FDA Authorizations Reveal Big Tobacco’s Growing Hold on the THR Marketplace

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Key Points:

• FDA Authorization: On August 21, the FDA authorized 11 ZYN ULTRA nicotine pouch products from Swedish Match USA, including citrus and wintergreen flavors and nicotine strengths of 9 mg and 11 mg.

• Public Health Standard Met: The FDA determined the products met the “appropriate for the protection of public health” (APPH) standard under the 2009 Tobacco Control Act.

• Lower Toxicant Exposure: According to the FDA, the newly authorized ZYN ULTRA products contain lower levels of most harmful and potentially harmful constituents compared with other oral and smokeless tobacco products.

• Potential Switching Benefit: The agency also found the products may deliver enough nicotine to reduce cravings and withdrawal symptoms among adults who currently use more harmful tobacco products.

• Regulatory Concentration: While the authorization expands access to lower-risk products, it also highlights a broader concern: the companies best able to navigate the costly and complex PMTA process are increasingly dominating the authorized tobacco harm reduction marketplace.

• Restrictive PMTA System: Most modern e-cigarettes, nicotine pouches, and other novel products must undergo the Premarket Tobacco Product Application (PMTA) process because they lack appropriate products marketed before the February 15, 2007 grandfather date.

• Independent Innovation: Much of the early U.S. vaping market was developed by independent manufacturers and consumers, while major cigarette companies entered the category years later.

• 2020 Regulatory Deadline: Litigation ultimately forced manufacturers of products already on the market to submit PMTAs by September 9, 2020, followed by widespread FDA denials of flavored e-cigarette applications.

• Youth Vaping Has Fallen Sharply: In 2025, only 7.2 percent of U.S. middle and high school students reported past-month e-cigarette use, representing a 68.7 percent decline from 2019.

• Adult Vaping Continues to Grow: In 2024, more than 21.3 million American adults were current e-cigarette users – approximately one million more than in 2023.

• Long-Term Adult Growth: Between 2016 and 2024, adult vaping increased by 72.2 percent, demonstrating sustained consumer demand for smoke-free nicotine alternatives.

• Nicotine Pouch Growth: Nicotine pouches have also become increasingly popular, with a recent study estimating that 2.5 percent of U.S. adults have ever used them.

• PMI’s Growing Position: Philip Morris International acquired Swedish Match in 2022, bringing ZYN into one of the world’s largest tobacco companies and substantially expanding PMI’s presence in the FDA-authorized harm reduction market.

• Multiple ZYN Authorizations: The latest action follows the FDA’s January 2025 authorization of 20 original ZYN products and its June 2026 MRTP orders allowing those products to carry an authorized reduced-risk claim.

• Modified-Risk Claim: Swedish Match may state that using ZYN instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.

• Competition Concerns: The central issue is not whether large tobacco companies should receive authorization, but whether smaller manufacturers have a realistic opportunity to meet the same regulatory standards and compete.

• Historical Warning: Concerns that the Tobacco Control Act could favor incumbent tobacco companies date back to the law’s passage, when industry participants warned that the regulatory structure could reshape competition.

• Policy Implications: A regulatory system designed to protect public health should not make participation in the smoke-free marketplace dependent on having the financial and scientific resources of a multinational tobacco company.

• Bottom Line: FDA authorization of ZYN ULTRA is a positive development for adults seeking lower-risk alternatives, but it also underscores the need to modernize the Tobacco Control Act and PMTA process so companies of different sizes can compete on science, safety, and innovation – not simply regulatory resources.

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On August 21, the U.S. Food and Drug Administration (FDA) issued marketing authorization orders to Swedish Match USA, Inc. for 11 nicotine pouch products sold under the ZYN ULTRA brand name. The newly authorized products include a wide variety of flavors, from citrus to wintergreen, and nicotine strengths of 9 mg and 11 mg.

While many tobacco harm reduction advocates have applauded the agency’s relatively quick turnaround in authorizing Swedish Match’s premarket tobacco product applications (PMTAs), the latest orders also highlight a broader problem with the existing regulatory system: the companies best positioned to navigate the costly and complex process are increasingly securing a dominant position in the U.S. tobacco harm reduction marketplace.

In issuing the marketing orders, the FDA determined that Swedish Match’s PMTAs provided sufficient evidence to meet the “appropriate for the protection of the public health” (APPH) standard established under the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which gave FDA authority to regulate tobacco products.

According to the FDA, the newly authorized ZYN ULTRA products contain lower levels of most harmful and potentially harmful constituents compared with other oral and smokeless tobacco products. The agency also determined that the products may deliver sufficient nicotine to reduce cravings and withdrawal symptoms among adults who currently use more harmful tobacco products.

The authorization is good news for adults seeking alternatives to combustible cigarettes. Yet it also raises a larger question: Has the regulatory framework created by Congress inadvertently made it easier for the largest tobacco companies to dominate the very market that is disrupting combustible cigarettes?

The PMTA process remains extraordinarily restrictive and has failed to provide a regulatory framework capable of accommodating the rapidly evolving marketplace serving millions of American adults who use e-cigarettes and other smoke-free nicotine products.

Under the TCA, manufacturers of new tobacco products generally must receive authorization before legally marketing their products. The law also established February 15, 2007, as an important grandfather date for determining how products are regulated.

Products with appropriate predicate products already marketed by that date may be eligible for the substantial equivalence (SE) pathway. Newer products without such predicate – including most modern e-cigarettes and nicotine pouches – must generally undergo the more rigorous PMTA process.

That distinction has had enormous consequences.

E-cigarettes first entered the U.S. market around 2007, two years before Congress granted FDA authority over tobacco products. Before passage of the TCA, FDA attempted to regulate e-cigarettes as drug-delivery devices. Litigation ultimately established that e-cigarettes marketed for recreational use could instead be regulated as tobacco products.

Between 2007 and today, the tobacco harm reduction landscape has changed dramatically. The early market evolved from “cig-a-likes,” which resembled combustible cigarettes, to open-system devices, tanks, pod systems, disposables and nicotine pouches.

Much of that innovation initially occurred outside the traditional tobacco industry and was driven by consumers and independent manufacturers. Major cigarette manufacturers did not begin introducing their own significant e-cigarette offerings until years after the category emerged.

In 2016, FDA finalized its “deeming rule,” bringing e-cigarettes and other newly deemed tobacco products under its regulatory authority and subjecting manufacturers to the PMTA process.

Subsequent litigation brought by public health organizations ultimately resulted in a September 9, 2020 deadline for manufacturers to submit applications for products already on the market. The following year, FDA began issuing widespread marketing denial orders for flavored e-cigarette products, determining that applicants generally needed stronger product-specific evidence demonstrating that the potential benefits to adults who smoke outweighed risks to youth.

Those regulatory decisions came as youth vaping began a substantial decline. In 2025, only 7.2 percent of U.S. middle and high school students reported past-month e-cigarette use. This was a whopping 68.7 percent decline from 2019.

At the same time, millions of American adults continue to use e-cigarettes and other tobacco harm reduction products.

According to the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System, more than 21.3 million American adults aged 18 years or older were current e-cigarette users in 2024. This represented a 3.9 percent increase from 2023 and approximately one million additional adult users in a single year. Between 2016 and 2024, adult vaping increased by 72.2 percent.

Nicotine pouches have also emerged as an increasingly popular smoke-free alternative. A recent study estimated that 2.5 percent of U.S. adults had ever used nicotine pouches.

Yet the number of products successfully navigating FDA review remains small compared with the size and diversity of the consumer marketplace.

That disparity has created an unintended consequence: a regulatory system designed to evaluate new tobacco products may increasingly favor companies with the financial resources, scientific infrastructure and regulatory expertise necessary to successfully navigate it.

Philip Morris International acquired Swedish Match in 2022, bringing ZYN into one of the world's largest tobacco companies.

The August authorization further expands PMI’s presence in the FDA-authorized smoke-free marketplace. It follows FDA’s January 2025 authorization of 20 original ZYN products and, more significantly, the agency’s June 2026 decision permitting those 20 products to be marketed with a specific modified-risk claim.

Under that order, Swedish Match may tell consumers that: "Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The modified risk tobacco product (MRTP) pathway is separate from the PMTA process and requires manufacturers to provide additional scientific evidence before making modified-risk claims.

PMI and its subsidiaries now account for a substantial share of both PMTA and MRTP authorizations. That concentration is particularly noteworthy because PMI remains one of the world's largest sellers of combustible cigarettes, even though cigarettes bearing PMI brands in the United States are sold separately by Altria.

There is nothing inherently problematic about a large tobacco company developing and successfully obtaining authorization for lower-risk products. Indeed, transitioning adults who smoke away from combustible cigarettes is precisely the type of population-level benefit the Tobacco Control Act directs FDA to consider.

The concern is whether smaller companies developing competing alternatives have a realistic opportunity to obtain the same regulatory approval.

Concerns that the Tobacco Control Act could favor the largest incumbent companies are not new.

During debate over the legislation in 2009, some tobacco companies warned that the regulatory structure could reshape competition within the industry. A spokeswoman for R.J. Reynolds argued that the legislation “would make it harder to let consumers know that there are options available to them.”

Philip Morris, meanwhile, supported the legislation and had spent years preparing for a regulatory environment in which companies would need extensive scientific evidence to bring new products to market.

Nearly two decades later, that history deserves renewed attention.

The FDA should be applauded when it authorizes smoke-free products that meet the statutory public health standard, including ZYN ULTRA. Adults who smoke benefit from having more – not fewer – lower-risk alternatives available to them.

But authorization of another portfolio from one of the world's largest tobacco companies also underscores the shortcomings of the existing system. A regulatory framework intended to protect public health should not make access to the smoke-free marketplace dependent on whether a manufacturer has the resources of a multinational tobacco company.

Rather than restricting products that FDA determines can benefit adults who smoke, policymakers should revisit the Tobacco Control Act and modernize its pathways for today's nicotine marketplace. A successful regulatory system should protect youth, establish reasonable product standards and provide adult smokers with access to lower-risk alternatives – while allowing companies of different sizes to compete on science, safety and innovation.

If only the largest tobacco companies can afford to successfully navigate the system, the problem is no longer simply which products FDA authorizes. It is whether the regulatory framework itself is helping determine who gets to compete.

Nothing in this analysis is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.