The role of the Texas Department of State Health Services Drugs and Medical Devices Group in regards to Tanning Facilities is to:
- Respond to consumer inquiries and provides technical assistance to tanning facility operators.
- Conduct periodic inspections of tanning facilities to determine compliance with state and federal regulations, including performance standards for tanning devices.
- Investigate consumer and trade complaints involving tanning facilities.
- Maintain and update state requirements affecting tanning facilities and disseminates these requirements to the tanning facility operators.
- Distribute consumer warning signs that are required to be posted in tanning facilities.
A sample Tanning Injury Form can be found at the Tanning Guidance Documents
Tanning Facility Updates
FDA to Require Warnings on Sunlamp Products – May 29, 2014
On May 29, 2014, the U.S. Food and Drug Administration (FDA) issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices. The order also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years. Manufacturers will now have to submit a premarket notification (also called a “510(k)”) to the FDA – and obtain FDA clearance – prior to marketing these devices, which until now were exempt from premarket review. Manufacturers also will now have to show that their products meet certain performance testing requirements and address certain product design characteristics, and will have to include certain warnings and contraindications on sunlamp products and in certain marketing materials for sunlamp products and UV lamps that present consumers with clear information on the risks of use. In addition to a warning placed on the sunlamp product advising that the product not be used on children under 18, certain marketing materials promoting sunlamp products and UV lamps must carry additional warnings and contraindications, including “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
Click on the link below for the complete FDA Press Release issued May 29, 2014:
IMPORTANT NOTICE: Effective September 1, 2013, Tanning Facilities May No Longer Allow Minors to Use a Tanning Device.
As a result of recent legislation passed by the 83rd Texas Legislature, tanning facilities may no longer allow any person younger than 18 years of age to use a tanning device on or after September 1, 2013. The Department of State Health Services will be responsible for enforcement of the new provision and for updating the current Rules for Licensure of Tanning Facilities to reflect this change in the law.
Texas Health and Safety Code, Chapter 145 (Tanning Facility Regulation Act), was amended by Senate Bill 329, relating to a prohibition on the use of a tanning facility by a minor, during the 2013 Regular Session. As amended, Section 145.008(f), Health and Safety Code, specifically prohibits a person younger than 18 years of age from using a tanning device at a tanning facility. On September 1, 2013, every tanning facility must be in compliance with this new legislative requirement. Please be aware that there are no exceptions or grandfathering provisions that apply to the amendment.
Tanning facilities who have allowed minors to tan at their facilities prior to September 1, 2013, must continue to maintain the customer records and informed consent records for those individuals as required under Subsections (g) and (i), Section 145.008, Health and Safety Code, until the third anniversary of the date of the customer’s last use of a tanning device.
The change in law made by this new legislation applies only to an offense committed on or after September 1, 2013, the effective date of the amendment. If you have any questions concerning this new legislative requirement, please contact Mr. Jeff Mansell, Compliance Officer, at (512) 834-6755 or by e-mail at: Jeff.Mansell@dshs.state.tx.us.
Letter to the Indoor Tanning Association on Red Lamps for Skin Rejuvenation Being Installed in Tanning Beds/Booths
NOTICE: Use of Red Light Therapy Lamps in Tanning Devices, June 29, 2011
The Texas Department of State Health Services (Department) has become aware that some tanning facilities have attempted to modify their tanning devices by replacing the ultraviolet tanning lamps with “red light therapy lamps” or “collagen lamps” in order to change the intended use of these devices. In some instances, labels on tanning devices (e.g., the exposure schedule label and recommended lamp type label) have been removed and replaced with red light therapy labels. Various types of unapproved promotional claims have been observed for red light therapy lamps used in tanning devices, including claims associated with collagen production, increased blood circulation, reduction of fine lines and wrinkles and photobiostimulation of the body.
Red light therapy lamps may not be used in tanning devices. Existing labels on tanning devices should not be removed and ultraviolet lamps may only be replaced with the type intended for use in that device as specified on the label by the tanning device manufacturer, or with ultraviolet lamps that are equivalent under the United States Food and Drug Administration (FDA) regulations and policies. Red light therapy lamps are not believed to emit light in the same wavelength as ultraviolet tanning lamps, are not intended to tan the skin and are not known to be equivalent to any legally marketed ultraviolet tanning lamp. In addition, tanning facilities may not claim or distribute promotional materials that claim that use of tanning devices will result in medical or health benefits.
Tanning facilities that have installed red light therapy lamps in their tanning devices should immediately cease using these devices until the red light therapy lamps have been replaced with ultraviolet lamps recommended by the tanning device manufacturer. Any original labels that have been removed from the tanning device should be reaffixed before use. For guidance on replacing ultraviolet lamps and labels associated with your tanning device, we recommend you consult the tanning device user instruction manual or contact the tanning device manufacturer.
The Department has taken steps to issue warnings to lamp manufacturers believed to be promoting red light therapy lamps for use in tanning devices. Use of such lamps in tanning devices is considered a violation under the Texas Health and Safety Code, Chapter 145 (Tanning Facility Regulation Act); 25 Texas Administrative Code, §§229.341 – 229.357, Rules for Licensure of Tanning Facilities; and Texas Health and Safety Code, Chapter 431, (Texas Food, Drug, and Cosmetic Act).
If you have any questions concerning red light therapy lamps, you may contact Mr. Jeff Mansell, Compliance Officer, at (512) 834-6755 or by e-mail at: Jeff.Mansell@dshs.state.tx.us.
FDA Warns of Possible Dangers from Portable Foot-Tanning Device
Incorrect exposure information could lead to overdose of ultraviolet radiation
Click on the link below for the complete FDA Press Release issued August 24, 2010:
The Patient Protection and Affordable Care Act (H.R. 3590), imposes a 10% tax on amounts paid for indoor tanning services. Similar to a sales tax, the person who performs the tanning service collects the tax from the person tanning when payment for the tanning services is made. If the person receiving the indoor tanning service does not pay the tax when the service is received, the person performing the procedure pays the tax. The person collecting the tax remits payment of the tax quarterly with Form 720. This provision applies to services performed on or after July 1, 2010. For more information, please visit the Indoor Tanning Services Tax Center.