FSVP for the first-time importer

You are the importer if you are the US owner or consignee at entry. What the programme has to contain, and the exemption most people never check for.

FSVP catches people out because it isn't a licence, a registration, or an approval. It's a programme you're required to have, in writing, that nobody asks to see until an FDA investigator does — and then they want it within 24 hours.

Checked against 21 CFR part 1 subpart L on 6 September 2026.

You are the importer if you own the food at entry

§1.500 defines the FSVP importer as the US owner or consignee of the article of food at the time of entry. If there is no US owner or consignee, it is the US agent or representative of the foreign owner or consignee, designated for FSVP purposes.

Note what this is not. It isn't whoever happens to be named on the customs paperwork, and it isn't the customs broker. The obligation follows ownership of the food, and it can land on a party who thought they were merely arranging logistics.

Check the exemptions first

§1.501 carries a real list, and people skip it:

• juice and seafood already covered by the HACCP regulations
• food for research or evaluation
• food for personal consumption
• certain alcoholic beverages
• food transshipped through the US, or imported for processing and export
• US food returned to the US
• meat, poultry and egg products subject to USDA jurisdiction

That last one matters commercially: a mixed catalogue can have USDA products sitting entirely outside FSVP while everything else on the same shelf falls inside it.

What the programme has to contain

§1.502(a) frames the whole thing — your FSVP must give adequate assurances that your foreign supplier produces the food in compliance with processes and procedures providing the same level of public health protection as the applicable US requirements.

In practice, written and followed:

1. A hazard analysis (§1.504) — see hazard analysis without a consultant.
2. Evaluation and approval of the foreign supplier (§1.505), reevaluated on new information or at least every 3 years.
3. Verification activities appropriate to the hazard (§1.506) — see what FDA actually accepts.
4. Corrective actions, and records of all of it.

The qualified individual is less exotic than it sounds

§1.503 requires a qualified individual to develop the FSVP and perform the required activities. The bar is:

the education, training, or experience (or a combination thereof) necessary to perform their assigned activities

plus the ability to read and understand the language of any records that must be reviewed.

There's no certification, no register, and no requirement that the person be your employee. The language point is the one with teeth: if your supplier's food safety records are in a language nobody in the chain reads, you can't review them — and reviewing them is one of the verification options.

The bit that shows up at the border

§1.509(a) requires that for each line entry of food, the importer's name, email address and unique facility identifier are transmitted electronically at entry. In practice that is a DUNS number, and it must be recognised as acceptable by FDA.

This is the part your broker touches, and the most common first failure looks like this: entries filed with a missing or wrong identifier, or naming a party as FSVP importer who has never heard of FSVP.

Records: two years, produced in 24 hours

§1.510 requires records be kept at least 2 years, be legible and stored to prevent deterioration, and be made available to FDA within 24 hours of request.

Twenty-four hours is the design constraint behind everything else here. A programme that's technically complete but scattered across inboxes and a shared drive fails at exactly the moment it's tested.

The realistic first month

1. Confirm you are the FSVP importer for each product, per §1.500.
2. Check the §1.501 exemptions before building anything.
3. Name your qualified individual and record why they qualify.
4. Do the hazard analysis; if no hazards require control, §1.504(f) means supplier verification is not required — but the analysis showing that is the deliverable.
5. Confirm what your broker transmits at entry.
6. Put the records somewhere one person can produce in a day.

General information, not legal advice. Every requirement links to the regulation — check those and talk to counsel or a qualified individual about your programme.