Does Your Food Facility Qualify for FDA Qualified Facility Status, and How Do You File the Attestation? (2026)
By Tam Nguyen | CEO, GOL Solution | 24+ years in international trade & cross-border logistics
Last Updated: October 2026
A food facility is a qualified facility if its average annual sales of human food over the three calendar years before the filing year are below FDA’s inflation-adjusted cutoff, which is $1,372,952 for 2023 to 2025 ($3,432,379 for animal food). If you qualify, you submit an FDA qualified facility attestation and FDA applies the modified requirements in 21 CFR 117.201 in place of the full preventive controls rules.
The timing matters this year. Food facility registration renewal and qualified facility attestations both run from October 1 to December 31, 2026, and FDA will treat a registration that is not renewed by December 31, 2026 as expired (FDA reminder, September 29, 2026). Since 2023, we have filed qualified facility attestations for 20 food clients across five countries, and all 20 were confirmed as qualified before we filed.
| Who this applies to | Foreign and domestic food facilities with low sales: under FDA’s inflation-adjusted cutoff for human food ($1,372,952) or animal food ($3,432,379), averaged over 2023 to 2025. |
| What is required | A valid FDA food facility registration, a documented status check by July 1 each year, an attestation (Form FDA 3942a for human food) every 2 years, and the records that support it. |
| Timeline | Filing window: October 1 to December 31, 2026. GOL registration takes 10 business days (standard), 2 business days (urgent), or up to 30 business days if the DUNS number is missing. The attestation is filed at the same time, so it adds no waiting time. |
| Typical cost (GOL service fees) | $890 due at registration for a qualified facility, against $670 for a regular facility. A regular facility then adds FSMA training at about $850 per person, optional implementation at about $3,000 to $5,000 per facility, and ongoing record keeping. |
Does my facility qualify as a qualified facility?
You qualify if your business, including subsidiaries and affiliates, averages less than FDA’s inflation-adjusted cutoff for the three calendar years before the filing year. For a 2026 filing, those years are 2023, 2024 and 2025. The cutoff is set in 21 CFR 117.3 for human food and 21 CFR 507.3 for animal food, and it is adjusted for inflation every year.
| Food type | Regulation baseline (2011) | FDA inflation-adjusted cutoff, 2023 to 2025 average |
|---|---|---|
| Human food | Less than $1,000,000 | $1,372,952 |
| Animal food | Less than $2,500,000 | $3,432,379 |
Source: FDA, FSMA Inflation Adjusted Cut Offs, content current as of May 13, 2026. FDA updates the values each April, so check the page before you file.
The sales that count are sales of food plus the market value of food that you manufacture, process, pack or hold without a sale, for example food held for a fee. Foreign facilities count sales in all countries, not only sales to the United States (FDA guidance).
There is a second route for businesses that sell mostly to qualified end-users and have total food sales under $500,000 (inflation-adjusted). The screening we run is based on annual sales, so this guide follows the sales test.
What we check first
- Whether the food is for humans or animals, because the cutoff differs.
- Annual sales for each of the last three calendar years, in all countries.
- Any food you manufacture, process, pack or hold without a sale.
- Whether you have subsidiaries or affiliates, because their sales are counted too.
- The share of sales made directly to qualified end-users.
Client Experience
We screen every food client on annual sales before we file anything. Three recent examples: a Singapore company exporting fiber powder, and two coffee sellers, one in Nigeria and one in South Africa. Each had sales below $1 million.
As with every client, we started with a short list of profile questions. All three were confirmed as qualified before we filed, and we submitted the attestation at the start of the registration, together with the FDA registration itself. Nothing unexpected came up, and all three matters are closed.
Across all our food clients, we have filed qualified facility attestations for 20 clients in five countries since 2023.
What do the modified requirements remove, and what do they not remove?
A qualified facility is not subject to subparts C and G of 21 CFR Part 117, which are the hazard analysis and risk-based preventive controls requirements and the supply-chain program (21 CFR 117.5(a)). It is not a blanket exemption from all of FDA requirements for food products.
The exemption in 117.5(a) names subparts C and G only. Here is what stays in place.
- The modified requirements in 21 CFR 117.201: the attestations, the annual status determination and the supporting records.
- FDA food facility registration, including renewal every 2 years, and Prior Notice for each shipment.
- FDA’s power to inspect the facility, and to withdraw the exemption under subpart E of Part 117.
- A label statement with the facility name and complete business address, if you choose the second attestation option described below.
GOL Insight
In our experience helping facilities through FDA inspections, FDA inspects against the FSMA standard unless the facility’s attestation says otherwise. A regular facility must meet the FSMA preventive controls standard. A qualified facility that chose the second attestation option is held to applicable non-Federal food safety law, which can include the food safety standard of its own country.
That makes the choice of attestation option something to decide before you file, not after an inspection notice arrives.
How do I file the qualified facility attestation, and when is it due?
You file Form FDA 3942a (human food) or Form FDA 3942b (animal food), preferably through FDA’s electronic Qualified Facility Attestation module, once your food facility registration is valid, and you repeat it every 2 years between October 1 and December 31 (FDA attestation page).
Each submission has two attestations. The first says you are a qualified facility. The second is one of two options (21 CFR 117.201(a)):
- Option 1: you have identified the food safety hazards, you are implementing preventive controls for them, and you are monitoring those controls.
- Option 2: you comply with applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, supported by licenses, inspection reports, certificates, permits or other evidence of oversight.
If you choose option 2, your label must show the name and complete business address of the facility where the food was made. If no label is required, the same details go at the point of purchase.
FDA says a facility must have a valid food facility registration before it can submit the attestation. At GOL, we file the attestation for the client, on their behalf, as part of the FDA registration process. It happens at the same time as the registration, so it adds no waiting time.
Timeline
| Date or period | What happens | Source |
|---|---|---|
| By July 1, every year | Determine and document whether you are a qualified facility. | 21 CFR 117.201(c)(1) |
| By July 31 | If you stop being a qualified facility, notify FDA on Form FDA 3942a. | FDA guidance |
| October 1 to December 31, 2026 | Registration renewal window. Qualified facility attestation is resubmitted in the same window, every 2 years. | FDA reminder |
| December 31, 2026 | FDA considers a registration expired if it was not renewed by this date. | FDA reminder |
| December 31 of the year you lose qualified status | Comply with subparts C and G of Part 117, unless FDA agrees otherwise. | 21 CFR 117.201(d) |
| GOL: 2, 10 or 30 business days | Registration time: 2 business days urgent, 10 business days standard, 30 business days if the DUNS number is missing. The attestation is filed with it. | GOL |
A facility with no DUNS number should allow up to 30 business days, so start early enough to finish before December 31. You can find our current fees and process on our FDA food facility registration page.
What does qualified facility status change in cost?
It lowers your ongoing compliance cost, but it costs $220 more on the day we register you, because the attestation filing is added. The table compares the GOL service fees for the two routes.
| Item | Qualified facility | Regular facility (full preventive controls) |
|---|---|---|
| FDA food facility registration (every 2 years) | $220 | $220 |
| US Agent (per year) | $450 | $450 |
| Qualified facility attestation filing (per year, includes the annual status check) | $220 | Not applicable |
| FSMA training, one preventive controls qualified individual (one time, per person) | Not required | About $850 |
| FSMA implementation at your facility (optional) | Not required | About $3,000 to $5,000 per facility, excluding transport and accommodation |
| Record keeping | Records that support the attestation | FSMA standard record keeping, ongoing, not priced here |
| Due at registration | $890 | $670 |
| Total, first 2 years | $1,560 | $1,970 minimum, $4,970 to $6,970 with implementation |
GOL service fees. Totals assume one year of US Agent at registration, a second year in year 2, one trained person, and no implementation unless stated. We assess each client and quote their exact cost, so your figure can differ.
Some clients ask why the qualified route costs more up front. A regular facility can do the FSMA training and the FSMA implementation after the registration is complete, so its first invoice looks lower. The cost arrives later.
GOL Insight
The $850 buys a training certificate for one person, issued by the course lead trainer, not by FDA (FDA FSMA training page). The certificate belongs to that person. If they change job, the company needs a new one.
A regular facility also carries FSMA record keeping every year. In our experience, the total compliance cost of a regular facility ends up a lot higher over the years than a qualified facility’s, even though it looks cheaper on day one.
What changes for my US importer if my supplier is a qualified facility?
The importer can use the modified FSVP in 21 CFR 1.512 instead of the full set of supplier verification steps.
- Before first importing, and at least every 2 years, the importer gets written assurance from the supplier that it complies with applicable FDA food safety regulations or comparable foreign law.
- The assurance must include either a brief description of the preventive controls the supplier is implementing, or a statement that it complies with non-Federal food safety law.
- The importer confirms the supplier’s qualified facility status each year, and keeps the records.
- The importer is not required to carry out the full hazard analysis, supplier evaluation, verification, corrective action and reevaluation steps of 21 CFR 1.504 to 1.508.
If you are an importer, see our FSVP service and our guide What is FSVP?.
What records should I keep to support a qualified facility attestation?
You must keep the records you relied on to support the attestation and give them to FDA promptly on request (21 CFR 117.201(f) and the FDA attestation instructions). FDA’s guidance also recommends records for your sales calculation.
| Status | Records |
|---|---|
| Required | The records you relied on to support the attestations. For option 1, records that document your hazard identification. For option 2, records that document your compliance with the non-Federal law you cite. |
| Recommended by FDA | The records you used for your annual sales calculation, and the calculation itself. |
| FDA’s examples for sales | Tax forms such as IRS Form 1120, line 1a (gross receipts or sales), income statements, invoices and bills of lading. These are examples, not a required list. |
At GOL, we recommend that clients keep their annual tax filing, sales records and calculation in hand in case FDA asks for them. In its guidance, FDA says it does not intend to review financial records during routine inspections, but it may ask to see them in a for-cause inspection (FDA guidance).
When does this not apply?
Qualified facility status does not apply to you, or does not fit, in these situations.
- Your average sales are above the cutoff. You follow the full preventive controls rules. If you lose qualified status, notify FDA on Form FDA 3942a by July 31 and comply with subparts C and G by December 31 of that year, unless FDA agrees otherwise.
- FDA withdraws the exemption. Subpart E of Part 117 allows FDA to withdraw a qualified facility’s exemption.
- You are close to the cutoff. Sales near the line need a fresh check every year by July 1, because one strong year can change the average.
- Your product is a dietary supplement. Dietary supplements follow different rules, and this guide covers food under Part 117 and animal food under Part 507.
- You are looking for a blanket exemption for very small business. There is none. Registration, Prior Notice, labeling and the modified requirements still apply, and FDA can inspect.
Frequently asked questions
Can FDA still inspect a qualified facility?
Yes. Qualified facility status changes which requirements apply. It does not stop FDA from inspecting the facility. In our experience, FDA inspects against the FSMA standard unless the facility’s attestation states otherwise.
Which sales count if I sell in several countries?
All of them. For a foreign facility, FDA’s guidance says to include sales of food in all countries, not only sales to the United States, plus the market value of food you hold or process without a sale.
Do I need a preventive controls qualified individual if I am a qualified facility?
The preventive controls qualified individual requirement belongs to the preventive controls subpart that qualified facilities are not subject to. If you choose attestation option 1, you still need to show that you identified hazards and are monitoring controls, and you keep those records.
What happens if my sales go over the cutoff?
Notify FDA on Form FDA 3942a by July 31 and comply with the full preventive controls rules by December 31 of that year, unless FDA agrees otherwise.
Who files the attestation for a foreign facility?
For our clients, we file it on their behalf as part of the FDA registration process, at the same time as the registration.
How often do I file, every year or every 2 years?
You file the attestation every 2 years during October 1 to December 31. What happens every year is the status check: you determine and document your qualified facility status by July 1.
What should I send GOL to check my status and file my attestation?
Send us the five items below and we will tell you whether you qualify, which attestation option fits, and your exact cost. Use the contact form on our FDA food facility registration page.
- Your product list, and whether each product is for humans or animals.
- Your sales for 2023, 2024 and 2025, in all countries, plus any food you hold or process without a sale.
- Your FDA food facility registration number and DUNS number, if you have them.
- Any food safety plan or certificate you already have, such as HACCP, ISO or a local license.
- Your October to December 2026 deadline, so we can plan the registration time (2, 10 or 30 business days).
