When importing dietary supplements into the United States, importers must comply with the U.S. Food and Drug Administration (FDA) regulations. Specific FDA regulations govern proper labeling, approved ingredients, and more. Taking care to properly file a Prior Notice before the shipment arrives at the port is essential.

Our guide below provides importers with everything they need to know about importing dietary supplements into the U.S.

What are Dietary Supplements?

Dietary supplements are foods that are orally ingested, usually in the form of a pill, tablet, capsule, gummy, liquid concentrate, powders, drinks or energy bars. They are taken to supplement the diet, promote general health and well-being, and affect the structure or function of the human body (like drugs). Dietary supplements must be ingested, so they are never topical creams, ointments, or oral or nasal sprays. The FDA will review how a product is marketed when classifying how to enforce its standards and failing to d...

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...

Prior Notice must be provided to the U.S. Food and Drug Administration (FDA) for all dietary supplements offered for import into the United States. Prior notice consists of the following information that must be provided before arrival of the shipment at a U.S. port:

• Information about the product, including quantity, packaging type and number of packages, manufacturer information, and FDA Product Code 
• Country origin 
• Country from which the article is shipped
• Anticipated port of arrival 
• Anticipated arrival date
• Anticipated arrival time
• Whether the shipment has been denied entry into another country

You will also need to submit documentation of your shipment, including a bill of lading, airway bill or tracking number, as appropriate.

If you fail to file a timely Prior Notice, the FDA will not authorize release of your dietary supplements, and the Customs and Border Patrol will not allow entry of the shipment. If you fail to file within the required timeframe depending on t...

Prior Notice must be filed with the U.S. Food and Drug Administration for all food offered for import into the United States. Prior notice consists of the following information that must be provided to the FDA before arrival of the shipment at the first U.S. port:

• Product information, including quantity, packaging type, number of packages, related facilities (e.g., name of manufacturer), and FDA Product Code 
• Country of origin
• Country from which the article is shipped
• Anticipated port of arrival 
• Anticipated arrival date
• Anticipated arrival time
• Whether the shipment has been denied entry into another country

You will also need to submit documentation of your shipment, including a bill of lading, airway bill or tracking number, as appropriate.

If you fail to file a timely Prior Notice, the FDA will not authorize release of your food product, and the Customs and Border Patrol will not allow entry of the shipment. If you fail to file within the required timeframe depending on...

All exporters of food and dietary supplements to the United States are required to provide the U.S. Food and Drug Administration (FDA) with advance notice of all arriving shipments. This advance notice allows the FDA to more effectively protect the U.S. food supply against foreign threats. Your shipment will be refused at U.S. ports if you fail to file Prior Notice on time. This can have devastating effects that reverberate all the way down your supply chain and interfere with your business.

What is Prior Notice?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Act”) directed the FDA to take measures to protect the public from threatened or actual terrorist attacks on imported food. Under rules promulgated by the Act, the FDA requires importers to alert them of incoming shipments by filing Prior Notice. In 2011, the FDA published a final rule that a person submitting Prior Notice disclose the name of any country in which their product was refuse...

Are you aware of the requirements to import food and beverage products into the U.S.? The process can be quite complicated, especially for newcomers in the food business. From food safety requirements to labeling guidelines, the U.S. FDA closely monitors imported products to ensure full compliance with Federal regulations. If a product does not comply, the consequences can significantly impact your business including refusal of entry at the port or seizure of the products. Before you import into the United States it is important to review these 10 key things to protect your brand and business.

1. Importers are required to designate an FSVP Agent

An FSVP Agent acts as a liaison between your business and the FDA for the purpose of complying with the Foreign Supplier Verification Program. The FDA requires that an FSVP Agent is a “qualified individual”. The agent handles the scheduling of inspections, verifying a foreign supplier’s compliance with food safety requirements, and a variety ...