Bringing food and ingredients from around the globe into the U.S. market is an exciting endeavor for any food brand. Importing food also comes with a series of regulatory requirements enforced by the FDA. While the process can seem daunting, here we'll break down the key elements of the import process and practical considerations for getting started.
All food items entering the U.S. face inspection by FDA agents at the border. The FDA electronically screens every shipment in advance, checking for any red flags that could indicate issues with food safety, adulteration, misbranding, or other non-compliance. Foods considered higher-risk are more likely to be flagged for additional inspection or sampling at the border.
To begin the import process, the importer must submit an entry with product details to U.S. Customs and Border Protection (CBP). This information is shared with the FDA to cross-check for any compliance issues.
Examples of common red flags that may lead to greater FDA scrutiny include:
If the FDA identifies any problems with an incoming shipment, such as issues with food safety, adulteration, misbranding, or non-compliance, they may refuse entry, request additional information, or impose other restrictions. If FDA finds that a product appears to violate FDA laws or regulations, the agency will typically place it on import alert and hold it for Detention Without Physical Examination (DWPE). This means that FDA can detain product without physically examining it.
It’s critical to be aware of the different types of import alerts, which can affect specific countries or areas, certain shippers, or entire product categories:
If a product is subject to DWPE, the importer will have the right to provide evidence to show that the product complies with U.S. regulations. Even if the shipment is eventually admitted, delays at the border can create uncertainty and major logistical headaches for a food business. Shipments may be held at port for days or weeks as FDA conducts testing or requests documents. Perishable products may spoil if the process drags on.
Companies should be prepared to quickly provide any records that the FDA requests to substantiate compliance and potentially have their shipment released. You may be responsible for extra storage fees, shipping delays, or logistics for the return and disposal of refused goods.
Have contingency supply plans in case inventory gets tied up. While not common, FDA action at the border can turn into an extended challenge. Staying on top of documentation and compliance will help minimize hassles.
In addition to screening imports at the border, the FDA also directly inspects and audits food production facilities. Both foreign and domestic facilities are selected for inspection based on their assessed risk level. Some key risk factors include: the type of food and inherent food safety risk, the risks of the manufacturing process, and the facility's past compliance and import history. FDA scaled back its inspection activity during COVID-19 but has been picking up inspections, especially at facilities making foods it deems higher-risk.
The person or company who owns the food when it arrives in the U.S. is considered the FSVP "importer" and faces the most regulatory responsibilities.
With the exception of dietary supplements, the importer must have a Foreign Supplier Verification Program (FSVP) in place for each imported food item. An FSVP outlines the importer's verification processes to ensure the safety and regulatory compliance of all imported foods. The FDA is currently emphasizing FSVP enforcement during its facility inspections, so importers must be prepared to present robust FSVPs.
Follow these best practices for successfully importing foods and supplements into the U.S.:
With the right preparation and support, food entrepreneurs can successfully navigate FDA import expectations and bring their products into the U.S. market.
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