FDA registration for exporting food and cosmetics to the U.S.

Food and beverages

Facility registration

Required for any facility that manufactures, processes, packs or holds food for the U.S. If another foreign facility packs the product before shipment, that facility is the one that registers.

DUNS number

A nine-digit company number in the Dun & Bradstreet directory. FDA issues the registration number once it has verified the DUNS. The address in DUNS must match the address in the registration.

U.S. Agent

Required for a foreign facility: the agent responds to FDA inquiries. The agent has 30 days to confirm the appointment, otherwise FDA deletes the application.

Renewal

Every 2 years, from October 1 to December 31 of each even‑numbered year. If a registration is not renewed, FDA considers it expired and removes it.

Prior Notice for every shipment

Prior Notice is filed before the shipment arrives: at least 2 hours ahead by road, 4 hours by air or rail, 8 hours by sea. The notice includes the manufacturer’s registration number.

Label

In English, with a Nutrition Facts panel, net weight in ounces and grams (fluid ounces and milliliters for beverages) and the 9 major allergens, including sesame.

Color additives

Red No. 3 (erythrosine, E127) is banned in food and dietary supplements from January 15, 2027.

Food safety plan

The facility keeps a written food safety plan under FDA rules (21 CFR 117). The U.S. importer verifies the supplier under the Foreign Supplier Verification Program (FSVP) and may request this plan, test results and production records.

Canned and pickled foods

Separate requirements apply to low-acid canned foods (LACF: pH above 4.6 and water activity above 0.85) and acidified foods such as pickled vegetables, lecho and vegetable spreads (ikra). At a vegetable cannery, most of the range falls under these rules, while jams, preserves and canned high-acid fruit do not.

Canned meat

Canned stewed meat and other canned livestock meat and poultry products are imported under the rules of the U.S. Department of Agriculture (USDA). Belarus, Russia, Kazakhstan and Uzbekistan are not on its list of eligible countries, so these products cannot be imported even with FDA registration.

Facility registration

The same as for any food facility: DUNS, a U.S. Agent, renewal every 2 years.

Food Canning Establishment (FCE) registration

Filed separately for each canning establishment before the first shipment to the U.S. A new establishment registers no later than 10 days after it starts producing canned foods.

Process filing (SID)

The sterilization or acidification process is filed for each product and each container size, and FDA assigns it a SID number. The process is filed before the product is first shipped to the U.S., and for a new product, before packing starts.

Trained supervisor

Retort and acidification operations run under the supervision of a person who has completed a course at an FDA-approved school, usually the Better Process Control School.

Detention at the border

Canned foods without a filed process are detained and may be refused entry into the U.S. If a facility avoids filing its processes, FDA puts it on an automatic detention list (Import Alert 99-37) and detains its products without physical examination.

Dietary supplements

Facility registration

The same rules as for food: DUNS, a U.S. Agent, renewal every 2 years, Prior Notice for every shipment.

Supplement Facts

Instead of Nutrition Facts, the label needs a Supplement Facts panel in the FDA format.

Structure/function claims

If the package says how the supplement affects the body, FDA must be notified no later than 30 days after sales start, and the label must carry the mandatory disclaimer. If the package promises to treat or prevent a disease, FDA considers the product a drug.

New dietary ingredient

If an ingredient was not sold in the U.S. in dietary supplements before October 15, 1994, and is not present in ordinary food in the same form, FDA must be notified at least 75 days before the product goes on the market.

Manufacturing

Current good manufacturing practice rules for supplements (cGMP, 21 CFR 111): specifications, production records, batch control. FDA checks them during inspections.

Cosmetics and personal care products

FEI number

The facility’s FDA number, which also serves as its registration number. It is obtained before registration, usually within 7–10 business days.

Facility registration

Required under MoCRA, including for contract manufacturers and for facilities certified to ISO 22716. Small businesses with average U.S. cosmetics sales under $1 million a year are exempt, unless their range includes products for the eye area, products that are injected or taken internally, or products meant to alter appearance for more than 24 hours.

Product listing

Each product is listed with FDA, including its full ingredient list; a new product must be listed within 120 days after it goes on the market. The listing is updated every year.

Responsible Person

The company whose name appears on the label. It reports serious adverse events to FDA within 15 business days and keeps the product’s safety substantiation.

Label

Ingredients are listed in English in descending order of predominance; net quantity is given in fluid ounces for liquids and by weight for creams and gels. The label also needs a contact for adverse event reports: a U.S. address, a U.S. phone number or a website.

Color additives

Only FDA-approved colors, and only for their approved uses, such as the eye area. Petroleum-based colors must come from a batch certified by FDA. E-numbers and CI numbers do not prove this. Color additive violations are a common reason for cosmetics being detained at the border.