Do You Need a U.S. Agent?

United States · FDA facility and establishment registration · Reviewed August 25, 2026.

Do you need a U.S. Agent?

You need a U.S. Agent for FDA registration only when the rule for your specific FDA program requires a covered foreign facility or establishment to name one. FDA forms and seller interfaces may write the same role as “US agent” without periods. The answer does not turn on whether your marketplace seller account is foreign or domestic. It turns on which facility is registering, where that facility is located, what it does, and whether an exemption applies.

Covered foreign food facilities, human-drug establishments, medical-device establishments and cosmetic facilities each use a U.S.-agent role in the applicable registration record. The definitions and responsibilities are similar, but they are not one interchangeable appointment. A food-registration agent is not automatically an FSVP importer, and a cosmetic-facility agent is not automatically the Responsible Person named on a product label.

JurisdictionUnited StatesFederal scope

Start with the FDA program, not a service quote. Identify the product, the actual manufacturer or processor, the facility location and the applicable registration regime before buying U.S.-agent or filing help.

DOMESTIC FACILITY

No registration U.S. agent

A U.S. facility does not appoint a U.S. agent for its own domestic FDA facility or establishment registration. Other import, listing, correspondent or responsible-party duties can still apply.

FOREIGN FACILITY

Check the program rule

A covered foreign food, drug, device or cosmetic facility generally identifies one U.S. agent as part of the relevant registration record. Exemptions and role-specific rules still control.

U.S. SELLER

The manufacturer may need one

A domestic seller can source from a foreign manufacturer whose registration names its own U.S. agent. The manufacturer’s appointment does not become the seller’s registration.

FOREIGN SELLER

The seller may not be the registrant

A foreign brand or reseller may use domestic or third-party facilities. Determine whose facility is subject to registration instead of appointing an agent solely because the seller is abroad.

FDA U.S.-agent rules by program

FDA program Who identifies the agent Core function Different role not to merge
Food facility registration A covered foreign food facility Routine and emergency communication with FDA FSVP importer, customs importer of record or broker
Human-drug establishment registration A covered foreign drug establishment FDA communications, import questions and inspection scheduling Official contact, labeler, listing filer or application holder
Medical-device establishment registration A covered foreign device establishment FDA liaison for the establishment and imported devices Official correspondent, initial importer, MDR reporter or 510(k) submitter
Cosmetic facility registration under MoCRA A foreign cosmetic facility within MoCRA’s registration duty FDA communications, product questions and inspection scheduling Responsible Person, product-listing filer or OTC-drug agent

Food facility registration

FDA defines a food-facility U.S. agent as a person residing or maintaining a place of business in the United States whom a foreign facility designates for the registration regulation. The agent must be physically present in the United States; a mailbox, answering machine or unsupported service address is not enough.

The role is a communications link for routine and emergency matters. Unless the registration identifies a different emergency contact, FDA contacts the U.S. agent when an emergency occurs. FDA also treats representations by the agent as representations by the foreign facility and treats information or documents sent to the agent as if they were sent to the facility.

A foreign food facility can authorize the agent to submit a registration, but the agent does not have to be the filer. The owner, operator or agent in charge can authorize another person. FDA verifies that the identified person has agreed to serve, so entering an unconfirmed contact can prevent the registration or update from being completed.

The food-registration U.S. agent is not automatically the FSVP importer. FDA’s FSVP guidance assigns supplier-verification duties to the FSVP importer. The same person may fill both roles only when that person separately meets the FSVP definition and confirms the FSVP appointment in a signed statement.

FDA does not require a food facility to use a private registrar, and it charges no government fee for food-facility registration. A private U.S. agent may charge for its service, but the provider is not affiliated with FDA and does not act on the agency’s behalf.

Human-drug establishment registration

Foreign establishments that manufacture, repack, relabel or otherwise process human drugs offered for import into the United States identify one U.S. agent in the establishment registration. FDA’s current drug-registration instructions call for the foreign establishment to include the agent’s name and DUNS number along with its importers.

Under the drug rule described in FDA’s U.S. Agents and Official Contacts training, the agent resides or maintains a place of business in the United States and cannot be only a mailbox, answering machine or service. The agent reviews and routes FDA communications, responds to questions about drugs imported or offered for import, and assists with inspection scheduling. When FDA cannot contact the foreign registrant directly or quickly, delivery to the agent counts as delivery to the registrant.

The drug establishment’s official contact is separate. The official contact is responsible for the accuracy of registration and listing information and for FDA communications at the establishment. A submission vendor named as U.S. agent needs to accept the agent’s actual regulatory responsibilities; being able to transmit an SPL file is not enough.

This distinction matters for OTC and medicated cosmetics. A product with therapeutic claims may be a drug or both a drug and cosmetic. Use the TikTok Shop FDA/NDC document guide to separate establishment registration, drug listing, NDC records and marketplace evidence before treating a cosmetics-only agent appointment as the answer.

Medical-device establishment registration

FDA requires a covered foreign device establishment engaged in manufacturing or processing a device imported into the United States to identify one U.S. agent. The agent confirms the appointment electronically as part of the registration process. If the person denies consent or does not respond within the stated verification period, the establishment must designate another agent.

The device U.S. agent assists FDA communications, responds to questions about imported devices and helps schedule inspections. The agent may also be the official correspondent, while the foreign establishment may keep those roles separate.

The device role has defined limits. FDA states that a registration U.S. agent does not, merely by holding that role, become responsible for Medical Device Reporting or for submitting a 510(k) premarket notification. Those responsibilities need their own assignment and regulatory analysis.

Cosmetic facility registration under MoCRA

A foreign cosmetic facility that is required to register under MoCRA provides contact information for a U.S. agent. FDA’s final registration and listing guidance describes the agent as an individual or business entity that resides in the United States or maintains a U.S. place of business and is physically present there. FDA does not recommend or endorse a particular agent.

The cosmetic agent’s responsibilities are limited to assisting communications, answering questions about products imported or offered for import, helping schedule inspections and receiving information when FDA cannot reach the foreign facility directly or quickly.

The agent is not automatically the Responsible Person. Under MoCRA, the Responsible Person is the manufacturer, packer or distributor whose name appears on the cosmetic label and who handles cosmetic product listing. FDA also recognizes exemptions for certain small businesses and facilities or products covered by drug or device requirements. Confirm that the facility must register before appointing an agent solely for a cosmetic submission.

The requirement follows the facility, not the seller account

A marketplace can ask a seller to prove the manufacturer or facility behind a product. That does not make the marketplace account the holder of the federal registration. The registration U.S. agent represents the foreign facility or establishment identified in the relevant FDA record.

For example, a U.S. dietary-supplement seller may buy from a registered foreign contract manufacturer. The foreign manufacturer, not the seller account, names the food-facility U.S. agent. A foreign brand may instead use a U.S. contract manufacturer, in which case that domestic facility does not appoint a U.S. agent for its own domestic food registration.

When TikTok Shop says FDA facility registration is missing, first match the label, invoice and product to the correct facility. The dietary-supplement rejection guide covers that platform workflow. For shelf-stable food, the food-registration proof guide explains the platform’s evidence routes. Neither platform rule changes which foreign facility has the federal agent obligation.

What a registration U.S. agent does not promise

  • No FDA approval. Naming an agent and completing a registration do not approve, clear, certify or endorse a facility or product.
  • No marketplace guarantee. A correct federal appointment does not force TikTok Shop, Amazon, Walmart or another platform to accept a listing or document.
  • No universal importer role. The agent is not automatically the FSVP importer, customs importer of record, initial device importer or distributor.
  • No automatic filing scope. The agent may be authorized to file, but the appointment alone does not mean it will prepare product listings, NDC records, 510(k) submissions, adverse-event reports or label reviews.
  • No ownership transfer. The facility remains responsible for accurate registration information and for its underlying legal duties.
  • No FDA affiliation. A commercial agent is a private service provider unless it is simply a qualifying person within the facility’s own organization.

How to choose and document the appointment

  1. Identify the exact registrant. Record the legal name, physical location and activities of the foreign facility or establishment.
  2. Select the FDA program. Food, drugs, devices and cosmetics use separate registration records and should not share an appointment by assumption.
  3. Check exemptions and product overlap. Confirm whether the facility falls within the registration rule and whether a cosmetic is also a drug or device.
  4. Define the service scope in writing. State whether the agent only receives communications or also handles initial filing, renewals, updates, product listings, inspection coordination or verification letters.
  5. Confirm physical presence and availability. Verify that the person or business satisfies the program’s U.S.-presence rule and can handle FDA communications during normal operations and emergencies.
  6. Complete the program’s verification step. Make sure the named agent accepts the role and responds to FDA verification or deficiency notices.
  7. Separate every additional role. If the same provider will also act as FSVP importer, official correspondent, Responsible Person or filing agent, document that second appointment and its separate duties.
  8. Record renewal and exit terms. Keep the price, term, cancellation process, record-transfer procedure and change-of-agent workflow with the registration file.

Do not name an agent that has not agreed to serve. An ignored verification request can delay or invalidate the registration step. Also avoid a contract that makes it difficult to transfer the registration record or change agents when the relationship ends.

When paid help is useful

A paid agent can be useful when the foreign facility has no qualifying person in the United States, needs dependable FDA communication coverage or wants one provider to manage filings and changes. A service can also help coordinate a marketplace proof packet, but only after the correct facility and FDA program are known.

Compare the service as an operating responsibility, not as a certificate purchase. Ask which program is covered, whether the price includes registration and renewal work, how urgent FDA notices are routed, whether inspection scheduling is included, what happens after cancellation and which tasks cost extra. The FDA registration services comparison separates the free FDA submission routes from private service fees and compares provider scope without treating commission as a ranking factor.

Frequently asked questions

Does every foreign seller need a U.S. Agent?

No. The FDA registration requirement follows a covered foreign facility or establishment under a specific program, not a seller’s nationality or marketplace account by itself.

Does a domestic U.S. facility need a U.S. Agent?

No for its own domestic FDA facility or establishment registration. The business may still have separate duties as an importer, Responsible Person, official correspondent or other regulated role.

Can my importer or distributor be the U.S. Agent?

Possibly, if that person satisfies the applicable program’s U.S.-presence requirements, agrees to serve and can perform the agent’s communication duties. The importer or distributor role does not automatically create the appointment.

Is a food-facility U.S. Agent the same as an FSVP importer?

No. The registration agent is principally an FDA communication link. The FSVP importer has supplier-verification duties. One person may hold both roles only through separate qualification and consent.

Is a cosmetic U.S. Agent the same as the Responsible Person?

No. The U.S. agent represents a foreign facility for registration and communications. The Responsible Person is the manufacturer, packer or distributor named on the cosmetic label and is responsible for product listing.

Does appointing a U.S. Agent make a product FDA approved?

No. The appointment supports a registration record and FDA communications. It does not approve, clear, certify or endorse the facility, product, label or marketplace listing.

Sources and review date

Last fact-checked: August 25, 2026.

XrdaGrid provides general informational content about United States FDA facility and establishment registration. This page is not legal or regulatory advice, does not decide whether a facility or product is exempt, does not create an agency relationship, and does not guarantee FDA or marketplace acceptance.