By Timothy S. Donahue

Top Takeaways:

• Enforcement shift: FDA finalizes enforcement guidance for certain unauthorized ENDS and nicotine pouches
• Regulated-market push: Agency says the approach is meant to support “an orderly shift” toward compliant products
• Immediate effect: Guidance is already in effect, though Federal Register publication is scheduled for May 12

The U.S. Food and Drug Administration is shaping new policy around one of the nicotine industry’s biggest unresolved questions: what is going to happen to unauthorized ENDS and nicotine pouch products still on the market that have not submitted a premarket tobacco product application (PMTA)?

In an unpublished Federal Register notice scheduled for official publication May 12, the regulatory agency announced the availability of final guidance titled “Enforcement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 do not have premarket authorization.”

The framing matters.

FDA is again formally stating that “new tobacco products may not legally be marketed without premarket authorization,” and that “all new tobacco products, including those that are ENDS and nicotine pouch products, on the market without authorization are illegally marketed products.”

The agency seems to be signaling a more structured enforcement approach as it seeks to move the market away from illegal products and toward products with marketing granted orders (MGOs).

FDA said the guidance is intended “to promote transparency” and help the agency “efficiently allocating enforcement resources by focusing regulatory oversight on products that are more likely to meet the applicable public health standard.”

For manufacturers, retailers, and distributors, that is the most important sentence in the document. FDA is not saying unauthorized products are legal. It is saying its enforcement priorities are being organized around the likelihood that certain products can meet the public health standard and move toward compliance.

Laura Leigh Oyler, vice president of regulatory affairs for Haypp Group, said that for four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability 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 the FDA, through the Department of Justice and the Drug Enforcement Administration, will begin taking harsher action against products on the market that lack at least a pending 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, and if FDA has determined the application includes data necessary to evaluate whether the product is appropriate for the protection of public health in the case of non-tobacco flavored ENDS products,” the agency wrote in a release. “FDA does not intend to prioritize enforcement against products falling within the categories set forth above, unless they have certain 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.”

The FDA would also consider whether a tobacco product poses a significant public health or safety concern that exceeds the level generally associated with e-cigarette or nicotine pouch products or other tobacco products, such as a product that: 

• Has high nicotine content 
• Has serious adverse experiences or a larger number of unexpected associated adverse experiences compared with authorized e-cigarettes or nicotine pouch products 
• Lacks child-resistant packaging (CRP) in accordance with Child Nicotine Poisoning Prevention Act of 2015
• Is a potential fire hazard

To promote transparency for consumers and retailers, FDA will also create and maintain a publicly available list of products that identifies manufacturers and their products that FDA does not intend to prioritize for enforcement under this policy.

The policy recommends those manufacturers whose products are marketed under this policy and who wish to be listed on this publicly available webpage should reach out to the regulatory health project manager (RHPM) for their pending application or may wish to contact CTP_enforcementpriorities@fda.hhs.gov.

Manufacturers using the email address will receive an automated reply and can expect more details regarding the webpage soon.

The agency said it expects the approach to “encourage the development of applications for potentially less harmful tobacco products” and “support more timely evaluation and marketing authorization decisions for products that may benefit public health.”

The notice also confirms that the guidance is immediately in effect, even though it remains open to public comment under FDA’s good guidance practices regulation. FDA said it is implementing the guidance without prior public comment because prior participation was “not feasible or appropriate.”

That is another important procedural point for the industry.

The agency said the guidance “represents the current thinking of FDA,” but also emphasized that it “does not establish any rights for any person and is not binding on FDA or the public.” Companies may use “an alternative approach” if it complies with applicable statutes and regulations.

The docket number is FDA-2026-D-5083. Comments may be submitted at any time, either electronically via Regulations.gov or in writing to FDA’s Dockets Management Staff.

The announcement also refers to the legal foundation of FDA’s authority under Section 910 of the FD&C Act, which defines a “new tobacco product” as any tobacco product not commercially marketed in the United States as of Feb. 15, 2007, or any post-2007 modification involving design, components, parts, constituents, nicotine content, delivery, form, or additives.

The FDA has recently authorized additional nicotine pouch and ENDS products while facing pressure from Congress, industry, and public health groups over the scale of unauthorized flavored disposables and other illegal products still on the market.

This updated/new notice suggests the agency is trying to draw a clearer line between unauthorized products that are simply illegal and those that may be moving toward a more evidence-based, regulated path.

In a statement on May 7, Bret Koplow, acting director of the Center for Tobacco Products (CTP), said that there is no longer a queue for applications pending Acceptance 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.

“Over the past year, we have realized efficiencies in filing reviews for nicotine pouch products and electronic nicotine delivery systems (ENDS),” Koplow said. “Upon review, if there are products included in a submission that can receive marketing granted orders (MGOs) while others require additional information, these are being reviewed separately where appropriate.

“By doing so, products being issued a marketing granted order may be made available to consumers sooner rather than past practice where entire submissions moved together. “