FDA Authorization Comes First
The starting point is federal law. The Tobacco Control Act generally prohibits the marketing of a new tobacco product without FDA authorization. Congress also extended FDA’s tobacco-product jurisdiction in 2022 to products containing nicotine from any source, including synthetic nicotine.
For most new nicotine products, therefore, the threshold question is:
Does the specific product have a marketing granted order (MGO), or otherwise qualify for lawful marketing under an applicable statutory pathway?
A pending Premarket Tobacco Product Application (PMTA) is not the same as an MGO. Nor does FDA’s acceptance or filing of a PMTA authorize the product for sale. That distinction applies across product categories. FDA has authorized 26 nicotine pouch products, for example, but those orders apply only to the specific products FDA reviewed; they do not authorize nicotine pouches generally. Similarly, FDA’s May 2026 authorization of four Glas ENDS products applied only to those products. FDA described that action as its first authorization of non-tobacco and non-menthol flavored ENDS products. The relevant regulatory unit is therefore the product, not the category.
The PMTA process is likewise product-specific. Under the statutory “appropriate for the protection of the public health” (APPH) standard, FDA must consider the risks and benefits of that individual product to the population as a whole, including the likelihood that existing tobacco users will stop using tobacco products and that nonusers, particularly youth, will begin.
That makes the precise status of an application important. Companies should not rely on shorthand descriptions such as “we have a PMTA” or “FDA accepted our application” without determining what FDA has actually done with the specific product. Acceptance or filing means that the application has passed a threshold stage of FDA’s review; it does not mean that FDA has determined the product is appropriate for the protection of the public health or authorized its marketing.
An Unauthorized Product May Still Be Subject to FDA Enforcement Discretion
On May 8, FDA issued its Guidance for Industry, “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.”[1] The Guidance describes FDA’s current enforcement policies for certain ENDS and oral nicotine pouch products that have not yet received an MGO. It is not a blanket enforcement discretion policy, but it materially changes the practical risk analysis for products that fall within its scope.
For products within the Guidance, FDA generally does not intend to prioritize the enforcement of the PMTA requirement when specified conditions are met. Among other things, the policy focuses on whether pending PMTAs have been accepted and filed and, for certain flavored ENDS products, whether FDA has determined that the application contains the data necessary to evaluate whether the product is APPH. “PMTA pending” alone is therefore not the test.
The Guidance also identifies circumstances that can remove a product from the enforcement policy. These include certain presumptively underage-appealing product characteristics such as:
- cartoon-like fictional characters;
- designs that disguise a vaping product’s nature;
- products resembling children’s toys; and
- products resembling phones or gaming platforms.
FDA likewise reserves enforcement priority for products presenting a significant public health or safety concern greater than that generally presented by ENDS or nicotine pouch products, including products with high nicotine content, serious or unusually numerous unexpected adverse experiences, inadequate child-resistant packaging, or potential fire hazards.
These specifics are particularly important because a company seeking to rely on the May policy needs to consider not only the procedural status of its PMTA, but also the product’s design, packaging, branding, marketing, nicotine content, and safety profile.
It is also critical to understand that an enforcement posture is not the same as an authorization. The Guidance represents FDA’s current approach to prioritizing enforcement against certain unauthorized products. FDA continues to state that a new nicotine product must have FDA authorization before it can legally be marketed and that the pendency of an application does not itself create a legal safe harbor.
For a company relying on enforcement discretion, that distinction matters because FDA can change its enforcement priorities or a product can cease to satisfy the policy’s conditions. The May Guidance therefore creates a potentially important regulatory operating position, but not a permanent legal status.
FDA Continues to Enforce Against Certain Unauthorized Products
The distinction between enforcement discretion and authorization is not merely theoretical. FDA has continued to take enforcement action against unauthorized products, including products that present the kinds of youth-appeal and safety concerns identified in the May Guidance.
On May 20, 2026, FDA announced warning letters to eight retailers selling unauthorized tobacco products[2], including nicotine pouches and dissolvable tobacco products, that used labeling, advertising, or design features that caused them to resemble candy, breath strips, and cough drops. FDA stated that continued violations could result in additional actions, including injunctions, seizure, and civil money penalties.
FDA has also continued to describe enforcement against manufacturers, distributors, and retailers selling unauthorized nicotine products. FDA’s current enforcement materials state that unauthorized ENDS products remain among the agency’s enforcement priorities and that products without authorization generally remain at risk of enforcement action.
Those actions demonstrate why companies should not treat the May Guidance as a general permission to market products without authorization. The relevant question is whether the specific product and the company’s conduct fall within the policy’s stated enforcement priorities.
For distributors and retailers in particular, this distinction matters. A company should not assume that a manufacturer’s representation that a product has a pending PMTA – or even that the manufacturer believes the product falls within FDA’s enforcement policy – eliminates the need to assess the product’s regulatory status and the company’s own federal and state law obligations.
The Enforcement Policy is Now Being Challenged
The May Guidance is also the subject of newly filed federal litigation. On July 14, 2026, the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Heart Association, American Lung Association and others filed suit against FDA in the U.S. District Court for the District of Maryland.[3] The plaintiffs allege that the Guidance unlawfully permits certain unauthorized e-cigarette and nicotine pouch products to be marketed without the scientific review and marketing authorization required by federal law.
The plaintiffs also challenge the agency’s decision-making process and allege that FDA’s policy is arbitrary and capricious and exceeds the agency’s statutory authority. The lawsuit seeks to invalidate the Guidance.
The lawsuit does not, by itself, establish that the Guidance is invalid or prevent companies from relying on it. But it adds another layer of uncertainty to a regulatory position that is already distinct from an FDA authorization. Companies relying on the Guidance should therefore monitor the litigation and consider the possibility that the policy could be modified, enjoined, or invalidated.
FDA’s 2026 draft Guidance on Flavored ENDS
FDA’s March 2026 draft guidance[4] provides additional insight into the agency’s current approach in evaluating flavored nicotine product PMTAs. The draft, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” addresses FDA’s current thinking about the risk to youth from flavored e-cigarettes and the added benefit to adults needed to outweigh that risk.
The draft guidance addresses, among other things, the role of e-cigarettes in youth use and initiation; a risk-proportionate approach to evaluating applications; evidence needed to demonstrate sufficient benefit for adults who smoke in switching behavior or significantly reducing cigarette use; potential approaches to assessing youth initiation and use; and novel device-access restriction technology.
The draft guidance is significant because it places the comparative benefit analysis into a broader evidentiary framework. FDA’s approach focuses on the risk that flavored ENDS pose to youth and the evidence needed to demonstrate that a particular flavored product provides sufficient benefits to adults who smoke to satisfy the APPH standard.
For companies developing flavored or other differentiated nicotine products, that means the regulatory strategy should begin well before the PMTA is submitted. The question is not simply whether the product can be described as safer or preferable to cigarettes. The question is what evidence will allow FDA to conclude that marketing this product, with these characteristics, will benefit the population as a whole.
Recent PMTA Litigation Shows How High the Bar Can Be
FDA’s approach to flavored nicotine product PMTAs is not new. Recent litigation involving flavored ENDS provides the clearest illustration of what FDA is demanding in PMTA review and the limits the courts are beginning to place on how the agency may impose those requirements.
In VDX Distro, Inc. v. FDA[5], decided June 24, 2026, the Fifth Circuit upheld FDA’s denial of applications for flavored ENDS. FDA had applied a comparative efficacy approach, requiring evidence that the flavored products provided an additional benefit to adult smokers sufficient to justify the additional youth risk associated with non-tobacco flavors. The Fifth Circuit rejected the argument that FDA had effectively created a new “tobacco product standard” without notice-and-comment rulemaking. Instead, the court treated the comparative efficacy approach as a methodology FDA could use in applying the statutory APPH standard to individual PMTA applications. The court did not, however, resolve the separate question whether the Administrative Procedure Act independently required notice-and-comment rulemaking – a question that would become central in subsequent litigation.
That question soon came to the foreign Vertigo Vapor, LLC v. FDA[6]. On August 19, 2026, the Fifth Circuit held that FDA’s comparative efficacy standard was a substantive rule requiring notice-and-comment rulemaking under the APA. The court concluded that FDA had used informal adjudication to establish a generally applicable standard that bound the agency and applied prospectively to an unbounded class of PMTA applicants. The court vacated the challenged marketing denial orders and remanded the cases to FDA. Importantly, the decision did not hold that FDA may never consider comparative evidence in reviewing flavored ENDS PMTAs; rather, it held that FDA could not establish the binding comparative efficacy standard through the process it used.
The Ninth Circuit reached the same bottom-line result on the PMTA denials in in Drip More LLC v. FDA[7], but its reasoning on notice-and-comment now stands in direct tension with Vertigo Vapor. Drip More, decided August 10, 2026, involved 64 candy-and fruit-flavored e-liquids. FDA denied the applications because Drip More had not provided robust and reliable evidence demonstrating a benefit to adult smokers from its flavored products compared to tobacco-flavored ENDS. FDA explained that, given the known youth risks associated with flavored ENDS, it needed evidence showing the magnitude of the potential benefit to adult smokers. Drip More argued that FDA should have considered other evidence, including its marketing plan, contractual restrictions on distributors and retailers, sales data, and National Youth Tobacco Survey information. Among other things, Drip More pointed to the absence of identified youth use of its products. The Ninth Circuit rejected the challenge. It concluded that Drip More had not provided evidence or an explanation distinguishing the youth risk posed by its flavored ENDS from the broader risks associated with ENDS. The court also held that FDA was not required to consider Drip More’s proposed marketing and access restrictions before addressing the missing comparative efficacy evidence.
The Ninth Circuit further held that FDA did not have to engage in notice-and-comment rulemaking before applying the comparative efficacy requirement. Relying on its prior decision in Lotus Vaping Technologies, LLC v. FDA[8] and the Supreme Court’s 2025 decision in FDA v. Wages & White Lion Investments, LLC[9], the Ninth Circuit held that FDA could apply the requirement through PMTA adjudication. That decision now stands in significant tension with Vertigo Vapor.
The broader lesson is more important than the particular products at issue: A PMTA is not merely a filing that puts a product in line for FDA review. The evidence submitted with the application can determine whether the product receives authorization at all. Drip More demonstrates that courts may give FDA substantial latitude in deciding what evidence is necessary to make an APPH determination. But Vertigo Vapor adds an important qualification: FDA’s discretion in evaluating individual applications does not necessarily give the agency authority to establish generally-applicable substantive requirements through adjudication without notice-and-comment rulemaking.
Even if FDA Does Not Prioritize Enforcement, Can the Product Actually Be Sold?
For most companies, this is the question that matters most.
FDA’s federal enforcement posture does not necessarily determine whether a product may be sold in a particular state or locality. A product can be unauthorized under federal law, fall within FDA’s current enforcement priority policy, and still be subject to a state law that prohibits its sale. For example:
State Directory Laws
Recent litigation over state nicotine directory laws illustrates this point. In Wisconsinites for Alternatives to Smoking & Tobacco v. Casey[10], decided on April 21, 2026, the Seventh Circuit affirmed the denial of a preliminary injunction against Wisconsin’s directory law.
The statute generally permits the sale of ENDS only if the product has FDA authorization, satisfies specified PMTA-related criteria, or falls within a statutory exception. The Seventh Circuit held that federal tobacco law did not preempt Wisconsin’s authority to regulate or prohibit the sale of tobacco products.
The Fourth Circuit reached a similar result in Vapor Technology Association v. Wooten[11], decided July 30, 2026, affirming the denial of preliminary relief against North Carolina’s directory regime. The court held that federal tobacco law did not preempt North Carolina’s law, emphasizing the Tobacco Control Act’s preservation of state authority over the sale of tobacco products.
On the same day, the Eighth Circuit likewise recently rejected a preemption challenge to Iowa’s directory law in Iowans for Alternatives to Smoking & Tobacco, Inc. v. Mosiman[12], vacating a preliminary injunction that had blocked enforcement of the law. The court held that federal tobacco laws did not preempt Iowa’s requirements.
Virginia, however, presents a significant counterexample. In NOVA Distro, Inc. v. Miyares[13], the Eastern District of Virginia found portions of Virginia’s directory regime impliedly preempted. Virginia’s law requires products to be listed on an Attorney General-maintained directory, with eligibility tied in significant part to FDA premarket authorization or the status of a pending FDA application. The court held that provisions conditioning lawful market access and imposing penalties based directly on FDA premarket authorization determinations impermissibly intruded on the federal government’s exclusive authority to enforce the FDCA. At the same time, the court upheld other provisions of the law that it viewed as independent state regulation of tobacco sales, including certification, reporting, recordkeeping, and inspection requirements. The court enjoined enforcement of the preempted provisions, and the litigation is now proceeding in the Fourth Circuit.
The practical takeaway is not that every state may impose the same requirements. It is that federal authorization or enforcement discretion status does not necessarily mean market access in every state. And the Virginia litigation shows that the line between permissible state regulation of tobacco sales and impermissible state enforcement of federal premarket requirements may be consequential – and remains unsettled.
State and Local Flavor Restrictions
Directory laws are not the only obstacle. Some states and localities impose independent restrictions on flavored nicotine products, regardless of whether FDA has authorized the product or chosen to prioritize federal enforcement.
California provides a particularly useful example. The state generally prohibits the retail sale of flavored tobacco products and defines “characterizing flavor” broadly, including fruit, candy, dessert, menthol, mint, wintergreen, and cooling sensations. California’s treatment of nicotine pouches illustrated why federal authorization and actual market access must be analyzed separately when a state applies its flavor restrictions to particular pouch products.
What Nicotine Companies Should Do Now
For companies with nicotine products currently on the market or under development, the analysis should begin with the individual product.
At a minimum, companies should ask:
- What is the product’s federal status?
- Is it authorized?
- Is a PMTA pending?Has it been accepted and filed?Has FDA issued an RTA, RTF, MDO, or other adverse action?
- What has FDA actually determined with regard to the specific product?
- Is it authorized?
- If it is unauthorized, does the FDA enforcement policy actually cover it?
- For ENDS and nicotine pouches, that requires a careful analysis of the May 2026 Guidance. A pending PMTA is not enough.
- Does the product raise youth appeal or safety concerns?
- Companies relying on the May Guidance should examine product design, packaging, branding, marketing, nicotine content, child resistant packaging, and other characteristics identified by FDA.
- Does the PMTA contain the evidence FDA is likely to require?
- VDX Distro and Drip More demonstrate the importance of developing a product-specific evidentiary record, particularly weighing adult benefits against youth risks, rather than assuming that general evidence about nicotine products or adult smokers will carry the application.
- Who in the supply chain bears the regulatory risk?
- Manufacturers, importers, distributors, and retailers should not assume that a manufacturer’s PMTA status or claimed reliance on FDA enforcement discretion eliminates their own federal or state law exposure.
- Can each product actually be sold in each intended jurisdiction?
- That requires a separate state and local analysis. Directory requirements, flavor restrictions, licensing rules, and other sales restrictions may apply even when FDA is not prioritizing enforcement.
- What is the company’s contingency plan if FDA changes its enforcement posture?
- A company relying on enforcement discretion should understand what happens if FDA changes its policy, takes enforcement action, issues an adverse PMTA decision, or a state changes its sales requirements.
These questions are particularly important when a company is considering a product launch, entering into a distribution agreement, acquiring a nicotine business, or determining whether an existing product line can remain on the market. They also matter in transactions. A product line with substantial sales may appear commercially attractive while due diligence would reveal that its federal authorization status, FDA enforcement posture, and state-by-state market access tell a very different story about its regulatory risk.
Conclusion
For nicotine companies, regulatory risk cannot be assessed by looking at FDA authorization alone – or at FDA’s current enforcement priorities in isolation. The relevant analysis is product-specific and must account for the product’s federal status, the evidence supporting its PMTA, any applicable FDA enforcement policy, the stability of that enforcement position, and the laws governing sales in each intended jurisdiction. That analysis is particularly important when launching, distributing, acquiring, or continuing to sell a nicotine product. A product that is commercially successful may nevertheless carry significant regulatory risk if its federal status or state-by-state market access has not been carefully evaluated.
[2] https://www.fda.gov/news-events/press-announcements/fda-warns-retailers-selling-illegal-tobacco-products-look-everyday-products
[3] Campaign for Tobacco-Free Kids v. Food and Drug Administration, No. 8:26-cv-02767 (D.Md.) https://www.publichealthlawcenter.org/sites/default/files/case/CTFK-v-FDA-complaint.pdf
[5] VDX Distro, Inc. v. FDA, No.24-60537 (5th Cir. June 24, 2026). https://www.ca5.uscourts.gov/opinions/pub/24/24-60537-CV0.pdf
[6] Vertigo Vapor, L.L.C. v. FDA, No 24-60332 (5th Cir. Aug. 19, 2026). https://www.ca5.uscourts.gov/opinions/pub/25/25-60369-CV0.pdf
[7] Drip More LLC v. FDA, No 21-71380 (9th Cir. Aug. 10, 2026). https://caselaw.findlaw.com/court/us-9th-circuit/310740.html
[8] Lotus Vaping Technologies, LLC v. FDA, 73 F.4th 657 (9th Cir. 2023). https://caselaw.findlaw.com/court/us-9th-circuit/310740.html
[9] FDA v. Wages & White Lion Investments, LLC, 604 U.S. 542 (2025). https://caselaw.findlaw.com/court/us-9th-circuit/310740.html
[10] Wisconsinites for Alternatives to Smoking & Tobacco, Inc. v. Casey, 172 F.4th 976 (7th Cir. 2026). https://law.justia.com/cases/federal/appellate-courts/ca7/25-2565/25-2565-2026-04-21.html
[11] Vapor Technology Association v. Wooten, No. 25-1745 (4th Cir. July 30, 2026). https://www.ca4.uscourts.gov/opinions/251745.P.pdf
[12] Iowans for Alternatives to Smoking & Tobacco, Inc. v. Mosiman, No. 25-2087 (8th Cir. July 30, 2026). https://ecf.ca8.uscourts.gov/opndir/26/07/252087P.pdf
[13] NOVA Distro, Inc. v. Miyares, No. 3:25-cv-857 (DJN) (E.D. Va. Dec. 18, 2025). https://law.justia.com/cases/federal/district-courts/virginia/vaedce/3:2025cv00857/583629/26
