FDA Compliance
FDA Consulting
In order to sell food products (including general foods, beverages, acidic and low-acid foods, health foods, etc.), animal feed and pet food in the U.S., proper notification, registration, and application with the FDA (U.S. Food and Drug Administration) or approval from the FDA are required before sales.
FDA Food Establishment Registration
All facilities related to the manufacture, packaging, and storage of food, beverages, and dietary supplements must register with the FDA. EATUSA can handle the registration and renewal procedures with the FDA on your behalf.
FDA U.S. Agent
When registering food production facilities with the FDA, overseas facilities are required to have a U.S. agent who can be contacted in the U.S. at any time.
This is a person who can be reached in the U.S. on a regular basis, and does not include answering machines or other such services.
EATUSA can act as your company's U.S. agent to contact the FDA on your behalf, based on our experience and track record in dealing with the FDA.
Labeling and Packaging
EATUSA performs label and package reviews for food and beverage products in accordance with FDA regulations. Labels and packages are items that are inspected by the FDA at customs clearance, and many products have been denied importation due to incorrect labeling or package descriptions.
FDA U.S. Agent Request Application
Please read the following information carefully before submitting your application.
If you have any questions before applying, please use the form.
① The fee for U.S. agent commissioning is US$800- per year (maximum 2 years).
The fee is US$800- per year (maximum 2 years). 2) One year is from January 1 of odd-numbered years to December 31 of the following even-numbered years, which is
the same period as the expiration date of the FDA facility registration.
(e.g., January 1, 2023 - December 31, 2024)
The fee will not change even if you apply in the middle of this period.
(3) Upon submission of this application form and payment of the commission fee, we will provide you with the name, address, telephone number, e-mail address,
and other details of the U.S. agent with whom we are affiliated.
(4) The fee should be paid in Japanese yen to the account in Japan indicated on the invoice.
The fee for the second and subsequent courses (US$800-) will be invoiced in October of each even-numbered year or later.
◆Included in this commission fee:
⑥ U.S. agent service for the applicant's FDA facility registration
⑦ If there is any communication from FDA during the term, we will promptly inform the client of the contents of the communication.
Items not included in this fee:
⑧ FDA facility registration work (registration work on behalf of the applicant, available for US$400)
⑨ Answering questions from FDA (extra charge, amount varies depending on the contents, from US$200)
⑩ Scheduling and attending factory audit, etc. (extra charge, amount varies depending on the contents, from US$5,000). (US$5,000 and up)
Food Export to the U.S.
When exporting food products from Japan, it is necessary to comply with various regulations in the U.S. on an item-by-item basis.
JETRO (Japan External Trade Organization) has compiled some easy-to-understand information.