Why Your Supplement Ingredients Will Sit in Quarantine (And How to Prevent It)

You’ve done everything right. Formula finalized. Film ordered. Production date booked. Ingredients shipped to us on time. And then we call you to say your ingredients are in quarantine and we can’t run your product until we resolve an identity testing issue.

For a lot of brands, this comes out of nowhere. They didn’t know identity testing was required. They didn’t know their COA alone wasn’t sufficient. This isn’t an obscure technicality. It’s federal law. And it catches more brands off guard than almost anything else in the supplement world.

What the Law Actually Says

Under 21 CFR Part 111 — the FDA’s cGMP regulations for dietary supplements — every dietary ingredient must have its identity verified before it’s used in production. Verification means documented proof that the ingredient you received is actually what it’s supposed to be.

A Certificate of Analysis tells you what the supplier tested for and what they found. But the key question is: did they actually test for identity? Did they run a method — HPLC, FTIR, organoleptic, whatever’s appropriate — that confirms this material is what the label says it is?

If yes, and if that supplier is ISO 17025 accredited, that COA may satisfy the identity requirement. If no — if the COA is essentially a spec confirmation without a real identity test result documented — it doesn’t matter how clean the rest of the paperwork is. The identity requirement isn’t met.

What Happens at Our Facility

When your ingredients arrive, we receive them in, assign an internal lot code, and tag them with a quarantine tag. We review your COAs. If your supplier is ISO 17025 accredited and their COA includes documented identity test results, we can often clear the quarantine and release the ingredients for production. If your COA is missing identity test data, your ingredients stay in quarantine. We legally cannot blend your supplement product without verified identity on every dietary ingredient.

Your Three Options

Option 1 — Use ISO 17025-accredited suppliers. If your ingredient suppliers carry that accreditation and their COAs document identity test results, you may not need any additional testing. This is the cleanest solution for brands running the same formula repeatedly.

Option 2 — Ship us a pre-blended product from a contract blender. Companies like Glanbia or Prinova blend your formula, perform identity testing on the finished blend, and ship us a tested, finished powder ready to fill. One identity test on the blend instead of individual tests on every ingredient. Cost is typically $500–$1,000 per test, passed through at lab cost with no markup.

Option 3 — We blend your ingredients and test each one individually. Every ingredient, every run. Maximum documentation, maximum protection. This is the highest-cost option but also the most defensible from a regulatory standpoint.

It’s a five-minute conversation that can save you a week of delays and real money. Have it with us before anything ships. — Ole