Tattoo inks contain unhealthy levels of toxic metals, suit claims.

About 40 million Americans have tattoos because they like the look, but this decorative feature may have some unattractive consequences. The ink used in dermal implantation exposes consumers to potentially unhealthy levels of lead and seven other metals, according to a lawsuit filed in Los Angeles Superior Court by the California nonprofit American Environmental Safety Institute (AESI). (American Environmental Safety Institute v. Huck Spaulding Enterprises, Inc., No. BC319440 (Cal., Los Angeles County Super. Ct. filed Aug. 2, 2004).)

The complaint alleges that Huck Spaulding Enterprises and nine other tattoo ink and pigment manufacturers, distributors, and sellers failed to warn California residents about their exposure to hazardous materials as required by state law. It seeks injunctive relief and civil penalties.

"These defendants know, while the general public does not, that their products contain toxic metals," the complaint reads. "More specifically, consumers of defendants' products, whether adults or teenagers, take these poisonous heavy metals into their bodies each time they have a tattoo placed on and/or under their skin to feel 'sexier' or more 'attractive,' yet they are never warned by defendants that their tattoo contains these toxic metals."

Under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, businesses must warn California residents before exposing them to chemicals that the state lists as causing cancer or birth defects or other reproductive harm. AESI says tattoo inks contain antimony, arsenic, beryllium, cobalt, lead and lead compounds, nickel, and selenium, each a "dangerous toxic chemical that is known to the state of California to cause cancer and/or reproductive harm."

AESI President Deborah Sivas said the institute's research found that the amount of ink needed for a medium-size tattoo of 3-by-5 inches could contain between 1 and 23 micrograms of lead--far more than the 0.5 microgram-per-day limit set by Proposition 65.

"The institute asked these tattoo ink and pigment manufacturers to change their practices, but the companies refused to take appropriate or responsible actions to voluntarily lower the dangerous levels of toxics in their tattoo ink and pigment products, comply with current law, or notify consumers of the inherent health risks from the use of their" products," Sivas said in a press release.

The FDA regulates pigments used for tattoos or micropigmentation (permanent makeup--usually for eyebrows, lip liner or eyeliner) as cosmetics and color additives. The agency has approved more than 50 different pigments and shades for use in cosmetics, but none for injection under the skin. Nor does the agency regulate the tattoo artists and aestheticians who apply the colors.

"The FDA has not traditionally regulated tattoo inks for the pigments used in them. "file actual practice of tattooing is regulated by local jurisdictions," states an FDA talk paper.

But tattoos are increasingly popular--36 percent of people ages 25 to 29 have them, as do 13 percent of all teenagers, according to a 2003 Harris poll--and the FDA is beginning to look at safety concerns. Side effects, possibly from pigmentation, include allergic reactions (which can develop even years after the tattoo was applied) and granulomas--chronically inflamed tissue masses that form around material the body perceives as foreign, such as particles of tattoo ink.

Most worrisome are tattoos drawn using ink that has been "adulturated" with pigments that are not approved for any skin contact and may contain the industrial-grade colors used for printers' ink or automobile paint.

The agency is working with its Center for Food Safety and Applied Nutrition and the National Center for Toxicological Research to develop methods for testing the safety of pigments used for tattoos.

The FDA is also investigating Premier Products of Arlington, Texas, which manufactures ink used in permanent makeup. It issued a warning about the company's ink shades after it received reports of more than 50 adverse reactions, including swelling, blistering, cracking, peeling, scarring, and formation of granulomas around eyes and lips. Some of the effects caused serious disfigurement, impeding eating and talking.

The AESI suit seeks damages for people in California tattooed with the toxic-metal products without a warning, as well as punitive damages from the pigment manufacturers and distributors. Civil penalties under Proposition 65 can reach $2,500 per day per violation. AESI also wants the companies to lower the levels of toxic metals in their pigments and label them to warn tattoo artists and customers of the possible risks.

AESI attorney Roger Carrick of Los Angeles said, "We will prove in court that these defendant companies have knowingly and intentionally exposed consumers, especially teenagers and women of child bearing years, to potentially dangerous levels of lead and other toxic heavy metals without providing clear and reasonable warning of the health risks associated with being tattooed with these companies' inks and pigments."