U.S. FDA Registration & Labeling Compliance Assistance

U.S. FDA Color Additive Requirements

U.S. FDA strictly regulates the color additives that are being used in the manufacturing process of foods, beverage and dietary supplements. All color additives must be properly declared on the product labels. Use of unapproved color additives violates FDA regulations.

For the color additives used in food and beverage, and dietary supplements, U.S. FDA requires that manufacturers receive either batch certification or otherwise get an exemption from certification by FDA. To obtain the color additive batch certification, manufacturers must submit a sample of the Color Additive for each batch along with the related batch-specific paperwork. After proper examination, U.S. FDA will certify your Color Additive if the analysis of the sample meets the FDA requirements.

FDA Listing Inc. assists food, beverage and dietary supplement manufacturers in demonstrating to FDA that the color additives used in their manufacturing are certified, and approved by FDA. We initially provide you with an assessment of your color additive to determine if batch certification is needed or not. If so, our experts we will assist you through filling for batch certifications and the approval process. For assistance regarding color additive review and batch certification click here the start button in the front.