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...

In addition to other label requirements, dietary supplements sold in the United States must provide the contact information of the person responsible for receiving reports of adverse events related to taking or using the supplement.  These adverse events must then be reported to the United States Food and Drug Administration.

The adverse agent contact information on your label must be either (1) a United States mailing address, or (2) a United States toll free telephone number.  The responsible person must be located within the United States.  If the label does not include a U.S. address or phone number, the product is misbranded and may be denied entry into the U.S.  US Imports can serve as the agent for purposes of this required adverse event reporting. 

What is the definition of an adverse event?

An adverse event is an undesired experience that occurs after using or taking a dietary supplement. These experiences can vary from mild, unexpected symptoms to extreme reactions. Risk...

Some major trading partners (such as the European Union and China) require that companies importing certain products be certified by the U.S. Food and Drug Administration (FDA). This is because these countries have certain restrictions on imports of some products. Common products requiring placement on an approved export list are dairy, honey, seafood, collagen/gelatin, and infant formula. Criteria for inclusion in the FDA Export List depends on the country of export and products being exported.   

For example, the EU only accepts live, chilled, and processed shellfish harvested in certain U.S. approved production facilities in certain states that have equivalency arrangements with the EU. These facilities will appear on the EU Interstate Certified Shellfish Shippers List (ICSSL).  

The only currently approved states on the ICSSL are Massachusetts and Washington. If your shellfish was grown and harvested in these states then you are eligible to apply for certification to export your ...

Businesses that export food products, dietary supplements and other FDA-regulated products from the United States are not required to obtain a certificate from the FDA to legally export these products. However, many foreign countries and customers will request a “certificate” with every shipment. To help businesses meet these requests, the FDA will issue certain export certificates upon request.       

The FDA will issue one of three types of certificates (listed below), depending on the type of product being exported and the businesses’ need.  

Certification to a Foreign Government

•  The certification to a foreign government is available for exporting conventional foods, food additives, food contact substances, infant formula products, and seafood that meet the Federal Food Drug and Cosmetic Act’s (FDC Act) requirements for marketing in the U.S. and may be legally exported from the U.S.
• This certificate states that a product (or products) are under the jurisdiction of the FDA and...

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...

Importers of food and dietary supplements into the U.S. must pay close attention to import alerts issued by the U.S. Food and Drug Administration (FDA). Failure to do so could cause your product to be detained at the port and ultimately refused entry.

What is an FDA import alert?  

An import alert is issued by the FDA to inform its field workers and the U.S. Customs and Border Patrol that a product appears to be in violation of the United States law. Food products subject to an import alert will also be subject to a Detention Without Physical Examination (DWPE). Products subject to a DWPE will be detained until the importer can show that the product is safe and meets U.S. standards. If an importer cannot demonstrate this, then product will be refused entry.   

Import alerts can be based on a number of key identifiers, such as: (1) the country or area of the product’s origin; (2) the name of the manufacturer; (3) the type of product being imported; (4) the name of the shipper; and/or...

Certain countries require U.S. exporters to be listed in FDA’s export list for certain products. Without a spot on the  export list, U.S. exporters of certain food products are barred from access to applicable foreign markets. If you’re wondering whether your U.S. food export business is subject to these requirements, keep reading to learn more about the FDA’s export list.

What products are required to be on an FDA export list?

Although each country requires export lists for different products, the types of products include:

•  Dairy
•  Seafood
•  Shellfish
•  Infant formula
•  Collagen products
•  Gelatin products

Which countries require exporters to be listed?

Each country has their own requirements for the types of products appearing on export lists., so U.S. exporters’ eligibility may differ from one country to another. The three countries/territories that require exporters to be listed on the FDA export list for certain products are: 

•  European Union — The EU uses certain co...

You’ve worked hard caring about and developing your food product. You know what’s in it and you selected the best ingredients because it matters to you what goes into your customers bodies. But just because you think it’s “healthy” doesn’t necessarily mean you can label your product that way without knowing the law.

Whether you can call your product “healthy” depends on a number of factors. The first thing to figure out is what laws apply to your product. If you import food into the United States, you are most likely governed by the Federal Food, Drug, & Cosmetic Act and subject to the FDA’s definition of “healthy.” Most processed and packaged foods (excluding primarily meat and poultry products) will fall into this category. 

The term “healthy” -- or any similar term -- can only be used if your food meets certain nutrient requirements for total fat, saturated fat, cholesterol, sodium and certain other nutrients. Note that if your food does not meet the low fat requirement, the FDA w...

Imported food, beverage and dietary supplements offered for sale as “organic” in the United States must be certified by the U.S. Department of Agriculture’s (USDA) National Organic Program (NOP), or under a program with equivalent standards. Labeling products as organic that are not certified can result in refusal of entry into the U.S., fines for each violation and/or criminal enforcement actions. 

Imports can meet these standards in one of three ways:

1. The product was certified by an agency accredited through the NOP. Accredited agencies are listed in the USDA’s INTEGRITY database, available online.
2. The product was produced under an equivalency arrangement with a foreign country. The only countries with equivalency agreements with the U.S. are Canada, the European Union, Japan, Korea and Switzerland.   
3. The product was produced under a recognition agreement, which is an agreement with foreign countries that do not have equivalent organic standards. These agreements allow specifi...

If you’re creating a label for your food product, you may be inclined to include the word “natural” on it. But think twice before you do, as many food companies have found themselves at the wrong end of a lawsuit for stating "natural" on their label.

“Natural” is not synonymous with “organic.” The Food and Drug Administration (FDA) has yet to define “natural”, but any food product labeled as organic must comply with the requirements of the Organic Foods Production Act of 1990, which is administered by the U.S. Department of Agriculture. In short, this means that organic ingredients must be grown on land free of certain pesticides, and for meat products, animals cannot be given growth hormones. Many consumers do not know there’s a difference between organic and natural, but legislators, food lawyers and the courts do. Using “organic” when not appropriate can get you into trouble.

What does “natural” mean on a food label?

Businesses are routinely face lawsuits for making “natural” cla...