The FDA issued a Safety Advisory on May 15, 2019 warning consumers, tattoo artists, and retailers nearly using or selling certain tattoo inks contaminated with microorganisms.

For details on all tattoo ink recalls, please see our Recalls & Alerts Page. Equally with whatsoever cosmetic product, if you feel an adverse result that yous call up may be related to the utilise of tattoo inks, you should written report the result to the FDA.

Consumers, manufacturers, tattoo artists, and health care providers may have questions on tattoos, permanent makeup, temporary tattoos, and henna (mehndi). Here is condom and regulatory information on these products.

Safety and Regulatory Groundwork

FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics. When we identify a rubber trouble associated with a cosmetic, including a tattoo ink, we investigate and take action, every bit appropriate, to prevent consumer illness or injury. The pigments used in the inks are colour additives, which are subject to premarket approval under the Federal Nutrient, Drug, and Cosmetic Human activity. However, considering of other competing public health priorities and a previous lack of evidence of safety issues specifically associated with these pigments, FDA traditionally has not exercised regulatory dominance for colour additives on the pigments used in tattoo inks. The actual do of tattooing is regulated by local jurisdictions.

During 2003 and 2004, FDA became aware of more than 150 reports of adverse reactions in consumers to certain permanent makeup ink shades, and it is possible that the actual number of women afflicted was greater. The inks associated with this outbreak were voluntarily recalled by the company that marketed them in 2004. In the jump of 2012, we received reports of infections from contaminated inks, resulting in their recall and market withdrawal. 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 addition, concerns raised by the scientific customs regarding the pigments used in tattoo inks have prompted FDA to investigate their safe use. FDA continues to evaluate the extent and severity of agin events associated with tattooing and is conducting inquiry on tattoo inks. As new data is assessed, nosotros will consider whether additional actions are necessary to protect public wellness.

In add-on to the reported adverse reactions, areas of concern include tattoo removal, infections that result from tattooing, and the increasing diversity of pigments and diluents existence used in tattooing. More than l different pigments and shades are in use, and the list continues to abound. Although a number of color additives are approved for use in cosmetics, none is approved for injection into the pare. Using an unapproved color condiment in a tattoo ink makes the ink adulterated. Many pigments used in tattoo inks are non canonical for pare contact at all. Some are industrial grade colors that are suitable for printers' ink or automobile paint.

Nevertheless, many individuals cull to undergo tattooing in its various forms. For some, it is an aesthetic option or an initiation rite. Some choose permanent makeup as a time saver or because they accept concrete difficulty applying regular, temporary makeup. For others, tattooing is an adjunct to reconstructive surgery, particularly of the face or breast, to simulate natural pigmentation. People who have lost their eyebrows due to alopecia (a form of pilus loss) may choose to have "eyebrows" tattooed on, while people with vitiligo (a lack of pigmentation in areas of the skin) may try tattooing to assistance camouflage the condition.

Whatever their reason, consumers should be aware of the risks involved in order to brand an informed determination.

Risks Involved in Tattooing

The following are the main complications that can upshot from tattooing:

  • Infection. Unsterile tattooing equipment and needles can transmit infectious diseases, such as HIV, hepatitis, and skin infections caused past Staphylococcus aureus ("staph") and other bacteria*. Tattoos received at facilities not regulated by your state or at facilities that utilise unsterile equipment (or re-apply ink) may prevent you from existence accepted as a blood or plasma donor for twelve months. Infections as well have resulted from contaminated tattoo inks, even when the tattoo creative person has followed aseptic procedures. These infections tin can crave prolonged treatment with antibiotics.
  • Removal bug. Despite advances in laser technology, removing a tattoo is a painstaking process, usually involving several treatments and considerable expense. Complete removal without scarring may be impossible.
  • Allergic reactions. Although FDA has received reports of numerous agin reactions associated with sure shades of ink in permanent makeup, marketed by a particular manufacturer, reports of allergic reactions to tattoo pigments accept been rare. However, when they happen they may be particularly troublesome because the pigments can be difficult to remove. Occasionally, people may develop an allergic reaction to tattoos they have had for years.
  • Granulomas. These are nodules that may form effectually material that the body perceives as foreign, such equally particles of tattoo pigment.
  • Keloid germination. If yous are prone to developing keloids -- scars that abound beyond normal boundaries -- you are at risk of keloid formation from a tattoo. Keloids may form whatever time you lot injure or traumatize your skin. Micropigmentation: State of the Art, a book written by Charles Zwerling, Chiliad.D., Annette Walker, R.N., and Norman Goldstein, G.D., states that keloids occur more frequently as a effect of tattoo removal.
  • MRI complications. There accept been reports of people with tattoos or permanent makeup who experienced swelling or burning in the affected areas when they underwent magnetic resonance imaging (MRI). This seems to occur only rarely and apparently without lasting effects.In that location have also been reports of tattoo pigments interfering with the quality of the MRI epitome. This seems to occur mainly when a person with permanent eyeliner undergoes MRI of the eyes. However, the risks of avoiding an MRI when your doctor has recommended one are likely to be much greater than the risks of complications from an interaction between the MRI and tattoo or permanent makeup. Instead of fugitive an MRI, individuals who accept tattoos or permanent makeup should inform the radiologist or radiologic technologist.

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A Common Problem: Dissatisfaction

A common problem that may develop with tattoos is the desire to remove them. Removing tattoos and permanent makeup can exist very difficult.

Although tattoos may be satisfactory at outset, they sometimes fade. Likewise, if the tattooist injects the pigments too deeply into the peel, the pigments may migrate beyond the original sites, resulting in a blurred appearance.

Some other cause of dissatisfaction is that the man torso changes over time, and styles modify with the season. The permanent makeup that may have looked flattering when offset injected may later disharmonism with changing pare tones and facial or body contours. People who plan to take facial cosmetic surgery are advised that the appearance of their permanent makeup may become distorted. The tattoo that seem stylish at the fourth dimension may become dated and embarrassing later. And changing tattoos or permanent makeup is not every bit easy as changing your mind.

Consult your healthcare provider about the best removal techniques for you.

Temporary Tattoos, Henna /Mehndi, and "Black Henna"

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days afterwards application. FDA has issued an import alert for certain strange-made temporary tattoos containing colors that are not permitted for this use or don't comport the FDA-mandated list of ingredients. Additionally, FDA has received reports of allergic reactions to temporary tattoos.

In a similar action, FDA has issued an import alert for henna intended for apply on the peel. Henna is approved merely for use every bit a hair dye, not for straight awarding to the skin. Also, henna typically produces a ruby-red brown tint, raising questions about what ingredients are added to produce the varieties of colors labeled as "henna," such as "black henna" and "bluish henna." Hair dyes are not approved for use on the pare, and some people may exist sensitive to them. FDA has as well received reports of allergic reactions to temporary tattoos that incorporate henna and those consisting only of hair dye. Some reactions take resulted in scarring.

To learn more, come across Temporary Tattoos, Henna/Mehndi, and "Black Henna."

Reporting Adverse Reactions

FDA urges consumers and healthcare providers to report adverse reactions from tattoos, permanent makeup, and temporary tattoos, also as problems with tattoo removal.

Consumers and healthcare providers can report bug to MedWatch, FDA'south problem-reporting program, on the Web or at 1-800-332-1088 ; or by contacting the nearest FDA consumer complaint coordinator.

For more information, see the boosted resources listed under Tattoos and Permanent Makeup.

* For related data on infections from tattooing, see the following documents from the Centers for Disease Control: Viral Hepatitis B Fact Sheet and "Methicillin-Resistant Staphylococcus aureus Skin Infections Among Tattoo Recipients --- Ohio, Kentucky, and Vermont, 2004-2005" (published in Morbidity and Mortality Weekly Report, June 23, 2006).

Related Resources

  • Tattoo Inks Pose Health Risks--Consumer Update
  • Tattoo Ink-Related Infections--Awareness, Diagnosis, Reporting, and Prevention
  • Think Before Y'all Ink: Are Tattoos Safe?--Consumer Update
  • Tattoos and Permanent Makeup: Market place and Chemistry--Webinar
  • Temporary Tattoos & Henna/Mehndi
  • Import Warning #53-xix: Detention Without Physical Examination of Henna Based Skin Color