucket, pushing the court to give the agency deference to interpret its role under the Tobacco Control Act. 

    Under the Biden administration, the FDA rejected more than a million flavored products, saying companies failed to show that flavored vapes will do more to benefit public health by helping smokers quit tobacco products than the harm they cause by appealing to young people.

    Vaping companies hope they’ll find a friendlier regulatory environment under the Trump administration, as the President previously promised to “save” flavored vaping.

  • FDA Tobacco Case Heads to Supreme Court

    FDA Tobacco Case Heads to Supreme Court

    The Supreme Court will hear oral arguments on Tuesday in a clash between RJR Vapor and the U.S. Food and Drug Administration (FDA) centered around the rules in which the FDA can be challenged in court. The FDA argues that the Tobacco Control Act allows cases to be argued in one of three areas: in the D.C. Circuit, in the place where the plaintiff resides, or in the place where it has its principal place of business. RJR Vapor, a subsidiary of British American Tobacco based in North Carolina, however, is trying to challenge the FDA in the conservative U.S. Court of Appeals 5th Circuit based in Louisiana.

    RJR Vapor filed a petition for review along with Avail Vapor, a Texas retailer, and by a trade association for Mississippi gas stations and convenience stores that sell RJR Vapor’s products— states that reside in the 5th Circuit. RJR’s North Carolina home resides in the 4th Circuit, which had previously turned their appeal against the FDA denial of applications aside. The 5th Circuit, however, previously ruled against the FDA denials, saying the government agency was sending companies on “a wild goose chase.”

    RJR Vapor and the retailers argue the law states “any person adversely affected” can challenge the FDA, to include retailers within the 5th Circuit trying to sell RJR Vapor’s popular menthol-flavored Vuse brand e-cigarettes who could potentially go out of business. In 2016, the FDA rejected RJR Vapor’s application, saying the product would not be “appropriate for the protection of the public health.”

    The FDA argues that its rulings are “always or nearly always” regulating the manufacturer and that any effects on retailers are indirect and thus irrelevant, and that allowing this case in the 5th Circuit would allow “ready evasion” and create incentives for “forum-shopping.” The FDA contends the stakes are high in this case, as the 5th Circuit’s previous ruling would allow manufacturers to get around federal restrictions and cherry-pick the courts where its cases would be heard.

    The FDA approached the Supreme Court, and in October 2024, it agreed to hear the case. RJR Vapor argues the Supreme Court doesn’t have the authority to rule over “non-final” cases like this one to begin with, and wants the case dismissed without decision.

  • Supreme Court Won’t Hear Graphic Warning Challenge

    Supreme Court Won’t Hear Graphic Warning Challenge

    The U.S. Supreme Court won’t hear a challenge to a federal requirement that cigarette packages and advertising include graphic images demonstrating the effects of smoking.

    The nation’s top court declined to hear the case in a brief written order handed down Monday.

    R.J. Reynolds appealed to the high court after the 5th U.S. Circuit Court of Appeals found the warnings do not violate the First Amendment, the AP reports.

    They include pictures of smoke-damaged lungs, feet blackened by diminished blood flow and a picture of a woman with an immense growth on her neck and the caption “WARNING: Smoking causes head and neck cancer.”

    Nearly 120 countries worldwide have adopted more prominent, graphic warning labels. Studies from those countries suggest that image-based labels are more effective than text warnings at publicizing smoking risks and encouraging smokers to quit. The U.S. has not updated its labels since 1984.

    It’s not clear when new labels might appear. Some legal claims remain, and the FDA has said it doesn’t plan to enforce any new requirements until at least December 2025.

  • Industry Group Files Amicus Brief in Triton Case

    Industry Group Files Amicus Brief 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.