How does FDA handle foreign dietary supplement facility registrations and U.S. agent requirements?

1. Legal basis and what “registration” means in practice

The registration requirement flows from the FD&C Act and related FDA guidance: owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food—explicitly including dietary supplements—must register with FDA unless an explicit regulatory exemption applies ^{[1] [5]}. Registration does not equal FDA approval of the product or facility; the agency issues an FFR (Food Facility Registration) number to identify the registered establishment and uses the registration as a tool for inspections, recalls, and communications rather than as a certification of safety ^{[6] [2]}.

2. Which foreign facilities must register and sensible exceptions

Foreign establishments that produce dietary supplements for the U.S. market generally must register, and the obligation covers manufacturers, processors, packers, and storage/holding facilities; the FDA and several industry guides make clear that only narrow exemptions—such as certain intermediate foreign processing when subsequent foreign processing occurs before U.S. import—might limit the duty to register ^{[7] [8] [2]}. Third‑party vendor sites that perform only minimal functions (e.g., merely affixing a label) are frequently treated as requiring registration for both sites, a detail stressed in FDA summaries and trade guidance ^[8].

3. Identifiers, renewals, and updating registration data

Registrations include a unique identifier for the facility—FDA currently recognizes UFIs such as the DUNS number under implementing rules—and facilities receive an 11‑digit FFR number after successful submission; registration data are treated as nonpublic by FDA though the number is used for customs and agency processes ^{[9] [6]}. FDA requires biennial renewal of food facility registrations in even‑numbered years and mandates that any material changes to the mandated information be updated within a 60‑day window, obligations reflected in agency pages and industry advisories ^{[8] [6]}.

4. The U.S. agent: role, who can serve, and information required

Every foreign food or dietary supplement facility must designate a U.S. agent who is physically located in or maintains an office in the United States to act as the domestic communications representative for FDA; the agent is the conduit for regulatory communications, including inspection notices and emergency contact ^{[3] [10]}. FDA’s guidance specifies that the registration must include contact details for the U.S. agent—title, phone, and fax/email as appropriate—and agencies and industry services note there is no requirement that related facilities use the same agent, allowing flexibility in corporate structures ^{[4] [9]}.

5. Commercial reality, compliance support, and caveats in the record

A robust commercial market has emerged to help foreign firms register and serve as U.S. agents—consultancies and law firms advertise registration, renewal, and U.S. agent services and emphasize compliance with the Bioterrorism Act and FSMA‑era rules—but these are private services rather than FDA endorsements, and providers sometimes overstate certificates or “approval” language, so companies should understand registration is procedural and not a product endorsement by FDA ^{[3] [11] [10]}. Public sources show the contours of the rule set clearly—who must register, the U.S. agent requirement, renewal cadence, and update timelines—but they do not supply exhaustive operational templates; for gaps in practice (e.g., how an agent handles specific communication failure scenarios), the public guidance is less detailed and firms often rely on specialized advisers ^{[7] [9]}.