FDA Facility Registration vs. FSVP vs. Prop 65: Which Applies to Your Tea?

Buyers and suppliers routinely treat “FDA compliance” as one task. It is three.

The short answer is three facts, already published on this site:

1. FDA facility registration is a legal registration for a foreign factory that makes, processes, packs, or holds food for US consumption. It must be renewed every two years. It is not a quality certificate.
2. Under the Foreign Supplier Verification Program, the legal duty sits with the US importer, not the foreign supplier. The evidence in that importer’s file — hazard analyses, process controls, verification records — still comes from the supplier.
3. Proposition 65 is a California warning-and-disclosure law. It is not an FDA import rule, and it does not travel with an FDA refusal or warning letter.

These three regimes measure different things. Compliance with one does not guarantee compliance with the others.

Side by side

	FDA facility registration	FSVP	Prop 65
What it is	A legal registration with the FDA for a facility outside the US that manufactures, processes, packs, or holds food for US consumption. Renew every two years.	The Foreign Supplier Verification Program: a legal mandate on the US importer to run risk-based verification that the food meets US safety and labeling standards. Codified at 21 CFR Part 1, Subpart L; took effect January 26, 2016.	California’s Safe Drinking Water and Toxic Enforcement Act of 1986. A warning-and-disclosure law. OEHHA sets a Maximum Allowable Dose Level (MADL) for listed chemicals.
Who it names	The foreign facility.	The US importer — the US owner or consignee of the food at the time of entry (or the US agent of the foreign owner if no consignee exists). Not the exporter.	Any business with ten or more employees that knowingly exposes Californians to listed chemicals.
What it is not	A quality endorsement. A registration number does not mean the product passed a safety test.	A letter addressed to the supplier. The FDA does not audit the exporter directly for FSVP; it audits the importer’s file.	An FDA import rule. It does not travel with an FDA refusal or warning letter. A product can be legal to sell and still require a warning.
Who looks	A buyer’s compliance team typically asks for the registration number early. Without it, onboarding stops.	The FDA audits the importer’s file. An FSVP warning letter names the importer.	Private parties can serve a 60-day notice as private attorneys general. Lead’s reproductive MADL is 0.5 micrograms per day; oral cadmium is 4.1 micrograms per day.
What “ready” looks like for tea	You can produce the current FDA registration number.	The importer’s file already contains your current hazard analysis, process-control information, and dated, batch-specific verification records.	Batch-specific heavy-metal tests against the MADL — more targeted than a general pesticide panel — before the tea reaches California.

Each cell above restates a fact already reviewed in the source articles: the buyer QA checklist for registration and the importer’s document set, FSVP warning letters for duty versus evidence, and Prop 65 lead and cadmium in tea for the California thresholds.

Why the three get conflated

A US buyer’s onboarding email often asks for “FDA registration, FSVP documents, and heavy-metal tests” in one list. That list is real. The legal objects behind it are not the same.

Registration is the factory’s baseline. It is the item a buyer’s compliance team requests first, and it is the one the supplier can produce without waiting for an importer. It still does not tell anyone whether the tea is safe, correctly labeled, or below a California MADL.

FSVP is the importer’s duty. Exporters who treat a warning letter as “the buyer’s problem” are reading the addressee correctly and the commercial consequence incorrectly: if the importer’s file is empty, the importer stops buying to protect their own license. The letter will not carry the supplier’s name. The next purchase order might not either.

Prop 65 is California disclosure. FDA import data and Chinese food-safety limits do not substitute for it. The lead and cadmium MADLs are intentionally low; a serving that meets other regimes can still require a warning.

A fourth, related failure — not a fourth column — is US-format labeling. In Easterlies’ review of FDA import-refusal data, mislabeling accounted for 40.0 percent of China-origin tea refusals. That is border enforcement of FDA labeling rules, not registration, not FSVP, and not Prop 65. See the refusal breakdown.

What this does not change

Relief from confusing the three regimes is not relief from any of them.

• Registration still has to be current. Buyers will ask for the number.
• FSVP still has to be built from supplier evidence, even though the legal name on the file is the importer’s.
• If the tea reaches California, the employee-count threshold and the MADL numbers apply.

Easterlies does not register facilities with the FDA, is not the importer of record, does not sign FSVP documents, and does not certify a Prop 65 “pass.” Those acts belong to the facility, the importer, accredited labs, and counsel. We coordinate the specialists and the record so a buyer’s file is usable before someone asks for it.

Easterlies view — Treat the three as a sequence, not a synonym. Get the registration number on the table first. Put the hazard analysis, process controls, and batch tests into a form a US importer can file. Then, if California is in the path, test lead and cadmium against the MADL rather than assuming an FDA-clean shipment is finished work.

If you want a reading of which of the three actually applies to a named product and channel, that is a conversation. If the answer is “not yet,” we will say so.