FDA Registration of Food Facilities

The US Public Health Security and Bioterrorism Preparedness and Response Act 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 receives a prior notice of food imported into the United States so that fda certification is not refused. A 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. FDA will now use 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 that lists their FDA registration number as proof that the facility has complied with this rule by registering with FDA. There are instances when some companies and their products can be refused under the prior notice ACT. If a foreign manufacturer who is not registered with FDA sells an article of food, imports or offers to import it, then the item of food can be refused under section 801 of the ACT of prior notice. Similarly, if registration is required and and the correct registration number of the foreign manufacturer is not submitted then 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 approval 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 in the market use in the general population. Drugs that are marketed without required FDA registration and approval may not meet modern standards for safety, effectiveness, quality, and labeling. Some older products may be in the market, that do not have FDA approval and since many health care providers are unaware of this status they have continued to prescribe them nonetheless. For this purpose, FDA has issued a guidance entitled “Marketed Unapproved Drugs Compliance Policy Guide” to make sure that all the 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 FDA establishment registration numbers.

Domestic facilities are required to 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 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 required FDA Certification.
Exempt from FDA Register 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 and where to examine the food article.

Russell K. Statman, Esq., is a founder and Executive Director of FDA Registrar Corp., a firm providing registration, compliance assistance and U.S. Agent Services for the food and beverage, cosmetics and medical device industries. Mr. Statman is an attorney-at-law representing firms in FDA-regulated industries for the past eighteen years. Contact the author at: statman@fdaregistrar.com