FDA FOOD
About
Domestic and overseas facilities that manufacture, process, pack, and store food and feed for consumption in the United States must register for the FDA food facility registration. Facility registration must be completed before manufacturing, processing, packaging, and storing food for distribution in the United States.
Exports of products made from domestic meat or poultry are restricted, and import is prohibited for all packaged foods containing substances harmful to the human body or prohibited food additives.
Necessity and Expected Outcomes of the Certification
- Essential for entering the US market.
- Enhancement of corporate and brand image.
- Establishment of product safety and reliability through FDA certification.
- New business opportunities
Certification Process
Certification Requirements
General food: processed food, canned food, frozen food, confectionery, beverage, natural food, etc.
- It is mandatory to attach a nutritional analysis table after a nutritional testing according to the FDA
- It is recommended to conduct a safety test along with the nutritional testing as it may be required by the FDA
- Mandatory labeling: English product name, net weight, nutritional information table, list of all ingredients, manufacturer’s name and address, country of origin
Health supplements: health functional food, etc.
- Safety must be checked after performing a product safety test before marketing the product
- Label and nutritional information must be indicated
Liquid products that are heat sterilized (low-acidic food/acidic food)
- The factories for the following foods must be registered before marketing and must be given an FCE (Food Canning Establishment) number. The sterilization process must be accurately registered to the FDA. Products can only be exported to the United States when they have the SID (Submission Identifier) numbers.
- Low-acidic food (pH>4.6, water activity>0.85)
- Acidic food (if pH≤4.6, water activity >0.85)
Pet Food
- Pet food must meet the requirements of the Federal Food, Drug, and Cosmetic Act like regular products.
GSC is doing our best to support customers' global corporate activities by getting the latest information and expertise through the US FDA U.S Agent that can respond in real time.
