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ITA Today Promoting Responsible Sun Care and Sun Burn Prevention. Founded in 1999, the Indoor Tanning Association today represents thousands of indoor tanning manufacturers, distributors, facility owners and members from other support industries. |
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06-25-2014, 01:38 PM | #24 (permalink) |
Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56
Posts: 2,888
Rep Power: 22 | Re: FDA Reclassification Summary Lamps will have to have some additional warnings included on the user sheets. We have a few questions pending with the FDA and once they are clarified I will list all the relevant information here. |
06-25-2014, 01:43 PM | #25 (permalink) |
Join Date: Feb 16 2009 Location: Alaska
Posts: 626
Rep Power: 16 | Re: FDA Reclassification Summary I was trying to figure it out myself, but there is so much double speak from the FDA that conflicts itself. So I figured it was time to ask the lamp pros. Thanx so much!!!
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07-08-2014, 10:23 PM | #26 (permalink) | |
Join Date: Jan 21 2012 Location: Utah
Posts: 1
Rep Power: 0 | Re: FDA Reclassification Summary • Quote:
Are these labels going to essentially be pretty standard and available from our distributors??? The manufacturer of much of my equipment is out of business and not otherwise available to help me with the relabeling of my equipment. Is that going to be an issue with the FDA or do I just need to label??? I won't have to do any form 510 compliance crap myself, will I??? Are lamps purchased today or hereafter which have not been labelled or approved by the FDA (according to whatever the final compliance rules require) likely to become obsolete or, more specifically, a violation once the 450 days elapses??? | |
07-09-2014, 07:03 AM | #27 (permalink) |
Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56
Posts: 2,888
Rep Power: 22 | Re: FDA Reclassification Summary Labels will be readily available from most tanning companies. Lamps will have some updated info on the user sheets and that is about it. Virtually no impact at the salon level is anticipated at this point. More to come after we meet with the FDA. |
07-09-2014, 07:38 AM | #28 (permalink) | |
Join Date: Mar 18 2005 Location: GA
Posts: 1,153
Rep Power: 20 | Re: FDA Reclassification Summary Quote:
The noose is tightening around our necks..... | |
07-15-2014, 09:27 PM | #29 (permalink) |
Join Date: Jan 14 2014 Location: Birmingham
Posts: 2
Rep Power: 0 | Re: FDA Reclassification Summary 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? |
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