U.S. Food Regulation

The United States represents one of the largest and most commercially attractive consumer food markets in the world, offering substantial growth opportunities for international food enterprises. Successfully entering this market requires a comprehensive understanding of its complex, multi-layered regulatory environment. The U.S. regulatory system operates under a hybrid model, which imposes strict pre-market authorization requirements for certain ingredients and product categories, while placing significant emphasis on post-market surveillance and manufacturer accountability.

1. Competent Authorities

The U.S. food safety regulatory system involves multiple federal agencies with distinct yet complementary roles. The table below outlines the primary federal agencies governing the U.S. food supply:

2. Regulatory Framework

The legal foundation of U.S. food safety is built upon several landmark statutes and implementing regulations. Effective compliance requires a working knowledge of both laws enacted by Congress and regulations codified in the Code of Federal Regulations (CFR).

3. Market Access

3.1 Product Registration

Most conventional prepackaged foods do not require product-specific registration or pre-market approval from FDA. However, certain categories are subject to pre-market authorization requirements, such as infant formula and low-acid canned foods.

Example: new infant formula requires pre-market submission under 21 CFR Part 106

1) New infant formula registration

Before a new infant formula may be introduced into interstate commerce, the manufacturer shall register with the FDA. The registration shall include:

• The name of the new infant formula;

• The name of the manufacturer;

• The street address of the manufacturer's place of business;

• The name and street address of each establishment where the formula will be manufactured.

Manufacturers may register at any time prior to market introduction. The FDA recommends submitting the registration concurrently with the new infant formula submission(described below) to facilitate review.

2) New infant formula submission

At least 90 days before introducing a new infant formula into interstate commerce, the manufacturer shall submit notice to the FDA of its intent to market the product. The submission must include:

• Product name and description of physical form

• Explanation of why the product qualifies as a new infant formula

• Quantitative formulation

• Description of any reformulation or processing changes, if applicable

• Assurances that the infant formula will not be marketed unless it meets the quality factors under 21 CFR 106.96 and 21 CFR 106.121, and the nutrient requirements under 21 CFR 107.100

• Assurances that processing complies with section 412(b)(2) of the FD&C Act

3) Verification submission

After first production and before marketing, the manufacturer shall submit written verification to the FDA, including:

• Name of the new infant formula, filing date and identification number of the new infant formula submission

• Statement confirming the marketed product is the same as the product which has gone through the new infant formula submission

• Summary of nutrient test results

• Certification that current good manufacturing practices have been established and implemented

3.2 FDA Food Facility Registration

Under the Bioterrorism Act of 2002, as amended by the FSMA, all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA. Key requirements include:

• A Unique Facility Identifier (UFI), typically a D-U-N-S number, prior to registration

• Foreign facilities must designate a U.S. agent as the primary contact with the FDA

• Registration must be submitted through FDA Industry Systems (FURLS FFRM)

• Required registration information includes facility details, parent company information, U.S. agent information, food categories, types of activities for each category, and relevant statements, etc.

• Biennial renewal between October 1 and December 31 of each even-numbered year

• Failure to register results in refusal of imported food

Detailed registration requirements are specified in the 21 CFR Part 1 Subpart H. FDA guidance on registration process can be found in the Step-by-Step Instructions for Registration. 

3.3 Foreign Supplier Verification Program (FSVP)

The FSVP places primary responsibility for imported food safety verification on the U.S. importer. The importer shall:

• Conduct a hazard analysis for each imported food (biological, chemical, and physical hazards)

• Evaluate food risk and supplier performance including:

The hazard analysis

The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier's raw material or ingredient supplier

A foreign supplier's procedures, processes and practices related to the safety of food,

Applicable FDA food safety regulations, and information regarding the foreign supplier's compliance

The foreign supplier's food safety history, including the responsiveness of the foreign supplier in correcting past problems

Other factors as necessary

• Determine appropriate supplier verification activities (e.g., onsite auditing, sampling/testing, records review)

• Conduct verification activities as required

• Conduct corrective actions when applicable

• Maintain FSVP records and make them available to FDA upon request

The evaluation of the risk posed by the imported food and the supplier's performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier's performance.

More verification requirements are specified in the 21 CFR Part 1 Subpart L and FDA guidance.

3.4 FDA Prior Notice

Before any food shipment arrives at a U.S. port of entry, the FDA requires advance notification, known as Prior Notice. This must be submitted electronically by any person with knowledge of the required information via the FDA's Prior Notice System Interface (PNSI) or through the CBP's Automated Broker Interface (ABI). Information required in a prior notice are specified in the 21 CFR 1.281.

Prior notice must be submitted no more than 15 days before arrival and no less than:

• 2 hours before arrival by road

• 4 hours before arrival by rail

• 4 hours before arrival by air

• 8 hours before arrival by water

More requirements are specified in the 21 CFR Part 1 Subpart I and FDA guidance

3.5 Import Restrictions and Import Certification

While most FDA-regulated foods do not require specific pre-market import permits, certain milk products (including milk and cream) shall apply for permits under the Federal Import Milk Act.

In addition, meat, poultry, and egg products must originate from USDA certified countries and establishments, and are subject to FSIS inspections upon entry.

Where systemic food safety concerns exist in a region, or where contamination risks arise from natural disasters or other incidents, the FDA may require import certification issued by FDA-designated certifying entities for affected products.

3.6 Import Process

Upon arrival, food shipments are subject to the following review process:

• Entry submission to CBP and then reviewed by the FDA for FDA-regulated products (Details on entry submission can be found on FDA guidance.)

• Prior notice verification by the FDA

• FDA admissibility review – may result in:

May proceed – no further action required

Physical examination – sample collection and laboratory analysis

Detention – held pending demonstration of compliance

Import Alert – automatic detention without physical examination (DWPE)

4. Product Standards

4.1 Standards of Identity

Standards of Identity are detailed federal regulations that define the mandatory composition, allowable ingredients, and manufacturing processes for specific food categories. If a product is marketed under a standardized name (e.g., "sweetened condensed milk," "white chocolate"), it must strictly adhere to the recipe mandated by law. Use of a standardized name for a non-conforming product may render the product misbranded and/or adulterated under the FD&C Act. Nevertheless, manufacturers may deviate from a standard pursuant to the 21 CFR 130.10, where the deviation is associated with an authorized nutrient content claim and the substitute food demonstrates similar performance characteristics to the standardized food.

FDA has established standards of identity for approximately 300 food products, primarily codified in 21 CFR Parts 130 through 169. Key standards include:

• Milk and Cream: 21 CFR Part 131

• Cheese and Cheese Products: 21 CFR Part 133

• Bakery Products: 21 CFR Part 136

• Cereal Flours and Related Products: 21 CFR Part 137

• Canned Fruits: 21 CFR Part 145

• Fruit Butters, Jellies, Preserves: 21 CFR Part 150

• Canned Vegetables: 21 CFR Part 156

• Eggs and Egg Products : 21 CFR Part 160

• Cacao Products: 21 CFR Part 163

• Beverages: 21 CFR Part 165

……

For imported products, standards of identity are a common area of enforcement focus, particularly where foreign product names or formulations differ from U.S. legal definitions.

4.2 Hygiene Standards

Unlike many jurisdictions that maintain a unified maximum residue limit (MRL) framework across contaminants, the United States regulates contaminants through multiple legal mechanisms depending on the substance and risk profile. Generally, contaminant levels are established through tolerances and action levels (as defined in 21 CFR Part 109 ), as well as other types of levels (e.g. guidance levels, derived intervention levels, recommended maximum levels, and advisory levels) which are not defined in the regulation but have been used to advise industry on levels of contamination that may pose a health risk or may be avoidable through good manufacturing practices. 

• Tolerances for pesticide residues in foods set by EPA: 40 CFR Part 180

• Action levels and other levels set by FDA

Integrated Guidance Documents for Chemical, Metals, Natural Toxins & Pesticides

Integrated Guidance Documents for Bottled Water

Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed

• Action levels for undesirable microorganisms in food generally focus "zero tolerance" for pathogens like Salmonella and Listeria monocytogenes.

CPG Sec 555.300 Foods, Except Dairy Products - Adulteration with Salmonella

CPG Sec. 555.320 Listeria monocytogenes

The FDA's Chemical Contaminants Transparency Tool provides a consolidated list of contaminant levels that are used to evaluate potential health risks of contaminants in human foods.

Contaminant type included:

• Toxic Elements

• Mycotoxins

• Persistent Pesticides (residues of cancelled pesticide chemicals that persist in the environment)

• Radionuclides

• Other Chemical Contaminants

5. Ingredient Compliance

5.1 Existing Compliant Ingredients

In the United States, only ingredients authorized by the FDA as permitted food additives, or substances that are Generally Recognized as Safe (GRAS) may be lawfully used in foods.

For dietary supplements, an ingredient must generally qualify as a lawful dietary ingredient under the Dietary Supplement Health and Education Act of 1994 (DSHEA). A dietary ingredient is either an old dietary ingredient marketed before October 15, 1994, or a new dietary ingredient subject to premarket notification.

The table below summarizes ingredient categories:

5.2 Compliance Pathways for New Ingredients

If a manufacturer intends to introduce a new ingredient, or expand the use of an existing ingredient beyond its currently authorized conditions of use, they must secure market access through one of the following legal pathways:

Notes

In March 2025, HHS Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking to eliminate the self-affirmed GRAS pathway, requiring all GRAS determinations to be submitted as FDA GRAS Notices. In the FDA 2026 Priority Deliverables, the key actions planned for 2026 includes a proposed regulation to mandate the submission of GRAS notices to the FDA for all substances claimed to be GRAS. This signals a fundamental shift that will significantly increase the regulatory burden for new ingredient compliance.

6. Labeling

Food labeling is one of the most heavily scrutinized areas by the FDA. All mandatory labeling information must be presented in English and formatted in accordance with detailed requirements set out in 21 CFR Part 101.

Mandatory labeling items for general prepackaged foods are as follows:

• Statement of identity: name specified by federal law, common or usual name, or appropriately descriptive term reflecting the true nature of the food

• Net quantity of contents: must be expressed in U.S. customary units; metric units are strongly recommended in practice

• Ingredient declaration: in descending order of predominance by weight

• Name and address of the manufacturer, packer, or distributor: country of origin statement required for imported foods

• Nutrition facts label

• Allergen statement for major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame)

• Product specific declaration if applicable

The statement of identity and net quantity of contents must appear on the Principal Display Panel (PDP). Other labeling items shall appear either on the principal display panel or on the information panel.

Nutrition facts label

Nutrition labeling is required for most prepackaged foods intended for human consumption unless a specific exemption applies.

Name and sequence of mandatory nutrients are as follows:

• Calories (may be expressed in kj)

• Total fat (g)

Saturated fat (g)

Trans fat (g)

• Cholesterol (mg)

• Sodium (mg)

• Total carbohydrate (g)

Dietary fiber (g)

Total sugars (g)

       Added sugars (g)

• Protein (g)

• Vitamin D (mcg)

• Calcium (mg)

• Iron (mg)

• Potassium (mg)

Nutrient content shall be declared on a per serving basis in relation to the applicable serving size derived from the Reference Amount Customarily Consumed Per Eating Occasion under 21 CFR 101.12. In addition, the nutrient content shall also be declared as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI) as appropriate, and expressed as a Percent of Daily Value (%DV).

Nutrition Facts Label

* Global Food Compliance Service

We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.

Our Services

• Food Ingredient Review

• Label Review

• Product Registration

• Regulatory Consultation

• Monitoring, Training and Customized Report

Particularly, if you're still unsure about the GRAS process or would like to explore it further, our team is here to help. We offer professional consulting and tailored support to guide food companies through GRAS-related challenges, including:

• GRAS Certification Consulting & Training

• Self-Affirmed GRAS

• FDA Notified GRAS

Please feel free to contact us via [email protected] if you need any help.