Foreign manufacturers face several linked requirements before a product can legally reach U.S. shelves: confirming the right regulatory pathway (FDA, CBP, or both), classifying the product under the Harmonized Tariff Schedule (HTS), determining duty rates, and lining up the logistics and paperwork needed for customs clearance.

Every product entering the U.S. is assigned a 10-digit HTS code—the first six digits come from the internationally shared Harmonized System used in more than 200 countries, and the last four are U.S.-specific. That code determines the duty rate charged at the border, so an incorrect classification can mean overpaying duties, delays, or penalties.

U.S. Customs and Border Protection (CBP) also requires a Manufacturer Identification (MID) code for every formal or informal entry, built from the manufacturer's name, address, and postal code. Between HTS classification, MID setup, entry documentation, and any FDA or other agency clearance, first-time importers often underestimate how many moving parts need to line up before goods can clear customs.

Because these requirements touch different agencies (FDA for food/drug/device compliance, CBP for tariffs and entry, USTR/USITC for trade policy), manufacturers without US representation frequently discover a missing requirement only after a shipment is already in transit—the most expensive time to find out.

Any facility that manufactures, processes, packs, or holds food for the U.S. market must register with the FDA. Registration is submitted through FDA's online system and must be renewed every two years during the biennial renewal period.

As part of registration and renewal, FDA requires a Unique Facility Identifier (UFI). FDA currently recognizes the DUNS Number (Dun & Bradstreet) as the accepted UFI. The catch: the company name and address entered in the FDA registration must match Dun & Bradstreet's records exactly—including punctuation and capitalization.

• If the UFI is missing, incorrect, or mismatched, the registration can be rejected or stuck in verification.
• If an inaccurate UFI is submitted, FDA generally allows a 30-day window to correct it.
• Processing typically takes 5–10 business days, longer if verification issues arise.

Under 21 CFR 1.227, every foreign food facility registered with FDA must designate a U.S. Agent—a person or entity residing or maintaining a place of business in the United States.

The U.S. Agent is FDA's communications link to the foreign facility for both routine and emergency matters, and is who FDA contacts first when an issue arises (unless a separate emergency contact is specified).

Two requirements trip up foreign facilities most often: the agent cannot be a mailbox, answering machine, or answering service with no one actually present, and the agent must be available during normal U.S. business hours.

Without a valid, responsive U.S. Agent on file, the facility's FDA registration is considered invalid—and products from that facility cannot legally enter the United States.

Imported food must meet the exact same FDA labeling requirements as food produced domestically. There is no lighter version of the rules for foreign manufacturers.

Two areas cause the most compliance issues: the Nutrition Facts label, which must follow FDA's current format and nutrient declaration rules, and allergen labeling, which requires clear declaration of the nine major allergens—milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (sesame became mandatory more recently, and is still a common gap on labels designed for other markets).

FDA has also updated its food labeling compliance program to strengthen oversight of both domestic and imported foods. Noncompliant labels can lead to enforcement action, including detention at the border—often the most costly and time-sensitive way to discover a labeling issue.

Under the FDA Food Safety Modernization Act (FSMA), the U.S. importer of a food product must develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for each food and each foreign supplier. A separate FSVP is needed for each supplier-food combination—multiple suppliers of the same food, or multiple foods from one supplier, each require their own FSVP.

The goal is to ensure imported food is produced with the same level of safety assurance required of U.S. producers, and is not adulterated or misbranded, including with respect to allergens.

In practice, this means importers need a hazard analysis for each food, a process for approving suppliers based on risk and performance, ongoing supplier verification activities (which can include audits, sampling and testing, or review of food safety records), and re-evaluation of each food and supplier at least every three years—or sooner if new risk information emerges.

At the time of entry, the FSVP importer must also be identified to CBP by name, electronic mailing address, and Unique Facility Identifier (UFI).

The Importer of Record (IOR) is the party CBP holds accountable for a shipment entering the United States. The IOR's name and identification number appear on all official import documentation, and the role carries real legal and financial responsibility.

To qualify as an IOR, the person or entity generally must own the goods or hold a financial interest in them, be a registered business entity, and hold a valid IRS Employer Identification Number (EIN) or a CBP-assigned importer number.

• Ensuring duties, taxes, and fees are correctly assessed and paid
• Filing accurate, complete entry documentation—including the CBP Form 7501 Entry Summary, commercial invoice, packing list, and bill of lading
• Securing a customs bond (single-entry for a specific shipment, or continuous for multiple shipments over a year) that guarantees compliance with customs laws
• Obtaining any product-specific licenses, authorizations, or certifications required for entry
• Retaining import records for five years, as CBP may request them

The regulatory bar for being an IOR is also rising: a June 2026 executive order directs CBP and DHS to strengthen customs enforcement, including higher bonding and tangible domestic asset requirements for importers of record, and a new prohibition on foreign IORs filing informal entries. That makes having a compliant, U.S.-based IOR partner more important than before, not less.