According to the U.S. Food and Drug Administration (FDA), about 15% food supply of the U.S. is imported from overseas. More than 200 countries and territories and roughly 125,000 food facilities plus farms supply approximately 32% fresh vegetables, 55% fresh fruit, and 94% seafood that Americans consume annually. Facing such a large market, inevitably, stakeholders need to understand how the United States regulates imported food.

Food Regulatory Supervision System

Compared with Europe and other American countries, the United States implements a multi-departmental food safety supervision system, whose functions are mainly divided according to the type of food. Among them, USDA, FDA, and EPA are the three core institutions. Besides, the customs is responsible for monitoring imported food by regularly inspecting and retaining samples.

Major Food Safety Regulations

• Federal Food, Drug, and Cosmetic Act (FD&C)

FD&C is the core of the United States food safety law, providing the basic principles and framework of food safety supervision. It empowers FDA to supervise the production, processing, packaging, and storage of U.S. domestic and imported foods other than meat, poultry, and eggs.

FD&C stipulates general labeling requirements. In addition, along with other regulations (including Nutritional Labeling and Education Act (NLEA) and Fair Packaging and Labeling Act (FPLA), etc.), FD&C formulates the complete U.S. food labeling regulations. ChemLinked will have a webinar introducing the labeling requirements in the United States on November 22, 2022. Feel free to register here.

• Food Safety Modernization Act (FSMA)

FSMA is a significant revision of FD&C, emphasizing that food safety should be guaranteed based on the prevention of food safety problems. This Act expands FDA's law enforcement and management authorization for U.S. domestic and imported food safety supervision, especially strengthening the supervision for imported food and putting forward more stringent national food supply safety requirements. Details includes but are not limited to:

1. Expanding the current registration regulations to require all food facilities to be registered and re-registered every two years. FDA has the right to revoke the registration of a food facility if there is evidence that the products from the food facility may cause serious health problems or even death to humans and/or animals.

2. Authorizing FDA to require high-risk food to be imported with safety certification, and deny entry to food without certification or from foreign food facilities/countries that do not allow U.S. personnel to inspect.

3. Establishing a voluntary program for qualified importers so that the imported products can quickly enter the United States. Besides, it allows importers to participate in the voluntary program for qualified importers by using third-party certification or certification complying with the import certification regulations set by FDA.

• Federal Meat Inspection Act (FMIA)

• Poultry Products Inspection Act (PPIA)

• Egg Products Inspection Act (EPIA)

The above three Acts stipulate that FSIS, the Food Safety and Inspection Service under USDA, is responsible for regulating meat, poultry and egg products, ensuring that the products are hygienic, non-adulterated*, and correctly marked, labeled and packaged.

*''adulterated'' food refers to food that is poisonous, and/ or unhygienic, and/or contains harmful substances. For example：

a. Food with unsafe food additives, colourants, pesticide or veterinary drugs;

b. Food with excessive pesticide or veterinary drug residues;

c. Food produced under unsanitary conditions, or processed from sick or dead animals;

d. Food irradiation that exceeds the standard;

e. Foods in which active ingredients are missing or substituted;

f. Foods with other substances added to increase the weight and volume;

Meat, poultry and egg products are only allowed to be sold and transported after USDA’s inspection mark is applied. Countries that export these products to the U.S. are required to have inspection capabilities for corresponding inspection items equivalent to that of the U.S. Besides, the quality of products produced under the inspection system of the exporting countries should be equivalent to that of the U.S.

• Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

The Act requires EPA to register and set usage for pesticides used in pasture and feed crops, etc., and to avoid using chemicals, bacterial contaminants, and other substances that may threaten the food supply safety.

• Food Quality Protection Act (FQPA)

The Act establishes uniform standards for all pesticides applied to foods, provides exceptional protection for infants and children, and expedites the approval of pesticides with high levels of safety. Registration and residue limits for pesticides must be reassessed regularly to ensure that registration data are in line with the latest production situation.

• Public Health Service Act (PHSA)

The Act requires FDA to formulate regulations to prevent the spread of infectious diseases, clarify procedures for defining severe infectious diseases, formulate infectious disease control regulations, specify the responsibilities of quarantine officials, and make detailed quarantine provisions.

Risk Warning

The U.S. food safety early warning mechanism includes a series of laws and regulations, such as FQPA, scientific risk analysis principles and various early warning measures. Due to the different responsibilities undertaken by food management agencies in the United States, there are different early warning measures and diverse risk assessment methods.

The Hazard Analysis Critical Control Point (HACCP) is the most significant warning mechanism. It mainly analyses each link of food production, finds out the specific safety hazards, and takes corresponding preventive and control measures, to effectively control the main links that may have problems in food production, processing and packaging. In the United States, aquatic products, meat, dairy products as well as fruit and vegetable juices processing enterprise are obliged to apply for HACCP certification.

In addition, in food quality control, the production process applies to the Pesticide Program Residue Monitoring (PPRM), National Shellfish Sanitation Program (NSSP), etc. Food circulation process applies to the whole food safety monitoring approach, chain liability investigation, quality and safety self-inspection for foods on the market, etc.;

Food Import

When importing regulated products, importers must first submit a notice to customs. When FDA receives the notice from customs, it will decide whether to allow the product to enter the country. FDA will inspect imported food in three ways: "immediate release", "random inspection", and "automatic detention". Most of the imports are released directly, but after the product enters the market, the FDA will conduct random inspections and supervision to ensure that the food delivered to consumers is safe.

If the goods are selected for spot inspection, an FDA representative will take a sample from the goods for laboratory evaluation. When FDA requests an imported sample, the owner or recipient of the product should keep the goods and not distribute the product until further notice regarding the sample inspection results is received.

In the event of violation, FDA will send the owner or recipient of the goods a notice of "automatic detention". After the product is shipped to the United States, it must be tested in local U.S. laboratories and approved by FDA before release. Notably, the importer needs to bear the testing fee for "automatic detention" products.

Additionally, imported food (including food additives) and food contact materials must be registered or certified by FDA before they can be sold in the U.S. All companies engaged in producing, processing, packaging and/or storing food (including food additives, health food, etc.) must complete FDA food company registration. Registration renewals are required from October 1 to December 31 of each even-numbered year. Besides, the food enterprises shall guarantee to allow FDA to conduct factory inspections as permitted by the FD&C Act.