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FDA Will Review Toxic Tattoo Chemicals


Permanent makeup involves tattooing the face to create effects similar to those produced by more conventional makeups such as eye or lip liners.

News of the study was welcomed by many consumer advocates and health professionals.

"The FDA doesn't do anything. If you are concerned about public safety, we need rules and guidelines," said Charles Zwerling, an ophthalmologist and chairman of the American Academy of Micropigmentation.

The new investigation marks the first time the agency has chosen to exercise its authority to regulate the inks used in tattooing, an authority granted by the Federal Food, Drug & Cosmetic Act. Due to budget limitations and having more pressing priorities, the FDA has previously left the $2.3-billion tattoo industry to regulation by individual states, which have focused on basic sanitation. Tattoo colorants are a legal paradox. Although they are used for cosmetic purposes, the colorants are placed in the human body (injection/skin penetration), a procedure which seems to be outside the scope of the Cosmetic Act.

It has long been known that using non-sterile tattoo needles can lead to skin infections or even more serious conditions including tetanus, hepatitis and HIV.

The FDA also plans to study how the chemicals contained in tattoo ink break down in the body, whether they pose long-term health risks, and whether some chemicals pose greater risks than others. The study is expected to take several years to complete.

According to FDA spokesperson Stephanie Kwisnek, the investigation was triggered by reports of adverse skin reactions to tattoo inks, the growing popularity of tattooing among the U.S. population, and "concerns raised by the scientific community."

The European Commission had sent out a warning already in July 2003, where they asked 'Would you inject car paint into your skin?,' that somehow was summarizing the possible health risks associated with tattooing. The report of the European Commission said most chemicals used in tattoos were industrial pigments originally used for other purposes, such as automobile paints or writing inks, and there was little or no safety data to support their use in tattoos.

Most adverse reactions to tattoo ink are similar to those caused by skin allergies. In 2005, 52,114 containers of tattoo ink were recalled after more than 150 cases of skin reactions including blistering, cracking, swelling, peeling and chronic inflammation were reported to the FDA. Consumers have also reported developing rashes after tattooing.

Rudy Saltzman, a tattoo shop owner from New Jersey, said he was unaware of any bad reactions in any of his customers, but acknowledged that any chemical could be potentially dangerous.

"I'm not a chemist, and I don't know what's in the inks and pigments," Saltzman said. "But you can have a reaction to a deodorant. There is no way of telling how a person will react to anything."

Earlier results from chemical analysis presented during the 229th national meeting of the American Chemical Society in 2005 suggest that closer regulation of the tattoo industry may be warranted. Lack of regulation effectively gives a tattoo artist license to inject whatever he or she deems appropriate under the skin, according to the researchers.

One of the chemicals known to be used in tattoo ink is thimerosal, also called thiomersal, an organic compound containing ethylmercury. In the US, thimerosal is commonly included in tattoo inks, vaccines, antivenins, and eye and ear products as a preservative. Due in part to mercury's toxic effects, thimerosal is very effective at killing off fungal and bacterial growth.

Mercury is a well-known neurotoxin, with effects that can be particularly severe in pregnant women, infants and children. Due to concern over mercury toxicity, the United States and European Union have removed thimerosal from vaccines recommended for young children, with the exception of certain influenza vaccines. But vaccines recommended and often even required for older children in the US, including those for diphtheria and tetanus, still contain the chemical. Thimerosal is also contained in several anti-venom treatments, and in most vaccines found outside of North America and Europe.

Related studies

Emma Marris, Is tattoo ink safe ?, Nature, (2005). DOI: 10.1038/news050314-3

Rudolf Vasold, Eva Engel, Burkhard König, Michael Landthaler, Wolfgang Bäumler, Health risks of tattoo colors, Anal. Bioanal. Chem., 391 (2008) 9-13. DOI: 10.1007/s00216-008-1978-z

Giovanni Forte, Francesco Petrucci, Antonio Cristaudo, Beatrice Bocca, Quantification of Sensitizing Metals in Tattooing Pigments by SF-ICP-MS Technique, The open chemical and biomedical methods journal, 2 (2009) 42-47. DOI: 10.2174/1875038900902020042

Giovanni Forte, Francesco Petrucci, Antonio Cristaudo, Beatrice Bocca, Market survey on toxic metals contained in tattoo inks, Sci. Total Environ., 407 (2009) 5997-6002. DOI: 10.1016/j.scitotenv.2009.08.034

Related information

Wikipedia: Tattoo
FDA: Tattoos and Permanent Makeup: Guide to Resources
EVISA Link-database: All about Thimerosal

Related News

Natural News, September 28, 2007: The Truth About Tattoos: Health Risks, Toxicity and More
Medical News Today, March 14, 2005: Chemicals in tattoo inks need closer scrutiny
Medical News Today, July 19, 2003: Tattoo chemicals warning
EVISA News related to Thimerosal

last time up-dated: June 27, 2020


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