Import Alert 45-02
Import Alert 45-02: Foods Containing Illegal/Undeclared Colors
Background
Manufacturers must use FDA-approved colorants in food. FDA has determined that some colorants are unsafe and therefore illegal to use in human and animal foods. Colorants that are illegal in the United States may be permitted in other markets, such as the European Union, so a Company could accidently send the wrong product to the USA rather than a market where the color is permitted. Regardless of whether the manufacturer meant to use the illegal colorant or to send the shipment to the USA, FDA will add the manufacturer and its food to the Import Alert Red List.
How do Firms get on this Import Alert?
FDA reviews product labels and randomly tests products entering the United States. If an adulterated colorant is found, FDA detains the goods and adds the firm to Import Alert. Also, if a food label ingredient list declares a color incorrectly, FDA will presume that the color is not permitted or from an uncertified batch. This can cause FDA to add the company to the Import Alert Red List.
Effects on Businesses Involved
Manufacturers on this Import Alert will experience costly delays when FDA automatically detains the products. Some foods listed on this Import Alert are perishable. Automatic detentions of perishable food items can take so long to resolve, the shipment is spoiled and commercially lost. Moreover, many holiday items contain specific colors that FDA will suspect are illegal, resulting in additional testing of other foods from the same Red Listed manufacturers. Missing delivery windows for holiday items can be financially devastating to a company.
How do Companies get off this Import Alert?
Food Companies on the Red List will be required to identify, correct and document the manufacturing or labeling problems that originally caused FDA to add their food products to this Import Alert. A firm should consider receiving an Import Alert Petition Viability Review to correct the critical safety and manufacturing issues. In addition, if FDA originally placed the company on the Import Alert based upon a labeling error, food companies should consider a Food Label Review.
