Uncertified Pigments & Neons - FDA Batch Certification

We Take Colors (And Our Customers) Seriously

TLDR: Any pigment labeled as containing polyeurethane 11 (and) a "certified" dye is NOT cosmetic grade, and you are legally liable for using it in your product! If you are interested in why, please read on!

We have seen many colors containing dyes or lakes marked as safe for cosmetic use, but are not. Nurture Handmade holds your safety in the highest regard, and will not falsely market uncertified colors as cosmetic grade. These colors are meant to be used in soap only, such as our neon pigments, Trial By Fire, and Really Red!

Cosmetic color regulations are very complex, and it is the responsibility of the supplier to hold knowledge of and navigate these regulations for you. The typical maker is not going to know that an uncertified color marked as certified is considered misbranded by the FDA. Unfortunately buying a misbranded color and using it in your products can have legal consequences - for you!

The "FDA may take regulatory action if we have reliable information indicating that a cosmetic is adulterated or misbranded. For example, FDA can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, FDA may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Cosmetics that are not in compliance with the law may be subject to seizure. “Seizure” means that the government takes possession of property from someone who has violated the law, or is suspected of doing so. FDA also may initiate criminal action against a person violating the law." Read more here.

How Color Certification Works

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 Handmade 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, as Polyurethane 11 (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.

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.

For example:

  • Uncertified D&C red no. 28 is acid red 92.
  • Uncertified FD&C yellow 5 is tartrazine.

Staying Legal

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.

The only batch certified neon colors available at this time are from an Ohio manufacturer named Dayglo. They have fantastic fluorescent colors such as the Elara Series. These mixtures are made from batch certified dyes and lot information is available for them. They featured in our Revolutionary Red Dye/Pigment Blend.

The INCI for truly batch certified neon colors will look like this:

  • Elara Series: Norbornanediamine/Resorcinol Diglycidyl Ether Crosspolymer, Aluminum Hydroxide, D&C Colorant(s)
  • Elara Luxe Series: Hydrolyzed Rice Extract, D&C Colorant(s) Aluminum Hydroxide

Know Who To Trust

Nurture Handmade will always protect our customers with staying on top of FDA regulations and sharing our knowledge with you! We will never knowingly offer misbranded colors and will maintain consistent contact with both manufacturers and the FDA Office of Cosmetics and Colors to ensure adherence to the latest regulatory standards.

Learn more about FDA Color Certification