A foreign buyer or government will often ask a U.S. food exporter for a certificate of free sale, a document saying the product is sold freely at home. For most foods, FDA doesn't call it that: it issues a Certificate to a Foreign Government, which states that the product may be marketed in and legally exported from the United States. FDA's own Certificate of Free Sale is only for dietary supplements, medical foods and foods for special dietary use, and it's free. The Certificate to a Foreign Government costs $175 for the first certificate, $155 for a second for the same products on the same request, and $100 for each one after; the law caps the fee at $175 a certificate and asks FDA to issue within 20 days. FDA doesn't require any certificate to export; the buyer's country decides. Dairy, seafood, honey and egg products have certificates from other federal agencies, and some state agriculture departments issue their own. In the example below, a Michigan preserves maker answers a buyer in Taiwan.
The short version
- For most foods, FDA issues a Certificate to a Foreign Government, not a certificate of free sale.
- It states the product may be marketed in and legally exported from the United States.
- FDA's Certificate of Free Sale is for dietary supplements, medical foods and special dietary foods.
- Fees: $175, then $155 for a second, then $100 each.
- Dairy, seafood, honey and egg products: other federal agencies.
- FDA doesn't require a certificate; the buyer's country decides.
- TaroStack keeps each export order's lots and dates. More below.
Which certificate
| Product | Certificate | From | Fee |
|---|---|---|---|
| Conventional foods, food additives, food contact substances, infant formula sold legally in the U.S. | Certificate to a Foreign Government | FDA | $175, $155, then $100 each |
| Foods that can't be sold in the U.S. but meet the export rules | Certificate of Exportability | FDA | $175, $155, then $100 each |
| Dietary supplements, medical foods, foods for special dietary use | Certificate of Free Sale | FDA | No fee |
| Dairy products | Export certification | USDA AMS Dairy Grading Branch | Set by the agency |
| Seafood | Health certification | NOAA Seafood Inspection Program | Set by the agency |
| Honey | Export certification | USDA Specialty Crops Inspection Division | Fee for service |
| Egg products | Export certification | USDA AMS | Set by the agency |
Some countries also require the maker to be on an export list. A facility that makes food for sale registers with FDA, in fda food facility registration, and origin labeling at home is in country of origin labeling requirements.
The rules
| Rule | Where |
|---|---|
| The law | An exporter may ask FDA to certify in writing that a food meets U.S. requirements; FDA issues within 20 days of the request, for no more than $175 a certification (21 U.S.C. 381(e)(4)) |
| Certificate to a Foreign Government | For conventional foods, additives, food contact substances and infant formula that meet U.S. requirements; states they may be marketed in and legally exported from the U.S.; $175, then $155 for a second for the same products on the same request, then $100 each (FDA, Food Export Certificates) |
| Certificate of Free Sale | Only for dietary supplements, medical foods and foods for special dietary use; no fee (FDA, Food Export Certificates) |
| Other agencies | Dairy: USDA AMS Dairy Grading Branch; seafood: NOAA Seafood Inspection Program; honey: USDA Specialty Crops Inspection Division; egg products: USDA AMS; alcohol: TTB (FDA, Food Export Certificates) |
| Not required by FDA | FDA doesn't require written certification for exports; follow U.S. law and the importing country's (FDA, Exporting Food Products) |
This is general information, not legal advice.
An example: a first export order
Old Mission Preserves, the made-up preserves maker in Traverse City, Michigan, I use in these examples, got its first export order: a specialty importer in Taipei wanted tart cherry preserves, cherry salsa and dried cherries, and asked for a "certificate of free sale" in three copies. The owner worked out what to apply for:
| Certificate | Who it's for | Fee |
|---|---|---|
| Certificate to a Foreign Government, listing the preserves, salsa and dried cherries | The importer | $175 |
| A second, same products, same request | The importer's customs broker | $155 |
| A third | The Taipei retailer | $100 |
| Total | $430 |
The importer called it a certificate of free sale, but FDA's certificate by that name is only for dietary supplements, medical foods and foods for special dietary use, so the owner applied online for a Certificate to a Foreign Government and told the buyer what it would receive. The preserves maker's registration and labels were already in order. The salsa is an acidified food, which brings its own process filing, in process authority letter.
Get the checker
Download the export certificate checker. One sheet: each product or group of products, its kind and how many certificates you need on the same request; which certificate, who issues it and FDA's fee fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The certificate covers the products named on it. The importer's customs agent may also ask which lots are in the shipment and their dates, and that comes from the order, not the certificate.
How TaroStack does it
TaroStack keeps each export order's lots and dates, so what's in the shipment is on record.
Lots on every order. The Taipei order records the lots of preserves, salsa and dried cherries it took, with their dates.
Lot labels. Lot labels print with the lot, and an item with a GTIN carries its use-by date in its GS1-128 barcode.
Recalls. If a lot has to be pulled, one report shows every customer who got it, the importer included.
| The job | Notebook | In TaroStack |
|---|---|---|
| Which lots went to Taipei | A packing list by hand | Lots on the order |
| The date on each case | Typed into the label file | From the lot, in the barcode |
| Who got a recalled lot | Invoices | One recall report |
Orders, lots, lot labels and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.