FDA Color Additive Requirements

Food & Beverages | Color Additive Requirements

FDA strictly regulates color additives for use in the manufacture of foods, drugs, cosmetics, and medical devices. Under U.S. law, all color additives for use in cosmetics must have specific FDA approval for their intended cosmetic applications. FDA requires that color additives receive either batch certification (to ensure composition and color standards compliance) or an exemption from certification by FDA regulation.

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Use of an unapproved color additive or unsafe color additive violates FDA regulations. In addition, all color additives must be properly declared on food labels and beverage labels. Otherwise, the presence of the undeclared color additive will cause the imported food or imported beverage to be misbranded and possibly adulterated under U.S. law, depending upon the color additive that is present.

Color Additives Used in Other Countries, But Not in the U.S.A.

Some food color additives and beverage color additives used commonly in other countries are illegal or not permitted for food use in the United States. Using illegal food colors or non-permitted food colors in any food or beverage will likely result in FDA import detentions and delays, FDA Import Alerts, and FDA import refusal of the product because it bears or contains an unsafe color additive.

Color Additive FDA Import Alerts

FDA has a specific Import Alert for foods and beverages from foreign manufacturers and shippers that have been found to contain illegal food color additives and non-permitted beverage colors. FDA’s listing of the foreign manufacturer or shipper on FDA Import Alert is particularly troublesome for the foreign food or beverage manufacturer. The use of an unsafe color additive is a formulation problem that can only be remedied by reformulating the product. FDA routinely tries to capture such shipments containing non-permitted food colors or illegal beverage colors in order to place the foreign manufacturer on FDA Import Alert. Once on an FDA Import Alert, the foreign manufacturer’s imported food must be tested by private lab analyses to prove that the illegal or non-permitted color is not in the product anymore. This creates uniform FDA enforcement in all ports of entry — making it difficult, if not impossible, to evade FDA—and significantly increases the costs to the importer. Foreign manufacturers can petition FDA for removal from FDA Import Alerts, but specific criteria must be followed and evidence must be submitted for FDA review.

Undeclared Color Additives; Improper Declaration of Color Additives

Other routine problems involving imported food or imported beverage color additive violations include failing to declare on the food label or the beverage label the presence of a color additive. Such foods or beverages are considered misbranded under the Food Drug and Cosmetic Act and are subject to FDA import detention, FDA Import Alert, and FDA import refusal of admission. Again, FDA ordinarily will pursue such situations by adding the manufacturer or shipper on an FDA Import Alert, which lists the product that FDA found contained an undeclared color additive as well as its foreign manufacturer and foreign shipper.

Improper declaration of color additives (for instance, failing to use the color's correct name as defined by FDA regulation or failing to use its common or usual name on the food label or the beverage label) also results in a misbranded food or beverage. It is important that foods, beverages, dietary supplements, drugs, and cosmetics in particular declare all color additives in the product label's Ingredients Statement.

FDA has issued hundreds of Import Alerts covering imported food, imported beverages, and imported cosmetics that contain illegal colors, non-permitted colors, undeclared colors, or uncertified color additives. Proper product formulation, color batch certification, and ingredient labeling is critical to obtaining and maintaining access to the US market.

FDAImports.com, LLC regularly assists foreign and domestic manufacturers and importers in demonstrating to FDA that color additives contained in imported products are certified, permitted, legal, and properly declared. In addition, we review product ingredients to ensure the colors used in them are safe and legal. Further, FDAImports.com, LLC advocates before FDA by filing Import Alert petitions seeking (and obtaining) removal from FDA Import Alerts involving color additives in foods, beverages, dietary supplements, drugs and cosmetics.

Parallel Imports and Color Additives in Foods, Drugs and Cosmetics

In some instances, foreign firms manufacture the same foods, beverages, drugs and cosmetics using different color formulations for different markets. When a parallel importer purchases a food, beverage, drug, or cosmetic manufactured for a non-U.S. market and diverts it into the U.S. market, FDA may discover the presence of an illegal color. In that case, FDA will take action against the manufacturer, potentially even placing the manufacturer on FDA Import Alert.

Foreign manufacturers who have discovered that parallel shippers have exported their products (with illegal colors) to the U.S. must then demonstrate to FDA how they are controlling their supply chains to reduce the likelihood of future diversion. Without such evidence, FDA may not be willing to remove the manufacturer from an FDA Import Alert list.

FDAImports.com, LLC is well suited for managing these parallel market problems. Our services are highly integrated across the relevant areas of law (FDA, Customs, and International Transportation) enabling comprehensive legal and regulatory solutions.

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.