Category: Litigation

  • RICO-Based Hemp Case Headed for Supreme Court

    RICO-Based Hemp Case Headed for Supreme Court

    Credit: Adobe Stock

    For the first time since the 2018 Farm Bill became law, the Supreme Court of the United States will decide a case about hemp. The lawsuit, Medical Marijuana, Inc., et al. v. Douglas J. Horn, involves the Racketeer Influenced and Corrupt Organizations Act (RICO) and asks whether product manufacturers can be held responsible for a person’s lost earnings and other job benefits under that powerful statute.

    The plaintiff is a commercial truck driver who was fired for failing a random drug test after taking a CBD product that was marketed as THC-free. The plaintiff then filed a RICO claim and state law claims against the companies that marketed the CBD product. He asserted that his lost job earnings and benefits are “business or property” damages that are recoverable under RICO.

    The federal district court dismissed the plaintiff’s RICO claim, finding for the companies that RICO does not provide for personal injury losses. However, the Second Circuit Court of Appeals reversed the district court and reinstated the RICO claim. The Supreme Court agreed to take up the case. If the Supreme Court affirms the Second Circuit’s ruling, the plaintiff could recover up to three times his lost earnings, plus attorney’s fees.

    The U.S. Hemp Roundtable has filed a “friend of the court” brief supporting the defendants’ position that Congress did not intend RICO to apply to personal injury losses. As the brief argues, expanding RICO has major implications for the hemp products industry.

    Industry experts have stated that increased costs will be passed on to consumers, potentially making products unavailable to people who need them. Additionally, more liability may cause manufacturers, distributors, or retailers to exit the industry entirely, which will reduce economic opportunities for hemp farmers and businesses.

    The case is expected to be heard during the court’s next session, which begins in October.

  • Top Court Upholds Philippines FDA Vapes Authority

    Top Court Upholds Philippines FDA Vapes Authority

    Photo: natatravel

    The Supreme Court of the Philippines upheld its 2021 decision to grant the country’s Food and Drug Administration regulatory authority over the health aspects of tobacco products, reports the Inquirer.

    “All products affecting health, including tobacco products, are covered by the FDA’s mandate to ensure the safety, efficacy, purity, and quality of health products,” the Supreme Court said.

    “Thus, the inclusion of tobacco products in the implementing rules of the FDA Act is in accordance with the law,” it added.

    The case stemmed from an attempt to stop the enforcement of the FDA implementing rules and regulations. In a case filed in 2011 before the Regional Trial Court of Las Pinas City, the Philippine Tobacco Institute (PTI) alleged that those rules improperly expanded Republic Act No. 9711 by classifying tobacco products as health products.

    The PTI argued that under the Tobacco Regulation Act of 2003, the Inter-Agency Committee on Tobacco (IACT) had exclusive jurisdiction over tobacco products.

    In 2012, the Las Pinas court ruled in favor of PTI and nullified the provisions of the FDA implementing rules and regulations relating to tobacco.

    The Department of Health and the FDA then petitioned the Supreme Court for review, which overturned the Las Pinas court decision in 2021. The PTI then challenged the high tribunal’s ruling, but was rebuffed.

    The denial of the motions for consideration means the IACT and the FDA will continue to share authority over tobacco, with each overseeing different aspects of the trade.

    Under the Tobacco Regulation Act, the IACT is chaired by the trade secretary with the health secretary as vice chair and includes a representative of the tobacco industry as a member. The PTI previously held the position of representing the tobacco industry in the committee.

  • Kentucky Judge Dismisses Vape Registry Lawsuit

    Kentucky Judge Dismisses Vape Registry Lawsuit

    Credit: Andreykr

    A Kentucky judge has dismissed a lawsuit challenging the constitutionality of a 2024 law banning the sale of some vaping products.

    In doing so, Franklin Circuit Court Judge Thomas Wingate sided with the lawsuit’s defendants — Allyson Taylor, commissioner of the Kentucky Department of Alcoholic Beverage Control, and Secretary of State Michael Adams — who filed a motion to dismiss.

    Greg Troutman, a lawyer for the Kentucky Smoke-Free Association, which represents vape retailers, had argued that the law was too broad and arbitrary to pass constitutional muster because it is titled “AN ACT relating to nicotine products” but also discusses “other substances.”

    The state constitution states that a law cannot relate to more than one subject. Wingate found the law doesn’t violate the state constitution, according to media reports.

    The law’s title “more than furnishes a clue to its contents and provides a general idea of the bill’s contents,” stated Wingate. He wrote that the law’s “reference to ‘other substances’ is not used in a manner outside of the context of the bill but rather to logically indicate what is unauthorized.”

    The lawsuit centers around House Bill 11, which passed during the 2024 legislative session and goes into effect Jan. 1. Backers of the legislation said it’s a way to curb underage vaping by limiting sales to “authorized products” or those that have “a safe harbor certification” based on their status with the U.S. Food and Drug Administration (FDA).

    Opponents have said it will hurt small businesses, lead to a monopoly for big retailers and could drive youth to traditional cigarettes.

    Altria, the parent company of tobacco giant Phillip Morris, lobbied for the Kentucky bill, according to Legislative Ethics Commission records. Based in Richmond, Virginia, the company is pushing similar bills in other states. Altria, which has moved aggressively into e-cigarette sales, markets multiple vaping products that have FDA approval.

    “The sale of nicotine and vapor products are highly regulated in every state, and the court will not question the specific reasons for the General Assembly’s decision to regulate and limit the sale of nicotine and vapor products to only products approved by the FDA or granted a safe-harbor certification by the FDA,” Wingate wrote in a Monday opinion. “The regulation of these products directly relates to the health and safety of the Commonwealth’s citizens, the power of which is vested by the Kentucky Constitution in the General Assembly.”

  • Court Bans Soul Vapor From Selling Illegal Vapes

    Court Bans Soul Vapor From Selling Illegal Vapes

    Credit: Yelp

    The United States District Court for the Southern District of West Virginia enjoined Soul Vapor LLC, a West Virginia-based company, and the company’s owner, Aurelius Jeffrey, from “directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product” that has not received marketing authorization from FDA.

    The court also ordered Soul Vapor and Jeffrey to destroy e-cigarette products that were manufactured by Soul Vapor and are in their custody, control, or possession.

    “FDA vigorously enforces the law and will continue to work with the U.S. Department of Justice to take enforcement actions, such as pursuing permanent injunctions, against those who defy the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “This injunction is another reminder that FDA will use the full scope of its enforcement tools to protect public health.”

    According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, the defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products by failing to first obtain marketing authorization from FDA. The complaint also alleged that the defendants submitted materially false information to FDA.

    “The court’s order is yet another example of how FDA – in coordination with federal partners – is successfully ramping up enforcement to combat unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “We will continue to work with our federal partners to identify and bring enforcement actions against bad actors, while continuing to educate stakeholders about the need for additional resources to best support these efforts.”

    CTP’s ability to pursue enforcement actions, including injunctions, is solely dependent on user fees. CTP is 100 percent funded by user fees, which the FD&C Act authorizes FDA to collect from manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. However, this authority has not been updated to reflect the realities of the tobacco product marketplace, including the emergence of e-cigarettes over a decade ago, according to a release.

    As a result of this inequity, e-cigarette manufacturers are currently paying no fees while continuing to profit off unauthorized products. In order to enhance the CTP’s enforcement actions, including pursuit of injunctions, the agency has requested updated authority from Congress to modernize the tobacco user fee framework to apply to all tobacco products regulated by the agency.

    The injunction against Soul Vapor highlights the successful cooperation between FDA and the DOJ to enjoin bad actors from manufacturing, selling, and distributing unauthorized e-cigarette products. FDA has taken numerous judicial enforcement actions as a part of its comprehensive approach to enforcing the law, including eight injunctions in coordination with DOJ since 2022, according to the FDA.

    Additionally, on June 10, 2024, FDA and DOJ announced the creation of an interagency task force focused on using an all-government approach to combat the illegal distribution and sale of unauthorized e-cigarettes in the U.S.

  • U.S. Supreme Court Overturns Chevron Deference

    U.S. Supreme Court Overturns Chevron Deference

    Credit: Sean Pavone Photo

    On Friday, June 28, the Supreme Court of the United States ruled 6-3 in favor of overturning the “Chevron deference,” a backbone principle for how the federal government keeps corporations in check. Chevron is the practice by which federal courts defer to federal agencies when sorting out ambiguities in a law. Justices Breyer, Kagan, and Sotomayor dissented.

    The ruling could impact the U.S. Food and Drug Administration and its process for authorizing vaping products through the premarket tobacco product authorization process. In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    Chris Howard, executive vice president, External Affairs & New Product Compliance for Swisher, said that for decades federal agencies have had too much power.

    “That ended today with the Supreme Court’s decision overturning the long-standing Chevron Doctrine. The decision marks a significant shift in the judicial landscape, correcting the balance of power between federal agencies and the judiciary,” said Howard. “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.”

    In the years since electronic nicotine delivery systems (ENDS) became subject to FDA regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    “For far too long, unelected bureaucrats at the FDA have been making up the law to suit their own ulterior agenda and Today, 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. “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.”

    It has been nearly 40 years since the Supreme Court indicated in Chevron v. Natural Resources Defense Council that courts should defer to an agency’s reasonable interpretation of an ambiguous statute.

    The court’s ruling could have ripple effects across the federal government, where agencies frequently use highly trained experts to interpret and implement federal laws, according to SCOTUSblog. Although the doctrine was relatively noncontroversial when it was first introduced in 1984, in recent years conservatives – including some members of the Supreme Court – have called for it to be overturned.

    The plea to overturn the Chevron doctrine came to the court in two cases challenging a rule, issued by the National Marine Fisheries Service, 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 came to the Supreme Court, asking the justices to weigh in on the rule itself but also to overrule Chevron. Roman Martinez, representing one group of fishing vessels, told the justices that the Chevron doctrine undermines the duty of courts to say what the law is and violates the federal law governing administrative agencies, which similarly requires courts to undertake a fresh review of 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’s 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.”

  • New York State Gets $112.7 Million From Juul Labs

    New York State Gets $112.7 Million From Juul Labs

    Credit: Standap

    New York State is set to receive $112.7 million from a multistate settlement with Juul Labs Inc. due to its involvement in the youth vaping epidemic, according to the Office of the Attorney General (OAG).

    Attorney General Letitia James announced on Friday that the Hudson Valley would receive over $13 million from the historic total of $462 million, to be divided among participating states,” according to media reports.

    “E-cigarette use among young New Yorkers shot up after JUUL flooded the market with advertising aimed at teenagers and lies about the safety of its products,” James said. “Now young people are suffering from physical and mental health issues fueled by vaping addiction.

    “This settlement puts new limits on JUUL’s marketing and will provide leaders in the Hudson Valley over $13 million to implement new anti-vaping programs to protect our kids.”

    The $112.7 million total going to New York State will reportedly be distributed among counties, the Board of Cooperative Education Services (BOCES), and the five largest cities in the state to support programs to reduce and prevent underage vaping.

  • Unconstitutional: Court Rules on Panama Vape Sales Ban

    Unconstitutional: Court Rules on Panama Vape Sales Ban

    Credit: Alexey Novikov

    The Supreme Court of Justice in Panama has ruled unanimously that Panama’s ban on the sale of all vaping products is unconstitutional.

    According to several media reports, the ruling, announced last week, was in response to a lawsuit brought by the Asociación por la Reducción de Daños del Tabaquismo de Panamá (ARDT Panama), a vaping consumer advocacy group.

    The court found that Law 315 violated parliamentary procedures spelled out in Article 170 of the Panamanian constitution, according to Panama America.

    Law 315 prohibited the sale and import of all vaping and heated tobacco products, with or without nicotine. It also banned online sales, prohibited vaping in any place where smoking is not allowed, and gave customs authorities the right to inspect, detain, and seize shipments into the Central American country.

    The law passed the National Assembly in 2021, and was given assent by Panamanian President Laurentino Cortizo nearly a year later, on June 30, 2022. Panama had previously prohibited vape sales under a 2014 health ministry decree.

    The ARDT Panama lawsuit challenged the vaping ban on the basis that it violated the constitutional right to health (depriving people who smoke of a lower-risk substitute). Also, it alleged that the National Assembly violated technical parliamentary rules in passing the law.

    According to El Capital Financiero, the legal challenge was also supported by the Association of Smokers and Families for a Smoke-Free Panama and the Medicinal Cannabis Association of Panama.

    It’s unclear if the high court also weighed in on the health-based challenge.

  • Vape Shop Owners Challenge Kentucky Registry Bill

    Vape Shop Owners Challenge Kentucky Registry Bill

    Credit: Adobe

    Several vape businesses, as well as the Kentucky Hemp Association and Kentucky Vaping Retailers Association, are suing the state government over House Bill 11, which will restrict vape sales starting in 2025.

    Among other policy changes, HB 11 will bar businesses from selling vapes that are either not authorized by the U.S. Food and Drug Administration or are not currently under review by the regulatory agency.

    During public debates, various arguments for and against HB 11 were made before the Legislature passed the law in late March.

    But the vape shops’ lawsuit, filed last week in Franklin Circuit Court, challenges the legislation on constitutional grounds, according to media reports.

    The lawsuit zeroes in on HB 11’s reliance on defining a “vapor product” in a way that includes devices that feature “vaporized nicotine or other substances.”

    The shops’ petition says this definition encompasses not only nicotine vapes but also hemp-derived vaping products they currently sell. And it says the definition is broad enough to apply to medical cannabis vaping products that will become legal in Kentucky next year.

    The lawsuit argues this makes the new law unconstitutional for two reasons.

    First, it claims HB 11 violates a provision in the Kentucky Constitution that says the Legislature can’t pass a law that relates to more than one subject, and that subject must be specified in its title.

    The plaintiffs say HB 11 is titled an “act relating to nicotine products” but actually affects non-nicotine products as well. They argue this effectively violates the constitutional rule.

    Second, the lawsuit says hemp-derived vapes generally aren’t regulated by the FDA, which makes it impossible for businesses to comply with HB 11’s requirement that they only sell vapes that have received or are seeking FDA approval.

    The suit argues this violates a due process clause in the U.S. Constitution and makes HB 11 an “arbitrary” law, which is prohibited by the Kentucky Constitution.

  • Ohio Preemption Law Forces 14 Cities to File Lawsuit

    Ohio Preemption Law Forces 14 Cities to File Lawsuit

    Credit: Zach Frank

    The Ohio General Assembly passed a preemption law earlier this year that prevents cities and counties from enacting tobacco regulations that are stricter than the state laws.

    The law was enacted after lawmakers overrode Governor Mike DeWine’s veto, which came after a year-long battle over the banning of flavored tobacco sales.

    This week, 14 cities filed a legal challenge to the law that, if successful, would allow those cities to introduce their own rules even if they are more stringent than state rules.

    The cities of Columbus, Bexley, Cincinnati, Cleveland, Dublin, Gahanna, Grandview Heights, Heath, Hilliard, Oxford, Reynoldsburg, Upper Arlington, Whitehall, and Worthington filed the case in Franklin County. The plaintiffs claim the law violates the state’s constitution, specifically a line that states that cities “have the ‘authority to exercise all powers of local self-government and to adopt and enforce within [their] limits such local police, sanitary and other similar regulations, as are not in conflict with general laws.’”

    According to Patrick Lagreid of Halfwheel, the suit also argues that the ban would adversely affect citizens. The Ohio legislature passed the preemption law during a special session, which DeWine later vetoed.

    The ban was again passed by the state’s General Assembly as part of its budget proposal, then vetoed again by DeWine before the General Assembly voted to override the veto in January. The case seeks a temporary injunction to keep the ban from going into effect on April 24.

    Republican state lawmakers have tried multiple times to prohibit local governments from restricting the sale of tobacco, only to be thwarted by DeWine’s vetoes.

    In 2022, he struck down such a proposal. Last July, he struck the provision from the rest of the state budget, saying that local bans were “essential” to curb nicotine use, especially among children, without a statewide ban in place.

  • New York City Files Suit for Illegal Disposable Sales

    New York City Files Suit for Illegal Disposable Sales

    A Billion Lives
    Credit: A Billion Lives

    New York City Mayor Eric Adams and New York City Corporation Counsel Sylvia O. Hinds-Radix announced that the City of New York has filed a lawsuit against 11 wholesalers for their part in the illegal sale of flavored disposable e-cigarettes.

    The 11 defendants – located in Brooklyn, Queens, Long Island, and upstate New York – are alleged to have distributed, and continue to distribute, flavored disposable e-cigarettes – such as Strawberry Colada, Mellow Mint, Blueberry Energize, and Frozen Creamsicle – to retail vape and smoke shops, convenience stores, and directly to consumers over the internet, in violation of federal, New York state, and New York City law, according to media reports.

    The lawsuit seeks to block the defendants from further selling the items and seeks damages and penalties under state and city statutes. It is a companion to the city’s pending 2023 federal lawsuit, in which two defendants are already subject to court orders barring their sales and shipments of flavored e-cigarettes into the city.

    “Part of protecting public safety means protecting the health of New Yorkers, including our most vulnerable – our children – and this administration is committed to enforcing the law when it comes to illegal vape sales,” said Adams. “This lawsuit will help hold 11 wholesalers accountable for their part in the illegal sale of flavored disposable e-cigarettes at a time when nicotine addiction among middle and high school youth is exploding. We will not stand by and allow this greedy, harmful, and openly illegal behavior to continue.”