Don Smith

FYI:

I'll post a complete report of the TEPRSSC meeting later today. I started the day yesterday with a 7:00 am (4:00 am my time) breakfast meeting and got home at Midnight (3:00 am Eastern time) and so I am still not funtioning too well yet. However, I wanted to give you all a "summary" of what took place.

1. Warning Labels. [Good News!] TEPRSSC voted unanimously to deny FDA approval to move forward with the proposed changes to the "warning label" language until the concerns raided at the meeting by (1) myself, (2) Joe Schuster (representing ITA), (3) TEPRSSC members (who asked some VERY tough questions of FDA) were addressed.

2. Amendment 3 - Definition of a Manufacturer. [Good News!] TEPRSSC voted unanimously to deny FDA approval to move forward with the proposed "Amendment 3 - Definition of a manufacturer" until the concerns raised by (1) myself, and, (2) TEPRSSC members were addressed. [No one from the indoor tanning industry other than myself spoke out against this Amendment.]

3. Eyewear. [Bad News!] TEPRSSC voted unanimously to approve FDA's proposal to modify the "eyewear" section of the Sunlamp Standard. When we broke for lunch we thought that this proposal was also to be remananded back to FDA for more work but when we got back for the "wind up" a TEPRSSC member made a motion to pass this proposal and it was seconded and unanimously approved before anyone could object. It appeared to this observer that TEPRSSC (1) was sincerely concerned about the safety of our client's eyes, and, (2) wanted to throw FDA a "bone" by passing this proposal. [Note: I don't know who was the most surprised about this proposal passing, the industry representatives or FDA.] The passage of this proposal will place a restriction of 5% T (transmission) on the amount of visible light that can pass through eyewear. Since I got some new information at the meeting from FDA about the way that the 5% is calculated, I can't comment yet about how serious the approval of this provision really is. More later.

The "bottom line" is that (1) Amendment 3 - Definition of a Manufacturer and (2) the "Warning Label" language was remanded back to FDA for more work and this is good news! Passage of the eyewear language was a "setback" but the extent of the "damage" won't be known until I do some testing using the new 5% protocol.

Don "Your Man On The Scene" Smith

Brenda at Eye Pro

Don,

Here's my recollection of the TEPRSSC meeting--

Yes, its true you were the only one from the indoor tanning industry to speak out against Ammendment 3, but that was because everyone attending the ITA pre-meeting decided you should carry the banner for the tanning industry. As you'll remember from that meeting, we had been scheduled for very little time on the agenda and we didn't want to confuse the matter by several people making similar statements. You were offered to speak on behalf of all of us for all topics but declined to speak on the new labeling changes the group wanted to propose, so Joe Schuster carried the banner on that.

Are you stating you thought it would have been helpful for more people to speak on Ammendment 3? We certainly would have! The ITA had no disagreement with your points on Ammendment 3, Definition of a Manufacturer,and so was happy to have you speak on their behalf. Do you think this weakened our position or strengthened it? Do you suggest more speakers on each topic at the next meeting?

We all spent a lot of time and money to get to the meeting, and we all are gravely concerned about the proposed FDA changes. I hope your post is not meant to indicate otherwise.

Brenda

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[ This Message was edited by: Brenda at Eye Pro on 2002-05-23 18:52 ]

solarmeter

Greg - READ the above from Brenda, twice if you need to. If you don't believe what I told you 'over there' then believe it from someone else here.

BTW - ITA finally reduced the rate for small potatos. Now I'll join, just like you used to say you would...