Wednesday, May 24, 2006
Tatoo Inks Are Not Regulated By The FDA And Can Be Deadly
FDA.....Tatoo inks are not regulated by the FDA and many have been found to contain.....Lead, Arsenic, Antimony, Beryllium, Chromium, Cobalt, Nickel and Selenium, all toxic metal poisons known to be hazardous to human health. Some of the ink pigments are suitable for printers' ink, automobile paint or solvents, and they are not approved for skin contact at all!
News Release
September 19, 2005: State Judge Issues Preliminary Injunction Requiring Warnings on Tattoo Ink Products Sold by Largest Ink Sellers in US
American Environmental Safety Institute
For Immediate Release: Monday, September 19, 2005
State Judge Issues Preliminary Injunction Requiring Warnings on Tattoo Ink Products Sold by Largest Ink Sellers in US
Los Angeles, CA – Los Angeles Superior Court Judge Irving Feffer today issued a preliminary injunction against Huck Spaulding Enterprises, Inc. ("Spaulding") and Superior Tattoo Equipment Co. ("Superior"), the largest tattoo ink sellers in the country. New York-based Spaulding sells the "VooDoo" brand, while Arizona-based Superior sells the "Prizm" brand of tattoo inks in California. The preliminary injunction requires these companies to place the following warning on their tattoo ink labels, catalogs and Internet sites for their California customers: "WARNING: Tattoo inks and pigments contain many heavy metals, including Lead, Arsenic and others. All of these heavy metals have been scientifically determined by the State of California to cause cancer or birth defects and other reproductive harm. Pregnant women and women of childbearing age in particular should consult with their doctor before getting any tattoo. A person is exposed to tattoo inks and/or pigments when they get a tattoo because they are injected with tattoo ink under their skin or the tattoo ink is applied on their skin."
Judge Feffer granted the motion for preliminary injunction brought by the American Environmental Safety Institute in its Proposition 65 lawsuit filed in 2004 against Spaulding, Superior and seven other tattoo ink and pigment manufacturers. The lawsuit alleges that these companies are exposing teenagers and adults who are tattooed using their inks to dangerous levels of Lead and seven other toxic metals.
The Institute’s President, Deborah A. Sivas, stated that, "Our scientific research shows that tattoo inks sold by these companies contain Lead, Antimony, Arsenic, Beryllium, Chromium, Cobalt, Nickel and Selenium, all toxic metal poisons known to the State of California’s health experts to be hazardous to human health. Tattoo customers have a right to know about this danger – before they get their tattoo." The Institute demonstrated in its preliminary injunction motion that these companies’ tattoo inks violate California’s Proposition 65, the state’s landmark consumer public health initiative statute that requires warnings be given to individuals before they are exposed to hazardous chemicals. Ms. Sivas observed that teenagers and adults in California are exposed to toxic metals in these tattoo inks when they are tattooed on or under their skin. Citing from a July 2003 Harris Poll, Ms. Sivas observed that tattoos are widely accepted and increasing in popularity in our modern culture, enhancing their potential for unknown and unwarned health risks, because, at least sixteen percent (16%) of Americans have at least one tattoo, with approximately equal numbers of men and women reporting that they have a tattoo. That means that approximately 40,000,000 million Americans, and perhaps 4,000,000 California adults, have one or more tattoos; and among younger adults, the numbers climb dramatically – in the age range from 25 to 29 years, 36% report they have at least one tattoo, while in the age range from 30 to 39, 28% similarly have at least one tattoo.The numbers are not significantly different for teenagers, Ms. Sivas pointed out, citing reports in the academic literature showing that thirteen percent (13%) of teenagers have at least one tattoo, with 5% reporting more than one tattoo. 29% of these respondents got their first tattoo before they were 17 years of age. Unlike among adults, the teenage girl respondents in these studies had tattoos far more often than boys (17% versus 8%, respectively).
"Against this background of rising popularity of tattoos among our teenagers and young adults, these tattoo ink sellers failed to take appropriate actions to either reduce the dangerous levels of these toxic metals in their products or warn these young tattoo consumers or their parents of the health risks from being tattooed with these inks. At levels found in the inks, these dangerous heavy metals, many of which cause birth defects or developmental toxicity while others cause cancer, pose an especially clear and present danger". American Environmental Safety Institute is a non-profit California organization founded in 1998 to investigate environmental and public health hazards affecting children and adults. Based upon its scientific research, both alone and working with other organizations, the Institute undertakes appropriate public education and/or legal action before state and federal government administrative agencies and the courts to correct violations of public policy and/or law. In addition to serving as the Institute’s President, Deborah A. Sivas is an attorney and serves as the Director of the Earthjustice Environmental Law Clinic and a Lecturer on Law at the Stanford University Law School in Palo Alto, California.
April 11, 2006
Tattoos and Permanent Makeup
FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities, FDA has not traditionally regulated tattoo inks or the pigments used in them. FDA is aware of more than 150 reports of adverse reactions in consumers to certain permanent ink shades, and it is possible that the actual number of consumers affected was greater. In some cases, the effects reported caused serious disfigurement. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
In addition to the reported adverse reactions, areas of concern include tattoo removal, infections that result from tattooing, and the increasing variety of pigments and diluents being used in tattooing. More than fifty different pigments and shades are in use, 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, automobile paint or solvents.
What Risks Are Involved in Tattooing?
The following are the primary complications that can result from tattooing:
Infection. Unsterile tattooing equipment and needles can transmit infectious diseases, such as hepatiti C. The risk of infection is the reason the American Association of Blood Banks requires a one-year wait between getting a tattoo and donating blood.
Removal Problems. 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.
FDA has received reports of numerous adverse ractions associated with certain shades of ink. When they happen they may be particularly troublesome because the pigments can be hard to remove. Occasionally, people may develop an allergic reaction to tattoos they have had for years. Granulomas, These are nodules that may form around material that the body perceives as foreign, such as particles of tattoo pigment. Keloid formation. If you are prone to developing keloids -- scars that grow beyond normal boundaries -- you are at risk of keloid formation from a tattoo. Keloids may form any time you injure or traumatize your skin
MRI complications. There have 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). There also have been reports of tattoo pigments interfering with the quality of the image. The cause of these complications is uncertain. Some have theorized that they result from an interaction with the metallic components of some pigments.
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 certain foreign-made temporary tattoos. 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." FDA has also received reports of allergic reactions to products applied to the skin that contain henna.
# posted by Joyfulstill @ 5:14 PM 
