August 28, 2026 · FSVP Associates

If you’ve come across the term “Very Small Importer” while researching FSVP, here’s the most important thing to understand right away. VSI status is not an exemption from FSVP. It’s a route to modified requirements, a smaller and more focused version of the program. Getting that distinction wrong is one of the most common and costly mistakes importers make.

If you’re new to FSVP entirely, start with our guide on what FSVP is and who it applies to before diving into VSI-specific details.

What is a Very Small Importer under FSVP?

A Very Small Importer is an importer that falls below specific, inflation-adjusted annual sales thresholds. Qualifying doesn’t remove your FSVP obligations. It changes which specific requirements apply, under 21 CFR 1.512.

Current 2026 VSI thresholds  (based on the applicable 2022–2024 three-year average):

• Human food: less than $1,333,031 per year
• Animal food: less than $3,332,577 per year

This isn’t simply “my company’s revenue is under $1.3 million.” The calculation includes your sales of the applicable food plus the U.S. market value of food you imported, manufactured, processed, packed, or held without sale, and it includes any subsidiaries and affiliates, not just the importing entity alone. A business that looks small on paper can still fall outside VSI eligibility once affiliate sales and held-without-sale inventory are factored in.

How do I know if I qualify?

A few specifics matter more than most importers expect:

• Human food and animal food have separate thresholds. If you import both, each is evaluated against its own cutoff.
• The averaging period is three years, ending one year before the calendar year you intend to import as a VSI. For example, VSI status for 2026 is based on the applicable 2022–2024 three-year period, not the three years immediately before 2026.
• Subsidiaries and affiliates count. The calculation isn’t limited to the importing entity in isolation.
• The calculation isn’t limited to sales revenue. It also includes the U.S. market value of applicable food that you imported, manufactured, processed, packed, or held without sale, as specified under the VSI definition.
• New businesses without three full years of sales history may still qualify as a Very Small Importer. FDA guidance addresses situations where a full three-year sales history is not available, including newly established businesses. Eligibility should be determined and documented based on the business’s individual circumstances and appropriate supporting records.

What is a Very Small Importer exempt from under FSVP?

A Very Small Importer (VSI) that qualifies for and chooses to follow the modified requirements under 21 CFR § 1.512 is not required to comply with the standard FSVP requirements in §§ 1.504 through 1.508 or § 1.510. This means the standard requirements for hazard analysis, foreign supplier evaluation and approval, supplier verification activities, corrective actions, and certain recordkeeping provisions do not apply in the same way to a qualifying VSI.

However, these obligations are not simply eliminated. Section 1.512 establishes a separate set of modified FSVP requirements for Very Small Importers.

For example, a VSI does not conduct the standard supplier verification activities required under § 1.506. Instead, for each food imported, the VSI must obtain the written assurance required by § 1.512(b)(3) from its foreign supplier before importing the food and at least every two years thereafter. A VSI must also take and document appropriate corrective action if the supplier does not produce the food consistently with that assurance.

Very Small Importers must also maintain an FSVP for each food and foreign supplier, use a Qualified Individual for required FSVP activities, document their VSI eligibility, identify the FSVP importer at entry, and maintain the records required under § 1.512.

In short, VSI status replaces several of the standard FSVP requirements with modified requirements. It does not eliminate FSVP compliance.

What does a VSI actually have to do?

Under the modified requirements, a VSI importer must:

• Document VSI eligibility before initially importing under VSI status, and then annually by December 31 of each year, for every subsequent year you rely on that status.
• Obtain the required written assurance from the foreign supplier for each food you import, before importing the food and at least every two years thereafter. The assurance must confirm the supplier is producing the food to at least the same level of public health protection required under applicable U.S. standards.
• Use a Qualified Individual for the applicable FSVP activities.
• Maintain records that are signed and dated upon creation and any modification, legible, and available to FDA promptly upon request. Records supporting your VSI eligibility specifically must be retained for at least three years.
• Take corrective action promptly if a supplier isn’t meeting the assurance provided, and document what you did about it.

What documentation should you have ready?

This is where a lot of importers underestimate the work involved. A reader can find the dollar threshold on FDA’s website in a few seconds. What’s harder is knowing whether your own numbers actually clear it, and having the right records on hand to prove it if FDA asks. Eligibility isn’t self-certified in the sense of just stating a figure. FDA expects a set of records that genuinely substantiate the calculation, and exactly what that looks like depends on your specific business structure, how your sales are recorded, and whether subsidiaries or affiliates are involved. This isn’t a rigid checklist FDA hands out for every case. It’s a judgment call that needs to hold up under scrutiny, and the Life & Food example below shows what happens when it doesn’t.

A Real FDA Example: What Happens When VSI Status Isn’t Properly Documented

On June 15, 2026, FDA issued a warning letter (CMS #731887) to Life & Food Inc., a Las Vegas-based importer of tea and matcha products, following an FSVP inspection conducted May 4–7, 2026.

FDA’s finding was direct. The company had not developed an FSVP for any of the foods it imports. In response, the company asserted VSI status and submitted VSI eligibility declarations along with written assurances from its foreign suppliers. On the surface, that looks like a reasonable response.

FDA found it fell short in specific, documented ways:

• No supporting documentation for VSI eligibility. The company asserted VSI status but didn’t provide the underlying financial records, such as tax forms or income statements, needed to substantiate it.
• Written assurances FDA questioned. FDA noted the assurances submitted appeared to be templates prepared by the importer, rather than independent documents provided by the foreign suppliers.
• No FSVP at all, even under VSI modified requirements. FDA was explicit that even if the company qualified as a VSI, it still had to develop and maintain a written FSVP under §§1.502, 1.503, and 1.509.

This case directly illustrates the lesson above. Claiming VSI status isn’t the same as being properly documented under it.

What are the most common FSVP mistakes Very Small Importers make?

• Declaring VSI status based only on a rough sense of revenue, without the records to prove it
• Not keeping the records that support the eligibility calculation
• Forgetting the annual by-December-31 eligibility documentation
• Assuming VSI means exempt from FSVP entirely
• Not having a qualified individual responsible for the applicable FSVP work
• Missing or inadequate supplier written assurances
• Letting the two-year assurance renewal period lapse
• Having supplier paperwork on file but no actual FSVP structure behind it

None of these are exotic failures. They’re gaps that show up when eligibility is assumed rather than documented.

The upside, for businesses that genuinely qualify

For businesses that meet the actual criteria, VSI status can significantly simplify FSVP compliance, with fewer required verification activities and a narrower program to maintain. The key is determining eligibility correctly and documenting the modified program properly from the beginning, rather than treating “we’re small” as sufficient on its own.

Frequently Asked Questions

Not sure whether you qualify as a Very Small Importer? FSVP Associates can assess your eligibility and develop your FSVP program through experienced Qualified Individuals (QIs), with ongoing QI and compliance support available as your imports grow. Introductory VSI pricing is currently available. Get a Quote