FD&C Dyes: What are They?

Have you ever thought about the color that is in your food, soft drinks, cosmetics, and medicines? If you have, you might wonder where they come from or what they are. Most of that color comes from Synthetic Organic Chemicals known as FD&C Dyes. The FDA approves these dyes for use in various products that we eat, drink, or put on our bodies.

The FDA has put these products through rigorous testing to make sure that they are safe for us to use. Some dyes are only for specific purposes while others have many different uses. Once the FDA approves a color for FD&C use, that product receives continuous trials. Testing of these types of products is ongoing, and if new information comes to light that is negative, de-listing of that product occurs. Also the FDA may place products on a conditional list if appropriate.

The US, UK, West Germany, and the European Economic Community all have standards for these types of products. There is a list of products that each country or countries has approved, and it is important to note that there are slight differences. In the US there are four different categories that the FDA is regulating.

• Food Dyes: There are synthetic as well as natural products. Some are subject to certification and others are not. There is a total of 11 products (synthetic) that need certification and 26 that do not need certification of which 6 are natural dye products.

• Drug Dyes:  There are those that are subject to certification (6) (dyes and pigments) and those that are exempt from certification (16) (natural dyes).

• Drug and Cosmetic Dyes:  This is by far the largest list and includes synthetic dyes and pigments all which are subject to certification. There is only one product on this list that is exempt from certification and that is a natural dye.

• Cosmetic Dyes: The are only 4 synthetic dyes that are subject to certification. There are 50 products that are exempt from certification. These are pigments, natural dyes, and metal salts.

All of the products in these categories are under a continuous review process conducted by the FDA. To get a product added to the list takes rigorous, long-term testing that also makes it expensive. Once a product makes it on the list the testing does not stop.

All dye batches made for FD&C use have to be tested to meet the minimum purity standards. If a batch passes that test, then it becomes certified and sold as an FD&C grade dye. After it’s certified, the dye has to follow the guidelines created by the FDA.

If a batch does not meet the purity specifications, industrial products are the only use it gets. It is not a FD&C grade product.

Because of the difficulty in setting up an FD&C grade production line, there are only a handful of recognized manufacturers of these products throughout the world. Two of them have manufacturing locations in the US. These plants are tested on a regular basis by the FDA to make sure they meet all regulatory requirements.

Food grade dye products have value to us because they make the appearance of our food and drinks more palatable. Drug dyes make the medicines we take more pleasing to the eye and easier to identify. Cosmetic dyes enhance beauty and allow creativity. If you are looking for FD&C dyes, click the picture below to check out First Source Worldwide’s list of Dyes, Pigments & Optical Brighteners. 

About the Author: James P. Bernard

James P. Bernard is Vice President of Colorants at First Source Worldwide. His skill at problem solving has led him through 48 years in the dye industry across virtually all areas of dye use. Once, he advised a university how to dye a bee population destroying crops. Now that’s strategic color management.

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