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  1. Color Additives

Compliance & Enforcement of Color Additives

Resources for FDA compliance staff and news about enforcement action related to color additives. For additional information, see Color Additives.

Compliance Resources

Enforcement News

Import Refusals and Import Alerts Involving Color Additive Violations 

The Food, Drug, and Cosmetic Act authorizes FDA to detain a regulated product that appears to be out of compliance with the Act. Color additive violations are one reason for such detentions.

The purpose of an Import Alert is to identify and disseminate import information (problems, violative trends, etc.) to FDA personnel, thus providing for more uniform and effective import coverage. Import Alerts identify problem commodities and/or shippers and provide guidance for import coverage. They also identify products or shippers that have met the criteria for Detention Without Physical Examination.

Import Refusals and Import Alerts involving color additives are listed on FDA's Web site according to the product category in which the color additive violation occurs.

To learn what products have been detained upon entry into the U.S., check FDA's list of Import Refusals, which is updated monthly.

For your convenience, we have provided links to color-related Import Alerts below. We review this list regularly to keep it up to date; however, we recommend that you also access FDA's Import Alert Web page to make sure you have the latest information on this subject.

Warning Letters Citing Color Additive Violations 

The FDA issues Warning Letters to let companies know that they have violated the laws we enforce and to tell them what corrective action they need to take. For more information on Warning Letters in general, please see: General FDA Warning Letters.

Matters described in FDA Warning Letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. Warning Letters may be obtained by searching Warning Letters. If you would like to obtain available additional information on the current status of an issue in a particular Warning Letter on this website, please contact FDA or the recipient of the letter directly. Inquiries to FDA should be sent to: Food and Drug Administration, Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. For instructions on submitting a request online, see How to Make a FOIA Request.



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