View Single Post
Old 07-16-2014, 07:30 AM   #31 (permalink)
Robert K
Team TanTalk
 
Robert K's Avatar
 
Join Date: Aug 27 2002
Location: East Coast
Age: 56
Posts: 2,888
Rep Power: 22 Robert K will become famous soon enough
Re: FDA Reclassification Summary

Quote:
Originally Posted by btaylor36 View Post
If I read the Federal Register Correctly the following label has to be applied to the tanning bed:

Attention: This sunlamp product should not be used on persons under the age of 18 years.

The rest of labeling requirement appears to only have to appear in the brochures etc. not on the bulb itself,

(ii) Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:
(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

Do others agree? If so this means that I have to put a sticker on my existing beds to be in compliance?
In short yes. You have over a year to comply and once we meet with the FDA the ITA will publish exactly when and what needs to be done. No worries at all.
__________________
Robert Klem
Superior UV Technologies
(888) 526-7712 x77
robertk@superioruv.com
Robert K is offline   Reply With Quote