Tag: colorants
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.
Import Alert 53-06
Import Alert 53-06: Detention of Cosmetics Due to Illegal Colors
Background
FDA originally issued this Import Alert in 1985 because they detected illegal color additives in cosmetics manufactured by Taiwanese firms. Later, FDA noticed manufacturers in other countries were also using illegal colorants in mascaras, eye dust, lipstick and other cosmetic products. FDA created this Import Alert so districts would automatically detain imported cosmetics containing illegal colors. In 2018 the alert was revised to include misbranding charges in addition to the original adulteration charge.
How do Firms get on this Import Alert?
Today, the country-wide Taiwanese automatic detention has been removed from this particular Import Alert. Cosmetics are not subject to automatic detention unless they are from a manufacturer that FDA has added to the Red List. Some companies may be on this import alert simply because they declared legal, permitted colors incorrectly. FDA will interpret such errors to mean the colors discovered or declared to be in the cosmetics are not permitted, illegal and unsafe or are from uncertified batches.
Effects on Businesses Involved
A firm will find this import alert especially expensive to deal with. It is common for imported cosmetic shipments to contain many, many different cosmetics with different colors. Color is one of the primary attributes of most cosmetics. Even if future cosmetic shipments do not contain illegal colorants, FDA will still automatically detain all entries for private testing, prolonging the entry process. Because there are so many different colors in most cosmetic shipments, each cosmetic type has to be separately sampled and tested. That is expensive. In addition, cosmetics are common holiday gifts. When FDA adds a cosmetic company to an Import Alert, it makes it harder for them to meet critical deadlines for holiday sales. Because such a large portion of retail sales in the USA are generated prior to or during holidays, missing the window for holiday products could be very devastating.
How do Companies get off this Import Alert?
Cosmetic Companies on the Red List will be required to identify, correct and document the manufacturing or labeling problems that originally caused FDA to add them to the Import Alert. A firm should consider receiving an Import Alert Petition Viability Review to determine and address the critical issues. In addition, if labeling was involved in FDA’s decision to add the company to the Import Alert, cosmetic companies should consider a Cosmetic Label Review.
