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Tattoo Dyes in FDA Crosshairs

Feb 11, 2008 | Parker Waichman LLP

Tattoo dyes and inks are finally getting some attention from the Food & Drug Administration (FDA) . The FDA is running the first-ever studies of tattoo dyes, prompted in part by reports of skin rashes, swelling blisters and other side effects linked to some types of tattoo dyes and inks.

The consequences of careless tattooing can lead to skin infections and diseases such as hepatitis, tetanus and HIV from the use of non-sterile equipment. But up until now, tattoo dyes and inks have received little scrutiny from the FDA, even though such cosmetic products fall under its jurisdiction. As tattooing has become more mainstream and popular, some consumer advocates have called for change.

Considering how large the tattoo industry actually is, it is shocking that federal health regulators have ignored it for so long.  Some 45 million Americans have at least one tattoo – and some have many more.  Inc. Magazine recently estimated there are 15,000 tattoo shops nationwide -- a $2.3 billion industry of mostly small, individually owned shops.  Regulation of tattoo shops has been left up to state and local authorities, and most regulations focus on issues of basic sanitation and health codes.

The FDA tattoo studies will focus on the chemical make up of tattoo dyes and inks, as well as the way these chemicals interact with body chemistry.  The FDA also wants to know the long-term safety effects of the tattoo dyes and what tattoo products may pose the greatest risk to consumers.

Some say the FDA’s action is long overdue.  "The FDA doesn't do anything. If you are concerned about public safety, we need rules and guidelines," Charles Zwerling, an ophthalmologist and chairman of the American Academy of Micropigmentation, a non-profit group that certifies permanent makeup professionals, told The Chicago Tribune.

Many tattoo dyes and inks have caused serious health problems in some recipients.  According to the Chicago Tribune, some of the inks have caused allergic reactions, including itchy and inflamed skin. In the case of a 2005 recall of 52,114 containers of pigments made by a Texas company, more than 150 cases of swelling, cracking, peeling, and blistering, scarring and chronically inflamed tissue were reported to the FDA.

The Chicago Tribune said that the FDA is aware of more than 50 pigments used in tattoo inks, none of which have been approved for injection into the skin. The federal agency said some of these pigments are "industrial strength colors suitable for printers' ink or automobile paint."  But budget constraints and staffing issues have kept the tattoo dyes off of the FDA’s radar until now.

According to The Chicago Tribune, the FDA’s tattoo research could take several years.


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