Synthetic color additives, also known as certified colors, are required to undergo batch certification, a process in which the FDA analyzes a representative sample of each batch of the color additive to ensure it meets the required identity and specifications before it can be used.
Nurture Soap has a certification account with the FDA, and we send each lake and dye to be analyzed before being released for sale. However, the rules are different for mixtures. A mixture is a combination of two or more lakes or dyes, or the addition of a diluent. A diluent commonly used in neon colors is polyurethane 11, such as our neon colors. A mixture containing dye or lakes must be made using certified colors at the manufacturer. We asked the Color Certification Branch Chief at the FDA, and were told a mixture cannot be certified by a distributor or down-the-chain supplier. The manufacturer must do it.
Here's the tricky part: There is one manufacturer that most neon colors come from. They are not US-based and perhaps exempt from US law. They market the neons as, for example, Polyurethane11 (and) D&C red no. 28, but when asked they stated that the dye used (D&C red no. 28) was in fact, not certified.
Ouch. The issue is that each batch of dyes and lakes must be analyzed and certified by the FDA to be used in cosmetics. If not, the dye or lake must be identified by its uncertified name and marked as non-cosmetic grade.
- Uncertified D&C red no. 28 is acid red 92.
- Uncertified FD&C yellow 5 is tartrazine.
It’s against the law to market FDA-regulated products in the United States that contain a certifiable color additive from an uncertified batch. If you see a neon color containing polyurethane 11 and "certified" dye, buyer beware. It is not truly certified, and it is not cosmetic grade. It does, however, make strikingly beautiful soaps!
Learn more about FDA Color Certification