Food Companies that want to export food to the United States must register Food Facility with the FDA, and must give the FDA a Prior Notice of Products to be exported before export.
The American Technology Clinical Solutions Inc. consults FDA-related work for companies that want to export to the U.S. for social contribution and, if necessary, deputizes FDA registration, inspection, approval, and agents through a trusted research institute in the U.S.
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended paragraph 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act: Federal Food and Drug Cosmetics Act). According to Section 415 a facility that manufactures, processes, packages and stores food ingested in the United States must submit information through registration with the FDA and agree to allow the FDA to inspect the facility at any time by means of the FD&C Act. In addition, every other year (every next year) these registrations must be renewed.
12 Items Required for Food Facility Registration
United States Agent registration of Section 7 is mandatory for food facility registration.
| 1 | Type of Registration |
| 2 | Facility Name / Address Information |
| 3 | Optional: Preferred Mailing Address Information |
| 4 | Parent Company Name / Address Information |
| 5 | Facility Emergency Contact Information |
| 6 | Trade Names |
| 7 | United States Agent |
| 8 | Seasonal Facility Dates of Operation |
| 9 | General Product Categories – Human/Animal/Both |
| 10 | Owner, Operator, or Agent in Charge Information |
| 11 | Inspection Statement |
| 12 | Certification Statement |
Registration period
about a week or three
Validity period
Until December of the following year after registration
Agency work
- FDA Industry Systems Account Open
- Handling all affairs related to food facility registration
- Identification and classification of classification
- U.S. Agent Registration and Cooperation
- Acting as Emergency Contact
- Notifying me that I need to extend before the expiration of my term.
Food labels are requested for most foods, including bread, cereal, cans, frozen foods, snacks, desserts, and beverages. Nutrient labels are voluntary for fruits, vegetables, and fish that are not processed. These foods are referred to as 'conventional' foods and, in the case of 'Dietary Supplements', a different label is requested.
* The terms 'Functional Foods' or 'Nutraceutical' are commonly used in the market, but the FDA regulates them under the FD&C Act.
General Food Labeling Requirements
1. Label Statements are all located in front of a. in Packages and Containers or b. There are two ways to locate PDP (parts shown to consumers at purchase) content on the front and Information Panel content on the right side of the PDP.
2. The identity, name and quantity of the product must be stated in the PDP.
3. Information Panel shall contain no other design elements and shall state the manufacturer's name, address, seller, Ingredient List, Nutrition Facts (nutritive component table) and, if required, allergy related details.
* Starting with a general and large framework like this, the product should be labeled after checking carefully according to FDA standards such as font size, language, % calculation of juice, multiplication notation, and nutrition table criteria.
Nutrition Facts example
As shown above, the font size and spacing should be carefully adjusted.
The criteria for the most recent changes in Nutrition Facts are as above.
Component inspection period
About three to six weeks
* The Nutrition Facts (component analysis table) on the label should generally be accurately recorded after component analysis through laboratories in the United States.
Agency work
- Process all tasks related to component analysis through American research institutes
- Provide a component analysis table
- Provide component analysis experimental data
- Partial support for label modification work
With the support of the U.S. Customer and Border Protection (CBP), the FDA is effectively checking that food imports to the U.S. do not threaten terrorism or public health. As part of this inspection, the FDA is receiving a Priority Notice for food imports to the United States. The exporter receives a confirmation number from the FDA through the Priority Notice when exporting.
Web Entry
The FDA Industry Systems opens the Web Entry to submit information about the type of food, delivery method, destination, expected arrival schedule, exporter, importer, forwarding company, etc.
Prior Notice
In addition to submitting the Web Entry information, we also open the Priority Notice and submit it together. Prior Notice prepares FDA product code, name, quantity, packaging type, and rejected record status for products, and submits information to companies exporting products after preparing the manufacturer, exporter, representative, recipient, etc. At this time, the manufacturer Food Facility Registration Number of the exported product is mandatory, so you must prioritize Food Facility Registration before exporting.
Registration period
About three to seven days
Validity period
One-time (new submission for each export)
Agency work
- FDA Industry Systems Account Open
- Priority Notice to handle all tasks
- Checking and categorizing product codes
- Acting on other inquiries to the FDA
CS Center
Tel 916) 940-8899 E-mail atcs@atcsfda.com