"GMP-certified" and "FDA-registered" appear on every supplement supplier's page — but they mean very different things. Understanding them helps you evaluate partners and avoid compliance surprises at customs or on the shelf.

GMP: Good Manufacturing Practice

GMP is a quality system for production: documented procedures, controlled environments, trained staff, validated processes and batch records. For supplements, the key reference is cGMP (21 CFR Part 111) in the US and equivalent frameworks elsewhere.

  • GMP is a process requirement — it governs how products are made, not what the product claims.
  • A "GMP-compliant" facility can be audited; ask whether it holds a third-party GMP certificate and which standard it follows.
  • For importers, GMP matters because retailers and regulators increasingly require evidence of compliant production.

FDA registration: what it actually covers

In the US, the FDA requires facility registration for manufacturers and importers of dietary supplements (and foods). Registration is a listing requirement, not an "FDA approval" of the product — the FDA does not approve dietary supplements before they go to market.

  • Facility registration ≠ product approval.
  • Importers should also understand the FDA's label requirements: supplement facts panel, ingredient list, net contents and more.
  • Ask your supplier whether they are registered and can provide their registration evidence for your import process.

ISO quality systems

ISO 9001 (quality management) and ISO 22000 / HACCP (food safety) are common additional certifications. They demonstrate systematic quality management but are not supplement-specific — treat them as supporting evidence alongside GMP compliance.

What about test reports?

Beyond certifications, ask for a Certificate of Analysis (COA) with each batch: assay, identity, purity and microbiological results. A COA is your direct evidence that the batch you receive matches spec — and it is what regulators and retailers will ask for.

Questions to ask your supplier

  1. Which GMP standard does your facility follow, and can you share the certificate?
  2. Are you FDA-registered for dietary supplement manufacturing?
  3. Can you provide a COA with every batch?
  4. Do you support label compliance for my destination market?
  5. What does your QC process cover — raw materials, in-process control, finished product testing?

How we work

At Haiyue Shengda we plan compliance before production: we confirm applicable requirements for your formula and destination, align documentation, and issue a COA with every batch. Compliance scope depends on your product and market — see our Quality & Compliance page, or ask us directly.

Planning a launch? Contact us with your product idea and target market — we respond within one hour.