Altria Announces PMTA Submission for on! PLUS™ Nicotine Pouches

Rhea-AI Summary

Altria Group announced the submission of Premarket Tobacco Product Applications (PMTAs) to the FDA for its new on! PLUS oral nicotine pouches. Developed by Helix Innovations, these pouches are made from a proprietary soft-feel material for a more comfortable user experience. On! PLUS pouches, designed for adult dippers and dual users, come in tobacco, mint, and wintergreen flavors with three nicotine strength options. Altria believes the product will significantly contribute to Helix's growth upon FDA authorization. In Q1 2024, on! pouches saw a 32% increase in shipment volume and captured a 7.1% market share in the U.S. oral tobacco category.

Positive

• Submission of PMTAs for on! PLUS oral nicotine pouches to FDA.
• Innovative soft-feel material for a more comfortable user experience.
• Three flavors and three nicotine strength options for on! PLUS pouches.
• On! reported a 32% increase in shipment volume in Q1 2024.
• On! captured a 7.1% market share in the U.S. oral tobacco category.

Negative

• Dependence on FDA authorization for market entry.

Regulatory Affairs Expert

The submission of Premarket Tobacco Product Applications (PMTAs) for Altria's new on! PLUS nicotine pouches marks a significant step. The FDA's review process for PMTAs is rigorous, requiring comprehensive evidence that the product is appropriate for public health, considering both users and non-users of tobacco products. This includes analyzing potential risks and benefits, which could impact the overall acceptance and market reach of on! PLUS.

Short-term impact: If the FDA grants market authorization, Altria could quickly expand its footprint in the growing oral nicotine pouch market, enhancing its portfolio of smoke-free products. However, the uncertainty and time involved in the regulatory process could delay these benefits, making it a point of concern for investors who prioritize short-term gains.

Long-term impact: Successfully navigating the PMTA process would position Altria as a leader in the reduced-risk product segment, aligning with its strategic vision of transitioning adults away from smoking. This could lead to sustained revenue growth and improved public perception. Nonetheless, investors should remain cautious about potential regulatory setbacks or additional compliance requirements that could arise.

It's important for investors to note that PMTA approval could set a precedent for future products, potentially streamlining future submissions.

Market Research Analyst

Altria's decision to submit PMTAs for on! PLUS nicotine pouches indicates a strategic move to capture a larger share of the oral tobacco market, which is experiencing notable growth. The product’s innovative qualities, such as the “soft-feel” material and seamless design, aim to attract adult users who prefer a more comfortable experience. Given that the existing on! brand has already achieved a 7.1% retail market share, this new product could further solidify Altria's market position.

Consumer Trends: The rising demand for smoke-free tobacco alternatives suggests a favorable consumer environment for on! PLUS. The emphasis on responsible disposal and multiple nicotine strengths could appeal to a broad spectrum of users, from those looking to reduce tobacco consumption to those seeking alternative nicotine sources.

Competitive Landscape: Altria faces competition from other nicotine pouch brands and e-vapor products, making it essential to differentiate on! PLUS through effective marketing and retail strategies. Helix's established distribution network and market penetration will be critical assets in this endeavor.

Investors should monitor how well the product resonates with consumers and its ability to gain authorization, as these factors will significantly influence market share and revenue.

RICHMOND, Va.--(BUSINESS WIRE)-- Today, Altria Group, Inc. (Altria) announces the submission of Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) for its innovative on! PLUS oral nicotine pouch products. The PMTAs were submitted by Altria’s wholly owned subsidiary Helix Innovations LLC (Helix).

on! PLUS is a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary “soft-feel” material to provide a more comfortable product experience. The on! PLUS pouch is designed for adults who dip and adult dual users (i.e., adults who smoke and dip). on! PLUS pouches are seamless and larger than the leading U.S. TDN brands. Similar to the currently marketed on!^® products, on! PLUS packaging features a compartment to responsibly dispose of used product. Helix submitted PMTAs for three distinct on! PLUS varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.

“Helix’s submission of the on! PLUS applications underscores Altria's commitment to addressing consumers’ evolving preferences through innovation in potentially reduced risk products. We firmly believe that on! PLUS is a transformative product that will meaningfully contribute to Helix’s growth in the U.S. market, upon timely FDA authorization,” said Nick MacPhee, Managing Director and General Manager, Helix.

“We’ve long believed in the value of a robust marketplace of authorized smoke-free products for adult tobacco consumers. We believe that these PMTAs demonstrate that responsibly marketed on! PLUS pouches can provide a compelling alternative in the marketplace,” said Paige Magness, Senior Vice President of Regulatory Affairs, Altria Client Services LLC.

Notes:

To secure market authorization under a PMTA, manufacturers must demonstrate that the marketing of a new tobacco product is appropriate for the protection of public health. This requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products, and youth. on! PLUS are products of Helix and upon authorization, we expect the products to be distributed by Altria Group Distribution Company (AGDC), which has significant U.S. retail coverage and decades of experience supporting the responsible retailing of tobacco products.

Helix currently sells on! nicotine pouches in the U.S. In the first quarter of 2024, on! reported shipment volume grew 32% versus the prior year and the brand achieved a 7.1% retail share of the total U.S. oral tobacco category.

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 1995. These forward-looking statements relate to regulatory filings that are inherently subject to risks and uncertainties, and we cannot predict any regulatory outcomes. Factors that might cause actual results to differ materially from those contained in the forward-looking statements included in this press release include failure to receive regulatory authorizations, among others. 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. 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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Investor Relations

Altria Client Services

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Altria Client Services

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Source: Altria Group, Inc.

FAQ

What is Altria's new product submission to the FDA?

Altria has submitted Premarket Tobacco Product Applications to the FDA for its on! PLUS oral nicotine pouches.

What are the features of on! PLUS nicotine pouches?

On! PLUS nicotine pouches feature a proprietary soft-feel material and come in tobacco, mint, and wintergreen flavors with three nicotine strength options.

What is the expected market impact of on! PLUS for Altria?

Altria expects on! PLUS to significantly contribute to Helix's growth in the U.S. market upon FDA authorization.

How did on! perform in the market in Q1 2024?

On! saw a 32% increase in shipment volume and captured a 7.1% retail share of the U.S. oral tobacco category in Q1 2024.

What are the flavors available for on! PLUS nicotine pouches?

On! PLUS nicotine pouches are available in tobacco, mint, and wintergreen flavors.