How U.S. Manufacturers Qualify a Foreign Ingredient Supplier

A U.S. manufacturer does not qualify a seller’s brand. It qualifies an ingredient together with the site that produced it. For an imported ingredient that means establishing who made it, verifying that their test results can be trusted and making sure someone in the United States has taken legal responsibility for the import.

Step 1: Identify the manufacturer

Everything else depends on this. The certificate of analysis should name the producing site, and the site should be registered with FDA as a food facility with a U.S. agent on record. If you are buying through a trading company or distributor, that is workable, provided the manufacturer is disclosed and its documents are available to you.

A seller that will not name the manufacturer cannot be qualified.

Step 2: Review the documents

Before spending laboratory time, most quality teams ask for:

• Specification sheet and a recent certificate of analysis
• Test methods
• Safety data sheet
• Completed supplier questionnaire
• Allergen, GMO and residual solvent statements
• Heavy-metal data
• Certificates the site holds: food-safety scheme, GMP audit, Kosher, Halal
• Country-of-origin statement

Read each certificate for its scope, issuing body and expiry date. “GMP aligned” or “compliant with” is a description, not a certificate.

Step 3: Test

For dietary supplements, 21 CFR Part 111 requires you to set specifications for each component and verify them. You must run at least one appropriate identity test on every lot of a dietary ingredient. To rely on the supplier’s certificate for the remaining specifications, you first qualify the supplier by confirming its results through your own testing, and then re-confirm at intervals.

In practice, qualification means full testing of the first several incoming lots and comparing your results against the certificate. Expect it to take a few months.

Step 4: Settle who the importer is

Two U.S. roles need to be filled for an imported food or dietary ingredient.

Importer of record. The party responsible to U.S. Customs for the entry, classification and duty.

FSVP importer. Under the Foreign Supplier Verification Program (21 CFR 1.500 to 1.514), the U.S. owner or consignee of the food at the time of entry must verify that the foreign supplier produces it safely. Dietary supplement manufacturers that are subject to Part 111 follow modified requirements under 21 CFR 1.511.

When you buy from a U.S. distributor that imports the goods, the distributor usually fills both roles. When you import directly, you do. Confirm it in writing before the first shipment.

Step 5: Check origin and traceability

Country of origin is the country where the ingredient was manufactured. Repacking, blending or relabelling elsewhere does not change it. Routing goods through a third country to avoid duty is illegal transshipment.

For goods from China, importers should also be able to show where the manufacturer’s raw materials come from. Under the Uyghur Forced Labor Prevention Act, U.S. Customs can detain goods until the importer shows the supply chain is clear. For fermentation products that means tracing the feedstock, such as glucose or corn, to its supplier.

A short checklist

1. Manufacturer named, with FDA registration.
2. Certificate of analysis with numeric results and methods.
3. Standard statements and current certificates on file.
4. Identity test on every lot; full testing on the first several.
5. Importer of record and FSVP importer agreed in writing.
6. Origin stated and feedstock traceable.

Our quality and documentation page sets out what we provide against each of these.