Labeling errors are among the most common U.S. Food and Drug Administration (FDA) violations for food companies. There are scores of FDA labeling regulations that may be applied to your product, and any error could cause FDA to deem your product “misbranded”. If your product is misbranded, you could be subject to FDA enforcement actions. If you attempt to ship a misbranded product to the U.S., your shipment may be refused at the port of entry.

Distributing a misbranded product in the U.S. is a prohibited act under the Federal Food, Drug, and Cosmetic Act. FDA can bring a civil or criminal action against a person who commits a prohibited act, even if done unintentionally. To continue successfully distributing your product, it is useful to understand the common food labeling violations so that you can avoid making costly mistakes.

Continue reading to learn about some of the most common food labeling violations and their possible consequences.

Fails to Bear the Required Nutrition Information

FDA requires most food and beverage labels to contain a nutrition facts panel. This panel displays certain mandatory nutritional information about the product such as serving size, servings per container, declaration of specific nutrient values, declaration of the percent daily value of the nutrients, and more. The nutrition facts label must be properly formatted and must include the required information to be compliant. If any element is missing or erroneous, FDA may detain or refuse entry to the product, add the manufacturer to an Import Alert, or take other enforcement action against your company. Shipments under an Import Alert are subject to detention without physical examination (DWPE), which can cause significant obstacles in your supply chain and take months to resolve..

The nutrition facts panel must include all required nutritional information on the “information panel” of the container. Most nutrients must be listed using a specified nutrient name, unit of measure, and in an order and format set forth by FDA’s regulations.

Does Not Contain an Accurate Statement of the Quantity of the Contents

The contents of a food package or container must be stated on the label in terms of weight, fluid measure or numerical count. Importantly, it must include both the imperial (avoirdupois) and metric systems of measure.

FDA requires a net quantity statement to appear on the label, and must only reflect the amount of food in the package. The net quantity must appear on the bottom 30% of the principal display panel (PDP) of a food label using the minimum type size for the net quantity statement in relation to the size of the PDP.

Does Not Contain the Name and Place of Business of the Manufacturer, Packer, or Distributor

FDA requires that the corporate name and address of the manufacturer, packer, or distributor be listed on a food label.  If the given contact information is not for the manufacturer, the label must state the firm’s relationship to the product (“manufactured for”, “distributed by”, etc.). The label must include the contact’s city, state, zip code, and street address (if the street address is not listed in the local telephone directory).

Consequences of a Label Violation

As described above, FDA examines food product labels at the U.S. port of entry and may detain or refuse the product. FDA may also examine labels during routine facility inspections. If FDA finds a non-compliant label during an inspection, it may reinspect your facility at a later date to ensure the labels have been brought into compliance, while deeming product misbranded until the label is corrected. If FDA needs to reinspect your facility, your firm will be responsible for paying a reinspection fee.