Exporting Dairy Products to the United States: FDA Requirements and Common Pitfalls

Dairy products are among the most complex food categories to export to the United States. Foreign dairy manufacturers must navigate overlapping federal and state regulatory frameworks, meet specific composition standards that may differ from international norms, satisfy labeling requirements unique to the US market, and in many cases obtain approvals or listings from multiple regulatory bodies beyond the FDA. The regulatory complexity explains why many experienced food exporters who successfully ship dozens of product categories to the US find dairy to be the one category where compliance consistently requires specialized knowledge and careful planning.

FDA food facility registration for dairy manufacturers

Like all food manufacturers exporting to the United States, foreign dairy facilities must register with the FDA under the Bioterrorism Act. The registration requires a DUNS number, a designated US Agent, and accurate identification of the facility and its product categories. For dairy manufacturers, the product category codes in the FDA registration system must accurately reflect the types of dairy products produced — fluid milk and cream, cheese, butter, yogurt, ice cream, dried milk products, and dairy-based beverages all have distinct product codes. An inaccurate product code can result in a mismatch between the registration and the Prior Notice filed for individual shipments, which can trigger FDA review or detention.

Grade A dairy and the Pasteurized Milk Ordinance

Fluid milk, cream, yogurt, and certain other dairy products sold at retail in the United States must comply with the Grade A Pasteurized Milk Ordinance (PMO), which is published by the FDA and adopted by all 50 states and the District of Columbia through the National Conference on Interstate Milk Shipments (NCIMS). The PMO establishes requirements for dairy farm operations, milk collection, pasteurization, plant sanitation, laboratory testing, and product standards. Foreign dairy plants that wish to export Grade A products to the US must be listed on the FDA Interstate Milk Shippers (IMS) List, which requires inspection and compliance evaluation by an authorized regulatory body. As of 2026, the countries with regulatory arrangements that allow Grade A dairy exports to the US are limited — not all countries have equivalence agreements with the FDA for Grade A dairy.

Cheese, butter, and certain other manufactured dairy products are generally not subject to the PMO's Grade A requirements, but they must still comply with FDA standards of identity (21 CFR Parts 131 through 135), CGMP requirements, and FSMA preventive controls. Cheese aged for 60 days or more at a temperature not less than 35°F (1.7°C) may be made from unpasteurized milk under FDA regulations, but fresh cheeses — including most soft cheeses — must be made from pasteurized milk or must undergo an equivalent heat treatment. This requirement differs from European regulations, where many traditional cheeses are made from raw milk without the 60-day aging requirement.

Standards of identity for dairy products

The FDA has established standards of identity for many dairy products under 21 CFR Parts 131 through 135. These standards define what a product must contain — and what it may contain — in order to be labeled with a specific name. For example, 'ice cream' must contain not less than 10 percent milkfat and not less than 20 percent total milk solids (21 CFR 135.110). 'Yogurt' must be produced by culturing specific bacterial species and must meet minimum milkfat requirements (21 CFR 131.200). 'Cheddar cheese' must be made from specific ingredients and must meet compositional requirements for moisture and milkfat content. Products that do not meet the standard of identity cannot use the standardized name and must be labeled with a descriptive or fanciful name instead.

Labeling requirements specific to dairy

In addition to the standard food labeling requirements (Nutrition Facts panel, ingredient list, allergen declaration, net contents, country of origin), dairy products have several category-specific labeling requirements. Milk and milk products must declare the grade designation if applicable. Pasteurized products must be labeled as pasteurized. Products made from raw milk must declare that fact. Cheese labels must identify the variety and may need to declare the milk source (cow, goat, sheep). Ice cream products must declare the characterizing flavor (chocolate, vanilla, strawberry) and must identify the source of the flavor (natural, artificial, or a combination). Milk allergen declarations must appear on all dairy products, but manufacturers of products containing multiple types of milk (cow, goat, sheep) must also declare each type.

Common pitfalls for foreign dairy exporters

The most frequent problem foreign dairy manufacturers encounter is the assumption that EU or Codex compliance translates directly to US compliance. It does not. EU dairy regulations allow the use of certain additives and processing aids that are not permitted under US FDA regulations. EU standards of identity for products like 'yogurt,' 'butter,' and 'cheese' differ from US standards in composition requirements. EU labeling uses different nutrition reference values, different serving size conventions, and different allergen declaration formats. A cheese that is legally sold in the EU may not meet the US standard of identity for that cheese variety, and a yogurt label that complies with EU Regulation 1169/2011 will not comply with US 21 CFR 101.9.

How FDABridge helps dairy exporters

FDABridge provides FDA food facility registration, US Agent services, and label compliance guidance for foreign dairy manufacturers. We help dairy exporters navigate the multi-layered US regulatory framework and ensure their registrations, labels, and documentation meet FDA requirements before the first shipment reaches a US port. Visit fdabridge.com/food to learn about our food services or fdabridge.com/contact to speak with our team.