Is Your Vape Legal to Sell in the U.S.? PMTA, STN, and the State Directories

Summary

Taken together — federal statute, the agency's position, appellate and Supreme Court authority, and state legislation — the great majority of vape products without an FDA Marketing Granted Order (MGO) cannot lawfully be sold in the United States. This report sets out the legal basis for that conclusion and dispels the two most common industry misconceptions: first, that filing a PMTA and holding an STN amounts to temporary compliance; second, that a product is not unlawfully sold so long as no MDO has issued. Neither proposition is sustainable in law.

The starting point for lawful sale is whether the product holds an FDA Marketing Granted Order — not whether an application was filed, and not whether a refusal was received.

I. Terms and Abbreviations

FDA (Food and Drug Administration) — the federal agency regulating food, drugs, devices, and tobacco products, with the Center for Tobacco Products (CTP) responsible for tobacco and vape regulation.

FDCA (Federal Food, Drug, and Cosmetic Act) — the foundational U.S. statute, amended in 2009 by the Family Smoking Prevention and Tobacco Control Act to bring tobacco products within FDA jurisdiction.

TCA (Family Smoking Prevention and Tobacco Control Act, 2009) — the statute authorizing FDA regulation of tobacco products and the legislative source of the PMTA regime.

ENDS (Electronic Nicotine Delivery Systems) — the FDA's regulatory term for vapes, e-liquids, and vapor products.

PMTA (Premarket Tobacco Product Application) — the application a new tobacco product must submit to the FDA before entering the U.S. market; the FDA then authorizes or denies.

STN (Submission Tracking Number) — the administrative number assigned when the FDA receives a PMTA. It is a receipt only and has no legal effect authorizing sale.

MGO (Marketing Granted Order) — the affirmative order the FDA issues after scientific review; the legal basis for lawful sale.

MDO (Marketing Denial Order) — the FDA's denial of a PMTA. Once issued, sale must stop immediately; continued sale carries administrative and civil liability.

RTA (Refuse to Accept) / RTF (Refuse to File) — decisions declining an application at intake or at initial review, meaning it never entered substantive scientific review.

APPH (Appropriate for the Protection of the Public Health) — the statutory standard for PMTA authorization.

CBP (U.S. Customs and Border Protection) — with authority to detain, re-export, and destroy imported vape products.

DOJ (U.S. Department of Justice) — may bring civil or criminal actions for FDCA violations.

AG (Attorney General) — federal and state; state AGs may sue unauthorized vape sellers under state consumer protection law.

UDAP (Unfair and Deceptive Acts and Practices) — the general term for state consumer protection statutes, the common basis for state AG actions.

DWPE (Detain Without Physical Examination) — enforcement under an FDA Import Alert: red-listed products are detained on entry without prior examination.

CAFC (U.S. Court of Appeals for the Federal Circuit) — with exclusive jurisdiction over patent appeals.

PACT Act (Prevent All Cigarette Trafficking Act) — amended in 2020 to cover vapes, restricting online sale, shipment, and tax collection.

II. The Statutory Basis: The Affirmative Authorization Regime of 21 U.S.C. § 387j

The starting point is 21 U.S.C. § 387j(a) (FDCA § 910), which provides that any "new tobacco product" — one marketed after February 15, 2007 — must, before entering interstate commerce, obtain an affirmative order from the FDA (an MGO) finding that its marketing is "appropriate for the protection of the public health." The FDA brought vapes wholly within that provision through the 2016 Deeming Rule.

The structure is one of affirmative authorization: the default is that sale is prohibited; authorization is the exception. In other words, the rule Congress legislated is:

Silence = prohibited. Not silence = permitted.

The statutory text contains no safe harbor providing that a product is lawful while an application is pending, or that the absence of a refusal constitutes authorization. That is the foundation of every conclusion in this report.

III. Legality by PMTA Status

As of May 11, 2026, the FDA had authorized only 45 ENDS products for lawful U.S. sale, and no Chinese-manufactured disposable flavored product holds an MGO. That factual state of affairs is the most direct basis for concluding that the great majority of Chinese vape exports cannot lawfully be sold in the United States.

IV. Dispelling Two Industry Misconceptions

(1) A pending PMTA plus an STN is not lawful sale

The industry commonly assumes that once a client has filed a PMTA and received an STN, it may treat the product as temporarily compliant and continue selling. That is unsustainable:

• an STN is a receipt, comparable to an acknowledgment of filing, and carries no legal effect authorizing sale;
• the FDA states expressly on its website (updated March 12, 2026) that a pending application is not a lawful safe harbor for selling a product;
• the statute requires an order. An STN is not an order, and the two are entirely different in legal character.

The misconception spread through the Chinese industry largely from the transitional enforcement forbearance the FDA applied around the 2020–2021 PMTA filing deadline. That period ended long ago and the FDA has repeatedly stated it will not continue — yet industry practice still treats "under review" as a basis for lawful sale.

(2) Not having received an MDO is not lawful sale

This is the most widespread and most misleading proposition. It fails on three levels.

1. A structural error: denial ≠ authorization

Section 387j establishes an affirmative authorization regime — sale requires the FDA to issue an affirmative order. "The FDA has not denied you" shows only that the FDA has not yet denied you. It cannot show that the FDA has approved you.

A simple analogy: customs never detained your shipment ≠ your shipment cleared customs. Under affirmative authorization, silence is not consent.

2. "No MDO" means entirely different things in different postures

The great majority of disposable flavored vapes exported from China fall into the first or second category — they never actually entered the FDA's review queue. They have "no MDO" not because the FDA tacitly permits their sale, but because the FDA has never seen them. Reading that as compliance fundamentally misstates the legal position.

3. Even in the third category, "no MDO" is only enforcement discretion

Even assuming a client's product is in the most favorable posture — an accepted-filed PMTA under review with no MDO — the product is still unlawfully sold as a statutory matter. The FDA has simply chosen not to prioritize enforcement. Enforcement discretion is policy, which the FDA may adjust at any time. It is not law, and not an inalienable right.

V. The Governing Case Law

The following decisions form the core of the current judicial position. Together they confirm the FDA's PMTA framework and foreclose the reasoning that a pending application, or the absence of a finding of illegality, equals lawful sale.

(1) FDA v. Wages & White Lion Investments, dba Triton Distribution, 604 U.S. 542 (2025)

The Supreme Court held 9–0 that the FDA's application of a "fatal flaw" standard in denying flavored vape PMTAs was not arbitrary and capricious. It is the most significant Supreme Court tobacco regulation decision since Loper Bright, and no Justice questioned the basic architecture of the PMTA framework. Triton effectively closed the principal litigation route for overturning the MDO regime through an APA "goalpost shifting" theory.

(2) Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022); cert. denied October 2023

The Fourth Circuit upheld the FDA's MDO for Avail's flavored vape PMTAs, holding that the agency's evaluative criteria did not exceed its TCA authority and that the denial was not arbitrary.

(3) Bidi Vapor LLC v. FDA, 47 F.4th 1191 (11th Cir. 2022); panel decision on rehearing, April 24, 2025

The Eleventh Circuit initially vacated Bidi's MDO on the ground that the FDA had not reviewed its marketing and sales-restriction plans. On remand, the panel unanimously denied Bidi's petition as to the MDO for its tobacco-flavored Bidi Classic disposable on April 24, 2025.

(4) VPR Brands, LP v. Shenzhen Weiboli Technology Co. Ltd., No. 23-1544 (Fed. Cir. Aug. 14, 2024) (nonprecedential)

This decision carries particular warning for Chinese exporters. The Federal Circuit vacated the district court's preliminary injunction and remanded, confirming that:

• the unlawful use doctrine may be raised as a defense to trademark infringement — a defendant may contend that the plaintiff's mark is unenforceable because its product violates the FDCA;
• a federal court may and should assess for itself whether a party has violated the FDCA, rather than leaving that determination to the FDA;
• a defendant raising the defense must meet a clear and convincing evidence standard and show a material nexus between the unlawful conduct and the trademark use.

The real significance: after VPR/Weiboli, an adversary in private litigation may ask a federal court to find that a client's product violates the FDCA without the FDA having acted first. "No one has found me unlawful" is no longer a stable defensive position in private litigation.

(5) Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024)

Loper Bright overruled Chevron deference, so federal courts no longer defer as a matter of course to an agency's reading of a statute. But it changed the degree of deference courts give an agency's interpretation; it did not rewrite the statute Congress enacted.

Read de novo, § 387j still means: no order, no sale. Loper Bright's practical effect on PMTA compliance is therefore limited — and it has been further diluted by Triton, decided after Loper Bright, in which the Court unanimously sustained the FDA.

VI. Parallel State Obligations

A federal MGO is necessary but not sufficient. Even where a product is lawful federally, the following state laws may independently bar its sale.

(1) State vapor product directories

These states require products to be listed on a state-maintained registry, with an MGO or proof of a timely-filed PMTA as the credential. Products not listed may not be sold at retail, with penalties typically accruing per day or per instance.

In effect as of May 2026: Alabama, Florida, Louisiana, Oklahoma, Kentucky, Wisconsin (early legislation, in force); North Carolina (effective May 1, 2025; Fourth Circuit litigation pending); Virginia (directory established July 2025; enforcement enjoined since December 18, 2025, on appeal); Arkansas (effective November 1, 2025); Mississippi (effective November 30, 2025); Tennessee (directory published January 2026, mandatory enforcement from January 2027).

Legislation pending: South Carolina, Georgia, Texas, Arizona, and others.

(2) Country-of-origin bans: Texas SB 2024

Effective September 1, 2025, Texas SB 2024 bans the sale in Texas of disposable vapes, cannabinoid vapes, disguised devices, and products with designs appealing to minors that are manufactured in China or other countries designated foreign adversaries.

The ban turns on country of manufacture and is unrelated to FDA authorization status. For Chinese exporters it is the most damaging: even a product holding an MGO cannot be sold in Texas if it is manufactured in China.

(3) Flavor ban states

California, New York, Massachusetts, New Jersey, Rhode Island, Utah, and others restrict flavored vapes to varying degrees. Even with a federal MGO, a product within a banned flavor category may not be sold in those states.

(4) State AG enforcement in non-directory states

Even in states without a directory, state AGs may pursue sellers of unauthorized products under state UDAP statutes and public nuisance theory. In April 2026, thirteen state AGs led by Iowa wrote jointly to Visa, Mastercard, American Express, and Discover asking them to help cut off U.S. sales channels for unauthorized vapes — the most recent development in state-level enforcement.

VII. Administrative and Border Enforcement

Even short of litigation, administrative and border enforcement alone can make U.S. sale of unauthorized products untenable. Crucially, none of these measures requires an MDO or a court judgment first.

FDA and CBP border seizure and destruction. The FY2026 agriculture appropriations act authorizes the FDA (with CBP assistance) to seize and destroy unauthorized vape products at the border directly, rather than holding them in extended detention pending review.

FDA Import Alert and DWPE. Import Alert 98-07 (vapes) and 98-06 (other new tobacco products) apply detention without physical examination: all shipments from a red-listed importer are detained first and examined later, until compliance is established.

Warning letters and retail penalties. As of May 2026, the FDA had issued more than 750 warning letters to manufacturers, importers, and distributors, and more than 800 to retailers; civil penalties for retail violations now exceed $21,000 per instance.

The proposed ACE rule. The FDA is advancing a rule under the Automated Commercial Environment requiring a PMTA STN in the import declaration. Once finalized, each imported shipment will be tied to a specific PMTA, further compressing the space for unauthorized products at the border.

The PACT Act. As amended in 2020 to cover vapes, online sellers must register with ATF, collect state taxes, and ship in compliance; USPS has prohibited most vape mailings.

VIII. Compliance Assessment Matrix

IX. Conclusion

As the law currently stands, the great majority of Chinese-manufactured vape products cannot lawfully be sold in the United States. That conclusion:

• does not depend on the FDA's enforcement choices;
• does not change because no MDO has been received or because an STN is held;
• is not unsettled by Loper Bright's change to Chevron deference;

but rests directly on:

• the statutory text of FDCA § 387j itself (no order, no sale);
• the factual position that the FDA has authorized only 45 products, none of them a Chinese disposable flavored product;
• judicial confirmation of that framework in Triton (2025), Avail (2022), and Bidi (2025);
• procedural confirmation in VPR/Weiboli (2024) that a court may find an FDCA violation itself in private litigation;
• legislative confirmation in the FY2026 agriculture appropriations act of the FDA's direct border seizure authority (with CBP assistance); and
• the state-level encirclement formed by 13+ state directories, Texas SB 2024, flavor bans, and coordinated multi-state AG action.

The simplest test: lawful sale turns on whether the product holds an MGO — not on whether a PMTA was filed, and not on whether an MDO was received.

Filing a PMTA and holding an STN is widely understood within the Chinese vape industry as an export license or as temporary compliance. That understanding has no basis in law. It is an extension of market custom formed during the FDA's early enforcement forbearance and does not constitute evidence of lawful sale under the FDCA. In conducting an affirmative compliance assessment before exporting to the U.S. market, a client should start from whether the product holds an MGO — not from whether a PMTA was filed or an MDO received.

Disclaimer

The analysis in this report is based on federal law, agency positions, appellate and Supreme Court authority, and state legislation and enforcement developments published as of the date of this report (May 2026). The U.S. vape regulatory system continues to evolve, and FDA policy, CBP enforcement, and state directory legislation may change at any time. This report does not constitute formal legal advice as to any specific product, party, or transaction. Before making specific export, sales, or compliance decisions, a client should obtain separate written legal advice on its particular facts. Cited decisions and statistics have been reviewed with reasonable care, but subsequent proceedings (rehearing, appeal, settlement) may alter the status of the authority on which this report relies.