What Does the FDA Require for Milk?

December 22, 2025 •

4 min read

According to the FDA, all milk products sold in interstate commerce for direct human consumption must be pasteurized. The agency enforces comprehensive requirements to ensure milk safety and quality, governed largely by the Grade 'A' Pasteurized Milk Ordinance (PMO).

Quick Summary

The FDA, primarily through the Pasteurized Milk Ordinance, mandates strict standards for milk production, processing, and labeling, covering sanitation, pasteurization, and quality testing. These regulations apply to all Grade 'A' milk and dairy products shipped across state lines, while state-level decisions govern intrastate raw milk sales.

Key Points

Pasteurized Milk Ordinance: All Grade 'A' milk is regulated under the PMO, a model code for safety and sanitation standards.
Interstate vs. Intrastate Sales: The FDA prohibits interstate sales of raw milk, while intrastate sales are decided by individual states.
Pasteurization Standards: Milk sold across states must be pasteurized, using specific time and temperature controls to kill harmful bacteria.
On-Farm Sanitation: Farms must adhere to strict sanitary practices, including rapid cooling of milk and preventing antibiotic contamination.
Labeling Requirements: All milk labels must include the product name, pasteurization method (if applicable), nutritional information, and manufacturer details.
Plant-Based Alternatives: The FDA issues separate guidance for labeling plant-based milks, acknowledging their distinct nutritional profiles from dairy.
Compliance and Enforcement: State and local agencies are responsible for enforcing PMO standards, with FDA oversight and evaluation.

Comprehensive FDA Requirements for Milk Production

To ensure the safety of the U.S. milk supply, the U.S. Food and Drug Administration (FDA) and state regulatory agencies work together under the National Conference on Interstate Milk Shipments (NCIMS). The core document governing this is the Grade 'A' Pasteurized Milk Ordinance (PMO), a set of model standards for milk production and processing that is adopted by states and territories. These standards cover everything from the health of the animals to the final packaged product.

Grade 'A' Standards for Raw Milk Production on Farms

The foundation of milk safety begins on the dairy farm. The PMO outlines stringent requirements for Grade 'A' raw milk before it even leaves the farm. These standards are critical for minimizing bacterial contamination and ensuring the milk is suitable for pasteurization. Key requirements include:

Healthy Animals: Milk must be obtained from healthy animals, free from diseases that could be transmitted through milk.
Sanitary Milking: Milking facilities and procedures must be clean and sanitary. Udders and teats are required to be washed or wiped before milking to prevent contaminants from entering the milk.
Rapid Cooling: After milking, the raw milk must be cooled rapidly. The standard requires cooling to 10ºC (50ºF) or less within four hours of the first milking and to 7ºC (45ºF) or less within two hours after the completion of milking.
Temperature Maintenance: The milk must be maintained at 7ºC (45ºF) or below in a bulk tank until it is collected by a licensed hauler.
Antibiotic Testing: Milk from cows treated with antibiotics must be withheld. Samples are collected from every bulk tank and tested for antibiotic residues to ensure none enter the food supply.
Facilities and Equipment: All equipment and facilities used for milking and storage must be constructed of impervious material and kept clean and in good repair.

Pasteurization and Processing Standards

Once the raw milk arrives at a processing plant, it must undergo pasteurization to kill harmful bacteria, a federal requirement for all milk products sold in interstate commerce for human consumption. The FDA specifies precise time and temperature combinations for pasteurization.

High-Temperature Short-Time (HTST): For most fluid milk, this involves heating milk to at least 161°F (72°C) and holding it for at least 15 seconds.
Ultra-Pasteurization (UP): Milk is heated to at least 280°F (138°C) for at least two seconds, providing an extended shelf life under refrigeration.
Other Methods: Other time and temperature relationships have been approved, provided they demonstrate an equivalent level of microbial destruction.
Post-Pasteurization Contamination: Processing plants must also have robust controls to prevent contamination after pasteurization, which is a common source of food safety issues. This includes controlling condensate, proper cleaning of equipment, and ensuring containers come from an approved source.

Milk Labeling Requirements

Accurate and truthful labeling is another crucial FDA requirement. Labels must clearly state the product's identity, net quantity, ingredients, and the name and address of the manufacturer. Specific labeling rules include:

Product Identity: The common name of the dairy product must be displayed prominently. For flavored milks, the flavoring must be declared.
Pasteurization Declaration: The term "ultra-pasteurized" is required on products processed with this method, while "pasteurized" is optional but commonly used.
Nutrient Labeling: The standard Nutrition Facts panel must be included, providing information on nutrients. Optional fortification with vitamins A and D requires specific labeling declarations.
Milkfat and Solids: For standard milk, the minimum milkfat and milk solids not fat content must meet the required percentages.
Plant-Based Alternatives: The FDA has specific guidance for labeling plant-based milk alternatives, recommending additional nutrient statements to inform consumers of nutritional differences from dairy milk.

Comparison of Raw Milk and Pasteurized Milk Regulations


Feature	Pasteurized Milk (Interstate)	Raw Milk (Intrastate)
Federal Regulation	Required by FDA for interstate commerce.	Interstate sales banned by FDA. State regulation varies widely.
Processing	Heated to specific temperatures for defined times to kill pathogens.	No heat treatment. Contains naturally occurring bacteria, which can be harmful.
Safety Risk	Low risk of foodborne illness due to pathogen destruction.	Higher risk of illness, especially for vulnerable populations, due to potential pathogens.
Standard	Governed by the Grade 'A' Pasteurized Milk Ordinance (PMO).	Varies by state; some have specific standards, while others may lack them.
Handling	Strict sanitary controls from farm to processing plant.	Farm sanitary practices are still required in states allowing sales, but no processing safeguards.

Conclusion: FDA’s Role in Milk Safety

In conclusion, the FDA's requirements for milk are a multi-layered system designed to safeguard public health. Through the PMO, the agency sets the national baseline for Grade 'A' milk quality and processing, with enforcement handled largely by state agencies. This system ensures that the fluid milk and dairy products shipped across state lines have been properly pasteurized and handled under sanitary conditions. While the FDA has not previously regulated intrastate raw milk sales, which vary by state, it consistently informs the public about the associated health risks. This comprehensive framework of standards, testing, and cooperative programs has dramatically reduced milk-borne illness in the United States over the last century.

For more information on the history and importance of milk pasteurization, see the Nevada Department of Agriculture's overview.

Frequently Asked Questions

The PMO is a set of model standards developed by the FDA in cooperation with the NCIMS, used by states and local agencies to regulate the production, processing, and packaging of Grade 'A' milk and milk products.

The FDA regulates raw milk by prohibiting its sale and distribution across state lines. The regulation of raw milk sold within state borders is left up to individual state governments.

For Grade 'A' raw milk, it must be cooled to 50°F (10°C) or less within four hours of the start of milking, and to 45°F (7°C) or less within two hours after milking finishes.

The FDA, through state regulatory programs, ensures milk is tested for antibiotic residues before it is processed and sold to the public. Any milk with positive test results is discarded.

Required labeling includes the product name, net quantity, a list of ingredients, nutritional facts, and the name and address of the manufacturer or distributor.

The FDA legally defines milk as the lacteal secretion from healthy, milk-producing animals, explicitly excluding plant-based beverages like soy or almond milk from this classification.

The most common FDA-approved methods are HTST (High-Temperature Short-Time) pasteurization, at 161°F for 15 seconds, and ultra-pasteurization, at 280°F for at least 2 seconds.