Food and beverages imported into the United States must comply with U.S. law which requires a Nutrition Facts Panel on every product label. Without a compliant Nutrient Facts Panel, your product may be detained upon entry at the U.S. port of entry. 

Every Nutrition Facts Panel must have the following:

1. Serving Information - the number of servings per container and the appropriate serving size
2. Calories - number of calories per package and per serving - this must be bolded and the largest font of the label
3. Nutrition - amount of macronutrients and certain micronutrients per serving 
4. Sugar - total sugars per serving and the amount of sugar added 
5. Daily Value  - the percentage of Vitamin D, Calcium, Iron and Potassium per serving
6. Ingredient List - list of all ingredients in descending order by weight and ingredients must be properly named

The Nutrition Facts Panel requirements were completely overhauled in 2018. Amendments to FDA regulations established new formatting requirement...

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...

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 food intended for human or animal consumption. Dietary supplements are included in this requirement. This allows FDA to have access to all food and dietary supplement facilities so that they may be inspected if necessary, in order to prevent serious adverse health reactions. Under FSMA, all dietary supplement facilities must renew their registrations with FDA every even-numbered year. 

Domestic dietary supplement companies can submit a registration form for facilities online. However, foreign dietary supplement companies 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 ...

When you’re importing food, beverages, or dietary supplements for sale on Amazon, you face a long checklist of steps to ensure your business complies with FDA regulations. Amazon is one of the largest markets in the world. In fact, more than 213 million unique U.S. individuals visit the site each month. As a result, many sellers vie to get their products featured on the popular platform. Although Amazon simplifies the selling process for many businesses, goods sold on Amazon still need to achieve FDA compliance. For example, Amazon sellers of food, beverages, and dietary supplements must obtain a DUNS number.

What is a DUNS number?

Created by Dun & Bradstreet, DUNS numbers are 9-digit identifiers assigned to businesses. DUNS numbers aren’t limited to businesses located in the United States. A business’s DUNS number allows third parties to look up information about that business, including their company name, location, and phone number. DUNS numbers can also provide details about any ...

Nearly all businesses must obtain an employer identification number (EIN) from the U.S. Internal Revenue Service (IRS). Foreign businesses need an EIN when filing U.S. Customs paperwork and registering a facility with the FDA.

What is an EIN?

An EIN is a 9-digit identification number for taxpayers. The IRS assigns an EIN to most businesses to comply with tax and U.S. Customs regulations. More specifically, it is used for paying taxes and claiming tax exemptions from the IRS. If you are buying and receiving goods in the U.S., your business will likely need an EIN number to comply with U.S. regulations.

How do you obtain an EIN?

Most businesses can apply for an EIN online through the IRS website. However, unless you either have a legal residence or principal place of business located in the U.S., then the online option will not work.

Most foreign importers will instead need to fill out Form SS-4 and send it in by mail or fax. Filling out this form without knowledge of the specificat...

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...

The Foreign Supplier Verification Program (FSVP) rule was issued by FDA as part of the Food Safety Modernization Act in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food or dietary supplements brought into the United States have been produced in a manner that meets U.S. food safety standards.

The FSVP rule requires food or dietary supplement importers to do the following:

• Conduct a hazard analysis to determine known or reasonably foreseeable hazards for each product requiring a preventive control
• Evaluate the foreign supplier’s performance and the risk posed by products requiring a preventive control 
• Use the evaluation to approve suppliers and determine appropriate supplier verification activities
• Conduct foreign supplier verification and related activities
• Take corrective actions (if necessary), and
• Maintain records of these FSVP activities

A key provision of the FSVP rule for foreign importers with no employees located in t...

Dietary supplements imported into the United States are governed by a complex body of laws and regulations. These laws and regulations govern manufacturing practices, product and ingredient safety, labeling, marketing claims, importing procedures, among other things.

Failure to comply can result in regulatory action by the U.S. Food and Drug Administration (FDA), including product detentions, warning letters, refusals of entry at U.S. ports, and fines. This is why it is imperative to be familiar with these laws and regulations before importing dietary supplements to the U.S.,.

FDA Facility Registration

All dietary supplement products offered for import must be manufactured in a facility register with the FDA. If the facility is located outside of the United States, you will need to appoint a U.S. Agent physically located in the U.S. to handle communications with the FDA. Upon registration, you will receive an FDA facility registration number. This number is important for confirming ...

All U.S. and foreign facilities that manufacture, process, pack or store food and/or beverages to be consumed in the United States must register with the Food and Drug Administration (FDA). Before importing food or beverages for sale in the U.S., familiarize yourself with these guidelines on registering your food facility with the FDA.

When to Register a Food Facility

The FDA requires food facilities to register before importing food into the U.S. in order to avoid regulatory enforcement action. After registering, you will receive a food facility number confirming your FDA registration. Most customers and suppliers, as well as customs officials, will require proof of U.S. FDA registration.

Renewing a Food Facility Registration

The Food Safety Modernization Act initiated the requirement of renewing food facility registrations every other year. Failure to renew a registration results in an expired registration. Food products offered for import with an expired registration will be ref...

Most food and beverage products sold in the U.S. require labels that meet FDA requirements. This includes prepared foods, such as cereal, snacks, desserts, and drinks. Foods that do not require labels are generally raw, like fruits and vegetables, and fish.

While it is the FDA’s responsibility to enforce labeling laws, the FDA does not pre-approve labels. Therefore, it is a seller's responsibility to ensure their food and beverage labels comply with FDA regulations. When products do not comply, sellers can face fines and delays that can severely impact their businesses — and their profits. Below are the basic guidelines to help your business avoid costly labeling mistakes.

Where should labels be placed?

There are two approved locations for the placement of FDA mandatory language. The front of the package, known as the principal display panel (PDP), and the panel immediately to the right of the PDP, known as the information panel. The PDP must list the name of your food or beverage a...