How can you know for sure what the U.S. Food and Drug Administration approves?
FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
Importers can import foods into the United States without prior sanction by FDA, as long as the facilities that produce, store, or otherwise handle the products are registered with FDA, and prior notice of incoming shipments is provided to FDA.
Please note that FDA does not issue or require any type of registration certificate. FDA considers adequate proof of registration to be a screen capture from the FDA food facility registration system that shows the company information and their food facility registration number(s).
Since you want to export to the US for the first time, here I am providing you with an overview of the exporting process. Please review the information in the following links to gain an understanding of the process:
FDA will schedule an inspection for a foreign facility and will notify facility management; however, in the meantime, with the issuance of a facility registration number, a company is permitted to ship product to the United States.
A U.S. agent must be identified in a foreign facility's registration application. (The designation of a U.S. agent is required when a foreign company registers a food facility with FDA. For more information on this, please access FDA's question and answer
document on food facility registration.
Within the "Definitions
" section, at Question(s) 21- there are various questions and responses on the role of the U.S. agent. Please review this section carefully. In particular, see the information beginning at C.7.1.)
Additionally, manufacturers of food packed in shelf-stable, hermetically sealed containers must register their facility and process
es with FDA.
For your operation in the United States, you will need to register that storage or warehouse location with FDA, too.
- Good Manufacturing Practices (GMPs) – your operations must comply with FDA’s agency GMPs. More detail is available below, per the Food Safety Modernization Act (FSMA).
- Labeling – Use FDA’s Food Labeling Guide for instruction on what is communicated on your label, and how to format labels for food packaged for consumer sale. We do not approve or review labels; we give you detailed instructions in this guide.
- Prior Notice – before each shipment of food to the United States, this online form, which gives us advance word and lets us know a commercial shipment of food is about to arrive from a registered facility, must be submitted. Often, the sender will submit this form, since global delivery services are reluctant to pick up food shipments that do not have a prior notice number on the outside of the package.
Obtain information concerning all of FDA’s requirements at How to Start a Food Business.
Additional information concerning the FSVP and the submission of U.S. importer information before a food shipment arrives can be found at ACE/ITDS
. That page has a link to a user guide for assistance, and other resources. If you require further information from FDA, please contact our Division of Import Operations at FDAImportsInquiry@fda.hhs.gov
, or 301-796-0356.Compliance dates
of the FSMA rules vary by rule and are phased in according to company size.
If you would like to take training on FSMA rules, please contact the Food Safety Preventive Controls Alliance (FSPCA
), which has partnered with FDA to conduct such training for FSMA rules such as Preventive Controls and the Foreign Supplier Verification Programs. FSPCA also has a Technical Assistance Network
that provides information on industry best practices, which may be helpful.