The FDA took action against a food importer who failed to establish procedures to verify food safety standards of their foreign supplier before importing to the US. While investigating a product recall that was associated with to a particular brand of noodles, FDA investigators visited the offices of the U.S.-based importer New India Bazar, Inc. To their surprise they discovered the importer had neglected to meet the FDA’s food safety requirements and failed to develop, maintain and follow an FSVP plan. As a result, the FDA issued the importer a Warning Letter and gave the importer 15 days to respond or face penalties, such as detention of all associated products, refusal to permit the products to enter the US, or other potential criminal penalties.

The Foreign Supplier Verification Program (FSVP) rule was issued by FDA after passage of the Food Safety Modernization Act. The FSVP rule requires food and dietary supplement importers to perform “risk-based activities” to verify that the ...

When importing food, beverages, and dietary supplements into the United States after selling through Amazon, everything must comply with the FDA regulations for not only labeling and ingredients but claims as well. Your specialists here at US Imports are here to assist sellers with FDA compliance so they are not shut out of the largest market in the world – Amazon.

How do I sell legally on Amazon?

That is a great question! To start selling on Amazon legally, our Amazon Sellers Essentials Bundle has everything you need! There are several things that need to be completed including FDA Registration, U.S. Agent, FDA Label Review, FDA Claims Review, and FDA Prior Notice. Here is a little breakdown of what each one consists of.

• FDA Registration and U.S. Agent – Importers are responsible for designating an FSVP Agent upon entry of a food product into the United States. As an FSVP Agent, you must be a qualified individual that is physically located within the U.S. to serve as the importer
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Running a business can be overwhelming if you don’t have all your ducks in a row. You think you’ve checked all the boxes and are ready to ship to the United States, only to find out the facility that manufactures your products is not registered with the FDA. If this is you, US Imports is here to help.

If your brand is manufactured by someone else, you must get permission to register their facility with the FDA. The FDA requires that all U.S. and foreign facilities that manufacture, process, pack or store food, beverages, or dietary supplements exported to the United States must register. If your facility is not registered with the FDA, your business may face serious consequences.

Why Do You Have to Get Permission to Register a Food Facility?

Only the owner of a facility can register with the FDA. However, the owner can give someone written permission to register their facility. If you fail to obtain permission from the owner the registration may be rejected by the FDA and your prod...

Are you interested in selling dietary supplements on Amazon, but don’t know where to start?  We hear that a lot and that’s why US Imports has created an Amazon Sellers Essential Bundle. This bundle gives foreign-based companies the essential U.S. Food and Drug Administration (FDA) compliance tools they need to start marketing on Amazon for sales in the United States.  

When you buy this bundle, US Imports will handle your FDA manufacturing facility registration, file your first Prior Notice of Shipment to the U.S., and serve as your U.S. Agent for purposes of compliance with the Foreign Supplier Verification Act.  These compliance tools are must-haves for any non-U.S. company selling dietary supplements in the U.S. 

With the purchase of the Bundle, US Imports will also review your product label for basic FDA compliance and perform an in-depth review of one product claim on your label.   

What’s included in the Bundle

FDA Registration and U.S. Agent

Before you can start selling di...

In 2011, the FDA Food Safety Modernization Act (FSMA) amended U.S. food safety laws, requiring all foreign and domestic food businesses to register their facilities that manufacture, process, package or store food. This allows FDA to have access to all food facilities so that they may be inspected if necessary, in order to prevent serious adverse health reactions. 

Under FSMA, all food facilities must renew their registrations with FDA every even-numbered year. 

Domestic owners of a food business can submit a registration form for facilities online. However, foreign food businesses must designate a U.S. Agent for their facilities before they are able to register. This Agent must physically reside in the United States and be  available 24-hours a day to handle all communications with FDA regarding questions about shipments and scheduling facility inspections. Your agent must be listed on your FDA registration documents. 

Each facility is also required to provide a Unique Facility Ide...