Robbie

Don,

Howard wrote back: “Somehow, I got sidetracked on this issue. The proposed revision to the Warning label says nothing about "exposure" or "overexposure". I think we could have an interesting scientific debate over this issue, but it doesn't appear, per se, in anything that I'm proposing to TEPRSSC.”
Are you proposing it May 22.

Also I can’t find your Amendment 3 info?

Please advise
Robbie

Don Smith

Robbie:

The 5/22/02 meeting allows us only to comment upon the proposals that FDA makes to TEPRSSC. We are not allowed to introduce anything new.

Moreover, we are given only 7 - 10 minutes to make our comments on everything FDA presents (Dr. Cyr will whatever time he needs) so the deck is really stacked against us.

REgarding defining "exposure" terms, my position is that we must first agree upon "standard test protocols" for testing (1) sunlamps (the subject of the 2/7/02 meeting) in a test stand, and, (2) sunbeds (yet to be discussed) before we can meet to resolve what constitutes overexposure, exposure and underexposure.

I have suggested that we have another 2 day meeting this fall to (1) follow up on the sunlamp standarization meeting of 2/7/02 and (2) to start the ball rolling toward the development of a standardized sunbed test protocol.

FYI, the complexity of testing a sunbed is greatly increased over testing a single sunlamp in a test stand.

So, IMHO, we have a lot of work to do before we can resolve these other issues.

Don

Brenda at Eye Pro

If any salon owner wants to point out that you would like the regs to say "Wear the eye protection provided" instead of "Wear the goggles provided", that would be great.

Wink-Ease and Viewkeepers are FDA compliant, as well as Australian Gold's No Rays, and these disposable products don't really fall into the goggle category. Eye Protection is a much better word in my opinion to ask tanners to wear, not "Goggles".

Dr. Cyr would be much more open to hearing this request from salon owners instead of the manufacturer.

Thanks!!