FDA is the abbreviation of the U.S. Food and Drug Administration. It is a federal government agency directly under the U.S. Department of Health and Human Services. Its main function is to be responsible for food, dietary supplements, drugs (including veterinary drugs), medical devices, cosmetics, and radiation-related electronic products, vaccines, and vaccines produced and imported into the United States. Supervision and management of biopharmaceutical preparations and blood preparations. All products regulated by the FDA must be registered with the FDA before entering the United States, and only after obtaining a valid registration number can the goods be cleared smoothly when entering the United States. Otherwise, you will face the risk of the goods being detained by FDA or refused entry. For food, beverages and dietary supplements, the FDA requires all companies engaged in the production, processing, packaging and storage of food to register with the FDA before exporting food to the United States, and designate an agent with an address in the United States to communicate with the FDA on their behalf. . In addition, before the goods arrive at the U.S. port, the interested parties of the goods also need to submit a Prior Notice to the FDA.

In addition to the required registration, is it necessary to have a HACCP plan? The answer is not necessarily. The FDA promulgated the Food Safety Modernization Act (FSMA) in 2017. In addition to its mandatory registration and pre-declaration, it also requires companies that produce, process, package, and store food to establish and implement a system that includes hazard analysis and risk-based preventive controls. A food safety system that includes measures, i.e. a written food safety plan. The HACCP plan does not comply with the FDA's latest food safety plan requirements. In addition to the original HACCP information, it also needs to include preventive control measures, such as allergen control, supply chain control, etc. However, some products can still use the HACCP plan, such as juices, seafood products, etc.

FSMA also stipulates that the food safety plan needs to be established, supervised, recorded and maintained by a properly trained preventive control qualified individual (PCQI). In recent years, not only the FDA and US importers have required companies to have this certificate, but many other certifications such as BRC and NSF also require companies to have at least one PCQI personnel.