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FDA guidance brings greater regulatory clarity to nicotine pouch manufacturers, suppliers, and retailers, moving the industry beyond a long-standing gray area. Photo credit: Jakubdrastich2, CC4.0.
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For nontobacco-flavored ENDS, FDA requires additional data to assess whether the products are appropriate for the protection of public health. Photo credit: TBEC Review, CC2.0.
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Klar nicotine pouches. Photo credit: Klar
The US Food and Drug Administration has spent much of the middle of the year sending a series of signals that together offer perhaps the regulatory agency’s clearest view yet of where tobacco and nicotine regulation is headed.
Within several weeks, the agency released new enforcement priorities for unauthorized electronic nicotine delivery systems (ENDS) and nicotine pouch products, proposed sweeping registration requirements for foreign tobacco manufacturers, and authorized the first modified-risk marketing claims for nicotine pouches.
Viewed independently, each action targets a distinct segment of the nicotine marketplace. Taken together, however, they illustrate an increasingly coordinated regulatory strategy—one that encourages manufacturers to enter the legal pathway while expanding the agency’s ability to identify, inspect, and remove products that remain outside it.
The message is hard to miss. FDA wants more compliant products, greater accountability from manufacturers, and clearer scientific distinctions between authorized reduced-risk products and those that continue to bypass federal review.
The following developments highlight how that strategy is beginning to take shape.
FDA sets ENDS, pouch enforcement priorities
The US Food and Drug Administration is shaping new policy on one of the nicotine industry’s biggest unresolved questions: what will happen to unauthorized ENDS and nicotine pouch products still on the market that have not submitted a premarket tobacco product application (PMTA)?
In a May Federal Register notice, the regulatory agency announced the availability of final guidance titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” According to the notice, the guidance outlines FDA’s “certain enforcement policies” for “certain electronic nicotine delivery systems [ENDS] and oral nicotine pouch products that lack premarket authorization.”
The framing matters
FDA is again formally stating that “all new tobacco products,” including nicotine pouches and vapes, on the market without authorization are illegally marketed. This time, however, the agency seems to be signaling a more structured enforcement approach as it seeks to move the market away from illicit goods and toward products with marketing granted orders (MGO). The agency stated that the guidance is intended “to promote transparency” and to help it allocate enforcement resources by focusing regulatory oversight on products more likely to meet the agency’s “appropriate for the protection of the public health (APPH)” standard.
For manufacturers, retailers, and distributors, that is the most important sentence. FDA is not saying unauthorized products are legal. It is saying its enforcement priorities are being organized around whether a product submitted a PMTA that is accepted and filed, and the likelihood it would gain marketing orders.
Laura Leigh Oyler, vice president of regulatory affairs for Haypp Group, said that for four years, nicotine pouch manufacturers, suppliers, and retailers have been patiently waiting for authorization decisions, and this guidance finally allows them to stop operating in a grey area of regulation.
“For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything they have explicitly listed they expect to see, wait 180 days, get an acceptance and filing confirmation, and then you can launch your product in the market,” she said. “This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”
The enforcement guidance suggests that FDA, through the Department of Justice and the Drug Enforcement Administration, will begin taking tougher action against products on the market that lack an accepted and filed PMTA application.
“FDA does not intend to prioritize if a product has a pending application that has been accepted and filed, or when a manufacturer has a pending and accepted supplemental PMTA,” the agency wrote, adding that all products will still be subject to marketing restrictions and must not have “presumptively underage-appealing elements such as depicting a cartoon-like fictional character; disguising its nature as a vaping product; or resembling a children’s toy, phone, or gaming platform.”
FDA would also consider whether a tobacco product poses a significant public health or safety concern that exceeds the level generally associated with authorized e-cigarettes, nicotine pouches, or other tobacco products, including those with higher nicotine content, lacking child-resistant packaging, causing adverse health effects, or posing a fire hazard, according to Azim Chowdhury, a partner with the law firm of Keller & Heckman.
“For foreign manufacturers, that means US compliance is no longer only a question of whether a distributor or retailer may be targeted,” said Chowdhury. “FDA is increasingly looking upstream at the product, the application status, the importer, and the manufacturer.” To promote transparency for consumers and retailers, FDA will maintain a publicly available list of products that identifies manufacturers and their products that FDA does not intend to prioritize for enforcement. The agency said it expects the approach to encourage companies to file PMTAs for lower-risk products and to bring those products to market more quickly.
The notice also confirms that the guidance is immediately in effect, even though it remains open to public comment. FDA said it is implementing the guidance without prior public comment because prior participation was “not feasible or appropriate.” Agustin E. Rodriguez, a partner with the law firm of Troutman Pepper Locke, told Tobacco Asia that the guidance greatly increases the incentives to submit (or improve) a PMTA. “Only products with applications that have cleared the acceptance and filing review qualify for enforcement forbearance,” he said. “This gives manufacturers a concrete reason to invest in application quality.
“And for nontobacco-flavored ENDS, there is an additional condition: the application must include data sufficient for FDA to evaluate whether the product is appropriate for protection of the public health. This would appear to raise the bar for that product category and prompt manufacturers to invest in consumer perception, cessation, and population-level health studies.”
There is even more motivation for companies to submit an application. Sometimes it took years for a company to receive an acceptance letter after submitting a PMTA; however, those long waits may be over. In a May statement, Bret Koplow, then-acting director of the Center for Tobacco Products (CTP), said there is no longer a backlog of applications awaiting acceptance for review. “For the first time in years, a PMTA will, upon receipt, almost immediately enter the first phase of Application Review,” he said. “The days when applicants might wait months or even years to learn if their application was complete enough to be accepted for further evaluation are behind us.”
CTP is also adopting new efficiencies for the second phase of review, in which FDA determines if an application contains sufficient information to enable substantive scientific review. The agency may now issue an MGO for a product’s tobacco flavor, while a flavored or higher-nicotine-strength product of the same brand undergoes a more rigorous review. “Over the past year, we have realized efficiencies in filing reviews for nicotine pouch products and electronic nicotine delivery systems,” Koplow said. “Upon review, if there are products included in a submission that can receive marketing granted orders while others require additional information, these are being reviewed separately where appropriate.”
Rodriguez stressed that while enforcement discretion is a step forward, questions remain. The big one: what will US states do? “We know that certain states and localities act in ways that are more prohibitionist and do not align with FDA’s present view on promoting harm reduction via selective enforcement,” he said. “Will states choose to use the underlying non-authorized nature of these deprioritized products as a way to try to keep them off the market, even as cigarettes continue to be lawfully sold in their jurisdictions?”
While the new enforcement policy outlines how FDA intends to prioritize unauthorized products already on the market, the agency also moved to strengthen oversight of the companies that manufacture them—particularly those located outside the United States.
FDA targets foreign tobacco product manufacturers
FDA has also proposed a rule that, for the first time, would require foreign tobacco product manufacturers to register their facilities and list their products with the agency. The move aims to strengthen oversight of imported tobacco products and help curb the flow of unauthorized vaping products and nicotine pouches into the United States.
If finalized, the rule would subject foreign manufacturers to many of the same FDA registration and product listing requirements that already apply to domestic tobacco companies, closing what the agency describes as a longstanding regulatory gap.
“All companies selling tobacco products in the United States should play by the same rules,” said Bret Koplow, CTP director. “The FDA is working hard to close the gap between domestic and foreign companies, level the playing field for American businesses, and ensure that all manufacturers are held to the same standards.”
It’s not the first time FDA has proposed rules for foreign manufacturers. In March 2023, FDA proposed the “Tobacco Product Manufacturing Practice (TPMP)” requirements. Those rules focus entirely on how tobacco products are made—dictating manufacturing quality control, contamination prevention, and design standards—and are still in the rulemaking process.
The newly proposed rule, “Establishment Registration and Product Listing for Tobacco Products,” would require domestic and foreign establishments that “manufacture, prepare, compound, or process” tobacco and nicotine products intended for the US market to register with FDA and submit detailed product listings.
For the first time, the proposal would establish several new compliance requirements for foreign manufacturers. Attorneys Bryan Haynes, Agustin Rodriguez, and Zie Alere of the law firm Troutman Pepper Locke noted in an analysis of the proposal that foreign manufacturers would be required not only to register their establishments before offering products for import into the United States, but also to designate a US-based agent and agree to permit FDA inspections of their overseas facilities as a condition of registration.
Haynes and his colleagues stated that the proposed product listing requirements exceed FDA’s current guidance for domestic manufacturers. In addition to identifying each product, manufacturers would be required to report the nicotine source and concentration, characterize flavors, and, for electronic nicotine delivery systems (ENDS), provide technical specifications such as e-liquid volume, propylene glycol/vegetable glycerin ratios, wattage, and battery capacity.
“By linking each listed product to its submission tracking number (STN), FDA can cross-reference product listings against its database of pre-market submissions to identify products on the market without authorization,” the attorneys stated. The proposal follows a series of high-profile enforcement actions against unauthorized disposable e-cigarettes manufactured overseas, including record seizures at US ports and increased collaboration between FDA and Customs and Border Protection. The agency has repeatedly identified foreign manufacturers—particularly those supplying unauthorized disposable products—as a major enforcement priority.
“The proactive establishment registration, systematic inspections, and product surveillance included in this proposed regulation would give the FDA significantly more tools to identify and act against illegal foreign tobacco products,” the agency said.
The proposed rule could enhance FDA’s ability to monitor imports and enforce regulations governing the importation of tobacco and nicotine products, according to Keller & Heckman’s Azim Chowdhury. “Today, FDA often sees the product at the border or in the marketplace and then has to work backward,” he told Tobacco Asia. “A registration and listing system would allow FDA to link products to establishments, product identifiers, submission numbers, labeling, advertising, import channels, and potentially foreign inspections. That would make FDA more proactive rather than purely reactive.”
The proposed rule would not apply only to vaping products and nicotine pouches. If finalized, it would apply to domestic and foreign establishments that manufacture, prepare, compound, or process tobacco products subject to Chapter IX of the Food, Drug, and Cosmetics Act, including cigars and other tobacco products imported or offered for import into the United States, according to Chowdhury.
“The proposed rule would not, however, apply to ‘premium cigars’ that are currently outside Chapter IX as a result of the premium-cigar litigation, provided they meet the applicable court-defined criteria,” he explained. “That treatment could change through further litigation or future FDA rulemaking. Foreign manufacturers of non-premium cigars, including many flavored, machine-made, and filtered cigars, as well as foreign pipe tobacco and pipe manufacturers, would generally be required to register and list products if those products are imported or offered for import into the United States.”
In 2023, the Premium Cigar Association (PCA) objected to the proposed TPMP rule. The newly proposed rule contains provisions that, like those in the 2023 proposed rule, would have burdensome impacts on small businesses, and PCA has similar concerns, according to the group’s c.e.o., Joshua Habursky.
“Our stance on this proposed rule is consistent with all of our previous filings that pushed back against overregulation of the makers and sellers of premium tobacco products,” Habursky stated in a release. “Registration and inspection are usually the opening salvo of more regulations to come. When Big Tobacco and anti-tobacco groups alike are celebrating an FDA proposed rule, you know there is a big problem for the overall marketplace.”
The rule would also require manufacturers, both large and small, to maintain records of labeling, advertising, and consumer information for at least four years. Manufacturers would also need to review facility registrations annually and update product listings twice a year.
The Troutman attorneys emphasized that establishment registration should not be confused with FDA marketing authorization. “Registration and product listing do not constitute marketing authorization; products subject to the premarket review requirements remain unauthorized unless and until a marketing authorization is in effect,” the Troutman team wrote.
The proposed rule is open for public comment through September 14, after which FDA will review submissions before determining whether to issue a final regulation.
As FDA increases pressure on manufacturers operating outside the regulatory framework, it is also demonstrating the potential benefits available to companies that successfully navigate the agency’s scientific review process.
FDA grants Zyn ‘modified risk’ marketing orders
After years of evaluating the scientific evidence on nicotine pouches, FDA has authorized the first modified-risk marketing claims for the category, marking what many observers consider an important milestone for tobacco harm reduction. The agency granted modified-risk tobacco product (MRTP) orders for 20 Zyn nicotine pouch products, authorizing Zyn nicotine pouches to be marketed with claims that switching completely from cigarettes reduces the risk of major smoking-related diseases. The decision allows Swedish Match USA Inc., a subsidiary of Philip Morris International (PMI), to market the authorized products with the following FDA-approved statement:
“Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” Stacey Kennedy, PMI US c.e.o., said FDA’s decision marks an important moment for the more than 45 million legal-age nicotine consumers in America.
“Today’s news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to Zyn reduces the risk of smoking-related diseases like heart disease and lung cancer,” Kennedy said. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the continuum of risk and communicating those findings transparently.”
The products previously received marketing authorization following a review of their PMTA applications in January 2025. The new MRTP orders go a step further by allowing Swedish Match to communicate the products’ reduced-risk profile to adult smokers, following FDA’s review of scientific evidence supporting the claim.
“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” said CTP’s Bret Koplow. The modified risk orders cover many Zyn products, each authorized in both 3 mg and 6 mg nicotine strengths.
In reaching its decision, FDA said it reviewed Swedish Match’s MRTP applications, scientific evidence on the products’ relative health risks, consumer perception studies, youth-use data, public comments, and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC), which met on January 22, 2026.
The agency concluded that Swedish Match demonstrated:
- The modified risk claim is scientifically accurate for the authorized products;
- Adult consumers understand the claim;
- Marketing the products with the claim is expected to benefit the health of the population as a whole.
FDA emphasized that modified risk orders apply only to the specific authorized products – not to nicotine pouches as a categorya – and that the MRTP order does not mean the products are safe. The agency also reiterated that completely quitting all tobacco products remains the best option for smokers. However, adults who completely switch from cigarettes to the authorized nicotine pouches “may reduce exposure to many harmful chemicals” present in combustible cigarettes.
“FDA has given Zyn the ability to tell their customers, and consumers at large, that their products have markedly lower risk than cigarettes,” said Laura Leigh Oyler, regulatory affairs vice president for Haypp Group and its subsidiary Nicokick.com. “While this is not the first MRTP ever granted, it is the first one given to a product with mass consumer appeal.
“At a time when misconceptions about the risk of nicotine are high, the ability to communicate this is monumental not just for the alternative nicotine industry, but for policy makers, public health leaders, and responsible retailers who can shift the conversation from fear-based, while keeping youth prevention front and center.
“Americans can finally hear the truth about lower-risk nicotine pouches.” The agency also retains authority to withdraw the orders if continued marketing no longer benefits public health, including if youth uptake increases significantly. “Being able to use a modified risk claim is a meaningful milestone for tobacco harm reduction,” said Shem Baldeosingh, director of the Global Institute for Novel Nicotine (GINN). “It signals growing recognition that non-combustible nicotine pouches, when appropriately regulated, can help reduce the burden of smoking-related disease.
“Significantly, the FDA’s post-market surveillance requirements will strengthen the evidence base even further — generating real world insights into usage patterns, behavior, and public health impact. This is a clear example of science-based, proportionate regulation in practice.”
FDA has authorized 26 nicotine pouch products for sale in the United States. The Zyn MRTP orders also establish the first FDA-authorized reduced risk messaging for nicotine pouches, potentially providing a regulatory framework for future MRTP applications by other manufacturers.
“This decision proves that a light-touch, evidence-based approach delivers for consumers,” said David Williams, president of the Taxpayers Protection Alliance. “The FDA’s authorization of Zyn products with an MRTP claim shows that policymakers can embrace harm reduction without resorting to bans or heavy-handed mandates.
“Consumers deserve accurate information about less harmful alternatives to cigarettes. And adults deserve the freedom to choose less harmful alternatives without Washington bureaucrats second-guessing their decisions.”
Martin Miller, e.v.p. of business development at IKE Tech, said the decision also underscores that product and regulatory innovation must advance together.
“FDA continues to place significant emphasis on youth access prevention and ongoing post-market oversight, reinforcing that compliance doesn’t end at authorization or at the point of sale,” said Miller. “As more products enter the market, the industry will need infrastructure that connects verified users, authenticated products and enforceable compliance throughout the product lifecycle.”
A clearer regulatory direction
One thing has become increasingly clear through the first half of 2026. Rather than relying primarily on enforcement after products enter the marketplace, FDA is working to establish a more structured regulatory framework—one that encourages manufacturers to follow the legal pathway, demands greater accountability from companies supplying the US market, and rewards those that can demonstrate their products meet the agency’s public health standard.
Whether that approach ultimately reduces the number of unauthorized products on the market remains to be seen. The foreign manufacturer registration rules would be burdensome for small manufacturers, and FDA has authorized only one vaping product brand from a company not affiliated with a major tobacco company. The enforcement guidelines may encourage companies that want to remain in the US market to submit more complete, better-supported PMTA rather than relying on a “market first, deal with FDA later” strategy. However, PMTAs remain costly and burdensome, especially for small manufacturers.
At the very least, FDA’s recent actions provide the industry with greater regulatory clarity. For companies worldwide—particularly in Asia—that manufacture nicotine products destined for the United States, understanding the agency’s evolving regulatory framework may soon be as important as understanding the products themselves.