FDA on Tattoos and Permanent Makeup

Updated March 24, 2020:

FDA Webinar on Tattoos and Permanent Makeup (PDF):  'via Blog this'

The FDA hosted a webinar on tattoos and permanent makeup. Bhakti Petigara Harp, Ph.D., of the Office of Cosmetics and Colors, Division of Color Certification and Technology in FDA's Center for Food Safety and Applied Nutrition, provided an overview of the composition of tattoo and permanent makeup inks and the pigments used in them, as well as their regulatory status. Dr. Petigara Harp talked about problems that have occurred with the use of these inks, such as allergic reactions, infections, and scarring, and addressed FDA's response to these occurrences. She also discussed misrepresentation of these inks and pigments as "FDA approved." 

Background:
FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA traditionally has not exercised its regulatory authority over tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
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Additional Resources:
Tattoos & Permanent Makeup: Fact Sheet - FDA.gov

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