Tag: NJOY

  • Altria, Njoy Disagree With ITC Determination

    Altria, Njoy Disagree With ITC Determination

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    Altria Group, and its operating company, Njoy, disagree with the U.S. International Trade Commission (ITC) Administrative Law Judge’s (ALJ) initial determination regarding Juul Labs’ patent infringement complaint against NJOY.

    Last week, the ALJ provided notice of their initial determination supporting Juul Lab’s allegations in its complaint and recommending an exclusion order prohibiting the importation of Njoy ACE into the United States.

    “Altria and NJOY respectfully disagree with the ALJ’s initial determination, and NJOY looks forward to presenting its position to the full ITC, which is expected to issue a final decision by December 23, 2024,” a press release states.

    In August 2023, Njoy filed a similar, independent patent infringement complaint against Juul Labs with the ITC seeking a ban on importing and selling JUUL products in the United States. A hearing before the ALJ was held in June 2024, and an initial determination is expected in late September. A positive outcome in this case would not preclude an exclusion order against ACE from taking effect.

    “We continue to work to bring this issue to resolution. The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes,” the release states. “In addition, Njoy recently filed Substantial Equivalence (SE) Exemption requests with the FDA to allow Njoy to market an already-developed ACE product with minor modifications that we believe avoid three of the four [Juul Labs] patent claims at issue in the case.”

    ACE is the first pod-based vaping product and the only pod-based menthol vaping product authorized by the U.S. Food and Drug Administration as appropriate for the protection of public health. “An exclusion order banning the importation of ACE  would severely limit FDA-authorized choices for adults and undermine public health,” the release states.

  • ITC Recommends Ban on U.S. Imports of Njoy Ace 

    ITC Recommends Ban on U.S. Imports of Njoy Ace 

    Photo: JHVEPhoto

    An administrative law judge (AJL) of the International Trade Commission (ITC) has recommended a ban on importing Njoy Ace products into the United States following a patent-infringement claim filed by Juul Labs.

    Ace is the first pod-based vapor product and the only pod-based menthol vapor product authorized by the U.S. Food and Drug Administration as appropriate for the protection of public health. According to Njoy parent company Altria Group, an exclusion order banning the importation of Ace would severely limit FDA-authorized choices for adults and undermine public health.

    “Altria and NJOY respectfully disagree with the ALJ’s initial determination, and Njoy looks forward to presenting its position to the full ITC, which is expected to issue a final decision by December 23, 2024,” Altria Group wrote in a statement.

    In August 2023, Njoy filed a similar, independent patent infringement complaint against Juul with the ITC seeking a ban on the importation and sale of Juul products in the U.S. A hearing before the ALJ was held in June 2024, and an initial determination is expected in late September. A positive outcome in this case would not preclude an exclusion order against Njoy Ace from taking effect.

    “We continue to work to bring this issue to resolution,” Altria wrote in its statement. “The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes. In addition, Njoy recently filed substantial equivalence (SE) exemption requests with the FDA to allow Njoy to market an already-developed Ace product with minor modifications that we believe avoid three of the four Juul patent claims at issue in the case.”

  • FDA Authorizes First Flavored Vape: NJOY Menthol

    FDA Authorizes First Flavored Vape: NJOY Menthol

    Image: Tada Images

    The U.S. Food and Drug Administration today authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 2.4%.

    The two authorized ACE pods are the NJOY ACE Pod Menthol 2.4% and the NJOY ACE Pod Menthol 5%.  All four of the newly authorized products are pre-filled and non-refillable.

    The decision is significant because it is the first non-tobacco flavored vapor product to be authorized by the FDA. In his TPL Review, Office of Science Director Matthew Farrelly said that NJOY had “demonstrated the potential for these new products to benefit adults who smoke [combustible cigarettes] as compared to those who continue to use [combustible cigarettes] exclusively,” and that the company had “also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization.” Farrelly also highlighted data from a longitudinal cohort study that NJOY submitted with its application, which pointed to “robust absolute switching rates” as well as a higher rate of complete switching than tobacco-flavored NJOY DAILY ENDS.

    The FDA noted, however, that applications are reviewed on a case-by-case basis, and that this authorization of menthol products does not apply to any other menthol-flavored vaping products.

    “It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” said CTP Director Brian King in the agency’s press release. “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”    

    Altria welcomed the authorizations. “With the addition of NJOY menthol e-vapor products, we are now uniquely positioned with an FDA-authorized portfolio to support adult smokers in their transition to smoke-free alternatives. We believe these marketing orders are a testament to the quality of the NJOY products and the strength of evidence supporting the authorizations of the NJOY menthol e-vapor products,” said NJOY President and CEO Shannon Leistra in a statement.

    “We believe that, for tobacco harm reduction to succeed, adult smokers must have access to a robust marketplace of FDA-authorized smoke-free alternatives,” said Paige Magness, senior vice president, regulatory affairs of Altria Client Services. “FDA authorization of NJOY menthol e-vapor products provides adult smokers and vapers with regulated alternatives to the illicit flavored disposable e-vapor products on the market today. We believe the NJOY menthol marketing orders are a positive outcome for public health.”

    The FDA previously authorized the NJOY Ace and three of its tobacco-flavored pods on April 27, 2022.  In March of 2023, Altria acquired NJOY for $2.75 billion cash.  The acquisition was completed on June 1, 2023.  However, the transaction terms included $500 million in additional cash payments contingent upon the product approvals received today, which would bring Altria’s total spend to $3.25 billion.

  • Altria Wants FDA to Crack Down on Illegal Vapes

    Altria Wants FDA to Crack Down on Illegal Vapes

    Altria sign
    Vapor Voice archives

    Altria Group Inc. is calling on the U.S. Food and Drug Administration to do more to crack down on unauthorized vaping products that compete with its own authorized products produced by Njoy.

    “We believe the FDA’s enforcement approach is not of the scale or scope needed to bring about fundamental change in the marketplace,” Altria CEO Billy Gifford said on the company’s first-quarter earnings call.

    He described the proliferation of e-cigarettes that the agency hasn’t authorized as a “threat to public health.”

    Altria’s reported revenue fell 2.5 percent year-over-year to $5.58 billion. The drop was primarily driven by lower net revenues in the smokeable products segment, partially offset by higher revenue in the oral tobacco products segment and all other categories, according to media reports.

    Altria’s (MO) revenue net of excise taxes decreased 1.0 percent to $4.7 billion. Adjusted diluted EPS decreased 2.5% to $1.15 to match the consensus expectation, primarily driven by lower adjusted OCI, partially offset by fewer shares outstanding.

    “In spite of the absence of an effective regulatory environment, we saw continued early momentum from NJOY and believe our businesses are on track to deliver against full-year plans,” said Gifford. “We also demonstrated our continued commitment to maximizing the return on our investments and delivering strong shareholder returns through the sale of a portion of our investment in ABI and the subsequent expansion of our share repurchase program in March.”

  • 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.

  • Altria: Illicit Disposable Vapes Impacting NJOY Sales

    Altria: Illicit Disposable Vapes Impacting NJOY Sales

    Credit: Apichat

    Altria says a booming illegal disposable flavored vape market is causing a major decline in the sales of its authorized vaping products.

    Sal Mancuso, Altria’s CFO, pointed out on a call with select media and financial analysts that traditional cigarette industry volumes had dropped even more than usual in the third quarter. The decline was caused by inflation and economic issues influencing customers, as well as the heightened usage of illegal flavored disposable e-cigarettes.

    Mancuso further stated that there appeared to be more switching between different categories than initially assumed and that e-cigarettes alone were causing a 1.5 percent to 2.5 percent reduction in traditional cigarette industry volumes.

    BAT subsidiary R.J. Reynolds Vapor Co. holds the top market share in the U.S. at 41.8 percent as of the latest Nielsen convenience store report released Oct. 7.

    NJOY, which Altria purchased for $2.75 billion in June, has struggled to increase its No. 3 market share.

    “The current state of the (vaping) market is intolerable for both legitimate manufacturers and consumers,” Billy Gifford, Altria’s CEO, said during the call. “As we have noted repeatedly for months, the regulated market is being overrun by illegal-flavored disposable e-vapor products made and distributed by companies violating virtually every rule and guidance FDA has issued since 2016.

    “A lot of these products are imported. They’re imported illegally and then they’re sold illegally.”

    Saying a “strong course correction is needed,” Gifford noted that Altria has filed federal lawsuits in California against 34 organizations that include manufacturers, distributors and online retailers.

  • Altria’s NJOY Sues 34 Disposable Vape Companies

    Altria’s NJOY Sues 34 Disposable Vape Companies

    Credit: Kristina Blokhin

    Altria Group today said that its e-cigarette subsidiary NJOY, LLC has filed lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. If successful, the lawsuit could potentially decimate the flavored disposable vaping market.

    Altria joins its largest U.S. competitor, BAT-owned RJ Reynolds, in using the courts to remove unauthorized vaping products (and their competition) from the U.S. market.

    On Oct.13, Reynolds filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors, and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves. Several legal scholars have told Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without an FDA marketing authorization could be stopped at the border and prevented from entering the U.S. market.

    The NJOY suit alleges that the disposable products are unlawfully marketed and sold in the State of California and other U.S. states in violation of California’s flavor ban law and federal marketing rules.

    The products are illegal under federal law and subject to action by the U.S. Food and Drug Administration and illegally compete against companies that comply with state and federal laws, according to an Altria press release.

    The suit seeks a nationwide injunction against the import, marketing and sale of these illicit products and significant compensatory and punitive damages. If successful the lawsuit could lead to the removal of all disposable flavored vaping products without an FDA marketing order from the market.

    “These companies knowingly violate federal and state laws and need to be held accountable,” said Murray Garnick, Altria’s Executive Vice President and General Counsel. “Today there are two markets – one for those who play by the rules and one for those who flagrantly ignore them. We are taking this action because the current state of the illicit e-vapor market is intolerable, and we must see more action from FDA and others.”

    The litigation, filed in the United States District Court for the Central District of California, is brought under four claims: unfair competition, false advertising, false advertising in violation of the Lanham Act and violation of the Prevent All Cigarette Trafficking Act of 2009.

    Named Defendants in the suit manufacture and distribute illicit disposable e-vapor products which include, but are not limited to, brands including Breeze, Elf Bar, EB, EB Create, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar (many of these companies were also named in the Reynolds suit). Domestic Defendants include companies doing business in Arizona, California, Delaware, Florida, Michigan, Minnesota, New Jersey, New York and Texas. Foreign Defendants are all based in China.

    None of the Defendants has received premarket tobacco product authorization (PMTA) approval from the FDA. In many instances, Defendants also have not filed PMTA applications. Several of these Defendants have already received warning letters from the FDA stating that their products are adulterated and misbranded and cannot be sold without marketing authorization.

    Additionally, some of these Defendants are subject to an FDA-ordered import alert authorizing U.S. Customs and Border agents to seize their products. NJOY may add additional manufacturers, distributors and retailers to this complaint and will consider further litigation activity, the release states.

    Despite a ban on the sale of flavored tobacco products that went into effect in December 2022, flavored vapor products make up more than 97 percent of the California market according to a recent study commissioned by Altria. Conducted by an independent research firm WSPM Group, “the study collected 15,000 empty discarded cigarette packs and 4,529 e-vapor product packages” from May 1st through June 28th in 10 California cities.

  • Altria Seeks U.S. Importation Ban of Juul Products

    Altria Seeks U.S. Importation Ban of Juul Products

    Image: inimalGraphic

    Njoy has asked the U.S. International Trade Commission (ITC) to ban on the importation and sale of certain Juul products, including its currently marketed Juul device and Juul pods, citing patent infringements.  

    “Protecting our intellectual property is critical to achieving our vision,” said Murray Garnick, executive vice president and general counsel of Njoy parent company Altria Group, in a statement. “Juul has infringed upon our patents through the sale of its imported products, and we ask the ITC to impose appropriate remedies in response to these trade violations.”

    Njoy has also filed a complaint against Juul in the U.S. District Court for the District of Delaware based on the same patent infringement. Njoy Ace is currently the only pod-based e-vapor product to have received marketing authorization from the FDA, which deemed the marketing of the ACE device and three ACE tobacco-flavored pods as “appropriate for the protection of public health.”

    Njoy’s ITC complaint against Juul alleges trade violations associated with the sale of imported products that, according to Njoy, infringe U.S. Patent No. 11,497,864 and U.S. Patent No. 10,334,881. Njoy acquired the Asserted Patents from Fuma International, concurrently with the settlement of a patent infringement lawsuit filed against the company by Fuma.

    Njoy’s complaint is the latest development in a broader intellectual property dispute.

    In July, Juul Labs asked the ITC to block sales and imports of Njoy Ace, claiming that the product infringes several Juul patents. It has also filed a complaint against Njoy with the U.S. District Court for the District of Arizona.

    Juul Labs complain also targets Altria Group, which agreed to acquire the NJOY in March after exchanging its minority investment in Juul for a heated tobacco product intellectual property license.

  • Juul Labs Accuses NJOY Maker of Patent Violations

    Juul Labs Accuses NJOY Maker of Patent Violations

    Juul Labs has asked the U.S. International Trade Commission (ITC) to block sales and imports of the NJOY Ace vapor device, claiming that the product infringes several Juul patents. It has also filed a complaint against NJOY with the U.S. District Court for the District of Arizona.

    “Our technology, designed internally and in the U.S. and protected by our robust patent portfolio, has been the most effective product development to transition adult smokers from combustible cigarettes—switching over 2 million adult smokers in this country. Innovation is critical in this space to advance tobacco harm reduction,” said Juul Labs Chief Legal Officer Tyler Mace in a statement.

    “When others infringe on our technology, we have no choice but to protect our intellectual property rights.”

    This ITC complaint follows three prior successful actions from Juul Labs at the Commission, which all resulted in barring the importation and sale of infringing products, according to Juul Labs.

    “Just like we have in three prior successful ITC actions that vindicated our company’s IP rights, we intend to reach the same result here,” said Mace.

    The Juul Labs complaint also targets Altria Group, which agreed to acquire the NJOY in March after exchanging its minority investment in Juul for a heated tobacco product intellectual property license.

    The NJOY Ace device received marketing authorization from the Food and Drug Administration in April 2022.

  • Altria’s Acquisition of Njoy Comes to a Close

    Altria’s Acquisition of Njoy Comes to a Close

    Image: Tobacco Reporter archive

    Altria Group has completed its acquisition of Njoy Holdings. The tobacco giant has also updated its guidance for 2023 full-year adjusted diluted earnings per share (EPS) in connection with the transaction.

    “The completion of this transaction is a transformative step in our goal of ‘Moving Beyond Smoking,’” said Billy Gifford, Altria’s CEO. “We are pleased to have received antitrust clearance, and we are now fully focused on responsibly accelerating U.S. adult smoker and adult vaper adoption of Njoy Ace, currently the only pod-based e-vapor product to receive marketing authorization from the FDA.

    “Our updated 2023 full-year EPS guidance range includes planned investments behind the U.S. commercialization of Njoy Ace and reflects our goal to deliver strong shareholder returns while making progress toward our vision.”

    “We are excited to combine our resources with Njoy’s talented team to benefit adult tobacco consumers across the country,” said Shannon Leistra, the new president and CEO of Njoy.

    As a result of the transaction, Altria expects to deliver 2023 full-year adjusted diluted EPS in a range of $4.89 to $5.03, representing a growth rate of 1 percent to 4 percent from an adjusted diluted EPS base of $4.84 in 2022.

    “Our 2023 full-year adjusted diluted EPS guidance range includes planned investments in support of the company’s vision, such as (i) continued smoke-free product research, development and regulatory preparation expenses, (ii) enhancement of the company’s digital consumer engagement system and (iii) marketplace activities in support of the company’s smoke-free products, including planned investments behind the U.S. commercialization of Ace,” Altria wrote in a press note.

    Altria’s updated guidance range also includes estimated amortization charges of approximately $50 million for the remainder of 2023 related to intangible assets acquired in the transaction.