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...

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...

Food products imported into the United States must have an ingredients statement declaring all ingredients contained in the product. But it’s not as simple as a mere declaration. FDA regulations require that ingredients be listed in a certain order, named in the correct manner, and placed on a specific location on the packaging. Therefore, it is not a given that you can simply use the product’s existing ingredient list. You must review the ingredient statement for FDA compliance.

Complying with U.S. labeling requirements is not just a matter of common sense, nor is compliance something that can be done after your import deal is inked. As you will see below, FDA regulations require a meticulous examination of every ingredient to determine the proper placement, nomenclature and other ingredient statement requirements.  

Failing to comply can be very costly. Ingredient errors and omissions are one of the top reasons for food being denied entry into the United States. Inaccurate ingredie...