Quick Links: Tattooing | Intradermal Cosmetics | Body Piercing | General Tattoo Studio Requirements | Tattoo and Body Piercing Studio Rules
The Texas Department of State Health Services Drugs and Medical Devices Group is responsible for the enforcement of Health and Safety Code, Chapter 146, Tattoo and Certain Body Piercing Studio Act. New rules adopted under the Act went into effect May 4, 2000, and provide guidelines for minimizing infections and to reduce the occurrence of minors being tattooed and body pierced.
Voluntary Nationwide Recall of Tattoo Ink, Tattoo Needles, Tattoo kits due to Microbial contamination
FOR IMMEDIATE RELEASE - July 15, 2014 - White & Blue Lion, Inc. in the City of Industry, CA is recalling all lots of tattoo Inks and tattoo needles due to pathogenic bacterial contamination. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. As of an extra precaution, we are also recalling all tubes and ink cups as well. The recall includes all tattoo ink, tattoo needles, tubes, ink cups and kits distributed by White & Blue Lion including the ones specifically listed below:
(sold in kits and separately)
| Multi colored Chinese Dragon Image with black and white lettering
||Lot No. OR20036
Best if used by 16/12/16
|5 ml bottle
| Tattoo Needles (included in kits)
| Individually packaged in groups of 5
|| None – labeled as “CE0197 Pre-made tattoo needle”
“sterilized by E.O. Gas”
Art No. 1203RL, 1205M, 1205RL,
1205RS, 1209RL, 1207RL, 1207M,
1207RS, 1209M, 1209RS
|201308, 201307, 201312,
201402, 201311, 201310
The inks and needles are sold in tattoo kits and the inks are also sold separately by 8Decades and White & Blue Lion, Inc. through www.amazon.com & www.ebay.com
There was a report of one illness as of today’s date.
FDA Laboratory testing has found microbial bacterial contamination in both the inks and needles.
From the tattoo kits (ink and needles) a variety of potentially pathogenic organisms were isolated and identified including: Gram negative bacteria, Gram positive rods and cocci, which when identified to the genus and species levels included: Bacilllus spp. Sphingomonas paucimobilis, Micrococcus lutes, Corynebacterium spp., Clostridium botulinum and other Clostridium spp. No Mycobacteria were isolated.
From the ink sets a variety of potentially pathogenic organisms were isolated and identified including: Gram negative bacteria, Gram positive rods and cocci, which when identified to the genus and species levels included: Bacillus spp, Acinetobacter spp., Staphylococcus haemolyticus, Sphingomonas paucimobilis. No Mycobacteria were isolated.
This recall is being made with the knowledge of the US Food and Drug Administration.
Consumers with any questions should contact us at 1-626-586-3485 from Monday to Friday between the hours of 9am to 6pm PST.
Risk of Infection from Contaminated Tattoo Inks
August 23, 2012
The Food and Drug Administration (FDA) is alerting tattoo artists, ink and pigment manufacturers, public health officials, health care professionals, and consumers that some tattoo inks, and the pigments used to color them, can become contaminated by bacteria, mold, and fungus. Contaminated inks are known to have caused serious infections in people in at least five states over the past year.
Anyone who receives a tattoo with a contaminated ink is at risk for infection.
Tattoos inks can become contaminated with a variety of bacteria, but the family of bacteria called nontuberculous Mycobacteria (NTM), which has been linked to a 2011-2012 outbreak of infections, is of particular concern.
M. chelonae, one of several disease-causing NTM species, can cause a rash or raised red bumps in a tattooed area within a couple of weeks of receiving a tattoo. The infection can be difficult to diagnose and may be mistaken for an “allergic” reaction. M. chelonae can also cause lung disease, joint infection, eye problems, and other organ infections, and can require treatment lasting six months or more.
Tattoo artists can help to minimize the risk of infection by only using inks that have been processed to be free from harmful microorganisms. When purchasing inks, artists should ask the ink distributors what steps were taken to ensure that the product is free from harmful microorganisms.
Use of sterile water to dilute inks helps to ensure that bacteria are not introduced during the dilution process. (Unboiled tap, bottled, distilled, and filtered water are not sterile and should not be used to dilute inks.)
Companies and individuals who manufacture or market cosmetics, including tattoo inks, have a legal responsibility to ensure the safety of their products. Steps to help ensure tattoo inks are free of harmful contaminants may include: carefully choosing the inks ingredients, using hygienic processing techniques, using preservatives to prevent the growth of microorganisms, validating post-manufacture processing and testing to ensure safety, or a combination of these and/or other approaches.
At present there is no specific FDA regulatory requirement that tattoo inks be sterile; however, consumers can reduce the likelihood of experiencing infections by asking tattoo artists if the inks have been formulated or processed to ensure they are free from harmful pathogens. In addition consumers should ask that the artist only use sterilized water to dilute the inks.
For more information:
CDC and FDA Investigation of Infections Associated with Tattooing
| Dear Tattoo Studio Operator:
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are investigating a cluster of skin infections among persons who received tattoos from May 2011 through February 2012. These particular infections usually appear between 1–3 weeks after tattooing. To date, all reported infections have involved clients who have received new tattoos with a commercially available tattoo ink.
If you have a client who reports having a skin infection after receiving a tattoo within the last 10 months (after April 2011), please ask that person to report it to their local health department and see a doctor for diagnosis of the organism causing the infection. Additionally, you are reminded that all tattoo studios must provide a written report to the Texas Department of State Health Services, Drugs and Medical Devices Group (DMDG), of any infection and/or allergic reaction resulting from the application of a tattoo. For instructions on reporting an infection or allergic reaction to DMDG, please refer to the attached Report of Infection or Allergic Reaction by a Tattoo or Body Piercing Studio (revised form DMDG – 118) or download the form from our website at:
If you have questions or require additional assistance regarding this notice, please contact us by phone at (512) 834-6755 or visit the DMDG website at: www.dshs.state.tx.us/dmd. Your cooperation in this investigation is very important for the protection of your clients. Thanks for your help.
Tom Brinck, Manager
Drugs and Medical Devices Group
Policy, Standards and Quality Assurance Unit
Environmental and Consumer Safety Section
Division for Regulatory Services
Texas Department of State Health Services
Report of Infection or Allergic Reaction By a Tattoo or Body Piercing Studio
Frequently Asked Questions (FAQs)
We require any business that is in the practice of producing an indelible mark or figure on the human body by scarring or inserting pigments under the skin using needles, scalpels, or other related equipment to license with the Department of State Health Services. This includes studios that perform traditional tattooing, permanent cosmetics, and scarification. An artist may not tattoo a person younger than 18 years of age without meeting the requirements of 25 Texas Administrative Code, §229.406(c), whose parent or guardian determines it to be in the best interest of the minor child to cover an existing tattoo.
Tattoos are applied using a small electric device that operates similar to a sewing machine. One to fourteen needles are grouped together and attached to the end of a rod called a needle bar. The other end of the needle bar is attached to the tattoo machine. The needle bar moves up and down through a tube or barrel, which serves two purposes--to keep the needle bar from moving side to side and as a handle for the tattooist to grip. The needles stick out only a few millimeters from the end of the tube, so they don't go very deelyp into the skin.
After preparing the skin with a germicidal soap, the artist dips the needles into a small amount of pigment or ink. As the machine is guided over the skin, the needle bar moves up and down allowing the needles to puncture the skin, depositing the ink. A tattoo machine can puncture the skin 50 to 3,000 times per minute. Once the tattoo is completed, the tattooist usually applies an antibiotic cream or ointment and covers the area with a sterile bandage. The artist is required to provide you with oral and written instructions on how to care for your newly applied tattoo.
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Intradermal cosmetic studios (sometimes referred to as permanent makeup studios) are becoming more and more common in Texas. The permanent makeup is generally applied to the eyebrows, eyelids, and lips. Some studios use traditional tattoo equipment, while others use devices that work on the same principle, but are smaller and look like pens. Generally, the components of the pen-type machine come pre-sterilized from the manufacturer and are disposable (one time use) items.
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We require any business that is in the practice of creating an opening in a person's body, other than the individual's earlobe, to insert jewelry or another decoration to license with the Department of State Health Services. This also includes studios that perform implants. An artist may not perform body piercing on a person younger than 18 years of age without the consent of a parent, managing conservator, or guardian and meeting the requirements of 25 Texas Administrative Code, §229.406(d). This can be done by one of two methods:
- The minor brings a notarized consent to the studio that contains the name, address, and telphone number of both the minor and parent, managing conservator, or guardian; the location of the body that may be pierced; and signatures of both the minor and the parent, managing conservator, or guardian; or
- The adult is present at the studio during the piercing and signs statements swearing that they are the parent, managing conservator, or guardian; the adult has the authority to consent to the procedure; the adult has provided valid government issued identification of the minor and of themselves to the studio; and that the adult will remain at the studio while the procedure is performed. In this case, the adult must also present identification and evidence to the studio that they are the parent, managing conservator, or guardian. In both cases, the minor must provide a valid, government issued, positive identification card that contains a photograph and a date of birth.
Before a body piercing is performed, the skin is cleaned with a germicidal soap. The artist pierces the skin with a very sharp needle. In a single motion, the artist places the jewelry to be inserted behind the needle and as the needle passes through the skin, the jewelry follows. The needle is then disposed of in a sharps container and the artist adjusts the jewelry to the piercing. Only approved materials may be used for new piercings. These include surgical implant grade stainless steel (minimum of 316L or 316LVM), solid 14k or 18k gold, niobium, titanium (minimum of 6AL4V), or platinum, which is free of nicks, scratches, or irregular surfaces and has been properly sterilized before use.
With implants, the skin is prepared with a germicidal skin preparation before an opening is made. The skin is cut with a scalpel and the layers of skin near the opening are separated to accommodate the implant. The implant is inserted under the skin and the opening is held closed to heal. Implants must also be made of an approved material. The artist is required to provide you with verbal and written instructions on caring for your new body piercing.
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General Tattoo and Body Piercing Studio Requirements
The Drugs and Medical Devices Group is responsible for conducting on-site inspections of tattoo and body piercing studios. During these inspections, we ensure that the studios comply with state and local laws and regulations. Some cities in Texas have local ordinances that are more stringent or ban tattooing and body piercing altogether.
- the building is well maintained and clean
- the artist practices universal precautions to prevent the spread of infection, such as
- washes hands with a germicidal soap
- wears clean clothing and single use gloves
- uses personal protective equipment
- uses instruments that are either disposable or that are routinely sterilized
- follows proper handling and disposal of waste
- there are sterilization records showing routine sterilization practices
- the artist prohibits the tattooing or body piercing of minors (unless above mentioned conditions are met)
- the artist prohibits the tattooing or body piercing of persons under the influence of drugs or alcohol
- the tattooist maintains records for each person receiving a tattoo or body piercing
- the tattooist reports any infection or adverse reaction to the Department of State Health Services
Another function of this program is to investigate complaints regarding significant health concerns, i.e. where personal injury has occurred or when personal injury could occur. Each complaint or concern that is forwarded to us is handled to ensure the artist and/or studio complies with state and local regulations.
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