FDA considers tattoo inks to be subject to regulation as cosmetics because they are “articles intended to be … introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” See 21 USC 321(i) definition for cosmetics. However, unlike typical cosmetics, tattoo inks are directly injected into a consumer’s skin by piercing the protective dermal skin barrier. Any puncture of the barrier increases the risk of infection and can lead to rashes, lesions, and scarring, among other potential health consequences. 

Tattoo ink manufacturers are responsible for ensuring that the ink has not been manufactured under insanitary conditions which may render the ink injurious to health. See 21 USC 361 (“Adulterated Cosmetics”). With approximately 30% of people living in the United States having a tattoo, the FDA has acknowledged the importance of taking necessary steps to ensure tattoo inks are manufactured under sanitary conditions.

To that end, on June 13, 2023, FDA issued draft guidance recommending steps manufacturers and distributors of tattoo ink can take to avoid microbial contamination. Recommendations in the draft guidance include testing the ink and its components, conducting adequate cleaning and sanitation of manufacturing equipment, ensuring sterilization methods are validated, and establishing corrective measures to prevent the release of any tattoo ink that testing shows contains microorganisms of a type or at a level that may harm any consumer.   

Under the Modernization of Cosmetics Regulation Act of 2022 (see p. 1389 of 1653), the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label is required to report any “serious adverse event” associated with the use of the product to FDA. FDA is also required to establish good manufacturing practice (GMP) regulations for cosmetics under that law but has not yet done so. Further discussion of the implications of this law can be found here.

FDA is accepting comments on the draft guidance until September 11, 2023.