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Submit Comments on FDA Reclassification Proposal Today

Monday, July 29th, 2013

The FDA reclassification proposal can have a detrimental effect on your salon, so it’s imperative that you submit a response immediately.

The U.S. Food and Drug Administration this Spring announced a proposed order to reclassify ultraviolet tanning lamps to a class II medical device. This proposal would change pre-market manufacturing standards for sunbeds, including a suggestion that sunbed labels add a contraindication against use on people under 18 years old. The reclassification would also require manufacturers to change the way they introduce new sunlamp products. Though this appears to be a manufacturer issue, the impact could significantly impact salons by driving up the cost of equipment.

FDA will be accepting comments on the matter until August 7, and it is critical that our industry is well represented in the discussion.

Smart Tan has been working with the American Suntanning Association to educate salons about the proposed regulations and encourage them to submit responses. The ASA has emailed a response template and directions to its salon database, and Smart Tan is calling salons as an additional reminder on behalf of the ASA.

Click here for directions for submitting your response.

If you have any further questions, please email info@americansuntanning.org.


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