The US route to market for a prefilled pod range.
The United States is not a compliance formality, it is a gate. This page sets out what has to exist before a pod can lawfully be sold there, and what the factory can and cannot provide.
The gate
Authorisation comes before shipping
Any ENDS product marketed in the United States after 15 February 2007 needs a marketing granted order. There is no size exemption and no route around it — the only question is which enforcement tier your product falls into while you wait.
In September 2025 the FDA and CBP seized unauthorised vape product worth $86.5M in a single joint operation, and FY2026 appropriations allow unauthorised goods to be destroyed at the port of entry rather than returned.
| Item | Position in 2026 | What it means commercially |
|---|---|---|
| Authorisation | Marketing granted order required | No lawful sale without it |
| Authorised ENDS | About 45 products | Almost all tobacco or menthol |
| Non-tobacco flavours | First authorisation May 2026 | Granted for e-liquid capsule form |
| Enforcement | Three-tier framework, May 2026 | Tier sets seizure risk while pending |
| State directories | 13 states | $2,000 to $50,000 per violation |
| Import | FDA and CBP joint enforcement | Destruction at port is permitted |
| Made in USA | 16 CFR Part 323 | Up to $53,088 per violation |
Swipe the table sideways to see every column →
Note the shape of the first non-tobacco authorisation: it was granted for a pod-format product. That is the format with an existing precedent in the United States.
Enforcement
The three tiers, and what they mean for a buyer
TIER 01
Authorised
The product holds a marketing granted order. Lowest enforcement risk. A short list, and the entry bar is a full PMTA.
TIER 02
Accepted and filed
A PMTA has been accepted and filed, so the product sits at lower enforcement priority — while the application is still pending.
TIER 03
No application
No PMTA on file. Highest enforcement risk, and the band that accounts for the seizure figures above.
A tier is not a licence. Being in tier two lowers priority, it does not authorise the product. Only a granted order does that.
Division of work
What the factory supplies, and what stays with you
We supply
Formulation and ingredient data, emissions test data, device specification, batch traceability and manufacturing records — the manufacturer-side evidence a filing rests on.
You hold
The PMTA itself, the marketing granted order and the product listing. Market authorisation belongs to the brand holder, not to the factory behind it.
Plan for
State directories on top of the federal position, and an honest answer on origin labelling — Made in USA is not available to a product made in China.
Buyer checklist
Before you commit to a US launch
- 01 · Know your tier
- No application is the highest-risk band
- 02 · Budget the filing
- A PMTA is a project, not a form
- 03 · Check every state
- 13 directories, penalties per violation
- 04 · Pick the format with precedent
- Pod-format non-tobacco was authorised first
- 05 · Drop the origin claim
- Made in USA is out for China-made goods
If the United States is the target, tell us at brief stage. The specification we produce for a filing is different from the one we produce for a market without a premarket requirement.
Questions
US questions buyers ask first
Not lawfully. Products marketed after 15 February 2007 need a marketing granted order. As of 2026 the FDA had authorised roughly 45 ENDS products, and almost all of them are tobacco or menthol.
In May 2026 the FDA finalised a three-tier framework: tier one covers authorised products, tier two covers products with an accepted and filed PMTA that carries lower enforcement priority, and tier three covers products with no application at all — the highest risk band.
Often more, in practice. Thirteen states run PMTA-style product directories, and selling a non-listed product carries penalties of roughly $2,000 to $50,000 per violation.
No. The FTC Made in USA standard under 16 CFR Part 323 requires all or virtually all manufacturing to be domestic. Chinese components with US filling does not meet that bar, and penalties can reach $53,088 per violation.
Manufacturer-side documentation: formulation and ingredient data, emissions test data, device specification and batch traceability. The application itself is filed by the brand holder.
Next step
Tell us the market before we quote the pod.
A US-bound project needs different documentation from a UK-bound one. Naming the destination at brief stage is what makes a quote usable.