FDA is the abbreviation of US Food and Drug Administration. As a federal government agency directly under the jurisdiction of the US Department of Health and Human Services, its main function is to supervise and manage foods, dietary supplements, medicines (including veterinary drugs), medical devices, cosmetics, radiation electronic products, vaccines, biomedical preparations and blood preparations produced and imported in the United States. All products subject to FDA supervision must be registered with the FDA before entering the United States and obtain a valid registration number, so that the goods can be cleared smoothly when entering the country. Otherwise, you will face the risk that the goods will be detained by FDA or refused entry. And for food and beverage &; Dietary supplements, FDA requires all enterprises engaged in food production, processing, packaging and storage to register with FDA before exporting food to the United States, and appoint an agent with an address in the United States to communicate with FDA on its behalf. In addition, before the goods arrive at American ports, the stakeholders of the goods also need to submit advance notice to FDA.

In addition to the necessary registration, is it necessary to have a HACCP plan? The answer is not necessarily. In 20 17, FDA promulgated the Food Safety Modernization Act (FSMA), which requires enterprises that produce, process, package and store food to establish and implement a food safety system including hazard analysis and risk-based prevention and control measures, that is, a written food safety plan. HACCP plan does not meet the requirements of FDA's latest food safety plan. Besides the original information of HACCP, it also needs to include preventive and control measures, such as allergen control and supply chain control. However, HACCP plan can still be used for some products, such as juice and seafood products.

In addition, FSMA also stipulates that food safety plans need to be established, supervised, implemented, recorded and maintained by properly trained PCQI. In recent years, not only FDA and American importers need to require enterprises to have this certificate, but also many other certifications, such as BRC and NSF, require enterprises to have at least one PCQI staff member.