Tag: litigation

  • The Hague Rules Dutch Flavored Vape Ban is Legal

    The Hague Rules Dutch Flavored Vape Ban is Legal

    Credit: GAPS Photo

    A court in The Hague has ruled that the Netherlands was allowed to introduce a ban on flavors in e-cigarettes to protect public health. The court ruled this in a substantive procedure initiated by tobacco products manufacturer British American Tobacco (BAT) and the related company Nicoventures. They consider the ban unlawful.

    The harmfulness of e-cigarettes and the “attractive effect” of sweet flavors on young people have been sufficiently established, the court stated.

    According to the 2020 ban, only certain flavors can be added to e-cigarettes, especially because young people are sensitive to other sweet tastes, according to media reports. The State also saw indications that the sweet-tasting e-cigarette will eventually encourage people to smoke regular cigarettes, while the government is aiming for a “smoke-free generation” in 2040.

    According to the court, any encouragement to smoke regular cigarettes does not need to be scientifically proven for a ban. The harmfulness of the e-cigarette and the attractive effect of the sweet flavors on young people justify the flavor ban in themselves, the judgment stated.

    The plaintiffs felt the ban violated the free traffic of goods within the European Union. They felt there was no evidence to suggest that the ban on flavors is good for public health. They also stated that the ban could have an adverse effect because fewer smokers will stop trying to quit smoking with the aid of e-cigarettes.

    But this possible disadvantage does not carry enough weight, the court ruled. The State has the “political discretion to give more weight to the interests of the youth and of a future smoke-free generation in the context of public health.”

    The court acknowledges that the ban on flavors infringes on the free movement of goods but says that such an infringement is permitted to protect public health if it is “appropriate, necessary, and proportionate.”

  • Oregon Court Strikes Down Vape Packaging Law

    Oregon Court Strikes Down Vape Packaging Law

    Image: Alexander Berdyugin

    The Oregon Court of Appeals on Oct. 16 struck down a law restricting the packaging of vape and cannabis products on the grounds that the legislation unconstitutionally restricts free speech, reports Keller & Heckman.

    The contested law prohibited an “inhalant delivery system” from being packaged “in a manner that is attractive to minors.” Subsequently, the Oregon Health Authority banned the use of cartoons, celebrities and other representations that are likely to appeal to minors.

    It also restricted descriptive words for flavors that are likely to appeal to minors, such as tart, tangy or sweet. In addition to a comprehensive list of items explicitly prohibited from packaging, the rule includes a general catch-all restriction to include any presentation, shape, graphic, coloring or writing that is likely to appeal to minors.

    Plaintiffs Paul Bates and No Moke Daddy argued that the packaging restrictions were overly broad and unconstitutionally vague and infringed on their right to free speech by prohibiting truthful, non-misleading communication.

    the Oregon Court of Appeals reversed a lower court’s dismissal of the challenge, noting that the law violates free speech as outlined in the Oregon Constitution.

    The Court of Appeals explained that selling products is a form of communicative behavior that may involve protected speech. The court stated that the law restricting “attractive” packaging is reasonably interpreted to refer to the communicative aspects of the packaging and not its functionality. Thus, the packaging restrictions are a direct restriction on expressive speech.

  • CMSA Files Amicus Brief With SCOTUS in Triton Case

    CMSA Files Amicus Brief With SCOTUS in Triton Case

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

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

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

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

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

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

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

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

    Supreme Court to Hear Avail, Reynolds ‘Venue’ Case

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

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

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

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

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

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

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

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

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

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

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

  • Federal Judge Provides Hope to Iowa Hemp Sellers

    Federal Judge Provides Hope to Iowa Hemp Sellers

    Credit: Zorbor

    A federal judge has given hope to 10 companies looking to block the enforcement of a new Iowa law, which they argue unfairly prevents them from selling products containing hemp-derived THC.

    During a hearing about their request for an injunction against the law, U.S. District Judge Stephanie Rose stated that their argument that the law is unconstitutional is unlikely to succeed. However, she acknowledged that there may be merit to their claim that the state is applying the law in a discriminatory manner.

    The Hemp Amendments, a law passed by the Iowa Legislature during this year’s session, became effective on July 1. Under this law, the sale of hemp products to individuals under the age of 21 is prohibited. It also mandates compliance with new regulations that restrict the amount of tetrahydrocannabinol (THC) allowed in a serving and requires specific labeling, according to media sources.

    Rose already turned down an injunction request by two of them: Field Day, a Johnson County maker of THC sparkling water, and Climbing Kites, a Des Moines-based joint venture of the Lua and Big Grove breweries, maker of a THC-containing seltzer. She rejected their argument that the law was unconstitutional because it failed to define a serving size but said at the time that she had “serious concerns” about how the law would be enforced.

  • New York City Wants Wholesalers to End Vape Sales

    New York City Wants Wholesalers to End Vape Sales

    Credit: Adobe Stock

    The mayor of New York City has requested a Manhattan judge to intervene immediately and halt the sale of illegal flavored vapes by 11 wholesalers in New York.

    The city filed suit against the wholesalers in April, citing data that kids and teens are getting hooked on flavored e-cigarettes at alarming rates.

    Now, the city’s lawyers say they need a preliminary injunction to force the illegal, flavored vape peddlers to quit their noxious practices immediately, according to the New York Post.

    “While we have already filed a lawsuit to hold these distributors accountable for their actions, the motion we have filed will help us ensure that they can no longer peddle this poison to our children while this case is being litigated,” Adams said in a statement after the request for an injunction was filed Monday.

    Court records show that city investigators were able to directly place orders from the wholesalers.

    The probers also were able to uncover sales invoices from vape distributors in the city, the documents show. 

  • Colorado Cracking Down on Pot Being Sold as Hemp

    Colorado Cracking Down on Pot Being Sold as Hemp

    Vapor Voice archives

    Colorado Attorney General Phil Weiser is pursuing legal action against a cannabis business for allegedly selling highly potent cannabis products marketed as federally legal industrial hemp.

    According to a Tuesday news release, the attorney general’s office filed a lawsuit in Weld County against Gee Distributors, LLC and its owner, Christopher Landon Eoff.

    The Greeley-based company, operating as CBDDY, is accused of illegally selling cannabis products containing THC levels up to 35 times higher than the legal limit.

    In 2018, Congress legalized the limited manufacture and sale of consumable industrial hemp, defined as containing no more than 0.3% of the psychoactive chemical Delta-9 THC, reports Denver7.

    This led to an increase in industrial hemp companies trying to evade state regulations and taxes applicable to recreational marijuana, according to Weiser.

    “Colorado’s legal cannabis regulations are designed to protect consumers, ensure the highest safety and quality standards, and keep cannabis out of the hands of kids,” said Weiser in a statement. “In this case, the defendant recklessly sold products that were, in some cases, more potent even than what is sold in state-licensed dispensaries with little regard for requirements like lab testing and age verification.

    “As this action shows, we will hold accountable anyone who evades Colorado cannabis laws.”

  • Distributors Want New York Flavor Suit Tossed

    Distributors Want New York Flavor Suit Tossed

    Credit: HTGanzo

    Two groups of e-cigarette distributors are urging a New York state court to dismiss claims from New York City alleging they’re violating city laws by selling flavored e-cigarettes. The defendants say the law in question only applies to retail sales, not distributor-to-distributor sales.

    In April, the City of New York filed a lawsuit against 11 wholesalers for their part in the illegal sale of flavored disposable e-cigarettes, according to media reports.

    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.

    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.

  • SWT Global Asks 8th Circuit to Stay PMTA Denials

    SWT Global Asks 8th Circuit to Stay PMTA Denials

    A Missouri-based maker of menthol-flavored e-liquids urged a federal appeals court to revive its application with the U.S. Food and Drug Administration to continue selling its products, saying the agency had not given it fair notice of what approval would require.

    The appeal by SWT Global Supply Inc. is one of a slew of similar cases by e-cigarette companies in the wake of the FDA’s rule deeming e-cigarette products to be subject to the same law as combustible cigarettes and the agency’s subsequent denial of millions of premarket tobacco product applications (PMTAs) by manufacturers to sell their products, according to media reports. The question of whether the FDA acted fairly has already created a split among federal appeals courts.

    Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.

    The question of whether the FDA acted fairly has already created a split among federal appeals courts. Most other appeals courts that have considered similar appeals by manufacturers over denied applications – including the D.C., 2nd, 3rd, 4th, 7th and 9th Circuits – have sided with the FDA. However, the 5th Circuit last month ordered the agency to reconsider the denial of two companies’ applications in a case also involving menthol-flavored products.

    Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.

    Navjar said the lack of fair notice was particularly hard on small companies like SWT with limited resources. “A client like mine doesn’t have a lot of arrows in its quiver when it’s trying to fight a decision by a federal agency,” he said.

    Catherine Padhi, a lawyer for the FDA, said that comparing products’ effectiveness to tobacco-flavored products was “a natural part of the risk-benefit analysis,” given that tobacco-flavored products have a “much-reduced risk of enticing children.” She also said that SWT could submit additional information to support its application.

  • Most Defendants Dropped From NJOY Vape Suit

    Most Defendants Dropped From NJOY Vape Suit

    Credit: Success Photo

    A U.S. District Court in California has dismissed a lawsuit filed by NJOY, the vape subsidiary of Altria Group, against multiple manufacturers, distributors, and retailers of disposable vapes. However, the case against IMiracle, the manufacturer of Elf Bar, has not been dismissed.

    NJOY filed the lawsuit last October. The company alleges that the companies named in the suit are selling products illegal in California and the United States. NJOY asked for a nationwide injunction that would prevent future importation and sale of the products, and compensatory and punitive damages paid to NJOY.

    Among the companies charged were manufacturers and distributors of Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar. Together the brands make up the majority of the U.S. disposable vape market.

    The dismissal order was entered on Jan. 18 by Judge Terry J. Hatter Jr. of the U.S. District Court for the Central District of California. The court found that the defendants did not participate in “the same transaction, occurrence, or series of transactions or occurrences,” and therefore were improperly joined in the lawsuit. Because of that, Judge Hatter dropped all parties from the suit except the first named defendant, IMiracle, according to media reports.

    The judge entered the orders “without prejudice” allowing NJOY to refile against the dismissed defendants individually or in smaller groups with demonstrable relationships. The court also dismissed NJOY’s claim of unfair competition and its motion for a preliminary injunction barring sales and distribution by the defendants.

    The court denied NJOY’s motion to serve IMiracle, the manufacturer of Elf Bar headquartered in Hong Kong, by email, citing an established international process, the Hague Convention, for serving legal notice to foreign defendants.

    NJOY’s lawsuit against IMiracle cannot proceed until the Chinese manufacturer is served notice.