FDA Compliances for Exporting Food Products in USA

| |

There is huge demand for food products and other items such as Drugs, Cosmetics, Colour Additives, Medical Devices, supplements, PPE Kits, etc.

So, if you plan to export food products or any other such item to the USA, you must know about FDA compliance. 

Mandatory FDA Compliances for Exporting Products to USA

1. US FDA Certification

US FDA Certification is the mandatory and primary requirement to start exporting food products to the USA.

A US FDA Certification serves as a formal acknowledgment that your product meets safety and efficacy standards for use. 

It signifies compliance with the Current Good Manufacturing Practices (CGMP) outlined by the FDA Guidelines for items exported to the United States. 

Failure to obtain this certification restricts entry into the US market.

You can learn more about US FDA Certification here: How to Get US FDA Certificate in India?

2. FDA Labelling Guidelines

A significant factor contributing to the rejection of shipments exported to the USA is the failure to comply with labeling regulations established by the FDA. 

From the Nutritional Facts chart and font size to the country of origin and information about food allergens, all these details must be included on the label to facilitate a more streamlined inspection process by the authorities.

A US FDA Certification expert can help you understand FDA Labelling Guidelines in depth thus saving you time and money while exporting to the USA.

3. Notification in Advance Before exporting

Submission of Prior Notice for each shipment is mandatory before you export your products to the USA. 

This involves providing advance information on the exporter, importer, product, and shipping method. 

You have to get the FDA issued a bar-coded confirmation number for Prior Notice, streamlining the entry process for food shipments into the United States and ensuring a hassle-free experience.

4. FSVP Agent or Importer

Foreign manufacturers must designate an importer for FSMA compliance in the USA. 

If you are an importer in the United States, you are responsible for supplier verification.

The fee for FSVP Agent services is determined by product and projected annual sales in USD.

5. GMP and HACCP Requirements 

Adhering to Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Points (HACCP) is crucial for food manufacturers, as these are key FDA regulations. 

To distribute food and dietary supplements in the United States, companies must adhere to GMP standards and maintain comprehensive documentation. 

Once the facility is registered, product shipments can commence; however, it’s important to note that the FDA may conduct inspections to verify food safety and GMP compliance.

Additional criteria for Low Acid or Acidified Products

All businesses engaged in processing low-acid and acidified foods within the United States, as well as processors from other nations exporting low-acid canned food or acidified food products to the United States, are obligated to register their processing facilities with the FDA. 

Entities such as wholesalers, importers, distributors, brokers, and the like are exempt from the registration and process filing mandate. 

Nevertheless, they ensure that the processing firms they represent adhere to all registration and process filing obligations.

Also Read:

How to verify US FDA Certification?


Take a call from Expert

If you want any other guidance relating to the US FDA Certificationplease feel free to talk to our business advisors at 8881-069-069.

Download E-Startup Mobile App and Never miss the latest updates narrating to your business.


How to Become a Member of Textile Export Promotion Council – RCMC License

Advantages of Incorporating Singapore Company 


Leave a Comment