Don Smith

FYI:

The following e-mail was sent to W. Howard Cyr, Ph.D., of FDA.

Is "Ask Don" getting paronoid? Or is it just that "Ask Don" has been blindsided before by FDA and doesn't want to see it happen again on 5/22/02?

Remember, just because you are "paranoid" doesn't mean that they aren't out to get you! LOL

Here is the text of my e-mail. Dr. Cyr is very good about answering, so I will post his response here for everyone to read.

Dr. Cyr:

In a previous e-mail you indicated that only (1) Warning Labels, and, (2) Amendment 3 - Definition of a Manufacturer will be presented by FDA to TEPRSSC. I notice in the Federal Register that it says that FDA may present "....certain initiatives of international standards organizations concering sunlamp products" and so I ask ny question once again in order to prevent our being "blindsided" at the meeting.

Are these the only two proposals that FDA will make to TEPRSSC or has there been a change in strategy since your e-mail? If there has been a change in FDA's strategy, we need to know what will be presented ASAP.

Thank you for your assistance.

Donald L. Smith
Executive Director/TSO/UVR-RI

Don Smith

FYI:

I asked "Is "Ask Don" getting paronoid?" about what will be presented by FDA to TEPRSSC and the answer is in! A quick response was received (by phone and e-mail) and here is the "latest information" about what will be presented by FDA to TEPRSSC:

1. Revised "Warning Label" language. (Amendment 4)

2. Warning Label "language" in catalogs, specification sheets and descriptive brochures, etc. (Amendment 5)

3. Definition of a Manufacturer. (Amendment 3)

There WILL be one more item presented at the meeting but I agreed to keep this information in confidence for the time being. It IS NOT anything that would "threaten" the industry like annual limits, irradiance caps, changing the calculation denominator from 156 J/m2 to 200 J/m2, etc., etc.

Don

Don Smith

FYI:

Now I can tell you what else will be proposed on 5/22/02.

FDA will recommend adoption of the CIE "Luminous Action Spectrum" (LAS) in an attempt to "quantitate" the amount of visible light (400 - 700 nm) that is allowe to pass through protective eyewear. [Note: The existing language simply says that "enough light must pass" to allow the user to see the "termination" button.]

Thus, the intent is good but the "upper limit" of the CIE/LAS must be questioned.

I will make some comments about the advisability of adopting the CIE/LAS based upon some work we have done at the UVR-RI. [Note: FDA sent us a copy of the CIE/LAS some time ago and we have been working with it ever since. To the best of my knowledge, we are the only ones with independent data.]

More later about what adoption of this provision will do to SOME of the products on the market.

Don

CancunRayz

Don,
I'm in no way a tanning eyewear expert, but will this proposed change by the FDA affect more likely to effect the disposable eyewear market or the traditional "goggle" market?
[ This Message was edited by: Erebus623 on 2002-05-17 08:47 ]

fungirlz

Dear Don:

Seems like A LOT right here.. maybe it's best you and Pat hold off on smelling the flowers for awhile.. I do not think there is another person who can represent us on these things.. as of right now.. correct me if I am wrong...Several others agree also.. It's gotta be you DON.. sorry...

Please start your Training Class with hand picked people you can teach all this to because..it looks like it's pretty complicated.. and I know you want to smell the flowers..but with-out people to replace you.. I'm sorry to be the one to tell you this.. YOU CAN'T.. not now at least.

I will fund raise.!!!! Shelia..Solar.. RichC. Mitzi..Chunn.. Jim.. get ready for training class.. anyone else brave enough to
jump in and learn this lingo? These laws?? these rules??
Like I said...I will fund raise..

Don Smith

Erebus623:

It will affect some of the new eyewear like "Sun Sets" and "Eye Candy" and the new "Eye Gear" that "allow" more light to pass through.

Interestingly, our tests show that the disposable eyewear we tested did well on meeting both the 0.1% UVB and 1.0% UVA AND meeting the new CIE/LAS.

Don

BooBop

Correct me if wrong here. But I remember a Smart Tan training class a couple years back where the instructor stated that the "disposible" Namely Winkease were the best eyeprotection out there for blocking the UV rays. Viewkeepers were not available at that time, and I am inclined to believe they are just as protecting.

Don?

Don Smith

Mitzi:

The both tested equally well. I personally like the larger ones because they are easier (for me) to handle.

Also, keep in mind that the "disinfecting" and "cross contamination" issues we discussed last Sunday night are also important when it comes to eyewear.

Don

Brenda at Eye Pro

Don was kind enough to call and keep me in the loop as eyewear hit the agenda. I'll be going out to Maryland to support our tanning contingent. Chris, don't worry, Don is going to be at the meeting along with a lot of other tanning industry players to make reasonable changes to the existing laws.

By the way, to reiterate what Don said, the spectrum being discussed at the meeting is visible light and that doesn't create any eye damage.

It's personal preference whether you like easy-to-see-through eyewear or dark eyewear (better for sleeping). It's the UVA and UVB rays that cause eye damage, and that portion of the law is not changing (just some wording).

My products, Wink-Ease and Viewkeepers, aren't any "safer" than any FDA compliant goggle. They are disposable, and that is a salon management option. And they might be more or less comfortable since they are adjustable, and that's a tanner's preference. But my preference is that tanner's wear compliant eyewear when they tan, and I'm happy there are so many choices available available--no excuses not to wear eyewear when tanning!

BooBop

So glad to hear you will be by Don's side Brenda.

As for the Eyepro protection, I swear that is what the seminar instructor said. This is not just a plug for eyepro. He really said it. It was at a TanSupply south symposism in Chattenooga a few years back. I can remember his face but can't put a name to it. (at the moment)