slider1

Food, Drug & Cosmetic (FD&C) Dyes and Lakes

Chemworld International is a certified supplier of FD&C dyes and lakes for the food, drug, and cosmetics industries in the United States. FD&C colorants are FDA-regulated certified color additives — the only colorants legally permitted in food, pharmaceuticals, and cosmetics sold in the US market. Our range covers all seven currently approved FD&C dyes (including FD&C Red 40, FD&C Yellow 5, FD&C Blue 1 & 2, FD&C Green 3, FD&C Red 3, and FD&C Yellow 6) as well as the full range of D&C and External D&C colors approved for cosmetic and drug applications.

FD&C Lakes are the water-insoluble aluminum salt forms of the corresponding dyes, used where a stable, dispersible color is needed in products with fat or oil bases, where water-soluble dyes may bleed or migrate.

FD&C Dyes vs. Lakes — Key Difference

FD&C Dyes are water-soluble and used in beverages, hard candies, gelatin desserts, and liquid pharmaceutical products. FD&C Lakes are oil-dispersible and are preferred for coatings, lipstick, pressed powder, tablets, and confectionery with fat or oil content.

Compliance

All Chemworld FD&C colorants are batch-certified by the FDA under 21 CFR Part 74. Certificate of Analysis (CoA) and batch certification documentation are provided with every order.

The color shades displayed should only be considered a representation of the indicated dye or pigment. Actual color can depend on varying factors, including the desired application. Product samples are recommended for testing before use and/or purchase.

FAQ

FD&C stands for Food, Drug, and Cosmetics — the categories of products in which these FDA-certified colorants are approved for use in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FD&C dyes are approved for use in food, drugs, and cosmetics. D&C dyes are approved only for drugs and cosmetics — not food. External D&C colors are approved only for externally applied cosmetics and drugs (not for ingestion or eye area use). The prefix indicates the approved use category.

No. FD&C Lakes are the aluminum salt form of the corresponding FD&C dye — they are water-insoluble and used as dispersions. Lakes provide stable color in products containing oils or fats where water-soluble dyes would migrate. Both the dye and its lake form are separately certified by the FDA.

Yes. All FD&C certified color additives we supply come with FDA batch certification documentation and a Certificate of Analysis (CoA). This documentation is required for regulatory compliance in food and pharmaceutical product labeling.

EU cosmetics regulation (EC 1223/2009) maintains its own approved colorant list, which partially overlaps with the US FD&C list. Some FD&C colorants are approved in the EU, others are not. Please consult with your regulatory team for EU compliance requirements and we can confirm which of our grades are appropriate.

FD&C Yellow 5 (also known as Tartrazine) is a synthetic lemon-yellow dye used widely in food, beverages, condiments, and pharmaceutical tablets. It is one of the most widely used certified food colorants in the US. All products containing FD&C Yellow 5 must declare it by name on the ingredient label under FDA regulations.