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FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

FDA Proposes New Safety Measures for Indoor Tanning Devices

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There are many risks from indoor tanning devices: Using sunlamp products such as indoor tanning beds or booths exposes you to ultraviolet (UV) radiation and increases your risk of eye injury, skin damage, and skin cancer—including melanoma, the deadliest type of skin cancer.

Due to these risks, the FDA already requires indoor tanning devices to be labeled with a visible, black-box warning stating that they should not be used by people under age 18. We know that the effects of exposure to UV radiation add up over one’s lifetime. Therefore, UV radiation exposure in youth and teenagers puts them at a greater risk for skin and eye damage later in life. That’s why the FDA now is proposing a rule to protect youth from the risks of these devices by restricting use only to adults age 18 and older. This proposed rule also would require indoor tanning facilities to inform adult users about the health risks of indoor tanning and to obtain a signed risk acknowledgement from these users.

The agency also is proposing a second rule that would require manufacturers and indoor tanning facilities to take more actions to help improve the overall safety of indoor tanning devices to protect adult consumers.

“There is increasing evidence that indoor tanning during childhood and early adult life increases the risk of skin cancer, including melanoma,” says Markham C. Luke, M.D., Ph.D., a dermatologist and the deputy office director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “Hundreds of youth also are injured each year across the country due to using sunlamp products.”

In fact, people who have been exposed to radiation from indoor tanning are 59 percent more likely to develop melanoma than those who have never tanned indoors, according to the American Academy of Dermatology.

On average, more than 3,000 emergency room visits in the United States happen each year because of injuries related to indoor tanning (based on data from 2003 through 2012), according to the Centers for Disease Control and Prevention (CDC). More than 400 of those patients each year were individuals under age 18.

“The FDA is particularly concerned about children and teens being exposed to UV radiation from indoor tanning because the effects of exposure add up over your lifetime,” Luke explains. “Exposure to UV radiation from indoor tanning is a preventable cause of skin cancer. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning.”

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How This Announcement Could Affect You

This action is intended to help protect youth from a known and preventable cause of skin cancer and other harms—and to help adults make decisions regarding tanning based on truthful information. The FDA is also acting to make sure manufacturers and tanning facilities take steps to help improve the safety of indoor tanning devices.

If the FDA’s first proposed rule becomes final, indoor tanning facilities would not be allowed to use indoor tanning devices on people under age 18. This proposal is intended to help protect the health of American youth.

And, adult users would have to sign a certification acknowledging that they have been informed of the health risks related to the use of indoor tanning devices. Adults would sign this certification before their first indoor tanning session, and every six months after that.

This certification would help the FDA make sure indoor tanning facilities are giving truthful and easy-to-read information to consumers. This certification also would help adults make informed decisions.

If the FDA’s second proposed rule on sunlamp products (regarding performance standards) becomes final, it would require manufacturers and indoor tanning facilities to take more actions to protect consumers. (Performance standards, among other things, help ensure devices function as intended, which can help reduce risks to consumers.)

Some key proposed changes would include:

  • Changing requirements for warning statements to make them more effective;
  • Improving eye safety by adding requirements that would limit the amount of visible light allowed through protective eyewear to protect consumers’ eyes from intense light;
  • Improving labeling on replacement bulbs so tanning facility operators make sure they are using the correct bulbs, reducing the risk of accidental burns;
  • Preventing changes to devices (for instance, preventing manufacturers from installing stronger bulbs) without re-certifying and re-identifying the device with the FDA; and
  • Requiring all sunlamp products to have an emergency shut-off switch (or panic button) that users can easily find and identify by touch or sight.

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You Can Comment on Proposed Rules

The two proposed rules are available online for public comment for 90 days. (See blue box below for links and instructions.)

"We want to hear from all users and their families, as well as from manufacturers, business owners, and other stakeholders who might have comments,” says Luke. “We will review all comments and viewpoints as part of the rule-making process."

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What to Know If You Still Plan to Use an Indoor Tanning Device

The FDA is proposing measures to reduce the risks posed by these devices. Users should remember that sunlamp products currently must include statements on the device warning against their use by youth under 18.

Also understand the following points.

  • Failure to wear appropriate protective eyewear, such as goggles, can lead to short- and long-term eye injury.
  • Long exposures (close to the maximum time for the sunlamp product), can lead to burning. Because sunburn takes 6 to 48 hours to develop, you may not realize your skin is burned until it is too late.
  • You should follow the manufacturer’s recommended exposure times on the label. People with skin that burns easily and does not tan should never use indoor tanning devices.
  • Tanning while using certain medications or cosmetics may make you more sensitive to UV radiation. Talk to your doctor or pharmacist first.

How to Comment on the Proposed Rules

To comment on the Restricted Sale, Distribution, and Use of Sunlamp Products:

  1. Read the proposed rule.
  2. Starting Tuesday, December 22, submit comments on the proposed rule on Regulations.gov.

Comment Now

To comment on the Amendment to the Performance Standard for Sunlamp Products:

  1. Read the proposed rule.
  2. Starting Tuesday, December 22, submit comments on the proposed rule on Regulations.gov.

Comment Now

The comment period closes March 21, 2016.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

December 22, 2015

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Page Last Updated: 12/22/2015
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