Establishment Registration
U.S. Agent
FCE / SID
Labeling
Food Additives
Color Additives
FDA's Seafood Regulatory Program
HACCP
Foods that are not regulated by FDA

Establishment Registration for Food companies

• The 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 register with the FDA by December 12, 2003.
  
• 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 register the facility with the FDA.

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U.S. Agent for foreign food companies

• This is a requirement for all foreign facilities (located in outside of U.S.). U.S. Agent means an entity located in the U.S. that is designated by a foreign facility for purposes of the registration regulation. The U.S. Agent acts as a communications link between FDA and the foreign facility. It is important to note that the US Agent here is not an agent for commercial or distribution purpose.
  
• It is important to register facilities and designate a US Agent before importing into the US.

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FCE (Food Canning Establishment) and SID (Submission Identifier)

• The FDA requires registration, manufacturing, and process filing for low-acid canned foods (LACF: ph of 4.6 or above and water activity of 0.85 or above) and acidified foods (AF: ph of 4.6 or below and water activity of 0.85 or above) in hermetically sealed containers.
  
• After completing all registrations, process filing and relevant studies, the FCE number and SID can be issued. The application for the FCE number requires information on adequate processing, controls, and appropriate processing methods, such as cooking the food at the proper temperature for sufficient times, adequately acidifying the food, or controlling water activity.
  
• The facility registered for the FCE needs to comply CGMP (Current Good Manufacturing Practice) regulations.

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Nutrition Labeling--Applicable Foods

• Nutrition labeling is required for most foods. In addition, voluntary nutrition information is available for many raw foods like fruits, vegetables, fish and meat (USDA's program should be referred).
  
• Under the label's "Nutrition Facts" panel, manufacturers are required to provide information on certain nutrients. The mandatory (underlined) and voluntary components and the order in which they must appear are:
  total calories, calories from fat, calories from saturated fat, total fat, saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, sodium, potassium, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugars, sugar alcohol (for example, the sugar substitutes xylitol, mannitol and sorbitol), other carbohydrate (the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol if declared), protein, vitamin A, percent of vitamin A present as beta-carotene, vitamin C, calcium, iron, other essential vitamins and minerals

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Food Additives

• If a substance is added to a food for a specific purpose in that food, it is considered a direct additive. For example, the low-calorie sweetener aspartame, which is used in beverages, puddings, yogurt, chewing gum and other foods, is considered a direct additive. Many direct additives are identified on the ingredient label of foods.
  
• To market a new food or color additive, a manufacturer must get the FDA approval in advance. Approximately 100 new food and color additives petitions are submitted to the FDA annually. Most of these petitions are for indirect additives such as packaging materials.

Color additives

• The FDA requires domestic and foreign manufacturers of certain colors to submit samples from each batch of color produced. The FDA scientists test each sample of these colors to confirm that each batch of the color is within established specifications. These certified colors are listed on labels as FD&C, D&C or external D&C.
  
• Using the uncertified versions of color additives that require certification is illegal in foods, drugs, cosmetics, and medical devices. Therefore all manufacturers need to confirm whether the FDA has certified each color they use. This violation is one of the most common reasons for detention or refusal.

The Food and Drug Administration's Seafood Regulatory Program

• The FDA operates an oversight compliance program for fishery products. Processors or importers are responsible for the product's safety, wholesomeness, identity and economic integrity, and they must comply with regulations such as the Federal Food, Drug and Cosmetic (FD&C) Act and the Fair Packaging and Labeling Act (FPLA).
  
• In addition, the FDA operates the Low-Acid Canned Food (LACF) program, which is based on the Hazard Analysis and Critical Control Point (HACCP) concept, and is focused on thermally processed, commercially sterile foods, including seafood such as canned tuna and salmon.

HACCP (Hazard Analysis and Critical Control Point)

• The HACCP focuses on preventing hazards that could cause food-borne illnesses by applying science-based controls, from raw material to finished products. Traditional approach of spot-checks on manufacturing conditions and random sampling of final products for ensuring safe food tends to be reactive, rather than preventive, and can be less efficient than the new system.
  
• Many of the HACCP's principles already are in place in the FDA-regulated low-acid canned food industry. The FDA also established HACCP for the seafood industry and the juice industry. The agency intends to eventually use it for much of the U.S. food supply.
  
• As well as domestic companies, foreign companies are required to implement the HACCP. Not only for the purpose of fulfilling the requirement, many foreign firms use the plan as a differentiating marketing strategy.
  
• HACCP involves seven principles:
  Analyze hazards
  Identify critical control points.
  Establish preventive measures with critical limits for each control point.
  Establish procedures to monitor the critical control points.
  Establish corrective actions to be taken when monitoring shows that a critical limit has not been met
  Establish procedures to verify that the system is working properly
  Establish effective record keeping to document the HACCP system.

Foods that are not regulated by FDA

• Alcohol
• Products without much nutrition (seasonings or coffee)
• Foods that are made and sold immediately
• Restaurant food
• Meat & Poultry