Selling food into the United States. Without the paperwork stopping it at the port.

What it is and why you are asked for it

Every foreign facility that manufactures, processes, packs or holds food for consumption in the United States must name a US agent (21 CFR 1.227 and 1.232). The agent is the FDA’s contact with the facility for routine and emergency communications, and it has to be a real physical address in the US: the FDA expressly rejects a PO box or an answering service.

What this service includes

• Acting as your US agent at a physical US address.
• The agent’s affirmative confirmation that it accepts the role for your specific facility, which the FDA requires.
• Identifying your facility in the FDA’s U.S. Agent Voluntary Identification System, so verification goes through without further steps when the data match.
• Receiving the FDA’s communications and passing them on to you the same day.

What it does not include

• The facility registration itself, which is a separate service.
• Any FDA fee: there is none for this.

What we need from you

• The facility’s legal name and address.
• Its FDA registration details, if it is already registered.
• A contact person with phone and email.

How long it takes

The FDA does not publish a verification deadline. What moves it is how quickly the agent confirms, and that is on us.

Price

USD 300 per year

What it is and why you are asked for it

Domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the US must register (section 415 of the FD&C Act, 21 CFR 1.225–1.243). Failing to is a prohibited act, and food from an unregistered facility can be held at the port (21 CFR 1.241). Farms, retailers, restaurants, fishing vessels, non-profits and what is regulated exclusively by USDA are exempt (21 CFR 1.226).

What this service includes

• The electronic registration in FURLS, the Food Facility Registration Module — mandatory since 4 January 2020.
• Every field required by 21 CFR 1.232, including food categories and activity types.
• Your registration number and PIN, in the same session.

What it does not include

• A registration certificate. The FDA does not issue one, whatever private companies sell.
• Any FDA fee: registering costs nothing (21 CFR 1.231(c)).
• The US agent, which the registration requires and is a separate service.

What we need from you

• The facility’s name and address, and any alternative trading name.
• A Unique Facility Identifier: the FDA recognises the DUNS number.
• The food categories and the types of activity.
• The owner or operator’s contact details, with email.
• Consent to inspection.

How long it takes

Filing is immediate and the number is issued in the same session. What takes longer is obtaining the DUNS number and the agent’s confirmation, and the DUNS depends on you. The FDA does not publish a processing time.

Price

USD 200

What it is and why you are asked for it

Registration has to be renewed between 1 October and 31 December of every even-numbered year — 2026, 2028, 2030 (21 CFR 1.230). Outside that window the system does not accept renewals. A registration that is not renewed expires and the FDA can cancel it (21 CFR 1.234), and from then on the facility is unregistered.

What this service includes

• Logging into FURLS with your credentials and PIN.
• Reviewing every field, correcting what has changed, and submitting.
• Having the US agent verified again, which the FDA does each cycle.

What it does not include

• Recovering a lost PIN from the FDA, which is the step that most often delays a renewal. We tell you in advance if it is needed.
• Any FDA fee: there is none.

What we need from you

• Your FURLS credentials and PIN.
• Any change to the facility since the last registration.

How long it takes

Immediate inside the window. The FDA does not publish a processing time. The only risk is the calendar: missing the window.

Price

USD 145

Free if you have our US agent.

What it is and why you are asked for it

Every imported food must be preceded by prior notice to the FDA (section 801(m) of the FD&C Act, 21 CFR 1.276–1.285). Without it, or with an inadequate one, the food is refused admission and held at the port unless it is exported immediately under CBP supervision (21 CFR 1.283).

What this service includes

• Preparing and filing one notice per shipment, through the FDA Prior Notice System Interface or through ABI/ACE/ITDS with your broker.
• Every data point required by 21 CFR 1.281.
• The confirmation number that travels with the shipment.

What it does not include

• The admission of the shipment. A flawless notice does not guarantee it: it removes the reason for refusal under 801(m), and nothing more.
• Examination, sampling or holds the FDA may order on that entry.

What we need from you

• The CBP entry type and number.
• The food’s identity: FDA product code, common name, quantity, unit and lot.
• The manufacturer or grower, the shipper, and the country of production.
• Port, date and expected time of arrival.
• Importer, owner and consignee, and the carrier details.
• The registration numbers of the facilities involved.

How long it takes

The rule sets minimum lead times, and these are published: 2 hours before arrival by road, 4 hours by rail, 4 hours by air, 8 hours by sea. At most 15 days ahead through the FDA interface, or 30 days through ABI/ACE/ITDS (21 CFR 1.279).

Price

USD 35 per shipment

What it is and why you are asked for it

The Foreign Supplier Verification Program (FSMA, 21 CFR 1.500–1.514) is an obligation of the importer, not of the exporter. When there is no US owner or consignee at entry, the importer is the US agent or representative of the foreign owner, confirmed in a signed statement of consent to act as importer (21 CFR 1.500). In other words: when you sell without a US buyer, someone in the US has to take that role in writing. Without a valid FSVP at entry, the food can be refused.

What this service includes

• Signing the statement of consent to act as FSVP importer.
• Building the programme: a written hazard analysis (1.504), evaluation of the supplier and of the food’s risk (1.505), verification activities (1.506) and corrective actions (1.508).
• Designating a qualified individual, with audits carried out by a qualified auditor (1.503).
• Providing the importer’s name, email and DUNS so your broker can transmit them in ACE with the role code FSV at each entry (1.509).
• Keeping the records the rule requires.

What it does not include

• An “FSVP approval”. It does not exist: the FDA neither approves nor stamps a programme.
• The outcome of an FDA inspection, which can find the programme insufficient.
• Products the rule exempts: fish and fishery products, juice, meat, poultry and eggs regulated by USDA, some alcohol, food in transit, and food for processing and re-export.

What we need from you

• Your products, suppliers and their facilities.
• The information needed for the hazard analysis and the supplier evaluation.
• The shipment details, so the importer data reach each entry.

How long it takes

The rule fixes these: records available to the FDA within 24 hours and kept for 2 years (1.510); supplier re-evaluation at least every 3 years (1.505); an annual on-site audit where the hazard can cause serious consequences, with an initial audit before importing (1.506); and written assurances renewed every 2 years for very small importers (1.512).

Price

from USD 600 per year

What it is and why you are asked for it

A food with a non-compliant label is misbranded (sections 403 and 201(n) of the FD&C Act, 21 CFR Part 101, and the Food Allergen Labeling and Consumer Protection Act): it can be refused at the border and withdrawn from the market. And the point most often misunderstood: the FDA does not approve labels. In its own words, “the FDA does not approve individual labels before food products can be marketed”. There is no FDA-approved label and no certificate. Whoever sells you one is not telling you the truth.

What this service includes

• A check of the label against the core sections of Part 101: principal display panel (101.1), information panel (101.2), statement of identity (101.3), ingredients (101.4), name and place of business (101.5), net contents (101.7), Nutrition Facts (101.9), nutrient content claims (101.13), health claims (101.14), spices, flavourings, colourings and preservatives (101.22), and dietary supplements (101.36).
• Allergen declaration under FALCPA.
• A written list of what to change.

What it does not include

• An FDA approval or certificate, because none exists.
• The cases where the FDA does decide in advance, which are not label review: colour additives, food additives, new infant formula (notified 90 days before marketing) and the authorisation of health claims.

What we need from you

• Final artwork in high resolution, every side.
• The complete quantitative formula, and the technical sheet of every compound ingredient.
• Lab data or the nutrition calculation behind the Nutrition Facts.
• Net weight or volume and serving size.
• The claims the brand wants to make.

How long it takes

Set between you and us. The FDA publishes none because it does not take part.

Price

USD 250 per label

What it is and why you are asked for it

The FDA can refuse admission because a shipment “appears to violate” the law (section 801(a)) — the appearance of a violation, not proof. It issues a Notice of FDA Action with the charges. Undefended, it becomes a Notice of Refusal of Admission, and the product must be exported or destroyed within 90 days. An import alert goes one step further: it puts the manufacturer, product or importer on the Red List, under Detention Without Physical Examination, so every shipment is held by default until removal or entry onto the Green List.

What this service includes

• For a detained shipment: testimony or written evidence before the division’s compliance officer, private laboratory analysis where there was sampling, or Form FDA 766 to recondition or relabel — all through ITACS, which the FDA says gets priority review over other channels.
• For an import alert: the removal petition to the FDA with the evidence that supports it.
• Tracking the entry and each line in ITACS.

What it does not include

• The lifting of a detention or removal from the Red List. Nobody can promise either, or a date for it.
• Testing laboratory fees, and export or destruction costs.

What we need from you

• The Notice of FDA Action and the entry details.
• The product’s documentation and any analyses you already have.
• Your history of shipments of that product.

How long it takes

Two deadlines are published and short: 10 business days from the date of detention to respond — notices usually allow 20 calendar days — and 90 days after a refusal to export or destroy. The FDA publishes no deadline for deciding a removal petition. And the “five clean shipments” that circulate as a rule are an illustrative example from the FDA, not a requirement: it sets no number.

Price

Priced after the consultation