NJOY Submits Premarket Tobacco Product Applications to the FDA for NJOY ACE 2.0 Featuring Bluetooth®-enabled Access Restriction Technology

Rhea-AI Summary

NJOY, an Altria company, has submitted a Premarket Tobacco Product Application (PMTA) to the FDA for its NJOY ACE 2.0 device, which incorporates Bluetooth®-enabled access restriction to prevent underage use. The company also re-submitted applications for Blueberry and Watermelon pods compatible with NJOY ACE 2.0. Already the sole FDA-authorized pod-based e-vapor product, the NJOY ACE expanded its distribution to over 80,000 stores in Q1 2024, aiming for 100,000 by year-end. Altria's vision is to transition smokers to smoke-free options responsibly. NJOY aims to address previous FDA concerns regarding underage access and hopes for expedited review and authorization.

Positive

• Submitted PMTA for NJOY ACE 2.0 with Bluetooth-enabled access restriction.

• Expanded distribution to over 80,000 stores in Q1 2024.

• Plans to reach approximately 100,000 stores by year-end.

• NJOY ACE remains the only FDA-authorized pod-based e-vapor product.

• NJOY ACE 2.0 aims to responsibly transition adult smokers to smoke-free options.

Negative

• Previous Marketing Denial Orders (MDO) for Blueberry and Watermelon pods.

• No FDA authorization for non-tobacco flavored e-vapor products yet.

• Potential regulatory risks pending FDA review and authorization.

Financial Analyst

The submission of the PMTA for NJOY ACE 2.0 is significant as it presents a dual opportunity. First, further penetration into the e-vapor market, leveraging the only FDA-authorized pod-based product, aligns with Altria’s strategic vision to transition adult smokers to smoke-free products. The fiscal impact is expected to be positive, especially with the device featuring Bluetooth-enabled access restriction technology aimed at preventing underage use. This could potentially boost sales while addressing regulatory compliance.

The targeted expansion to 100,000 stores by year-end also demonstrates strong distribution scalability, which is likely to reinforce revenue growth. However, there is some risk involved with FDA approval uncertainties, as previous Marketing Denial Orders (MDOs) were issued for the flavored pods in question. The resolution of these issues is important to unlocking the product's full revenue potential.

In the short term, NJOY's existing market authorization and its expansion efforts suggest stable revenue growth. Long term, successful FDA approval and market acceptance of these new products will likely bolster Altria's stronghold in the smoke-free market, contributing significantly to its revenue mix.

Regulatory Affairs Expert

From a regulatory perspective, the submission of a supplemental PMTA with enhanced access restrictions is a strategic move to address previous concerns leading to Marketing Denial Orders. The integration of device age and identity-based access restriction technology aligns with FDA’s stringent requirements to curb underage use, which has been a significant hurdle in the approval of flavored e-vapor products.

Given the FDA's mandate to ensure that new tobacco products are appropriate for the protection of public health, the incorporation of advanced access restriction technologies presents a compelling argument for approval. For investors, understanding the regulatory landscape and NJOY’s proactive measures to comply is crucial. A positive FDA review would not only validate NJOY's technological advancements but also potentially set a regulatory benchmark for other companies in the e-vapor space.

If the FDA prioritizes and approves these applications, NJOY would maintain its competitive edge, reinforcing investor confidence in Altria's regulatory strategy and commitment to responsible marketing.

RICHMOND, Va.--(BUSINESS WIRE)-- Today, NJOY, an Altria company, announces the submission of a supplemental Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) to commercialize and market the NJOY ACE 2.0 device. This new device incorporates access restriction technology designed to prevent underage use via Bluetooth^® connectivity to authenticate the user before unlocking the device. The company also re-submitted PMTAs for Blueberry and Watermelon pod products that work exclusively with the NJOY ACE 2.0 device.

“Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products. NJOY ACE 2.0 includes critical technology features to prevent underage access to flavored NJOY products, while also responsibly providing flavored options for adult smokers and vapers,” said Shannon Leistra, President & Chief Executive Officer of NJOY.

NJOY ACE currently remains the only pod-based e-vapor product with marketing authorization from the FDA. 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.

"Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, Senior Vice President, Regulatory Affairs of Altria Client Services LLC. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”

NJOY previously received Marketing Denial Orders (MDO) for its Blueberry and Watermelon pods. NJOY believes these applications sufficiently address the FDA’s concerns regarding underage use by both incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco flavored e-vapor products.

Notes:

To secure market authorization under a PMTA, manufacturers must demonstrate that marketing of a new tobacco product is appropriate for the protection of public health (APPH), which requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

On April 26, 2022, the FDA authorized the NJOY ACE device and NJOY ACE Classic Tobacco (2.4% and 5%) and Rich Tobacco (5%) pods as APPH.

The FDA issued MDOs for the NJOY ACE Blueberry (2.4% and 5%) and Watermelon (2.4% and 5%) pods noting:
“...Rather, for flavored Electronic Nicotine Delivery System (ENDS), only the most stringent mitigation measures – specifically device access restrictions – have such mitigation potential.”

NJOY is a wholly owned subsidiary of Altria. NJOY's products are distributed by Altria Group Distribution Company (AGDC). Our sales force has significant U.S. retail coverage and decades of experience supporting the responsible retailing of tobacco 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 that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements relate to regulatory filings that are inherently subject to risks and uncertainties, and we cannot predict any regulatory outcomes. Other risk factors 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 and our Quarterly Reports on Form 10-Q. 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.

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FAQ

What is NJOY ACE 2.0?

NJOY ACE 2.0 is a pod-based e-vapor device featuring Bluetooth-enabled access restriction technology to prevent underage usage.

What is the significance of the PMTA submission for NJOY ACE 2.0?

The PMTA submission seeks FDA authorization to market NJOY ACE 2.0, featuring technology to prevent underage use.

What flavors of pods are compatible with NJOY ACE 2.0?

NJOY ACE 2.0 is compatible with Blueberry and Watermelon pods.

How many stores currently distribute NJOY ACE products?

As of the first quarter of 2024, NJOY ACE products are distributed in over 80,000 stores.

What are the concerns related to NJOY's flavored pods?

The FDA previously issued Marketing Denial Orders for NJOY's Blueberry and Watermelon pods due to concerns about underage access.

How does NJOY ACE 2.0 aim to prevent underage use?

NJOY ACE 2.0 uses Bluetooth-enabled technology to authenticate users and restrict access to prevent underage usage.

What is Altria's vision regarding smoke-free products?

Altria aims to lead the transition of adult smokers to a smoke-free future by offering responsibly marketed and potentially less harmful options.

What potential regulatory risks does NJOY face?

NJOY faces regulatory risks pending FDA review and authorization of their new PMTA for NJOY ACE 2.0 and flavored pods.

What is NJOY's market strategy for 2024?

NJOY plans to expand its distribution to approximately 100,000 stores and continues to roll out its first retail trade program to enhance product visibility and fixture space.

Why is the PMTA for NJOY ACE 2.0 important?

The PMTA is important for securing FDA authorization to market NJOY ACE 2.0, which includes access restriction technology to mitigate underage use, balancing public health concerns.