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FDA Food Registration Regulations

The U.S Food and Drug Administration (US FDA) is responsible for assuring that food sold in the United States is safe, wholesome, and properly labeled. This applies to food produced domestically. as well as food form foreign countries. The Federal Food, Drug, and Cosmetic Act(FD and C Act) and the Fair Packaging and Labeling Act are Federal laws governing food products under US FDA jurisdiction.

FDA Food Registration- US FDA Food Facility Registration Requirements

Food labeling is required for most prepared foods, such as bread, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary. Under the FDA's laws and regulations, FDA does not pre-approve labels for food products

FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

The Bio-terrorism Act requires US FDA registration for domestic and foreign food facilities, that manufacture, process, pack, or hold food for human or animal consumption in the U.S. Owner, operator, or agent in charge of domestic or foreign food facility is required to register their facility with the US FDA. Domestic facilities require FDA registration whether or not food from the facility enters interstate commerce. Foreign food facilities that manufacture/process, pack, or hold food also require US FDA registration unless food from that facility undergoes further processing (including packaging) by another foreign food facility before the food is exported to the U.S. However, if the subsequent foreign food facility performs an only minimal activity, such as putting on a label, both food facilities require US FDA registration. Acidified and law-acid food manufacturers require FDA food canning establishment (FCE) registration also. The dietary supplement manufacturers also require US FDA registration

FDACE PRO provides assistance in US FDA food facility registration and helps to comply with FDA bioterrorism act requirements. LMG also provides US FDA Agent services for foreign food facilities. Please note US FDA does not issue a certificate of registration, nor does the US FDA recognize a registration certificate issued by a third party, but the US FDA issue a registration number for each registered food facility, FDA registration number does not denote the US FDA approval of the facility.

FDACE PRO provides

FDA food facility registration assistance

Food Labeling Review

US FDA Agent service for foreign food facilities

FCE registration assistance