Indoor Tanning Lamps Get New FDA Hazard Classification

Federal health officials have proposed recategorizing all tanning beds as a moderately dangerous medical device due to the risk of cancer, requiring new label warnings that would indicate youths should not to use them.  

The FDA announced a proposed rule on May 6, which would put tanning beds and similar products into a category known as sunlamps and reclassify the devices from a class I (low risk) medical device category to a class II (moderate risk) device.

The classification will not ban tanning bed use by those under the age of 18, but warns against children using a sunlamp.

Did You Know?

Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” said FDA Commissioner Dr. Margaret Hamburg. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”

The reclassification still needs to be finalized, but once that happens all sunlamp manufacturers will have to go through the FDA’s 510(k) approval process. The process, which is controversial because of its lack of testing requirements, typically only requires that a product show that it is substantially equivalent to an existing device that has been approved by the FDA.

The FDA indicates that putting tanning beds through the 510(k) process for approval will force manufacturers to make sure that their products have met some performance testing requirements and design characteristics. It will also require that they all carry label warnings, which would include a contraindication for people under 18 years old and would also warn that frequent use could increase the risk of skin cancer.

Tanning Bed Cancer Risks

The FDA reports that the American Academy of Dermatology estimates that there is a 75% increased risk of melanoma, an often deadly form of skin cancer, for people who use tanning beds. That risk increases every time they tan.

Concerns over indoor tanning came to the forefront following a report by the World Health Organization in July 2009, which determined that ultraviolet radiation from tanning beds was a definite carcinogen

Approximately 70,000 Americans are diagnosed with melanoma each year, causing nearly 9,000 deaths annually. Another 170,000 cases of non-melanoma skin cancer are found each year, linked directly to indoor tanning bed use.

The tanning bed industry has fought against pending restrictions even as study after study linked indoor tanning, particularly among young, white females, to increased skin cancer risk. New Jersey, California and Vermont now all ban the use of tanning beds by minors, and 30 states have some form of restriction on their use.

The proposed reclassification has been added to the Federal Register, the public and interested parties have 90 days to comment before a final determination is made.


"*" indicates required fields

Share Your Comments

I authorize the above comments be posted on this page*

Have Your Comments Reviewed by a Lawyer

Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Bard 3DMax Hernia Mesh Lawsuit Set for Trial To Begin in April 2024
Bard 3DMax Hernia Mesh Lawsuit Set for Trial To Begin in April 2024 (Posted yesterday)

With thousands of Bard hernia mesh lawsuits pending in the federal court system, a fourth bellwether trial will be held in the spring, involving allegations that defects with Bard 3DMax caused painful and permanent injuries.

Ozempic Gastroparesis Lawsuit Filed Over Failure To Warn About Permanent Stomach Problems
Ozempic Gastroparesis Lawsuit Filed Over Failure To Warn About Permanent Stomach Problems (Posted 3 days ago)

A South Dakota man has filed one of the first gastroparesis lawsuits against Ozempic manufacturers, alleging that users have not been adequately warned about the risk of severe vomiting and long-term stomach side effects.