Dynamic Color Inc – FDA Warning Letter, Dec 12, 2018

On September 18, 2019, the FDA issued a Warning Letter to Dynamic Color, specifically to President Darin Jenkins, following sample collections of their tattoo ink products. On November 7, 2018, and December 12, 2018, FDA collected samples of Dynamic Color WD1 (White) and Dynamic Color BLK (Black) from customers in Chandler, AZ, and Austin, TX, respectively. These products are classified as cosmetics under section 201(i) of the Federal Food, Drug, and Cosmetic Act (the Act).

FDA's microbial analysis of Dynamic Color BLK (Black) (Lots (b)(4) and (b)(4)) revealed significant microbial contamination, including the high-virulence pathogen *Bacillus cereus*, as well as *Staphylococcus equorum* and *Kocuria kristinae*. The presence of *B. cereus* is a serious concern due to its potential to cause severe skin infections and endocarditis, especially since tattooing bypasses the skin's natural protective barrier.

These findings render the Dynamic Color BLK (Black) product adulterated under section 601(a) of the Act, meaning it contains a poisonous or deleterious substance that may render it injurious to users. Introducing or delivering an adulterated cosmetic into interstate commerce is a violation of Section 301(a) of the Act.

Dynamic Color has already