FDA Requirements of all Texas Food Manufacturers and Wholesalers
- Food Facility Registration Requirement
Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in the regulation, for human or animal consumption in the U.S. must register with the FDA.
Information on registration may be obtained from the following website:
http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/default.htm
General information may be found by clicking on the following: Booklet (SECG): What You Need to Know About Registration of Food Facilities
November 2003
Or contact the FFR by phone at: 1-800-216-7331 or 301-575-0156
- Reportable Food Registry (RFR) Requirement
The RFR was established by section 1005 of the Food And Drug Administration Amendments Act of 2007 (Pub. L. 110-085) to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. The RFR covers all foods regulated by FDA except infant formula and dietary supplements. The RFR requires a responsible party to file a report through the RFR electronic portal when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.” “Responsible Party” is defined as the person who submits the registration information to FDA for a food Facility that manufactures, processes, packs or holds food for human or animal consumption in the United States. Federal, state and local public health officials may also use the portal to report information that may come to them about reportable foods. As of May 24, 2010, the RFR electronic portal became part of the Department of Human Services’ Safety Reporting Portal. For information please see:
http://www.fda.gov/ReportableFoodRegistry
The Safety Reporting Portal can be accessed at: www.safetyreporting.hhs.gov