FDA Tanning Bed Rule

FDA Tanning Bed Rule

The FDA is issuing a new tanning bed rule. The FDA tanning bed rule is actually a set of two proposed rules simultaneously released on December 18, 2015. The first FDA tanning bed rule proposes a restriction on the use of sunlamp products to individuals 18 and older. This FDA tanning bed rule would require, before their first tanning session and every six months thereafter, adult users over age 18 would have to sign a risk acknowledgement certification that states that they have been informed of the risks to health that may result from use of sunlamp products.

The second rule proposes new labeling requirements. This FDA tanning bed rule requires sunlamp manufacturers and tanning facilities take additional measures to improve the overall safety of these devices.  Key proposed changes would include:

  • making warnings easier to read and more prominent on the device;
  • requiring an emergency shut off switch, or “panic button”;
  • improving eye safety by adding requirements that would limit the amount of light allowed through protective eyewear;
  • improving labeling on replacement bulbs so tanning facility operators can make sure they are using the proper replacement bulbs, reducing the risk of accidental burns; and
  • prohibiting dangerous device modifications, like installing stronger bulbs, without re-certifying and re-identifying the device with the FDA.

The FDA tanning bed rule is a follow-up to a 2014 reclassification of tanning beds as Class II medical devices. These proposed device restrictions would primarily apply to tanning facility operators, but also to, device manufacturers and distributors seeking device approval. The proposed rule defined a tanning facility operator to be “any person offering for sale the use of sunlamp products.”

The FDA tanning bed rule is available for public comment for 90-days. After the public comment period it may be revised before going into effect. In total it could be 6-9 months before a final FDA tanning bed rule is in effect, perhaps longer.

Contact our Washington D.C. or Charlotte NC office with any questions.

Share this:
Posted in , and tagged with , , , , , ,

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

Leave a Comment

You must be logged in to post a comment.

Are you in trouble with the FDA?

Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.

Expert knowledge of FDA regulations that helps you strategically grow your business