In September 2019, the FDA sent warning letters to three tattoo ink manufacturers about microbial contamination in the products. The agency conducted microbial analysis of tattoo ink samples collected from customers around the country.
The warning letters noted that the tattoo inks contained pathogens and microorganisms that rendered them adulterated under the Federal Food Drug & Cosmetic Act (FFDCA). The agency regulates tattoo inks as “cosmetics” under the FFDCA because the inks are introduced into the body to “promot[e] attractiveness” or “alter the appearance.” See 21 U.S.C. § 321(i).