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A Food Producer's Guide to FSMA and FDA Regulation

Getting Started: Small Food Importers


What You Need to Know:

There are reduced requirements for small food importers. Here’s how to answer critical questions and determine the requirements for your business:

Step 1: Determine the Foreign Supplier Verification Requirements for Your Business

All food import businesses are required to confirm that their foreign supplier is handling food in a way that does not pose a risk to the consumer in the US. This burden falls on the importer and is called Foreign Supplier Verification (you can check out our guide, here)

However, certain business types, including very small importers are exempt from the bulk of foreign supplier verification program (FSVP). requirements.

To qualify as a Very Small Importer, you must import <$1mm in food product value (or $2.5mm for animal feed).

In this case, you are subject to modified requirements as it relates to verifying your suppliers. You can see those modified requirements in our guide to FSVP or in the federal regulation in 21 CFR §1.512

If not, then another exemption might apply, or else you will be required to conduct a more robust Foreign Supplier Verification Program (FSVP). If are looking to implement this type of program, we have a step-by-step guide

Step 2: Determine the FDA Requirements for the Other Activities you Conduct

If your business warehouses, re-packs, processes, distributes or arranges transport for the food that you import, then those activities are likely subject to additional FDA regulation. See below to learn how specific activities are regulated.

Transportation

If you transport or arrange for someone else to transport your product, then you are subject to the Sanitary Transport Rule. The requirements are contingent upon your role in the process:

  • If you ship a product for someone else to transport then you are accountable for specifying the conditions (e.g. frozen, refrigerated) under which your product is shipped. This can be as simple as a written agreement with the company transporting your business (i.e. the carrier), This is not required when using postal services as your carrier.

  • If you load a product (e.g. you put product onto your own or someone else’s trucks) then you must ensure that the truck is suitable for transporting products.

  • If you receive product, then you’re required to make sure it arrives in safe condition (e.g. temperature and quality)

  • If you are the carrier for a food product (i.e. you operate the trucks which transport the product), then you must ensure the product is kept safe (e.g. temperature, quality) throughout the transportation process.

Warehousing

Warehousing refers to the storage of fully packaged foods. If you store your product in the US, then you’ll need to align your space with the FDA standards. This typically entails keeping your facility reasonably clean and keeping refrigerated product sufficiently refrigerated.

Check out our FSMA for Food Distributors guide for more details.

Re-Packing or Processing

If you modify the food after it has been imported — even repacking the product into new containers— then you will be required to meet the requirements for a normal food processor.

The basic operational requirements for a food operation are known as Current Good Manufacturing Practices (cGMPs), and they are summarized in our guides below:

You can also see our Guide to 117 Subpart B for a more comprehensive guide to cGMPs,

Next, there are requirements related to maintaining a safe supply chain and managing risks in your production process. Businesses which conduct under $1mm sales per year (they are called Very Small Businesses) typically qualify for the Qualified Facility Exemption. If you apply for the exemption and notify the FDA, then you don’t need to worry about the sections below. If you are not a qualified facility, then you’ll need to consider these sections:

1. Hazard Analysis and Risk Based Preventive Controls If your imported product is refrigerated, frozen, or requires any sort of control (e.g. cooking, sanitizing) before consumption, then you are likely required to implement a food safety plan. Writing and implementing a food safety plan is a comprehensive process that requires an employee who has been certified to author this plan.

If you’re looking to move quickly, a 3rd party consultant (like us) can be the best choice.

Learn more in our Guide to Subpart C Hazard Analysis and Risk Based Preventive Controls

2. Supply-Chain Program: If your process involves non-foreign suppliers, then you may have to conduct the same types of supplier verification activities described above for your domestic suppliers.

Learn more in our Guide to Subpart G

Step 3: Register Your Food Facility

If you have a site where you are holding, packaging, or processing food (including the food that you import), then you must register it with the FDA. Don’t worry, this won’t trigger an inspection, it just let’s the FDA know where you are operating from, what you’re doing, and that someday they’ll want to stop by and make sure you’re following the rules.

Check out our guide to learn more about facility registration

 
 

This applies to you if…

∆ You import food for consumption in the uS

∆ The value of products you import/process is <$1mm

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