Many companies selling food online through platforms like Amazon have asked Registrar Corp what steps they can take to assure they comply with U.S. Food and Drug Administration (FDA) standards. Companies selling food products online to customers in the United States are typically subject to the same FDA requirements as food companies selling through traditional channels such as ocean freight, air freight, or by truck.

Read on to learn how you can prepare your food products for U.S. distribution.

FDA Registration and U.S. Agent

Any establishment that manufactures, processes, packs, or stores food for human or animal consumption must register with FDA. If your facility is engaged in any of the above functions, you may need to register with FDA. Registered facilities must renew their registrations between October 1 and December 31 of even-numbered years. Registrar Corp can help you register with FDA.

If your facility is located outside of the United States, you must also designate a U.S. agent in your registration. A U.S. Agent is a representative located in the United States who can answer FDA’s questions about your food facility’s shipments as well as assist in organizing inspections. Since FDA often requires immediate responses to inspection and regulation inquiries, the U.S. agent must be available 24 hours a day. Designate Registrar Corp as your U.S. Agent, and our regulatory specialists will provide expert assistance and year-round compliance.

Prior Notice

Before you ship your food products to the U.S., FDA requires that you submit a Prior Notice to inform FDA of your shipment’s pending arrival. Anyone with knowledge of the shipment can submit Prior Notice.

Prior Notice must be submitted to FDA no less than:
• Two hours if arriving by road
• Four hours if arriving by air or rail
• Eight hours if arriving by water

For shipments arriving by international mail, Prior Notice should be submitted before the package is shipped. Registrar Corp can help assure your Prior Notice is filed properly and on time.

Labeling

FDA has extensive requirements for labels on food products, and labeling errors are one of the leading causes for the detention of shipments at the U.S. port of entry. Your product’s label must comply with all relevant FDA labeling regulations, including how nutrition facts are displayed, claims, and much more.

FDA recently required all food businesses to obtain updated labels for compliance with new labeling rules. All food businesses must comply with these regulations as of January 1, 2021. Registrar Corp’s Regulatory Specialists can review your label for compliance with FDA’s new rules.

Food Safety Plans

FDA requires most food facilities to develop and implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) Food Safety Plans. These plans involve an analysis of known and reasonably foreseeable food hazards as well as documented controls for those hazards.

A facility’s Food Safety Plan must be written and overseen by a Preventive Controls Qualified Individual (PCQI) who has the necessary training or experience needed to develop a Food Safety System.

While most facilities need to comply with requirements for the HARPC Food Safety Plan, there are some exemptions. For example, seafood and juice companies must implement Hazard Analysis and Critical Control Points (HACCP) plans.

Registrar Corp’s Food Safety Specialists can develop or review your FDA-compliant Food Safety Plan. Additionally, you can receive an FSPCA PCQI training certificate by completing Registrar Corp’s 100% Online, self-paced PCQI training.

FSVP Agent

Under the Foreign Supplier Verification Program (FSVP) rule, the U.S. owner or consignee of a food at the time of U.S. entry must develop and implement an FSVP for that product.

In the case of an exporter shipping a food product with no owner or consignee at the time of U.S. entry, the exporter must designate an FSVP Agent, as confirmed by a signed consent statement. For example, when a food company ships a product to a U.S. warehouse through a service such as Amazon and there is no U.S. owner, an FSVP Agent must be designated to fulfill FSVP requirements.

The FSVP Agent is responsible for writing and implementing an FSVP that, among other things, determines reasonably foreseeable hazards in a supplier’s food product, verifies a foreign supplier’s compliance with FDA standards, confirms the inclusion of allergens on product labels, and performs corrective actions as necessary.

The FSVP Agent must be a Qualified Individual who has training or experience necessary to perform FSVP responsibilities. This Agent must assure that the FSVP is properly developed and regularly updated for all products the Agent has agreed to maintain FSVPs for. Registrar Corp’s Qualified Individuals can act as FSVP Agent for your food products.

Need assistance with FDA requirements for selling your food products online? Our Regulatory Specialists can help you with your FDA-related needs. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at https://www.registrarcorp.com/livehelp.