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U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
November 29, 2000; Updated July 1, 2004


TATTOOS and PERMANENT MAKEUP

The inks used in tattoos and permanent makeup (also known as micropigmentation) and the pigments in these inks are subject to FDA regulation as cosmetics and color additives. However, FDA has not attempted to regulate the use of tattoo inks and the pigments used in them and does not control the actual practice of tattooing. Rather, such matters have been handled through local laws and by local jurisdictions.

But with the growth in popularity of tattooing and permanent makeup, FDA has begun taking a closer look at related safety questions. Among the issues under consideration are tattoo removal, adverse reactions to tattoo colors, and infections that result from tattooing.

Another concern is the increasing variety of pigments and diluents being used in tattooing -- more than fifty different pigments and shades, and the list continues to grow. Although a number of color additives are approved for use in cosmetics, none is 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 at all. Some are industrial grade colors that are suitable for printers' ink or automobile paint.

Nevertheless, many individuals choose to undergo tattooing in its various forms. For some, it is an aesthetic choice or an initiation rite. Some choose permanent makeup as a time saver or because they have physical 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 hair 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 help camouflage the condition.

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

What Risks Are Involved in Tattooing?

The following are the primary complications that can result from tattooing:

The Most Common Problem: Dissatisfaction

According to Dr. Toombs, the most common problem that develops with tattoos is the desire to remove them. Removing tattoos and permanent makeup can be very difficult.

Skill levels vary widely among people who perform tattooing. According to an article by J.K. Chiang, S. Barsky, and D.M. Bronson in the June 1999 issue of the Journal of the American Academy of Dermatology, the main complication with eyelid tattooing is improperly placed pigment. You may want to ask the person performing the procedure for references and ask yourself how willing you are to risk permanently wearing someone else's mistake.

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

Another cause of dissatisfaction is that the human body changes over time, and styles change with the season. The permanent makeup that may have looked flattering when first injected may later clash with changing skin tones and facial or body contours. People who plan to have facial cosmetic surgery are advised that the appearance of their permanent makeup may become distorted. The tattoo that seemed stylish at first may become dated and embarrassing. And changing tattoos or permanent makeup is not as easy as changing your mind.

Removal Techniques

Methods for removing tattoos include laser treatments, abrasion, scarification, and surgery. Some people attempt to camouflage an objectionable tattoo with a new one. Each approach has drawbacks:

What About Temporary Tattoos?

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Most contain color additives approved for cosmetic use on the skin. However, the agency has issued an import alert for several foreign-made temporary tattoos.

According to OCAC Consumer Safety Officer Allen Halper, the temporary tattoos subject to the import alert are not allowed into the United States because they don't carry the FDA-mandated ingredient labels or they contain colors not permitted by FDA for use in cosmetics applied to the skin. FDA has received reports of allergic reactions to temporary tattoos.

In a similar action, FDA has issued an import alert for henna intended for use on the skin. Henna is approved only for use as a hair dye, not for direct application to the skin. Also, henna typically produces a reddish brown tint, raising questions about what ingredients are added to produce the varieties of colors labeled as "henna," such as "black henna" and "blue henna."

Reporting Adverse Reactions

FDA urges consumers and healthcare providers to report adverse reactions to tattoos and permanent makeup, problems with removal, or adverse reactions to temporary tattoos. Consumers and healthcare providers can register complaints by contacting their FDA district office (see the blue pages of your local phone directory) or by contacting FDA's Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS) by phone at (301) 436-2405 or by email at .

In addition, healthcare professionals and consumers may submit information about adverse events to MedWatch, the FDA Medical Products Reporting Program, as follows:

Consumers may obtain MedWatch reporting forms by calling the following FDA toll-free number: (888) 463-6332 [888-INFO-FDA]

For more information, see Temporary Tattoos and Henna/Mehndi and FDA's Import Alert on Tattoo Removers


FDA Alerts Consumers About Adverse Events Associated with "Permanent Makeup" July 2, 2004


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