DOI: 10.21276/ajptr
Sun, 21 Jul 2019

Think Before You Ink US-FDA Measures for Tattoos and Permanent Makeup

M. P. Venkatesh1*, Srijata Sur1

1. Dept. of Pharmaceutics, Regulatory Affairs Group, JSS College of Pharmacy, Jagadguru Sri Shivarathreshwara University, SS Nagar, Mysuru-570015, Karnataka, India.


A tattoo is a form of body modification by inserting indelible ink into the dermis of the skin to change the pigment. Permanent makeup is a cosmetic technique which employs tattoos as a means of producing designs that resemble makeup. In the United States, the percentage of adults with minimum one tattoo has increased from 21% in 2012 to around 38% in 2016. The process of tattooing exposes the recipient to risks of infections with various pathogens, which are serious and difficult to treat. Other risks include allergic reactions, swelling and burning, granulomas, keloid formation and complications with MRI. Removal of tattoo is cumbersome. The pigments used in the inks are color additives, which are subject to premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other competing public health priorities and a previous lack of evidence of safety problems specifically associated with these pigments, FDA traditionally has not exercised regulatory authority for color additives on the pigments used in tattoo inks. FDA only monitors problems from tattoos and permanent make-up and alerts the public when they become aware of a problem. Consumers should be aware of the risks involved in order to make an informed decision. FDA urges consumers and healthcare providers to report adverse reactions from tattoos, permanent makeup, and temporary tattoos, as well as problems with tattoo removal. But it’s high time that FDA takes a strong call on this matter and strictly regulates these practices to prevent further harm to public.

Keywords: Tattoo, US-FDA, Permanent Makeup, Regulations

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