FDA Registration of Food Facilities
The US Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to receive a FDA registration number by December 12, 2003. This act also requires that the FDA receive a prior notice for food imported into the United States so that the product is not refused. An FDA prior notice is an advance notification to the FDA that food is being imported into the US. The prior notice includes information usually provided by foreign companies to the Bureau of Customs and Border Protection (CBP) when they send food to the US. The FDA uses this data in advance of the arrival of the food product to assess and evaluate the information and decide whether to inspect the imported food.
Companies often use a Certificate of FDA Registration listing their FDA registration number as proof that the facility has complied with this rule and registered with FDA. There are instances when some companies and their products can be refused under the prior notice ACT. If a foreign manufacturer not registered with the FDA sells an article of food and imports or offers to import it, the item of food can be refused under section 801 of the ACT of prior notice. Similarly, if registration is required and the correct registration number of the foreign manufacturer is not submitted, the facility is considered incomplete for the purposes of prior notice.
The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be both safe and effective prior to marketing and widespread use in the general population. Drugs that are marketed without required FDA registration may not meet modern standards for safety, effectiveness, quality and labeling.
Similarly, The FDA Federal Register generally requires that drugs marketed in the United States should be both effective and safe prior to coming into market use with the general population. Some older products may be in the market without FDA registration, and many health care providers unaware of this status have continued to prescribe them. For this purpose, FDA has issued a guidance entitled "Marketed Unapproved Drugs Compliance Policy Guide" to make sure that all the drugs in use 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 FDA establishment registration numbers. Domestic facilities are required to receive FDA establishment registration numbers whether or not food from the facility that enters interstate commerce.
Foreign facilities that manufacture, process, pack, or hold food also require FDA certification unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities will require FDA Certification.
Exempt from FDA registration are farms, retail food establishments, restaurants, non-profit establishments that prepare food for or serve food directly to consumers, fishing vessels not engaged in processing (as defined in the FDA Federal Register), and facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture.
If the prior notice is not served, FDA may consider it as a factor in determining whether to examine and detain the food article.