FDA registration of food establishments

The U.S. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, package, or hold food for human or animal consumption in United States receive a registration number from the FDA by December 12, 2003. This law also requires FDA to receive advance notice of food imported into the United States so that FDA certification is not denied. An FDA Prior Notice is advance notification to the FDA that food is being imported into the US. Prior Notice includes information that foreign companies typically provide to Customs and Border Protection (CBP). in English) when they ship food to the US FDA will now use this data prior to the arrival of the food product to analyze and evaluate the information and decide whether to inspect the imported food.

Businesses often use an FDA Certificate of Registration that lists their FDA registration number as proof that the facility has complied with this rule by registering with the FDA. There are cases where some companies and their products may be refused under the Prior Notice Act. If a foreign manufacturer who is not registered with the FDA sells, imports, or offers to import an article of food, then the article of food may be refused under ACT section 801 prior notification. Similarly, if registration is required and the correct foreign manufacturer registration number is not provided, the installation is considered incomplete for advance notice purposes.

The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be safe and effective before they are widely marketed and used in the general population. Drugs that are marketed without the required FDA approval may not meet modern standards for safety, efficacy, quality, and labeling.

Similarly, the FDA’s Federal Register generally requires that drugs marketed in the United States be both effective and safe before reaching the market for use in the general population. Drugs marketed without the required FDA registration and approval may not meet modern standards for safety, efficacy, quality, and labeling. Some older products may be on the market, which do not have FDA approval, and since many healthcare providers are unaware of this status, continue to prescribe them. To this end, the FDA has issued guidance titled “Unapproved Marketed Drug Compliance Policy Guidance” to ensure that all drugs are safe and approved for use by the general population.

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to receive facility registration numbers from the FDA.

Domestic facilities must receive FDA establishment registration numbers whether or not food from the facility enters interstate commerce.

Foreign facilities that manufacture/process, pack, or hold food also require FDA certification, unless the food from that facility undergoes additional processing (including packaging) by another foreign facility prior to export to the United States. USA. However, if the subsequent foreign facility performs only a minimal activity, such as affixing a label, both facilities require FDA certification.

Farms are exempt from FDA registration; retail food establishments; restaurants; nonprofit establishments that prepare food or serve food directly to consumers; non-processing fishing vessels (as defined in the FDA Federal Register) and exclusively regulated facility-wide facilities by the US Department of Agriculture.

If advance notice is not provided, FDA may consider this as a factor in determining whether and where to examine the article of food.