FDA Import Milk Regulations (Federal Import Milk Act)

Every container of milk or cream entering the United States from a foreign country must carry an FDA permit tag and meet sanitary standards that FDA inspectors verify at the source — not just at the border. The Federal Import Milk Act of 1927 (21 U.S.C. §§ 141–149) was one of the earliest federal food import safety laws, requiring permits for all imported milk and cream and authorizing FDA to inspect foreign dairy farms and processing plants before issuing those permits. The implementing regulations at 21 CFR Part 1210 remain largely as written in the 1970s and 1980s, establishing a pre-entry farm-inspection and permit system that predates the modern FSMA food import framework by nearly a century.

Legal Authority

• 21 U.S.C. § 141 et seq. — Federal Import Milk Act (1927): prohibits importation of milk and cream into the United States unless the importer holds a federal permit; requires that imported milk meet federal sanitation standards; authorizes FDA inspection of foreign dairy farms and plants as a condition of permit issuance
• 21 CFR Part 1210 — FDA regulations implementing the Federal Import Milk Act; establishes permit requirements, inspection standards, and conditions for permit denial or revocation

Key Mechanics

The Federal Import Milk Act creates a permit system: any entity seeking to import milk or cream into the U.S. must hold a valid FDA permit. Permits are issued only after FDA (or a state cooperator) inspects and approves the dairy farm and processing plant of origin abroad. The sanitation standards applied to imported milk mirror those applicable to domestic Grade A milk under the FDA's Pasteurized Milk Ordinance (PMO). Permit holders must maintain ongoing compliance; FDA may revoke permits for sanitation violations or false statements. The practical effect is that most milk imported into the U.S. comes from Canada and must meet the same safety standards as U.S. domestic production.

Current Rule (2026)

What This Rule Does

The Federal Import Milk Act created a permit-based gatekeeping system for milk and cream imports decades before modern food safety frameworks existed. The FDA (then the Bureau of Chemistry, later the Food and Drug Administration) must inspect foreign dairy farms and processing plants and issue numbered permits before any shipper can legally import milk or cream into the United States. Unlike border inspections — which happen after goods arrive — the Import Milk Act creates a pre-approval, source-inspection model: the farm must be inspected and scored before the permit is granted, not after.

Every container of milk or cream imported under a permit must carry a government-issued tag bearing the shipper's permit number, the product type (raw milk, pasteurized milk, raw cream, or pasteurized cream), and other required information. The tags are not self-generated by shippers — each permit carries an individual number whose use is restricted solely to the named permittee. Any milk or cream imported without a valid permit is subject to seizure and destruction.

The practical scope of the law is relatively narrow today. Historically, most imported dairy came from Canada. The NAFTA/USMCA dairy trade regime, Canadian dairy supply management system, and competing FDA import authorities (including FSMA's foreign supplier verification program) have made the Federal Import Milk Act primarily a backstop for situations not covered by other frameworks. Canada's milk imports into the U.S. are subject to dairy tariff-rate quotas; large-scale liquid milk trade between the U.S. and Canada remains limited.

Key Provisions

• § 1210.2 — Scope: applies to all milk and cream offered for import into the continental United States; does not extend to non-dairy milk alternatives (soy, almond, oat), cheese, butter, or other dairy products — only whole milk, skim milk, cream, and mixed milk/cream products qualify as "milk" or "cream" under the Act
• § 1210.3 — Definitions: "milk" means the whole, fresh, clean, lacteal secretion from one or more healthy cows, properly fed and kept; "cream" means the fat-rich portion; milk substitute and milk products (butter, cheese, evaporated milk) are not covered by Part 1210
• § 1210.10 — Inspection access: dairy farms and plants from which milk or cream is shipped to the United States must be open at all reasonable times to authorized FDA agents; failure to permit inspection is cause for permit suspension or revocation — the right of access is a condition of holding the permit, not just an aspiration
• § 1210.11 — Farm sanitation: the sanitary conditions of any dairy farm producing milk or cream for U.S. import must score at least 50 out of 100 points on FDA's farm inspection score card; the 50-point threshold is a minimum — farms with borderline scores face heightened scrutiny; FDA inspectors use a standardized score card assessing herd housing, manure management, milking equipment cleanliness, water supply, and worker hygiene
• § 1210.12 — Cow health examination: every cow in a herd producing milk for U.S. import must be examined by an authorized veterinarian — U.S., state/municipal, or host-country official — to determine that the herd is in a healthy condition; the veterinarian must certify that no cow shows clinical signs of disease likely to be transmitted through milk
• § 1210.13 — Tuberculosis testing: for raw milk imports, every cow in the supplying herd must be free from tuberculosis as determined by a tuberculin test applied by an official veterinarian; a herd with any reactor to the tuberculin test cannot supply raw milk for U.S. import; pasteurized milk imports are exempt from the TB test requirement (pasteurization destroys the Mycobacterium bovis that causes bovine tuberculosis)
• § 1210.14 — Plant sanitation: any plant handling milk or cream for U.S. shipment must score at least 50 out of 100 points on FDA's plant sanitation score card, assessing equipment design, cleaning procedures, product storage, and facility conditions
• § 1210.15 — Pasteurization standards: all pasteurization must use equipment of sanitary construction capable of holding every portion of the milk or cream at the required temperature for the required time; the standards match domestic pasteurization requirements — HTST (high-temperature, short-time) at 161°F (71.7°C) for 15 seconds or LTLT (low-temperature, long-time) at 145°F (62.8°C) for 30 minutes
• § 1210.16 — Bacterial count methods: the bacterial count of milk and cream is determined by the standard plate method of the American Public Health Association — the same method used domestically; this incorporates APHA's published methodology by reference, updating automatically as APHA revises its methods
• § 1210.20 — Application for permit: shippers must apply to FDA using prescribed forms; FDA reviews compliance with all applicable requirements before issuing a permit; each permit carries a unique number and is non-transferable
• § 1210.22 — Tag requirement: every container of imported milk or cream must have a tag bearing the product type, permit number, and "Federal Import Milk Act, Department of Health and Human Services" — the tag system makes each permitted shipment traceable to its specific permit holder
• § 1210.25 — Pasteurized milk permits: permits for pasteurized milk or cream require compliance with the farm sanitation inspection (§ 1210.11), cow health examination (§ 1210.12), and plant sanitation inspection (§ 1210.14); the tuberculin test (§ 1210.13) and bacterial count requirements (§ 1210.28) are waived because pasteurization destroys the pathogens those tests detect
• § 1210.26 — Raw milk permits: permits for raw milk require compliance with all conditions — farm sanitation, cow health examination, tuberculin test (TB-free herd), and plant sanitation; raw milk imports face the strictest requirements because there is no pasteurization step to serve as a safety backstop
• § 1210.27 — Condensery waiver: a permit for raw milk destined for a creamery or condensery (evaporated or condensed milk production, where heat treatment occurs during processing) may waive the tuberculin test and bacterial count requirements; condenseries heat-process the milk, providing protection equivalent to pasteurization; creameries receiving raw milk for churning butter also benefit from the heat processing that occurs during churning
• § 1210.28 — Bacterial count waiver for condenseries: operators of condenseries may receive a permit waiver allowing milk with up to 1,200,000 bacteria per cubic centimeter (compared to the standard 200,000 per cc for pasteurized milk), provided the condensery heat-processes the milk before sale
• § 1210.23 — Certificate-based permits: in FDA's discretion, a permit may be granted based on a duly certified statement signed by an accredited official of a foreign government or U.S. state/municipal authority, in lieu of FDA conducting the inspection directly; this bilateral trust mechanism allows FDA to rely on equivalent foreign inspection results rather than duplicating inspections for every foreign dairy operation

How It Affects You

If you're a dairy importer or foreign dairy exporter: You cannot ship milk or cream to the United States without an FDA permit. The permit application process requires demonstrating farm sanitation (≥50/100 score), cow health examination, tuberculin test for raw milk, plant sanitation, and pasteurization compliance. Every shipment must be tagged with the permit number. FDA inspectors — or accredited foreign government officials — must have access to the farm and plant for ongoing inspections; denying access is grounds for permit revocation. For pasteurized products, the process is more straightforward: the key requirements are the farm and plant sanitation scores and pasteurization compliance. For raw milk (extremely rare in import trade), all requirements including TB-free herds apply.

If you follow dairy trade policy: The Federal Import Milk Act's permit system exists alongside the USMCA dairy provisions, U.S. tariff-rate quotas on dairy imports, and the Canadian supply management system. Liquid milk trade between the U.S. and Canada remains limited by both regulatory requirements and commercial realities — the permit and inspection requirements are a compliance cost that, combined with transportation costs and tariff-rate quotas, makes large-scale liquid milk imports commercially unusual. The primary market for Import Milk Act permits is specialty imported dairy products from countries with strong bilateral inspection agreements.

If you study FDA regulatory history: Part 1210 is a living relic of pre-FDA federal food regulation — enacted before the 1938 Federal Food, Drug, and Cosmetic Act, before HACCP, and before FSMA's foreign supplier verification requirements. Its permit-and-tag approach reflects the regulatory technology of the 1920s. The Act has never been significantly amended, though FSMA (2011) added a supplemental layer of foreign supplier verification requirements that operate alongside (not in place of) the Import Milk Act's permit system for regulated importers.

Statutory Authority

This rule implements:

• 21 U.S.C. § 141 — Prohibition: it is unlawful to import or transport in interstate commerce milk or cream unless authorized by a permit issued under the Act
• 21 U.S.C. § 143 — Permit requirements: the Secretary shall prescribe the conditions under which permits are issued, including inspections of farms and plants and testing of cows; permits may be suspended or revoked for violations
• 21 U.S.C. § 145 — Inspection authority: authorized agents may enter and inspect dairy farms, plants, and containers; samples may be taken; failure to permit inspection is grounds for permit revocation
• 21 U.S.C. § 147 — Definitions: milk, cream, and other terms as used in the Act
• 21 U.S.C. § 148 — Penalties: violation of the Act is a misdemeanor; second offense is a felony; prohibited milk or cream is subject to seizure and condemnation

Recent Rulemakings

No major amendments since 1976 (41 FR 48269 — updating bacterial count standards and inspection score card references). The Federal Import Milk Act's regulatory framework has remained essentially unchanged for nearly 50 years. Modern FDA food import programs — FSMA's Foreign Supplier Verification Program (21 CFR Part 1, Subpart L) and preventive controls requirements — layer on top of the Import Milk Act's permit system for covered dairy importers.

Pending Action