Friday (2/8/02) Afternoon Bombs: # 2 - Irradiance Caps

Don Smith · 04-05-2002, 09:58 PM

FYI:

The second "bomb" that was dropped on us late in the afternoon of 2/8/02 was the announcement by FDA that they intended to consider adopting IEC's "irradiance caps" for (1) commercial sunbeds, and, (2) home sunbeds.

1. Commercial Sunbeds would be "limited" to an "irradiance cap" of 0.6 W/m2. This means that (a) it cannot exceed a "delivery rate" of 24 UVI (Ultraviolet Index) units, (10.8 MED/hour or 0.18 MED/minute). The te (time to 4.0 MED) time could, therefore, be reached NO FASTER than in 22 minutes 4.0 MED divided by 0.18 MED/minute = 22.2 minutes).

Thus, the "impact" of the 0.6 W/m2 "irradiance cap" on commercial tanning beds would be to prohibit a manufacturer from selling a sunbed that reached 4.0 MED faster than in 22 minutes. As Jerry Frank of Cosmedico pointed out, this would eliminate the sale of all 160 watt high-intensity sunlamps and sunbeds and, for sure, the sale of most HP sunbeds.

2. Home tanning beds would be limited to an "irradiance cap" of 0.3 W/m2 which means that they could not be sold for home use if they reached 4.0 MED faster than in 44 minutes.

What FDA (and evidently IEC) overlooked is that the scientific literature is perfectly clear and unambiguous regarding reciprocity. The "Law of Reciprocity" states that it is "dose" and not "dose rate" that is important biologically. Thus, 4.0 MED is 4.0 MED no matter whether it is delivered in 5, 10, 15, 20 or 30 minutes!

This proposal is absolutely ridiculous and the indoor tanning industry must do whatever it takes to prevent this proposal from being adopted by FDA.

Don

[ This Message was edited by: Don Smith on 2002-04-05 21:02 ][ This Message was edited by: Don Smith on 2002-04-05 21:27 ]

MJ · 04-05-2002, 10:10 PM

Don,
They have to kidding that is absolutely outragious!!
What can we as salon owners, do to insure that our 10, 15, and 20 minute beds aren't rendered Useless to us?
Mj

Don Smith · 04-05-2002, 10:31 PM

MJ:

They would "grandfather" in all existing sunbeds. If adopted, these "regs" would be for sales after the effective date.

How valuable do you think a used 12 minute MTI high-intensity sunbed would be? $50,000? $75,000?

You are right about the need to "mobilize" the people who patronize this website to write letters to FDA protesting this absurdity. Historically, the industry has stood around with their head in the sand and complained about the regulations when it was too late to do something about them.

NO MORE!

Don[ This Message was edited by: Don Smith on 2002-04-05 21:32 ]

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04-05-2002, 09:58 PM	#1 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,619 Rep Power: 10	FYI: The second "bomb" that was dropped on us late in the afternoon of 2/8/02 was the announcement by FDA that they intended to consider adopting IEC's "irradiance caps" for (1) commercial sunbeds, and, (2) home sunbeds. 1. Commercial Sunbeds would be "limited" to an "irradiance cap" of 0.6 W/m2. This means that (a) it cannot exceed a "delivery rate" of 24 UVI (Ultraviolet Index) units, (10.8 MED/hour or 0.18 MED/minute). The te (time to 4.0 MED) time could, therefore, be reached NO FASTER than in 22 minutes 4.0 MED divided by 0.18 MED/minute = 22.2 minutes). Thus, the "impact" of the 0.6 W/m2 "irradiance cap" on commercial tanning beds would be to prohibit a manufacturer from selling a sunbed that reached 4.0 MED faster than in 22 minutes. As Jerry Frank of Cosmedico pointed out, this would eliminate the sale of all 160 watt high-intensity sunlamps and sunbeds and, for sure, the sale of most HP sunbeds. 2. Home tanning beds would be limited to an "irradiance cap" of 0.3 W/m2 which means that they could not be sold for home use if they reached 4.0 MED faster than in 44 minutes. What FDA (and evidently IEC) overlooked is that the scientific literature is perfectly clear and unambiguous regarding reciprocity. The "Law of Reciprocity" states that it is "dose" and not "dose rate" that is important biologically. Thus, 4.0 MED is 4.0 MED no matter whether it is delivered in 5, 10, 15, 20 or 30 minutes! This proposal is absolutely ridiculous and the indoor tanning industry must do whatever it takes to prevent this proposal from being adopted by FDA. Don [ This Message was edited by: Don Smith on 2002-04-05 21:02 ][ This Message was edited by: Don Smith on 2002-04-05 21:27 ]

04-05-2002, 10:10 PM	#2 (permalink)
MJ Join Date: Jan 21 2002 Posts: 3,060 Rep Power: 8	Don, They have to kidding that is absolutely outragious!! What can we as salon owners, do to insure that our 10, 15, and 20 minute beds aren't rendered Useless to us? Mj

04-05-2002, 10:31 PM	#3 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,619 Rep Power: 10	MJ: They would "grandfather" in all existing sunbeds. If adopted, these "regs" would be for sales after the effective date. How valuable do you think a used 12 minute MTI high-intensity sunbed would be? $50,000? $75,000? You are right about the need to "mobilize" the people who patronize this website to write letters to FDA protesting this absurdity. Historically, the industry has stood around with their head in the sand and complained about the regulations when it was too late to do something about them. NO MORE! Don[ This Message was edited by: Don Smith on 2002-04-05 21:32 ]

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