NJOY Receives First FDA Authorizations for Menthol E-Vapor Products

Rhea-AI Summary

Altria Group, Inc. (NYSE: MO) announced that the FDA has granted marketing orders for NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY Extra Menthol 6%. These are the first FDA-authorized menthol e-vapor products, following NJOY's PMTA submission in March 2020.

Altria's CEO, Billy Gifford, emphasized the company's commitment to transitioning adult smokers to less harmful alternatives. NJOY products are now available in over 80,000 stores, with plans to expand to 100,000 by year-end.

However, Altria is obligated to make an additional $250 million payment due to the FDA's issuance of these marketing orders, per the merger agreement. NJOY also submitted a supplemental PMTA for its new ACE 2.0 device, which includes technology to prevent underage use.

Positive

• FDA authorization of NJOY menthol e-vapor products.
• Expansion to over 80,000 stores with plans for 100,000 by year-end.
• Introduction of NJOY ACE 2.0 device with access restriction technology.

Negative

• Obligation to pay an additional $250 million due to FDA marketing orders.

Financial Analyst

Altria’s recent FDA authorization for NJOY menthol e-vapor products has significant financial implications. The expansion of authorized products within the NJOY portfolio adds substantial value to Altria’s investment. This will likely enhance revenue streams, particularly as NJOY aims to increase distribution from 80,000 to 100,000 stores by the end of the year. This growth clearly signifies a strategic push to capture a larger market share in the e-vapor sector.

This FDA authorization could lead to higher sales volumes and potentially better profit margins. The $250 million additional cash payments under the Merger Agreement also reflect Altria's confidence in the long-term profitability of NJOY products, despite the initial financial outlay.

Short-term impact: Investors might see a boost in Altria's stock price as the market reacts positively to the news. Long-term impact: Sustained revenue growth and market penetration could solidify Altria's position in the smoke-free product market, aligning with their vision to transition smokers to less harmful alternatives.

However, the investments required for the expansion and the supplementary PMTAs (e.g., for the NJOY ACE 2.0) should be monitored as they could affect short-term profitability.

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Medical Research Analyst

The FDA authorization for NJOY menthol e-vapor products is particularly noteworthy from a public health perspective. The regulatory approval indicates that these products have met stringent criteria demonstrating that they are appropriate for the protection of public health. This suggests that menthol e-vapor products offer a safer alternative to traditional combustible cigarettes.

This development is critical because flavors like menthol are essential in aiding smokers to transition to smoke-free products. The focus on flavors aligns with published data emphasizing their role in smoker adoption rates.

Short-term impact: The availability of FDA-authorized menthol e-vapor products could accelerate the decline in cigarette smoking rates, contributing to public health improvements. Long-term impact: Supporting a diverse range of regulated smoke-free alternatives could further reduce tobacco-related morbidity and mortality, aligning with broader public health goals.

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Legal Expert

The securing of FDA marketing orders for NJOY menthol e-vapor products represents a significant legal milestone. These orders provide a competitive advantage by positioning NJOY as the only company with FDA-authorized menthol e-vapor products, allowing it to operate within legal frameworks while competitors remain in regulatory limbo.

Moreover, the additional $250 million payment tied to the terms of the Merger Agreement with NJOY demonstrates the financial and strategic foresight. This contingent payment structure shows Altria's commitment to regulatory compliance and product innovation.

Short-term impact: The legal security provided by FDA authorization could minimize litigation risks and regulatory challenges, benefiting investors with reduced legal uncertainties. Long-term impact: Establishing regulatory compliance strengthens NJOY's market position and paves the way for future product innovations, potentially leading to further market authorizations.

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RICHMOND, Va.--(BUSINESS WIRE)-- Altria Group, Inc. (Altria) (NYSE: MO) announces today that the U.S. Food and Drug Administration (FDA) issued marketing orders for NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY Extra Menthol 6%. These authorizations follow FDA review of the Premarket Tobacco Product Applications (PMTA), submitted by NJOY, LLC (NJOY) in March 2020.

NJOY ACE remains the only pod-based e-vapor product with marketing authorization from the FDA, and now NJOY has the first and only menthol e-vapor products authorized by the FDA to date. “Altria is Moving Beyond Smoking™, taking action to transition millions of adult smokers to potentially less harmful alternatives. We’re pleased the FDA has determined that NJOY menthol e-vapor products are appropriate for the protection of public health,” said Billy Gifford, Altria’s Chief Executive Officer (CEO).

In the first quarter of 2024, NJOY broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end. NJOY also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space.

“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 Shannon Leistra, President and CEO of NJOY.

“We believe that, for tobacco harm reduction to succeed, adult smokers must have access to a robust marketplace of FDA-authorized smoke-free alternatives. 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,” said Paige Magness, Senior Vice President, Regulatory Affairs of Altria Client Services LLC.

Tobacco harm reduction requires that adult smokers have access to appealing and satisfying smoke-free tobacco products. Published data demonstrate that flavors are critical in adult smokers' trial and adoption of smoke-free products. To advance tobacco harm reduction, it is imperative to create a diverse marketplace of products to meet adult smokers' preferences.

As part of a PMTA, manufacturers must provide data and evidence, including related to flavors, to support marketing authorization for a new product and to demonstrate that marketing the product is "appropriate for the protection of public health" as required under the Tobacco Control Act. This federal law also requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

NJOY is a wholly owned subsidiary of Altria. NJOY's products are distributed by Altria Group Distribution Company (AGDC). The AGDC sales force has significant U.S. retail coverage and decades of experience supporting the responsible retailing of tobacco products.

As a result of the FDA's issuance of the Marketing Granted Orders (MGOs), Altria is obligated to pay $250 million in additional cash payments under the terms of the Agreement and Plan of Merger pursuant to which Altria acquired NJOY (the Merger Agreement). In May 2024, NJOY submitted a supplemental PMTA to the FDA to commercialize and market the NJOY ACE 2.0 device. This device incorporates access restriction technology designed to prevent underage use via Bluetooth^® connectivity to authenticate the user before unlocking the device. NJOY also re-submitted PMTAs for Blueberry and Watermelon pod products that work exclusively with the NJOY ACE 2.0 device.

Under the terms of the Merger Agreement, Altria may be obligated to pay up to $250 million in additional cash payments that are contingent upon the FDA's issuance of MGOs with respect to the Blueberry and Watermelon pod products.

Altria’s Profile

We have a leading portfolio of tobacco products for U.S. tobacco consumers age 21+. Our Vision is to responsibly lead the transition of adult smokers to a smoke-free future (Vision). We are Moving Beyond Smoking™, leading the way in moving adult smokers away from cigarettes by taking action to transition millions to potentially less harmful choices - believing it is a substantial opportunity for adult tobacco consumers, our businesses and society.

Our wholly owned subsidiaries include leading manufacturers of both combustible and smoke-free products. In combustibles, we own Philip Morris USA Inc. (PM USA), the most profitable U.S. cigarette manufacturer, and John Middleton Co. (Middleton), a leading U.S. cigar manufacturer. Our smoke-free portfolio includes ownership of U.S. Smokeless Tobacco Company LLC (USSTC), the leading global moist smokeless tobacco (MST) manufacturer, Helix Innovations LLC (Helix), a leading manufacturer of oral nicotine pouches, and NJOY, LLC (NJOY), currently the only e-vapor manufacturer to receive market authorizations from the U.S. Food and Drug Administration (FDA) for a pod-based e-vapor product.

Additionally, we have a majority-owned joint venture, Horizon Innovations LLC (Horizon), for the U.S. marketing and commercialization of heated tobacco stick products.

Our equity investments include Anheuser-Busch InBev SA/NV (ABI), the world’s largest brewer, and Cronos Group Inc. (Cronos), a leading Canadian cannabinoid company.

The brand portfolios of our operating companies include Marlboro^®, Black & Mild^®, Copenhagen^®, Skoal^®, on!^® and NJOY^®. Trademarks related to Altria referenced in this release are the property of Altria or our subsidiaries or are used with permission.

Forward-Looking and Cautionary Statements

This release contains certain forward-looking statements, including related to the expected timing of expanded NJOY distribution and regulatory authorizations, that are subject to a number of risks and uncertainties and are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Factors that might cause actual results to differ materially from those contained in the projections and forward-looking statements included in this press release include failure to receive regulatory authorizations or meet expectations with respect to the expansion of product distribution, among others. Other risk factors that may cause actual results and outcomes to differ materially from those contained in the projections and forward-looking statements included in this press release are detailed from time to time in our publicly filed reports, including our Annual Report on Form 10-K for the year ended December 31, 2023. These forward-looking statements speak only as of the date of this press release. We assume no obligation to provide any revisions to, or update, any projections and forward-looking statements contained in this release.

Learn more about Altria at www.altria.com and follow us on X (formerly known as Twitter), Facebook and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240621534102/en/

Investor Relations

Altria Client Services

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Media Relations

Altria Client Services

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Source: Altria Group, Inc.

FAQ

What NJOY menthol e-vapor products received FDA authorization?

The FDA authorized NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY Extra Menthol 6%.

When did NJOY submit the PMTAs for its menthol e-vapor products?

NJOY submitted the Premarket Tobacco Product Applications (PMTAs) in March 2020.

How many stores are NJOY products available in as of the first quarter of 2024?

NJOY products are available in over 80,000 stores, with plans to expand to approximately 100,000 stores by the end of the year.

What financial obligation does Altria have due to FDA's marketing orders for NJOY products?

Altria is obligated to pay an additional $250 million in cash payments due to the FDA's issuance of marketing orders.

What new NJOY device has been submitted for FDA approval and what feature does it include?

NJOY submitted a supplemental PMTA for the NJOY ACE 2.0 device, which includes access restriction technology to prevent underage use via Bluetooth connectivity.