US FDA requirements for Food Companies interested in exporting to US

Navin Pathak | Updated Apr 24, 2021 11:05 pm

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.

Food facility registration can be completed on FDA's website, free of charge, here: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities. From that page, you will be able to create an account, login and complete the registration form. FDA does not require you to register your product, only your facility. Food facilities are subject to FDA inspection but do not need to be inspected before manufacturing, processing, packing, or holding food. For more information please see FDA's questions and answers on food facility registration.

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).

To contact the Food and Cosmetic Information Center, call 1-888-723-3366 or visit https://cfsan.secure.force.com/Inquirypage to submit an electronic inquiry.

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:

• Importing Food Products into the United States.
• Import Basics.
• FDA's Regulated Products
• Importing Human Foods.
• Registration of production, processing or packing plant as a food facility – this can be done online (free of charge), and usually the submitter will receive an email response with a registration number in a few days. 

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 processes 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.

Finally, you may be aware that FDA is implementing final rules issued under the Food Safety Modernization Act (FSMA).
Processed foods generally come under the Preventive Controls for Human Food final rule. Read a fact sheet, an FAQ and a small entity compliance guide on the rule. There is also a Food Safety Plan Builder tool online that will help the manufacturer meet the rule requirement for developing such a document.

Another FSMA rule, Foreign Supplier Verification Programs (FSVP), may also apply to you if you are considered the U.S. importer of an incoming shipment to the United States. For more information, please see a fact sheet, FAQs, a small entity compliance guide and two helpful short articles: Am I Subject to FSVP? and FSVP: What Do Importers Need to Know?

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.

To remain abreast of FSMA developments, please subscribe to FSMA Email Updates using the link near the top of the main FSMA webpage.