Tattoos and Permanent Makeup Alarm

The inks used in tattoos and permanent makeup are subject to FDA regulation as cosmetics and color additives. However, the FDA has not attempted to regulate these inks. They have also not attempted to regulate tattooing and permanent makeup but have left them to local authorities and local laws. But now with more and more people opting for tattooing and permanent makeup, the FDA has come out with a public alert

One concern of the FDA is the quality of pigments and color additives being used, many of which are not approved for skin contact but are instead industrial grade, for example, "suitable for printers' ink or automobile paint." The FDA also wants consumers to be aware of the risks of tattooing and permanent makeup which include infections, allergic reactions, granulomas and keloids (disfiguring scars), and can even complicate a medical procedure (such as an MRI). This is not to speak of the difficulties removing tattoos or permanent makeup. Consumers are urged to report adverse tattooing reactions to the FDA.

Comment: The FDA now has more than 50 reports of "adverse events" and they are investigating "additional reports" regarding ONE manufacturer. How many reports will it take for the FDA to do more than issue another "Talk Paper?" The FDA is supposed to protect the health of the American public.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors,

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