Juul Labs received an emergency stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
The U.S. Court of Appeals for the D.C. Circuit on June 24 granted Juul’s request to delay the FDA’s ban. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.
In its court filing, Juul argued that the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay, according to The Wall Street Journal.
Juul said that the requirement to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period.
The e-cigarette maker also questioned the agency’s handling of the announcement, noting The Wall Street Journal reported on the ban a day before it was announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
Former FDA Center for Products Director Mitch Zeller said that Juul’s e-cigarettes were judged solely on the strength of the company’s application. Political pressure to ban Juul didn’t influence the ruling, nor did Juul’s past actions, he said. “This was a scientific review conducted by subject-matter experts,” he said. “That’s the way the system is supposed to work.”
In a statement, Juul Labs it was exploring all its options under the FDA’s regulations and the law.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Juul Labs Chief Regulatory Officer Joe Murillo.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
Among other options, Juul is reportedly exploring a bankruptcy filing if the company is unable to get relief from the government’s ban, reports The Wall Street Journal, citing people familiar with the matter.
Juul Labs today asked a federal appeals court to temporarily block the U.S. Food and Drug Administration’s marketing denial order until it can petition the court for an emergency review.
In its filing, Juul said the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay.
On June 23, the regulatory agency ordered Juul Labs to remove its products from the market, saying the e-cigarette company had provided insufficient evidence in its premarket tobacco product application to demonstrate that its products are “appropriate for the protection of public health.”
In particular, the FDA noted that its concerns about genotoxicity and potentially harmful chemicals leaching from the Juul Labs’ proprietary e-liquid pods had not been adequately addressed.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Joe Murillo, chief regulatory officer at Juul Labs, in a statement.
We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
In its court filing, Juul said the FDA’s decision followed “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping, even though several of its competitors now have a larger market share and much higher underage-use rates,” according to The Wall Street Journal.
Juul said that the FDA’s order to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period. The e-cigarette maker also questioned the agency’s handling of the announcement, pointing to the fact that the order had reported in the press before it was officially announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
In a press note, Juul Labs said it is exploring all of its options under the FDA’s regulations and the law. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” the company wrote.
Meanwhile, the announcement that Juul products must come off the market triggered a run on stores, according to various news outlets, including Bloomberg. “Gonna clear the shelves and hoard ’em like our incandescent bulbs!” one user wrote on Twitter following the news.
Philip Morris International was awarded $10.7 million by a jury in Alexandria, Virginia on Wednesday after finding rival R.J. Reynolds Vapor Co’s Vuse e-cigarettes violate its patent rights.
The federal court jury said RJR’s Vuse Solo and Alto devices infringe two Philip Morris patents covering parts of a vaping device for heating substances and preventing leaks. The case is part of multi-front patent dispute between Philip Morris and RJR parent company BAT.
A spokesperson for Winston-Salem, N.C.-based RJR said the company was disappointed by the infringement findings and said it may appeal, but was pleased that the jury cleared its Vuse Alto of infringing one of the patents, according to Reuters.
A Philip Morris spokesperson said the company was “grateful” for the verdict, which “rejects an attempt by BAT to free-ride on our hard work and investment.”
RJR’s Vuse line is one of the two top-selling e-cigarette brands in the United States, along with Juul. The Tuesday verdict concerned counterclaims in RJR’s ongoing patent lawsuit over Philip Morris’ IQOS heated-tobacco device, which is on hold.
Nearly every school district in the state of Utah joined a mass tort lawsuit against Juul Labs. Park City Schools is the only Utah school district not participating in the lawsuit.
The lawsuit claims Juul Labs was deliberately using youthful marketing strategies. The lawsuit also claims the company misrepresents and fails to mention that its e-cigarettes are “more potent or addictive” than cigarettes, according to KUTV.
Juul Labs removed all flavors other than tobacco, mint and menthol from their offerings in 2019 after federal regulators accused the vape maker of using the flavors to lure minors to vape. That same year, the company announced it was suspending its print, broadcast and online advertising in the United States.
The Frantz Law Group of California has filed the mass tort lawsuit on behalf of 700 school districts across the country. Salt Lake City law firm Kirton McConkie will head up the Utah portion of the lawsuit. Attorney Jim Frantz and William Shinoff say Juul Labs directly marketed to minors, “because we’re dealing directly with minors, and undermining them and addicting them and that’s really as low as you can go,” says Frantz.
Chicago-based e-liquid manufacturer Gripum had its lawsuit come before the Seventh Circuit on Wednesday morning, arguing it is the victim of regulatory malfeasance. The panel did not say when a decision would be reached.
Gripum markets vaping products under a number of different brand names. In September 2021, the U.S. Food and Drug Administration denied Gripum’s applications to enter its products into interstate commerce on the grounds that the products would induce more youth to start vaping than they would help adult combustible users to drop traditional cigarettes.
“All of [Gripum’s applications] lack sufficient evidence demonstrating that [their] flavored [vapes] will provide a benefit to adult users that would be adequate to outweigh the risks to youth,” the FDA’s rejection order stated.
Gripum argues the rejection was improper because the FDA had used unclear standards to evaluate the company’s products and its conclusion was based on a selective reading of the available research into e-cigarette use, according to Courthouse News. The company specifically claims it should not have been penalized for not including long-term longitudinal studies of vape use in its applications, as the FDA did not state Gripum had to include such studies when it first submitted its applications in September 2020.
“FDA repeatedly assured manufacturers that their [applications] would not need to include long-term studies (random controlled trials or longitudinal cohort studies). Gripum took FDA at its word,” the company’s brief to the Seventh Circuit states. “FDA, however, employed a secret ‘fatal flaw’ inquiry: it did not conduct an individualized review of the substance of Gripum’s [applications] once it observed the absence of long-term studies.” (Parentheses in original).
The company also says the FDA ignored studies showing that youth smokers typically preferred “closed-system” flavored tobacco products, a separate technology from the “open-system” vapes Gripum sold. Closed-system vapes such as Juul pods mimic traditional cigarettes in form and contain tobacco liquids with a high nicotine concentration to compensate for their small size and short battery life. Open-system vapes, by contrast, are larger devices using refillable tobacco liquid cartridges with a lower nicotine concentration. According to Gripum’s brief, these open-system vapes are generally preferred by adult smokers in their 40s, regardless of flavor.
Following this reasoning, Gripum’s attorney J. Gregory Troutman argued Wednesday that the company’s products, if allowed into interstate commerce, would help adult smokers quit traditional cigarettes more than they would attract young people in their teens or 20s. Getting people off traditional smokes is one element of the FDA’s evaluation criteria, given that the agency considers vaping relatively less harmful than traditional tobacco products for adult users.
“We take the agency and its representatives at the public statements they’ve made, where they’ve talked about these products as less harmful,” Troutman said. “That’s the real rub here.”
The three-judge panel was skeptical of this line of argumentation, however, given that the FDA’s statements referred to e-cigarettes in general and not Gripum’s products particularly.
“You don’t have any evidence that your products are going to induce adults to stop using [cigarettes] that I saw,” said U.S. Circuit Judge Diane Wood. “That’s half the equation.”
Troutman conceded that Gripum, in its applications, had not presented any evidence to the FDA that its specific products would help stop traditional tobacco use among adults. But he argued this is irrelevant given the studies it did provide the FDA, which showed e-cigarettes in general do lower the rate of traditional tobacco product use among adults.
U.S. Circuit Judge David Hamilton remained unmoved by this argument. He questioned Troutman as to why Gripum had not distinguished between its flavored and non-flavored vapes when filing its applications, given youths’ potential preference for flavored products. Troutman again laid blame for the oversight at the FDA’s feet.
“That was not something that we were told we had to do prior to the application deadline,” Troutman said.
The response did not impress Hamilton, who rebutted that the FDA was authorized to use its own discretion in approving products for market. After Troutman conceded that the FDA has not yet cleared any flavored vape product in the U.S. for interstate commerce, Hamilton said the FDA rejecting Gripum’s application “sounds pretty consistent.”
The judges were more sympathetic to the arguments put forward by the FDA. In both in its brief and via its attorney Kate Talmor, the agency said flavored vapes required further study before they could be approved for the market.
“FDA has granted applications to market certain tobacco-flavored e-cigarettes based on evidence that youth use of tobacco-flavored products is limited and that such products may help adults switch from combustible cigarettes,” the FDA’s brief states. “But for e-cigarettes with flavors other than tobacco, ‘the risk of youth initiation and use is substantial’ and well documented.”
Talmor added that the rejection of Gripum’s applications was “not a de facto ban” of all flavored vape products. Gripum, she said, simply failed to show that its products were more beneficial to adults than they were seductive to young people.
“Gripum failed to submit any evidence in its application demonstrating benefits from its products to adults,” Talmor told the panel.
She pointed out that there are many flavored vape products currently in markets across the U.S. with legally murky status, subject to FDA enforcement discretion. There are also several applications for flavored vape products from other manufacturers that are currently in consideration. In time and with further study, Talmor said, these applications may be approved.
When pressed by Wood regarding Gripum’s complaint that it was penalized for not including longitudinal studies that it was never advised it had to include, Talmor dismissed this as the company being obtuse. She argued the agency gave the whole e-tobacco industry a heads up in 2019 that it would be looking for “robust” evidence of flavored products’ public health benefits in any market application.
“Looking at the [2019] guidance as a whole, it plainly advised industry that they were going to need robust evidence to demonstrate the benefits of their products outweigh any harms,” Talmor said.
Talmor concluded her arguments by saying that the FDA had to be granular – Gripum, she argued, cannot use generalized research into e-tobacco products as the sole basis for asking that its own specific products be approved. If it could, she said, the FDA would have to allow far more potentially unsafe vape products onto the market than it currently does.
“Gripum… did not attempt to submit evidence that was specific to its products and made the required showing,” Talmor said. “And I just don’t think there’s any way to look at the 2019 guidance and conclude that could possibly meet [the guidance’s] standard.”
The panel – rounded out by the mostly silent U.S. Circuit Judge Thomas Kirsch – took the arguments under advisement but did not say when they would issue a ruling.
Juul Labs has agreed to pay $10 million to settle a lawsuit the Louisiana Attorney General’s Office filed for deceptive marketing practices. Juul has settled similar cases in Washington state — agreeing to pay $22.5 million — as well as Arizona and North Carolina.
“This settlement is another step in our ongoing effort to reset our company and we applaud the Attorney General’s plan to deploy resources to combat underage use,” reads a statement form Juul Labs. “We will continue working with federal and state stakeholders to secure a fully regulated, science-based marketplace for vapor products.”
In the Louisiana case, Attorney General Jeff Landry had accused Juul Labs of marketing its e-cigarettes to youth, according to a news report.
In a 76-page filing in November, Attorney General Jeff Landry claimed Juul used marketing tactics that included designing sleek, concealable devices that featured “fun flavors like mango and cool mint” and edgy ad campaigns directed towards youth.
Landry also accused Juul of “deceptive marketing practices” regarding the device’s concentrations of nicotine. Landry’s office had sought to prevent Juul from selling the product to minors and wanted to limit available flavors to tobacco and menthol. Prosecutors also sought financial penalties from Juul.
Juul Labs has reached another settlement in its youth marketing lawsuits. The vaping manufacturer has agreed to pay $22.5 million in a settlement with Washington state over claims that it unlawfully targeted underage consumers with deceptive advertisements.
“Juul put profits before people,” Washington Attorney General Bob Ferguson said Wednesday in a statement. “The company fueled a staggering rise in vaping among teens.”
The settlement comes after North Carolina last year struck a $40 million deal with Juul over how it markets products to underage users. The e-cigarette maker agreed to stop all marketing aimed at young people as part of that deal announced in June.
Juul didn’t clearly state that its products contained nicotine and for more than 20 months, from August 2016 until April 2018, “unlawfully sold hundreds of thousands of vaping products to Washington consumers,” according to Washington’s lawsuit filed in 2020, according to Bloomberg.
The company committed to reforms including stopping all its advertising that appeals to youth and ending most social media promotion in the settlement, according to the statement. Juul must also check Washington stores 25 times a month with secret shoppers to keep its products away from youth.
Juul said the settlement terms are consistent with its present practices and past agreements to help combat underage use.
“This settlement is another step in our ongoing effort to reset our company and resolve issues from the past,” the company said in a statement. “We support the Washington State Attorney General’s plan to deploy resources to address underage use, such as future monitoring and enforcement.”
Juul Labs continues to face similar suits from several states, including New York and California.
In a 2-1 decision, a panel of the U.S. Court of Appeals for the Ninth Circuit held that the Family Smoking Prevention and Tobacco Control Act neither expressly nor impliedly preempts Los Angeles County’s ban on the sale of flavored tobacco products.
On March 18, 2022, a divided panel of the U.S. Court of Appeals for the Ninth Circuit held that Los Angeles County’s flavored tobacco ban is not preempted by the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (June 22, 2009) (the “TCA”). Judge Lawrence VanDyke wrote the majority opinion, which was by joined by Judge Karen E. Schreier of the U.S. District Court for the District of South Dakota sitting by designation on the Ninth Circuit. Judge Ryan D. Nelson dissented. The case is R.J. Reynolds Tobacco Co., et al. v. Los Angeles County, et al., No. 20-55930 (9th Cir. Mar. 18, 2022).
As previously reported (here and here), the litigation focuses on a Los Angeles County ordinance making it unlawful for tobacco retailers/licensees to sell flavored tobacco products or components, parts, or accessories intended imparting a characterizing flavor to a tobacco product or nicotine delivery device. Enforcement of the ban was to begin May 1, 2020, and a few days later the plaintiffs initiated litigation in the U.S. District Court for the Central District of California. The plaintiffs contended that the County’s flavored tobacco ban is expressly preempted under the TCA, 21 U.S.C. § 387p(a), or impliedly preempted as an obstacle to the fulfilment of Congress’ purposes and objectives in enacting the TCA. At the trial level, Judge Dale S. Fischer of the U.S. District Court for the Central District of California held that the County’s flavor ban is not preempted. She denied the plaintiffs’ requests for a preliminary injunction and for summary judgment and dismissed the case for failure to state a claim.
The plaintiffs appealed to the Ninth Circuit. The Washington Legal Foundation filed an amicus brief in support of the plaintiffs. The State of California filed an amicus brief in support of Los Angeles County, as did a number of public health, medical, and local government organizations.
Judge VanDyke’s Majority Opinion
Judge Lawrence VanDyke
Judges VanDyke and Schreier affirmed Judge Fischer’s holdings, agreeing that the County’s flavored tobacco ban is not preempted.
On the issue of express preemption, the majority addressed 21 U.S.C. § 387p(a), including its “preservation clause” (subsection (1)), “preemption clause” (subsection (2)(A)), and “savings clause” (subsection (2)(B)).
In the majority’s view, [T]he TCA’s text sandwiches limited production and marketing categories of preemption between clauses broadly preserving and saving local authority, including any “requirements relating to the sale” of tobacco products. This unique “preservation sandwich” enveloping the TCA’s preemption clause reveals a careful balance of power between federal authority and state, local, and tribal authority, whereby Congress has allowed the federal government to set the standards regarding how a product would be manufactured and marketed, but has left states, localities, and tribal entities the ability to restrict or opt out of that market altogether.
As to the preemption clause, the majority held the County’s flavor ban is not a preempted “requirement which is different from, or in addition to, any requirement under the provisions of [the Food, Drug, & Cosmetic Act’s ‘Tobacco Products’ Subchapter] relating to tobacco product standards.” Seeid. § 387p(a)(2)(A). The majority read that clause’s reference to preempted “tobacco product standards” as “pertaining to the production or marketing stages up until the actual point of sale.” Thus, the majority concluded “that the phrase ‘tobacco product standards’ in the TCA’s preemption clause does not encompass the County’s sales ban.”
Ninth Circuit Court of Appeals
The majority continued, opining that even if the County’s flavor ban were covered by the preemption clause, it would still survive preemption as a permissible “requirement[] relating to the sale . . . of[] tobacco products [to] individuals of any age” under the savings clause. Seeid. § 387p(a)(2)(B). The majority opined that “[a] ban on the sale of flavored products is, simply put, a requirement that tobacco retailers or licensees throughout the County not sell flavored tobacco products.” As to the “of any age” language in the savings clause, the majority considered this to “suggest[] that state and local governments are not limited to enacting only age-based rules, but rather can enact regulations for people ‘of any age’—in other words, for everyone.
“Because the County banned the sale of flavored tobacco products to all individuals ‘of any age,’ the savings clause squarely applies.”
Holding that the County’s flavor ban also survived the claim of implied preemption, the majority said that the ban is not “‘an obstacle to the accomplishment and execution of the full purposes and objectives of Congress’ expressed in the TCA” as “the TCA does not mandate that certain flavors must remain available for sale, and expressly preserves local authority to enact sales regulations more stringent than the TCA.” (Citation omitted.)
Judge Nelson’s Dissenting Opinion
Judge Ryan D. Nelson
Dissenting, Judge Nelson opined that he would have found Los Angeles County’s flavored tobacco ban expressly preempted.
According to Judge Nelson, the focus of the County’s ban on the point of sale does not remove it from the preemption clause’s coverage as a “requirement which is different from, or in addition to, any requirement under the provisions of [the Food, Drug, & Cosmetic Act’s ‘Tobacco Products’ Subchapter] relating to tobacco product standards.” Seeid. § 387p(a)(2)(A). Judge Nelson referenced two preemption decisions of the Supreme Court addressing other statutory schemes, where the Court reversed the Ninth Circuit’s distinction of a State or local sales limitation from a preempted product standard. SeeNat’l Meat Ass’n v. Harris, 565 U.S. 452 (2012); Engine Mfrs. Ass’n v. S. Coast Air Quality Mgmt. Dist., 541 U.S. 246 (2004). He also considered the majority’s reasoning to rely too heavily on the TCA’s preservation clause, which expressly states that it applies “[e]xcept as provided in” the preemption clause. See21 U.S.C. § 387p(a)(1). The savings clause did not save the County’s flavored tobacco ban from preemption, as Judge Nelson read that clause only to “save[] for states the authority to enact age requirements.”
Judge Nelson concluded,
The majority reads these three clauses as a “preservation sandwich served up by the TCA.” Majority at 25. But in holding that Los Angeles’s ban is not preempted, the majority has actually folded itself into a pretzel. The majority argues that the preemption clause is “hardly useless,” because the federal government is still the only one that can technically set standards. Majority at 30–31. But under the majority’s reading, states and municipalities can ban anything made with standards that they don’t like, and thus can “opt out of [the federal standards]” entirely. Id. This is the very reasoning that the Supreme Court says “make[s] a mockery” of a preemption clause. Nat’l Meat, 565 U.S. at 464. By construing the TCA’s preemption clause to allow sales bans that defeat its entire purpose, the majority does just that.
(Alterations in original.)
References in the Eighth Circuit
Business concept about U.S. Eighth Circuit with sign on the piece of paper.
The Ninth Circuit’s majority and dissenting opinions have since been referenced by the parties to an appeal pending before the U.S. Court of Appeals for the Eighth Circuit. R.J. Reynolds Tobacco Co., et al. v. City of Edina, et al., No. 20-2852 (8th Cir.), on appeal fromNo. 0:20-cv-01402 (D. Minn. Aug. 31, 2020) (granting the City’s motion to dismiss and denying the plaintiffs’ motion for preliminary injunction). That case involves similar TCA preemption claims regarding the City of Edina, Minnesota’s prohibition on the sale of flavored tobacco products. It was argued before Judges Steven M. Colloton, Roger L. Wollman, and Jonathan A. Kobes on May 12, 2021.
**********
It remains to be seen whether the plaintiffs will seek further review of the Ninth Circuit’s decision en banc or before the Supreme Court.
For the time being, the Ninth Circuit’s decision is significant not only for Los Angeles County but also other jurisdictions within the Ninth Circuit that have enacted (or may enact) similar flavored tobacco bans. For illustration of the decision’s significance within the Circuit, as of the filing of California’s amicus brief on May 14, 2021, “at least 71 localities” in the State “ha[d] prohibited the sale of all flavored tobacco products,” and the State Legislature had passed similar legislation subject to a referendum to be held in November 2022. The majority’s holding and essential reasoning in Los Angeles County will be binding upon lower federal courts within the Circuit – and panels of the Ninth Circuit – addressing materially-similar TCA-preemption cases.*
It will also be interesting to see how the Eighth Circuit resolves the City of Edina case, including whether (and to what extent) that court considers Judge VanDyke’s majority opinion – or Judge Nelson’s dissenting opinion – more persuasive.
* Notably, there is a pending Ninth Circuit appeal involving claims that the TCA preempts San Diego County’s flavored tobacco ban, R.J. Reynolds Tobacco Co., et al. v. San Diego Cnty., et al., No. 21-55348 (9th Cir.), on appeal fromNo. 3:20-cv-01290 (S.D. Cal. Mar. 29, 2021) (granting the County’s motion to dismiss and denying the plaintiffs’ motion for preliminary injunction); however, that case has been administratively closed since May 28, 2021, and it is set to remain administratively closed until May 24, 2022
A patent infringement lawsuit has been filed by Zanoprima Lifesciences against Hangsen International Group for infringement on Zanoprima’s patent to produce synthetic nicotine.
Filed in the U.S. District Court in the Western District of Texas, Zanoprima claims Hangsen violated its patent entitled “Process for Making (S)-Nicotine” (U.S. Patent No. 10,913,962) and Hangsen has been importing products that include a a synthetic nicotine into the U.S. that is produced by using Zanoprima’s patent.
“Over many years, Zanoprima has invested substantial time, resources, intellectual capital, and scientific expertise into developing Zanoprima’s groundbreaking enzymatic patented process for synthesizing an (S)-nicotine that is devoid of tobacco-specific nitrosamines and other impurities,” stated Ashok Narasimhan, CEO of Zanoprima, in a press release. “Zanoprima’s legal action reflects our company’s dedication to vigorously protecting our intellectual property in the U.S. and around the world.”
The complaint alleges that, after publication of Zanoprima’s patent, Hangsen filed a Chinese patent application describing a process that copied the process invented by Zanoprima. However, as alleged in the complaint, Hangsen’s patent application was rejected by the Chinese Patent Office in June 2021 citing Zanoprima’s patent as prior art.
The complaint also alleges Hangsen imports into the U.S. from China and sells products containing “alleged high-purity synthetic (S)-nicotine and nicotine products that are marketed and sold under various names including as MOTiVO Synthetic S-Nicotine,” and that such imported products “are manufactured by a process that practices every step … of the Zanoprima patent.”
In addition to seeking damages for infringement, Zanoprima’s complaint seeks preliminary and permanent injunctive relief to prevent Hangsen from continuing infringing upon Zanoprima’s patent.
Zanoprima is the first company to manufacture and make commercially available an enzymatically synthesized form of pure (S)-nicotine, SynNic, according to the release. The synthetic nicotine is chemically identical to that derived from tobacco but devoid of harmful tobacco-specific nitrosamines, carcinogens, alkaloids, and other impurities that accompany tobacco-derived nicotine.
A U.S. Administrative Law Judge has dismissed the Federal Trade Commission’s (FTC) claims against Altria and Juul Labs arising out of Altria’s 2018 minority investment in Juul. Following a three-week trial, the judge found that the evidence failed to sustain the alleged violations.
The judge’s decision is subject to review by the FTC. Any decision by the FTC may be appealed to any U.S. Court of Appeals.
“We are pleased with this decision and have said all along that our minority investment in JUUL does not harm competition and does not violate the antitrust laws,” said Murray Garnick, executive vice president and general counsel of Altria, in a statement
In April 2020, the FTC issued an administrative complaint against Altria and Juul alleging that Altria’s 35 percent investment in Juul and the associated agreements constitute an unreasonable restraint of trade in violation of Section 1 of the Sherman Antitrust Act of 1890 and Section 5 of the Federal Trade Commission Act of 1914, and substantially lessened competition in violation of Section 7 of the Clayton Antitrust Act.
A public version of the decision is expected to be made available late this month.
