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FDA

AK Science Research Intemational Co. AK Science Asia Co.,LTD

Pre-regulation is applied in Korea and Japan; however, post-regulation is applied in the USA. Strong penalties are applied when illegal acts are discovered afterward and it can be fatal to the reputation of the exporting company. Therefore, FDA inspection in advance is essential and highly recommended.
1. General food: Inspection of three essential items
[Ingredient test, nutritional analysis, heavy metal test (residual pesticide test)]

(1) Nutritional analysis: A total of 17 items are tested.
[Nutrition facts are provided] → Packaging design is produced → Product is attached
(Calories, fat calories, fat, saturated fatty acids, trans fat, cholesterol, carbohydrates, dietary fiber, sugar, moisture, salt, protein, vitamin A, vitamin C, sodium, calcium, iron, etc.)
(2) Heavy metal test: A total of 8 items are tested.
(Arsenic, barium, cadmium, chromium, lead, mercury, selenium, silver, etc.)
(3) Residual pesticide test: A total of 29 items are tested.
Additional Inspection by Food Items
◎ Shrimp: Antibiotic testing, etc.
◎ Green tea: This item does not require any testing, but the U.S. consumers select tea products after analyzing the nutrition, so it is recommended to inspect food products to increase credibility.

2. Health supplements: Any description of the health supplement's effectiveness is restricted. (If indicated, drug regulation is applied.)
(refer to http://www.cfsan.fda.gov/~dms/supplmnt.aspl)
The health food manufacturers are responsible for conducting and verifying food safety inspections. Same as the general food items, food labels are mandatory and it is necessary to accurately fill out Nutrition Facts through inspection.

3. Food Supplements: Functional and efficacy labeling is possible after applying for separate FDA approval. -> "FDA approved" phrase can be used (Supplement Facts is indicated)

4. Low-acid food: It must be heated to be included in the target requirements.
Criteria: PH concentration of 4.6 or more, the water activity of 0.85 or more ⇒ FCE, SID required
(refer to http://www.cfsan.fda.gov/~lrd/lacfregs.aspl)
FCE: Factory registration (different from bioterrorism-related facility registration)
SID: process registration
You must register the manufacturing plant and facility for the related product with the FDA (FCE), and submit the information about the manufacturing process (SID).
Once the manufacturing facility and manufacturing process is registered with the FDA, the manufacturer is assigned a Food Canning Establishment Number (FCE No) by the FDA.
The purpose of FCE No. is to facilitate tracking by the FDA in case of problems with related products.
For FCE, a company only needs to register once, but for SID, it is required to obtain a registration number related to the manufacturing process for each product.
These food manufacturers will receive FCE No. and SID No. after submitting to FDA under GMP (Good Manufacturing Practices) regulations.
The purpose of this regulation is to ensure safety from bacteria and their toxins, which are only achieved through appropriate manufacturing processes and methods, i.e. cooking at the appropriate temperature for sufficient time, adequately acidifying food, and reducing water activity.
SID Exemption Items
Bacteria cannot live or multiply in the food production based on the listed environment:
- If the PH concentration is 4.6 or less or the water activity is 0.85 or less
- Alcoholic beverages (alcohol below 7% is under the jurisdiction of the FDA, and if it is above 7%, it is under the jurisdiction of the U.S. Department of the Treasury)
- Carbonated beverages
- Fermented food
- Refrigerated food
- Jelly, Jam, and Butter (Fruit Butter)