FDA Color Additive Requirements
FDA Color Certification and Declaration Requirements
FDA strictly regulates food, drug, cosmetic, and medical device color additives. Many color additives still require batch certification by FDA (Department of Health and Human Services) prior to their use in FDA regulated products intended for the US market.
Some colorants used commonly in other countries are illegal or not permitted in the United States. Using illegal or non-permitted colors in any food,drug, cosmetic, or medical device subjects the product to FDA refusal of admission because it bears or contains an unsafe color additive. In addition, FDA may list the foreign manufacturer or shipper onto an FDA Import Alert because use of an unsafe color additive is a formulation problem that can only be remedied by reformulating the product. If the product is manufactured in large lots, the FDA's interaction with only one portion of the lot means that the rest of the lot may be imported in another port or by another importer. FDA routinely tries to capture such shipments under an import alert because that requires the importer to demonstrate, by private lab analyses, that the illegal or non-permitted color is not in the product. This reduces FDA's expenses -- but significantly increases the costs to the importer.
A product that contains an added color that is not declared on the product label is misbranded under the Food Drug and Cosmetic Act and is subject to FDA refusal of admission. Again, FDA ordinarily will pursue such situations by adding the manufacturer or shipper on an Import Alert, listing the product that FDA found contained an undeclared color additive.
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) misbrands the product. It is important that food, drug, and cosmetics in particular declare all color additives in the product label's Ingredients Statement.
FDA has issued hundreds of Import Alerts respecting food and cosmetic products that contain illegal, non-permitted, undeclared, or uncertified color additives. Proper product formulation, color certification, and ingredient label is critical to obtaining access to the US market.
FDAImports.com consultants and affiliated attorneys regularly assist 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.
You can find FDA's Color Additive import alerts by following the link to FDA Import Alert 45-02 (foods) or FDA Import Alert 53-06 (cosmetics).
If you find your company or product listed on one of the import alerts, feel free to contact us for assistance in obtaining removal from the alert.
In many instances, foreign firms manufacturer the same products using different formulations (and colors) for different markets. When a parallel gray marketer purchases product intended for a different market and diverts it into the U.S. FDA may discover the presence of an illegal or non-permitted color. FDA will take action against the manufacturer, by placing the manufacturer on import alert. FDA will often not take action against the parallel shipper, who actually cause product intended for another market to enter the U.S. market, creating the violation.
Foreign manufacturers who have discovered that parallel shippers have exported their products (with illegal or non-permitted colors) to the U.S. must demonstrate to FDA how they are controlling their supply chains to reduce the likelihood that such diversion will occur in the future. Without such evidence, FDA may not remove the manufacturer from an Import Alert.
FDAImports.com consultants and affiliated attorneys are 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 a comprehensive solution.
