Tattoos are used for various reasons including beauty, self-expression, and after certain reconstructive surgeries to simulate skin pigmentation. A tattoo is permanent when a needle inserts colored ink into skin.
Common types of tattoos include:
- body art
- permanent makeup
- microblading inks
- temporary tattoos, henna/mehndi, and "black henna"
Inks used in intradermal tattoos, including permanent makeup, fall within the definition of cosmetics under the Federal Food, Drug, and Cosmetic Act. The actual practice of tattooing, including tattoo parlor practices and safety, is generally regulated by local jurisdictions.
Tattoos and Permanent Makeup
Because tattoos are permanent, they last a lifetime. Permanent makeup is a type of tattoo. A needle inserts colored ink into your skin to look like eyeliner, lip liner, eyebrows, or other makeup.
There are a variety of pigments and diluents being used in tattooing. More than 50 different pigments and shades are in use, and the list continues to grow. Although a number of color additives are approved for use in cosmetics, none are approved for injection into the skin. Using an unapproved color additive in a tattoo ink makes the ink adulterated. Many pigments used in tattoo inks are not approved for skin contact. Some are industrial grade colors that are suitable for printers' ink or automobile paint.
- Tattoos & Permanent Makeup: Quick Guide (PDF: 536 KB)
- Los Tatuajes y el Maquillaje Permanente: Una Guía (PDF: 522KB)
Tattoos can cause adverse effects, and some can be irreversible.
Some risks include:
- Allergic reactions
- Keloid formation
- Increased chance of sunburn, redness, or scarring
- Swelling and burning
- MRI complications
- Removal problems
When the FDA identifies a safety problem associated with a cosmetic, including a tattoo ink, the agency investigates and takes action, as appropriate, to prevent consumer illness or injury.
What Can Industry Do to Help Product Consumers?
Unlike most cosmetics, tattoo inks are injected into the dermal layer of the skin and present a unique challenge as they could potentially introduce harmful pathogens directly into the body. Because of this unique challenge, it is important for tattoo inks to be manufactured using methods to ensure a product is free of all forms of viable microorganisms.
On June 12, 2023, the FDA issued “Insanitary Conditions at Tattoo Ink Manufacturing and Distribution Facilities; Draft Guidance for Industry” to help tattoo ink manufacturers and distributors recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be potentially injurious to health. This guidance also recommends certain steps that manufacturers and distributors could take to help prevent the occurrence of these conditions, or to identify and remediate insanitary conditions that already exist during manufacturing and distribution.
Additionally, manufacturer testing of the final formulated tattoo ink products to ensure the inks are free of any microorganisms can help protect consumer safety. For more information on testing methods, please see Microbiological Methods for Testing the Sterility of Tattoo Inks and Method for Isolation and Detection of Nontuberculous Mycobacteria in Tattoo Inks.
The tattoo manufacturer and distributor are responsible for the safety of the products that they sell to retailers.
Safety Alerts, Recalls and Warning Letters
The FDA monitors the safety of tattoos and permanent make-up and alerts the public when the agency becomes aware of any issues associated with inks.
- In May 2019, the FDA warned consumers against certain contaminated tattoo inks.
- In the fall of 2017, a firm voluntarily recalled several colors and sizes of tattoo inks, due to microbial contamination identified by an FDA survey.
- In the summer of 2014, the FDA notified consumers of the voluntary recall of tattoo inks and needles due to confirmed bacterial contamination.
- In the spring of 2012, the FDA received reports of infections from contaminated inks, resulting in their recall and market withdrawal.
- In the fall of 2011, a firm initiated a recall for its product due to lab test results finding traces of bacteria in the ink.
- Additionally, in 2003 and 2004, the FDA became aware of more than 150 reports of adverse reactions in consumers to certain permanent makeup ink shades. The inks associated with this outbreak were voluntarily recalled by the company that marketed them in 2004.
For details on all tattoo ink recalls, please see our Recalls & Alerts Page.
- The FDA has also established Import Alert #53-19: Detention Without Physical Examination of Henna Based Skin Color.
Reporting Adverse Reactions
The FDA urges consumers and healthcare providers to report adverse reactions from tattoos, permanent makeup, and temporary tattoos, as well as problems with tattoo removal.
The FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on tattoo inks. As new information is assessed, the FDA will consider whether additional actions are necessary to protect public health.