Which food companies need to apply for FDA certification?

Owners, operators, responsible agents, or authorized individuals of domestic or foreign facilities that produce/process, package, or store human food or animal feed for consumption in the United States must certify their facilities to the FDA.

Foods that require certification:

Alcohol, flour sugar products, beverages, sweets, cereals, cheese, chocolate or cocoa, coffee or tea, food pigments, regular diet or meal alternatives, including pharmaceutical food, functional food (including Chinese herbal medicine), condiments, aquatic products, food additives, sweeteners, fruits and their products, gel, ice cream, imitation dairy products, pasta, meat, milk, broth or jam, nuts, eggs, vegetables and their products Most or all products used for human consumption, such as vegetable oil, simulated meat, flour or starch

　　Cereals, oilseeds, alfalfa, amino acids, animal products, brewed products, preservatives, citrus products, distilled products, enzymes, fats, fermented products, aquatic products, dairy products, minerals, molasses, non protein nitrogen products, peanut products, animal waste recycled products, sieves, vitamins, yeast, pet food, and most or all of the products used for animal consumption

Which food companies do not require certification?

Individual households engaged in food production, processing, packaging, and storage;

Collection and distribution institutions and facilities for non bottled water and drinking water, such as urban water supply systems;

As a means of transportation for transporting food as a routine business;

Farm refers to a facility established in a common physical location, engaged in the cultivation of crops or the raising of edible animals (including aquatic products), or both, for cleaning, pruning, cooling, and other processing; 'Farm' includes facilities for packaging or storing food, and all such food is grown, raised, or consumed on the farm; It also includes facilities for producing/processing food, all of which are consumed on that farm or on other farms owned by the same owner;

A restaurant refers to a facility that prepares and sells food, directly provides consumers with immediate consumption, including pet houses, dog farms, and veterinary stations that directly provide animal feed. Facilities that provide food for interstate transportation rather than directly providing food to consumers do not belong to restaurants;

Retail enterprises refer to facilities that only sell food directly to consumers. Retail facilities include but are not limited to: grocery stores and supermarkets, vending machines, and supply centers. The meaning of this term not only includes facilities that sell food directly to consumers, but also facilities that produce/process food solely for the purpose of selling food directly to consumers from that facility.

Non profit food enterprises are charitable organizations that prepare, supply, or provide food to the public.

Non profit food companies must be exempt from federal income tax under the United States Internal Revenue Code 501 (c) (3).

Fishing vessels include not only fishing vessels for capture and transportation, but also fishing vessels engaged in decapitation, evisceration, and freezing solely for storage purposes.

Meat, poultry, and egg processing enterprises that are separately regulated by the United States Department of Agriculture (USDA).

Food FDA Recertification

Starting from July 11, 2011, in accordance with the provisions of the FDA Food Safety Modernization Act, foreign food production, processing, packaging, and storage enterprises exporting to the United States are required to update and authenticate their original FDA registration number every 2 years from 12:01 am on October 1 to 11:59 pm on December 31 in even numbered years;

Is the food FDA registration and certification number long-term valid?

It is not long-term and must be re certified every two years to ensure that the original FDA certification number remains valid

How to handle changes in authentication information?

When the required enterprise certification information changes, such as when the operator, agent, or US agent changes, the owner, operator, or their agent, as well as individuals authorized by them, must submit the enterprise's certification update information through the internet or email within 60 days of the change.

US Agent:

When certifying foreign facilities, a US agent (such as the importer or broker of the facility) must be designated, who must reside or have a place of business in the United States and must be located in the United States.

Key points for food FDA certification/registration monitoring:

1. Freshness of food;

2. Food additives;

3. Food biotoxins and other harmful ingredients;

4. Seafood safety analysis;

5. Food labeling;

6. Tracking and warning after food is launched

According to the anti-terrorism law passed by the United States Congress in 2003, food companies outside the United States must register with the FDA before exporting to the United States and provide shipping notifications to the FDA at the time of export

More information：Detailed understanding of FDA