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  • 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.

  • Momentous Ruling

    Momentous Ruling

    Credit: JHVE Photo

    The end of Chevron deference could have ripple effects across the nicotine industry.

    By Timothy S. Donahue

    U.S. courts will no longer need to “humbly respect” how government agencies interpret the law. The end of Chevron deference means unelected officials will no longer have the leeway to subjectively decide what Congress intends when it passes regulatory legislation.

    The court’s ruling in Loper Bright Enterprises v. Raimondo and the related case Relentless v. Department of Commerce will likely have far-reaching impacts on nearly every action government agencies take. For the nicotine industry, it could change how courts view the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process. It could also impact the agency’s efforts to regulate menthol and lower the levels of allowable nicotine in combustible cigarettes.

    “For far too long, unelected bureaucrats at the FDA have been making up the law to suit their ulterior agenda and … the Supreme Court has thankfully put a stop to it once and for all,” said Allison Boughner, vice president of the American Vapor Manufacturers Association, in a statement. “No longer will it be good enough for [prohibitionists] in Congress to write vague, Crayola language and then connive behind closed doors with FDA to impose arbitrary policies on the American public that could never withstand the light of day. [This] ruling is a stirring rebuke of FDA and, we hope, with more soon to follow in pending cases.”

    In declaring the doctrine’s demise, Chief Justice John Roberts wrote that agencies “have no special competence” in resolving statutory ambiguities—but courts do.

    “Chevron is overruled,” wrote Justice Roberts in the Loper Bright decision. “Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA [Administrative Procedure Act] requires. Careful attention to the judgment of the Executive Branch may help inform that inquiry.

    “And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation while ensuring that the agency acts within it. But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”

    Agustin E. Rodriguez, a partner with Troutman Pepper, explained that “under the doctrine of Chevron deference, courts would defer to a federal agency’s interpretation of an ambiguous statute if the agency was charged with administering the statute in question and its interpretation was reasonable. However, the end of Chevron deference may alter that traditional thinking.”

    Bryan Haynes, also a partner at Troutman Pepper, added, “The Supreme Court’s decision overruling Chevron in the Loper Bright Enterprises v. Raimondo case could affect federal courts’ overall outlook on agency interpretations, possibly making courts hesitant to defer to agencies as a general practice.”

    The decision could potentially result in alterations to the FDA’s methods of regulating vaping products. The Supreme Court of the United States (SCOTUS) has agreed to hear its first-ever vaping case, Wages and White Lion Investments v. U.S. FDA, which is compelling because deferring to Chevron has been the standard for lower courts when deciding regulatory cases brought by manufacturers of nicotine products (the end of Chevron deference isn’t likely to directly impact the White Lion case, according to its attorneys).

    Robert Burton, an expert with more than 11 years of experience in the U.S. vaping industry and current group scientific and regulatory director for the U.K.-based vaping company Plxsur, said another general concern is that now, federal agencies may have to put more resources into the additional legal challenges that they will likely face and divert staff away from review/approval processes.

    “Agencies, such as FDA, may also have to look to improve their primary knowledge in those ‘gray areas’ to be able to demonstrate they actually have the knowledge and expertise rather than it being ‘assumed’ or deferred by judges based upon Chevron,” Burton explained. “I also can’t see anything changing soon; if anything, this will create a further backlog of court cases and delays in regulatory decisions based upon the potential for an agency to be challenged legally.”

    How it started

    The Chevron doctrine, based on the 1984 decision in Chevron v. Natural Resources Defense Council, held that courts should defer to the interpretations of “expert” federal agencies regarding ambiguous laws they are required to implement, as long as the agency interpretations are reasonable.

    In many cases, what would be considered “reasonable” was also left to government agencies to decide because nonelected bureaucrats were often considered “experts” even though they had little to no experience in the industries they were regulating.

    For 40 years, unelected officials were given latitude to decide on their own what Congress had intended when it wrote unclear laws—even if there were other sufficient interpretations that the courts could have considered. According to the New York Times, Chevron deference was applied in 70 Supreme Court decisions and 17,000 lower-court rulings during those years.

    The plea to overturn the Chevron doctrine came to the court in two cases challenging a rule issued by the National Marine Fisheries Service (NMFS) that requires the herring industry to bear the costs of observers on fishing boats. Applying Chevron, both the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of Appeals for the 1st Circuit upheld the rule, finding it to be a reasonable interpretation of federal law.

    The fishing companies brought their case to the Supreme Court, seeking the justices’ input on both the rule in question and the overruling of the Chevron doctrine. Roman Martinez, speaking on behalf of a group of fishing vessels, informed the justices that the Chevron doctrine undermines the courts’ responsibility to interpret the law and violates the federal law that governs administrative agencies, which calls for courts to independently review legal questions.

    Under the Chevron doctrine, he observed, even if all nine Supreme Court justices agree that the fishing vessels’ interpretation of federal fishing law is better than the NMFS’ interpretation, they would still be required to defer to the agency’s interpretation as long as it was reasonable. Such a result, Martinez concluded, is “not consistent with the rule of law.”

    Chris Howard, executive vice president of external affairs and new product compliance for Swisher, parent to the vaping company E-Alternative Solutions, welcomed the ruling, saying that federal agencies have had too much power for decades.

    “That ended with the Supreme Court’s decision overturning the longstanding Chevron doctrine,” said Howard. “The decision marks a significant shift in the judicial landscape, correcting the balance of power between federal agencies and the judiciary. It fundamentally alters how courts rule on agency statutory interpretation. As the majority states, courts will no longer be restrained by the need to provide deference.

    “Instead, ‘Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA requires.’ This transformation will likely lead to significantly less regulatory flexibility and increased judicial scrutiny. The implications of this decision will resonate across industries, including the tobacco industry, influencing regulatory practices and shaping the future of administrative law. Regulatory overreach will become the exception as opposed to the norm and enable courts to fulfill their duty to interpret the law.”

    Credit: Sean Pavone Photo

    Immediate uproar

    The end of Chevron deference is extremely far-reaching, with other industries, such as healthcare, likely to review previous decisions that have gone against them. Justice Elena Kagan, in her dissent, asserted that government regulators are best positioned to tackle highly technical subjects.

    “This court has long understood Chevron deference to reflect what Congress would want, and so to be rooted in a presumption of legislative intent,” Kagan wrote. “Congress knows that it does not—in fact cannot—write perfectly complete regulatory statutes. It knows that those statutes will inevitably contain ambiguities that some other actor will have to resolve and gaps that some other actor will have to fill.

    “Today, the court flips the script: It is now ‘the courts (rather than the agency)’ that will wield power when Congress has left an area of interpretive discretion. A rule of judicial humility gives way to a rule of judicial hubris. In recent years, this court has too often taken for itself decision-making authority Congress assigned to agencies. The court has substituted its own judgment on workplace health for that of the Occupational Safety and Health Administration, its own judgment on climate change for that of the Environmental Protection Agency and its own judgment on student loans for that of the Department of Education.

    “In one fell swoop, the majority today gives itself exclusive power over every open issue—no matter how expertise-driven or policy-laden—involving the meaning of regulatory law. As if it did not have enough on its plate, the majority turns itself into the country’s administrative czar. It defends that move as one (suddenly) required by the (nearly 80-year-old) Administrative Procedure Act. But the act makes no such demand. Today’s decision is not one Congress directed. It is entirely the majority’s choice. And the majority cannot destroy one doctrine of judicial humility without making a laughingstock of a second.”

    Several national healthcare groups made a joint statement expressing that Chevron deference protected the legal stability of public health programs such as Medicare and Medicaid. The groups claim that Chevron ensured that laws passed by Congress were interpreted and implemented by expert federal agencies such as the Centers for Medicare and Medicaid Services.

    “As our amicus brief noted, large health programs such as Medicaid and Medicare, as well as issues related to the Food, Drug and Cosmetic Act, are extremely complex, so it is key that decisions about how to interpret and implement relevant laws are made by experts at government agencies,” the statement reads. “Yet [this] majority opinion explicitly ends the use of this sensible doctrine.

    “As leading organizations that work on behalf of people across the country who face serious, acute and chronic illnesses and many people who lack access to quality and affordable healthcare, we will continue to work to ensure that healthcare laws are implemented in ways that benefit public health.”

    In its response to the Chevron ruling, the Public Health Law Center at the Mitchell Hamline School of Law stated that the Loper Bright ruling will “undoubtedly impact” the field of administrative law and implicate regulations that, in addition to promoting public health and safety, have served to protect consumers, workers, civil rights and the environment.

    “Legal experts differ on the degree to which Loper Bright may wreak havoc on the federal administrative state; however, the forceful dissent written by Justice Kagan in this case and its companion case, Relentless v. Department of Commerce, should not be ignored. The dissent expressed grave concern that these decisions ‘will … cause a massive shock to the legal system, cast doubt on many settled constructions of statutes and threaten the interests of many parties who have relied on them for years.’

    “In the absence of Chevron deference, the tobacco industry will doubtless feel emboldened to dispute any regulatory actions taken on its products. This includes e-cigarette manufacturers who will be eager for courts to undo FDA-issued premarket tobacco product application denial orders for many thousands of vape products.”

    The Biden administration called the Chevron decision “yet another deeply troubling decision that takes our country backward,” adding that President Biden’s legal team would work with federal agencies to do “everything we can to continue to deploy the extraordinary expertise of the federal workforce.”

    Reshma Ramachandran, a health policy expert and assistant professor at the Yale School of Medicine, said, “This term has been disastrous for public health in many ways.”

    In the vaping industry, however, Tony Abboud, executive director of the Vapor Technology Association (VTA), said that the decision clearly bolsters what the VTA has been saying for years: the FDA and, specifically, the Center for Tobacco Products overstepped their authority when they chose to implement a de facto ban on flavored e-cigarettes in their deeply flawed implementation of the PMTA process.

    “To be clear, it is [the] FDA’s responsibility under the law to create a regulation that clearly addresses the statutory standard of what is ‘appropriate for the protection of public health’ since the Tobacco Control Act is ambiguous on how that determination should be made. However, there is no question that the FDA violated the Administrative Procedure Act by implementing what the 5th Circuit Court of Appeals called ‘a de facto ban on flavored e-cigarettes’ through its shifty implementation of the PMTA regulation by imposing new requirements on products after applications were already filed, ultimately ensuring their application’s demise.

    “The Supreme Court’s decision elevates the importance of the Reagan-Udall Foundation’s findings after being convened at the request of the FDA commissioner, which specifically and clearly criticized the FDA’s Center for Tobacco Products for failing to inform companies what must be provided under the regulation to demonstrate APPH [appropriate for the protection of the public health] and, as importantly, for failing to inform the public on how FDA is applying this standard.”

    Beyond nicotine

    The cannabis industry also will likely be impacted by the Chevron ruling. Asheville, NC-based attorney Rod Kight, a global resource and expert in cannabis law, said that the recent ruling by the SCOTUS that Chevron deference is dead is welcome news to the cannabis industry. With respect to the hemp sector, the death of Chevron means that unofficial positions taken about various cannabinoids and processes to produce hemp products by both the U.S. Drug Enforcement Agency (DEA) and the FDA on their respective websites and in letters to stakeholders do not hold any weight, at least not with the courts.

    “In practical terms, this means that judges may not defer to federal agency positions and interpretations and, instead, must weigh their positions relative to the strength of the legal positions and interpretations put forth by the hemp industry,” explains Kight. “For instance, with respect to tetrahydrocannabinolic acid (THCA), the DEA has stated in two letters during the past year that ‘cannabis-derived THCA does not meet the definition of hemp under the CSA because upon conversion for identification purposes as required by Congress, it is equivalent to delta-9 THC.’

    “As I have discussed in several blog posts and interviews, this is partially incorrect and is not exactly what ‘Congress required.’ Rather, Congress requires a post-decarboxylation test for hemp production (i.e., cultivation) but not for harvested hemp or hemp products.”

    In the past, this type of unofficial guidance may have warranted a court’s deference to the DEA, even if an opposing position by a hemp industry participant was stronger and more well articulated. However, Kight said that, in the post-Chevron world, the DEA’s position will not hold any more weight with the court than a counter-position by an opposing litigant.

    “The same thing applies to any number of other issues, from vapes to synthetic cannabinoids,” said Kight. “Hopefully, this exciting legal development will curb the appetite for DEA and FDA to take strong positions that are often unwarranted while helping the hemp industry to carve out favorable judicial rulings based on the best and most well-articulated positions.”

    Abboud said the SCOTUS’ decision in Loper exposes the FDA’s improper regulation of flavored e-cigarettes. While the vaping cases that have gone before the SCOTUS were not explicitly decided on Chevron deference, it is hard to believe that the court will not look skeptically on the FDA’s prior “regulatory shenanigans and post-hoc justifications” laid bare by the 5th Circuit Court of Appeals in the White Lion case.

    “However, unlike the complete overturning of Chevron, it is likely that the court would issue a more limited ruling in the vape cases before it. That said, the real power of Loper is that it provides a template for new litigation against the FDA that is not limited to individual application decisions,” said Abboud. “This new regulatory challenge would reveal the full story of FDA’s tortured and disingenuous implementation of the ambiguous PMTA statutory provisions to ban flavored vaping products and possibly, as a result, spell the demise of the PMTA regulation.

    “VTA is once again calling for the FDA to immediately suspend any further denials based on its existing process and instead create a clear and streamlined tobacco product standard that will allow independent companies of all sizes to get less harmful nicotine alternatives on the market as it is required to do under the law.”

    Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
  • Vape Industry Anxious for Triton Hearing

    Vape Industry Anxious for Triton Hearing

    Credit: Flysnow

    The U.S. vaping industry is anxiously awaiting a decision from the highest court in the land.

    By Timothy S. Donahue

    The Supreme Court of the United States (SCOTUS) is poised to address a crucial case for the vaping industry that challenges the U.S. Food and Drug Administration’s decision to block the marketing of flavored e-cigarette products. The FDA is contesting a lower court ruling that favored two vaping companies, which argue that the FDA unjustly rejected over a million premarket tobacco product applications (PMTAs) to sell flavors other than tobacco or menthol.

    Under the agency’s PMTA pathway, companies must demonstrate that the marketing of a product would be appropriate for the protection of public health (APPH). When the FDA makes decisions about vaping products, it must take into consideration the risks and benefits to the entire population, not just users of the products.

    The case, Wages and White Lion Investments v. U.S. FDA, is compelling because a major factor in predicting how SCOTUS will rule in the first vaping case to be heard by the high court, and potentially at least three others, is that in the wake of another SCOTUS ruling, courts no longer need to defer to agency interpretation of the law simply because a statute is ambiguous (see “Principle Response,” page 22).

    Gregory Conley, an experienced industry attorney and director of legislative and external affairs at the American Vapor Manufacturers Association, said that the overturning of the Chevron deference could have a profound impact on the vaping and broader nicotine industries by reducing the deference courts previously granted to regulatory agencies like the FDA.

    “Judges will now critically evaluate the FDA’s regulatory processes and interpretations of ambiguous statutes rather than assuming the agency knows best,” Conley said. “In simpler terms, for the first time since its creation, the FDA’s Center for Tobacco Products will have to follow the law as written.”

    Vape companies secured a legal victory when the 5th U.S. Circuit Court of Appeals sided with Wages and White Lion (doing business as Triton Distribution) and Vapetasia when it overturned the orders denying the marketing of the companies’ flavored products. In its decision, the 5th Circuit condemned the FDA’s imposed requisites as “unfair,” noting that the agency “unexpectedly demanded” that the companies present studies demonstrating that flavored products would contribute to smoking cessation.

    In January, the en banc panel of the 5th Circuit voted 9-5 to grant the petitions for review. The judges ruled that the FDA had been “arbitrary and capricious,” in violation of a federal law called the Administrative Procedure Act (APA), by denying the applications without considering the companies’ plans to prevent underage access and use.

    “Over several years, the [FDA] sent manufacturers of flavored e-cigarette products on a wild goose chase. First, the agency gave manufacturers detailed instructions for what information federal regulators needed to approve e-cigarette products. Just as importantly, FDA gave manufacturers specific instructions on what regulators did not need,” Circuit Judge Andrew S. Oldham wrote in the majority opinion. “The agency said manufacturers’ marketing plans would be ‘critical’ to the success of their applications.

    “And the agency promulgated hundreds of pages of guidance documents, hosted public meetings and posted formal presentations to its website—all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy FDA’s instructions. The regulated manufacturers dutifully spent untold millions conforming their behavior and their applications to FDA’s say-so.

    “Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all 1 million flavored e-cigarette applications for failing to predict the agency’s volte-face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”

    The case began when the FDA rejected 55,000 applications to market flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval. The Office of the Solicitor General asked the Supreme Court to review whether the 5th Circuit’s decision relied upon “legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders.”

    The regulatory agency’s “legal theories” in Triton are based on administrative fairness and regulatory consistency, not Chevron deference. In most vaping industry lawsuits, appeals courts have supported the FDA, and manufacturers have sought appeals. In the Triton Distribution case, however, the FDA had to petition the court to review the 5th Circuit’s decision, which was based more on APA violations. SCOTUS is scheduled to hear the case sometime during its new session, which begins in October.

    Conley explained that, while the end of Chevron signals a new openness by the Supreme Court to scrutinize federal agencies, the 5th Circuit’s opinion focused on matters of statutory interpretation, including procedural conduct and the FDA’s sudden imposition of new standards without proper notification.

    “With or without Chevron deference, we believe that the ‘switcheroo’ pulled by the FDA was arbitrary, capricious and not in line with the Administrative Procedures Act,” said Conley. “This stance aligns with the court’s broader view that agencies should not have unchecked power to interpret and enforce ambiguous statutes without clear congressional authorization.”

    Much of the lower court’s opinion is based on APA violations. The APA process for creating federal regulations has (typically) three main phases: initiating rulemaking actions, developing proposed rules and developing final rules. In practice, however, this process is often complex, requiring regulatory analysis, internal and interagency reviews, and opportunities for public comments.

    At its most basic level, the APA requires that an agency create a draft proposed rule, review/approve it, publish a notice of proposed rulemaking in the Federal Register and open a public comment period of at least 30 days. In a footnote to the Triton decision, the court characterized the FDA’s denial of all PMTAs for nontobacco-flavored e-cigarettes as a “de facto flavor ban” that circumvented the APA’s required notice-and-comment rulemaking process:

    “(5) FDA’s categorical ban has other statutory problems. For example, the TCA states that FDA must follow notice-and-comment procedures before adopting a ‘tobacco product standard.’ See 21 U.S.C. § 387g(c)–(d). And Congress specifically called a ban on tobacco flavors a ‘tobacco product standard.’

    “See id. § 387g(a)(1)(A) (referring to tobacco flavors, ‘including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke’); see also id. § 387g(a)(2) (cross-referencing notice-and-comment obligation to revise flavor standards). FDA unquestionably failed to follow § 387g’s notice-and-comment obligations before imposing its de facto ban on flavored e-cigarettes.”

    Attorneys from the U.S. Department of Justice told the justices that the 5th Circuit’s ruling “has far-reaching consequences for public health and threatens to undermine the TCA’s central objective of ‘ensuring that another generation of Americans does not become addicted’” to nicotine products.

    In court papers, Solicitor General Elizabeth Prelogar told SCOTUS justices that the FDA has never adopted a categorical ban on flavored e-cigarette products. “Rather, it has recognized that, because such products pose a ‘known and substantial risk to youth,’ applicants bear a particularly high burden of proving a potential for benefit to adult smokers that could justify the risk,” she wrote.

    Robert Burton, a longtime player in the U.S. vaping industry and current group scientific and regulatory director for the U.K.-based vaping company Plxsur, said that concerning the Triton case, decisions will now need to carry a significant weight of evidence on both sides.

     “Without the Chevron precedent, it may come down to a judgment based upon who knows the market and consumer best and who understands ‘best’ what is in the interest of public health, but based upon facts and data rather than a gray area deferral,” said Burton.

    Attorney Eric Heyer, who is representing Triton, expressed intense anticipation for the Supreme Court’s hearing of the case. He strongly criticized the FDA for imposing “surprise, after-the-fact … study requirements” and failing to adhere to the guidelines the agency itself had developed.

    It is unclear whether SCOTUS will hear the three other vaping-related cases, which are also before it (Magellan Technology Inc. v. Food and Drug Administration; Lotus Vaping Technologies LLC v. Food and Drug Administration; and Logic Technology Development LLC v. Food and Drug Administration). In these cases, vaping manufacturers seek a review of their losses in FDA-issued marketing denial order appeals handed down by various other circuit courts.

    Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, has urged the high court to overturn the appeals court order, emphasizing that if allowed to stand, it could significantly harm public health, particularly that of children. Vaping companies have asserted that their products can mitigate the harm caused by smoking combustible cigarettes.

    When the Triton decision was announced, Tony Abboud, executive director of the Vapor Technology Association, welcomed the decision as a “blistering indictment” of the FDA’s Center for Tobacco Products for its “intentional misleading” of the U.S. e-cigarette industry.

    “The court was so stupefied by the FDA’s bad-faith efforts to reject all flavored e-cigarette products [that] it cited Shakespeare to illustrate the full extent of the FDA’s disingenuity, particularly after the court explained that the plaintiffs in that case provided scientific evidence that e-cigarettes ‘save lives,’” Abboud said. “The court also emphasized the dramatic and abrupt ‘FDA flip-flop,’ which led to the implementation of what the court called a ‘de facto ban’ on flavored e-cigarette products in the U.S.

    “This was in addition to the voluminous jurisprudence cited by the court laying bare just how egregious the behavior of the FDA administrative state has been toward e-cigarette products and the consumers that use them. As the court stated, ‘No principle is more important when considering how the unelected administrators of the fourth branch of government treat the American people.’”

  • Supreme Court Declines to Hear Avail Vapor Case

    Supreme Court Declines to Hear Avail Vapor Case

    Image: Clinton

    The U.S. Supreme Court declined on Oct. 10 to hear Avail Vapor’s objections to the Food and Drug Administration’s regulatory authorization process.

    In 2021, the regulatory agency denied Avail Vapor’s request to approve fruit-flavored and dessert-flavored e-cigarettes. The company protested that the agency had made the application process intentionally difficult.

    In a Supreme Court brief filed Aug. 3, Avail claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco-flavored products as an aid in adult smoking cessation.

    Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.

    In its petition, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.

    Among other things, Avail argues that the FDA’s decision-making 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.