Category: Litigation

Court Blocks FDA Graphic Health Warnings

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A federal judge has blocked the U.S. Food and Drug Administration from enforcing a rule requiring tobacco manufacturers to print graphic warning labels on their products, citing the companies’ First Amendment rights, reports Law360.
The Family Smoking Prevention and Tobacco Control Act of 2009 instructs the FDA to create visual health warnings, but the D.C. Circuit in 2012 blocked the agency’s first attempt, saying that regulators had not convincingly demonstrated that the warnings would actually reduce smoking.
In March 2020, the FDA released the final rule requiring new graphic warnings for cigarettes that feature some of the lesser known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.
R.J. Reynolds Tobacco Co., ITG Brands and Liggett Group filed a First Amendment challenge in April 2020. The rule was set to take effect in November 2023 after it was repeatedly pushed back by court.
In a lengthy opinion issued Dec. 7, U.S. District Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the FDA’s rule after finding that the required label statements and graphic images are not narrowly tailored to the agency’s interest in promoting public awareness of the health risks of smoking.
“The government has not shown that compelling these large graphic warnings is necessary in light of other options,” the judge said, noting that the government could put more effort into public awareness campaigns.
Public health campaigners were aghast. “Today’s decision by a federal judge to block implementation of graphic cigarette warnings ordered by the Food and Drug Administration is wrong on the law, inconsistent with decades of precedent and harms public health,” read a joint statement issued by the American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative.
“We urge the justice department to appeal this decision, and we are confident that the FDA’s warnings will ultimately be upheld by a higher court.”
The health groups also noted that the U.S. had fallen behind other countries with its tobacco control policies. Prior to 2009, when Congress passed the Tobacco Control Act, only 18 countries required graphic warnings for tobacco products, they pointed out. Today, more than 120 countries require them.
December 8, 2022
Juul Settles More than 5,000 Lawsuits

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Juul Labs has settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs, reports The Wall Street Journal. The deal resolves much of the legal uncertainty that had driven the company close to bankruptcy.
Juul announced on Dec. 6 that it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout that would cover legal liabilities.
According to Juul CEO K.C. Crosthwaite, the settlement addresses the vast majority of outstanding litigation facing the company, including two pending bellwether trials that were set to go to court early next year and four broad groups: personal injury plaintiffs, Juul consumers, government entities such as school districts and Native American tribes. Lawsuits brought by several attorneys general are pending.
A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.
Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.
Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.
In September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products.
Juul’s e-cigarettes were briefly banned in the U.S. in late June after the Food and Drug Administration concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.
In October, Juul published the details of its marketing denial order appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.
December 7, 2022
New Mexico Sues Over Tobacco Settlement

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New Mexico is suing over a dozen tobacco companies over payments relating to the 1998 Master Settlement Agreement, alleging conspiracy and breach of contract, reports the Albuquerque Journal, citing Attorney General Hector Balderas.
Balderas claims that the companies have withheld portions of annual payments due under a multistate tobacco settlement. According to the attorney general, New Mexico has lost more than $84 million over the past 14 years.
“There is no end to these baseless delay tactics, and it is time to force the tobacco companies to pay New Mexico what they owe for damages—funding much-needed health initiatives,” said Balderas.
Companies are obligated to pay annually under the settlement, but each year, the companies file disputes that result in a percentage of the payment being withheld, which triggers an arbitration process that can take years, according to the attorney general’s office.
The amount withheld grows each year, according to officials, and the lawsuit states that the tobacco companies do not disclose how much is withheld or where the withheld funds are held, and withholding practices can change annually.
“This conspiracy is a calculated strategy to permanently and fraudulently decrease defendants’ contractual payments under the (settlement agreement) and to frustrate the purposes of the (settlement agreement),” the suit reads.
November 30, 2022
Supreme Court Asked to Stop California Ban

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Tobacco companies have asked the U.S. Supreme Court to stop California from enforcing a ban on flavored tobacco products set to go into effect on Dec. 21, reports CBS News Bay Area.
On Nov. 8, Californians voted to uphold a state law ending the sale of most flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.
Originally passed by lawmakers in 2020, the measure was put on hold after opponents gathered enough signatures to force a referendum on the ban.
Following the Nov. 8 ballot, tobacco companies challenged the law in court, arguing that only the federal government can ban tobacco flavors, as the Family Smoking Prevention and Tobacco Control Act gives the U.S. Food and Drug Administration authority to regulate tobacco.
The Supreme Court filing states that the companies would suffer “irreparable harm” from being shut out of one of the country’s largest markets. Small retailers, they argued, would potentially have to lay off employees and close.
Previously the Ninth Circuit Court of Appeals denied the tobacco companies’ request to block the law pending appeal.
November 30, 2022
Court Dismisses Suit to Outlaw Tobacco

Photo: Alexey Novikov | Adobe Stock
A Kenyan court dismissed a petition by Ibrahim Mahmoud challenging the legality of the production, manufacturing and use of tobacco products, reports Business Daily.
The suit requested that the government ban the production, supply, management, dissemination, consumption and use of tobacco products and cigarettes as well as requesting that cancer be declared a tobacco-related ailment and a national disaster requiring special administrative action.
The suit was dismissed by Justice Hedwig Ong’udi on grounds that the petitioner did not prove that the Tobacco Control Act and the Tobacco Control Regulations 2014 are contrary to the constitutional provisions that were allegedly violated.
“It is not, therefore, enough for the petitioner to solely rely on his dissatisfaction in the use and legalization of tobacco products in Kenya. He should avail [sic] evidence to show how the statute and regulations are contrary to the provisions of the constitution complained of,” Ong’udi said.
November 29, 2022
Stabilization Settlement Funds Available

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Current and former tobacco growers who wish to claim funds from the U.S. Tobacco Stabilization lawsuit settlement should complete a proof of claim form by Dec. 12, 2022.
The settlement stems from a lawsuit against the Flue-Cured Tobacco Cooperative over withheld funds, which are now being returned to qualifying grower members.
Tobacco growers who were a member of the cooperative at some point between 1946 and 2004 are eligible for payment considerations.
Growers claiming funds must supply their FC Number. Alternatively, they must provide sufficient identifying information, including all names and addresses used during the period that they marketed flue-cured tobacco.
A copy of the qualified settlement fund procedures, the proof of claim form and additional relevant information is available at https://omniagentsolutions.com/lewissettlementclasstrust.
November 28, 2022
Baltimore Sues Tobacco Companies Over Litter

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The city of Baltimore is suing several major tobacco companies, requesting as much as $5 million annually for the cleanup of cigarette butt litter, according to WBALTV11.
Since 2014, more than 12 million cigarette butts have been cleaned up from the waters surrounding Baltimore, city officials said.
“There are all kinds of cleanup problems, from catching them [cigarette butts] to getting rid of the chemicals they leave in their wake,” said James Shea, Baltimore City solicitor.
The lawsuit alleges that the tobacco companies have refused to place warnings on their boxes explaining how to properly dispose of filters and that they have chosen not to make filters biodegradable.
“They didn’t change it—according to documents we’ve seen—to biodegradable filters because smokers preferred the draw that comes with the filter,” Shea said.
The ultimate goal is to see the companies become more environmentally friendly, according to Shea. “We’d like to have the practice stop, but, in the meantime, we want damages in the nature of cleanup costs and their fines associated with various litter ordinances that are being violated.”
The companies have 30 days to respond in court.
November 22, 2022
Tobacco Damaged by Fake Chemicals
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At least 400 ha of irrigated tobacco have been damaged in Zimbabwe after farmers applied counterfeit chemicals to their crop, reports The Sunday Mail.
Following reports of abnormally growing tobacco plants in October, plant health service officers determined that some farmers had used chlorpyrifos, a hazardous pesticide that is banned for use on tobacco and many other crops, according to the Tobacco Industry and Marketing Board (TIMB).
Remarkably, the symptoms on the affected crops are typically associated with 2,4D-related herbicide damage rather than the use of chlorpyrifos, according to TIMB director for research and extension services Susan Dimbi, who warned farmers against using unregistered agrochemicals.
Zimbabwean police and seed company officials have launched a campaign to crack down on counterfeit agricultural products, which are generally sold at considerably lower prices than genuine products.
November 21, 2022
Vapor Group Files Amicus Brief

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The Vapor Technology Association (VTA) has filed an amicus brief with the U.S. Supreme Court in support of a petition for writ of certiorari in a case against L.A. County’s ordinance banning flavored tobacco products.
Citing the substantial impact on America’s economy created by the sale of tobacco products, the trade group says Supreme Court review of the flavor ban is critical.
According to an economic impact report prepared by John Dunham and Associates, the independent vapor industry comprises more than 10,000 companies across the United States and is responsible for generating more than 130,000 jobs and more than $22 billion in economic activity for the U.S. economy.
In its amicus brief, the VTA argues that this industry would be devastated by unrestricted flavor bans given its unique and substantial reliance on the sale of flavored vapor products to adult consumers.
The trade group also notes that since the passage of the L.A. County Ordinance, leading tobacco control scientists have challenged the notion of banning e-cigarette flavors and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking cigarettes.
Instead of blanket bans, these tobacco control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products, the VTA notes in its amicus brief.
Permitting local and state governments to implement unscientific bans that directly interfere with the fundamental purpose of the Tobacco Control Act and would overrule the Food and Drug Administration’s decision-making for products deemed appropriate for the protection of public health is not only unlawful but is dangerous from a public health perspective, the VTA wrote.
Tobacco and vape flavor bans have gained momentum in the U.S. On Nov. 8, Californians voted to uphold a state law ending the sale of most flavored tobacco products.
November 17, 2022
California Sued Following Flavor Poll

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Tobacco companies filed a lawsuit against California in federal court over the state’s ban on flavored tobacco one day after voters backed the ban in a Nov. 8 referendum, reports the Courthouse News Service.
Though more than half the state’s ballots have yet to be counted, media outlets have declared that the referendum will pass. Unless a judge agrees to intervene, the ban is set to go into effect no later than Dec. 21, 2022.
In their suit, the tobacco companies argue that the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 allows states and municipalities to regulate tobacco products but not to ban their use or sale.
“The ban falls under the TCA’s express preemption clause, which preempts ‘any [state] requirement’ that is ‘different from, or in addition to,’ a federal requirement about a tobacco product standard,” the suit reads. “A flavor ban is a paradigmatic tobacco product standard.”
In 2020, California lawmakers passed a ban on all flavored nicotine products except hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.
Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.
Tobacco companies already sued California over the flavor ban in 2021. But a federal judge dismissed the case, telling the plaintiffs to wait for the voters to weigh in before suing.
November 11, 2022