The U.S. Food and Drug Administration has issued its final order reclassifying tanning beds as class II medical devices. Although some deem the ruling as controversial, many leaders assert that the change was not unexpected since the FDA published new proposed rules in May 2013.

What does the new Standard do?

Tanning beds have been reclassified from Class I (low risk) to class II (moderate risk) devices. The change requires manufacturers to submit to formal standards and reporting for lamps and equipment.

The order also requires that certain marketing materials include warning language such as, “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

Lastly, the new standard requires that a warning label, which is being referred to as a “black box” be affixed to all tanning equipment. These labels warn against use of tanning beds by persons under the age of 18.

What does it mean for my salon?

“This order will do little to alter the consumer experience in a professional tanning facility,” says Smart Tan Vice President Joe Levy. “It will increase the cost of bringing a new sunbed to market. But initial press coverage of the announcement seems to be missing the point that we already warn consumers about the dangers of overexposure, we already have warning labels and we already practice informed consent, skin typing and sunburn prevention.”

While the FDA’s reclassification mainly affects manufacturers of lamps and beds, tanning salon owners do have an important responsibility. For sunbeds that are already grandfathered into the market and in salons, owners are required to contact manufacturers to obtain the new labels and affix them to equipment. This is good news for salon owners, since they can continue using their existing equipment.

Click here to read the entire article in the latest issue of Smart Tan Magazine online.