Don Smith

FYI:

I just received the "final" version of the "Warning Label" that FDA intends to propose to TEPRSSC on 5/22/02. Also listed for your convenience is the FDA/IEC version that was presented on 2/8/02 and the recommendations that I made.

As you can see, a few (very few!) of my suggestions were incorporated into the "final" FDA version (which is still more like the IEC version).

IF you agree with my version, please "cut and paste" my version and e-mail it to Dr. Howard Cyr at FDA (hwc@cdrh.fda.gov)with a "note" stating that you recommend adopting the language that I have proposed. IF enough people do so, perhaps FDA will still change what they will propose to TEPRSSC. Remember, once it is approved by TEPRSSC, it goes to the Federal Register for comment and then it will be adopted. It is MUCH harder to get FDA to change their mind then than it is now.

1. FDA/IEC Version 9/8/02.

* WARNING - Ultraviolet radiation may cause injury to the eyes and skin, such as skin aging and eventually skin cancer.
* Read instructions carefully.
* Wear the protective goggles provided.
* Certain medicines and cosmetics may increase sensitivity.

2.FDA Version 5/8/02

·WARNING - Ultraviolet radiation may cause:
- injury to the eyes and skin
- skin aging
- skin cancer.
· Read instructions carefully.
· Wear protective goggles provided.
· Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation.

3.D.L. Smith Version.

* WARNING - Overexposure to ultraviolet radiation (UVR) may contribute to eye and skin injury, such as sunburn, skin aging and skin cancer.
* Read instructions carefully.
* Wear the protective eyewear provided.
* Certain medications, food and cosmetics may temporarily increase your sensitivity to UVR.

Note: My biggest problem with the FDA "final" version is leaving out the words "overexposure" and "may contribute" and "sunburn" and "may temporarily increase".

FDA seems to think that taking "and eventually" out of the IEC version was all that they had to do to make us happy. They are, obviously, still motivated more by "global harmonization" than they are with what makes sense for the USA.

Comments?

Don







[ This Message was edited by: Don Smith on 2002-05-08 19:55 ]

Robbie

Don,

Can you post the email I sent you? I can’t re-copy it. Just post the remarks I had regarding your label. The others can wait. They may promote discussion.

Also I hate to keep asking but where is it stated that the label issue is slated for May 22.

Thanks,
Robbie

Sheila in Minnesota

Dear Dr. Howard Cyr:

As a concerned salon owner providing the services of Indoor Tanning, I have attempted to keep current with the advances and setbacks that have been affecting my industry. There is much 'science' involved in the movement from point A to point C, and much does go beyond the grasp of the everyday salon owner. We look to certain people and groups within our industry to take on the necessary tasks of research, development and documentation of what exactly our newest technology and the newest medical advances uncovered about the benefits of moderate use of Ultra Violet Radiation.

Don Smith has provided the following suggestion for the changes now being considered. He has the support of the entire Indoor Tanning Industry and is the undisputed King of UVR. I have read the minutes of each of the past meetings that he has participated in. It certainly does appear that you NEED to take his advice seriously.

The task at hand is definitely a thankless one. I do not envy your position here. But there is a wealth of knowledge within our industry, a wealth of dedication and professionalism, a wealth of true love and value for the services we provide. Please adopt the following Warning Label as proposed by Don Smith in an effort to remain within what North America needs ~ sometimes 'global thinking' only leads to the need for clearer thinking.




* WARNING - Overexposure to ultraviolet radiation (UVR) may contribute to eye
and skin injury, such as sunburn, skin aging and skin cancer.
* Read instructions carefully.
* Wear the protective eyewear provided.
* Certain medications, food and cosmetics may temporarily increase your
sensitivity to UVR.


Please do not leave out the words:
"overexposure" and "may contribute" and "sunburn" and "may temporarily
increase".


Sincerely,

Sheila Mensching
Golden Tan Salon ~ Como
1021 Bandana Blvd. East #111
Saint Paul, MN 55108
651-645-9267

Don Smith

Robbie:

Here is a copy of your e-mail:

Don,

1. FDA’s: Is tolerable.

2. Yours: Interesting and I can see where you are going, but while the concept of "contribute" makes sense for the skin cancer warning, it does not for eyes (and overexposure for eyes doesn’t work either). Even "sunburn" which you introduced into the language would be more causally a consequence of OVERexposure, thus "contributes to" makes little sense here as well. I would think that eye injuries and skin injuries should be separated to make the warning more scientifically correct.

3. Canada’s: Terrible
4. Australia’s: Abominable. I’m glad I turned in my passport. It is interesting to note that both 3 and 4 are the result of socialized medicine, and accordingly the governments responsibility. The draconian measures vary only in degree to which these countries have socialized their medical professions.

Is this coming up at May 22? Should I be there?

Thanks.

Regarding your question as to what will be presented by FDA to TEPRSSC on 5/22/02. I have been informed by Dr. Cyr that ONLY the "Warning Label" language and "Amendment 3 - Definition of a Manufacturer" will be presented. We NEVER get the "agenda" until the day of the meeting. Could we be "blindsided"? Yes, but Dr. Cyr has never given us any reason not to trust him.

If you can get away to go, and I hope you can because you are very effective in these meetings, you need to "request" time to comment by e-mailing Dr. Orhan H. Suleiman and request time (ohs@cdrh.fda.gov) or calling him (301-594-3332) by TODAY 5/10/02.

Don

Don Smith

Sheila:

Good job! Thanks for taking the time to let Dr. Cyr know what you think.

My only "suggestion" to everyone who is considering lending your weight to this issue is to to put more "focus" on what YOU think about this issue (Dr. Cyr already knows what I think - I'm not shy!).

Don

Sheila in Minnesota

~ Don, I did receive a response from Dr. Cyr and will be continuing the correspondence ~

I will try to share more of "me" in my future e-mails - - - however, I am sure you understand . . .

The Hussey at 3:00 am after a truly horrendous day is NOT the one you want speaking to the kiddies at the FDA . . ..

Besides, I love the copy and paste function

Sheila

Sheila in Minnesota

From Dr Cyr:Thanks for your memo. I will take your suggestions back to our working group.

The distinction between "exposure" and "overexposure" might be hard to define. An "exposure" to one skin type might be an "overexposure" to another type. Aren't the words "may cause" sufficient? Use of "overexposure" might lead to many questions. Let me know your thoughts on these differences.



Certain drugs and foods are always sensitizers to UV. It's not a "temporary" situation that going to go away. What did you mean by "temporary"? I realize that if you stop taking these drugs, etc., the effect will go away. Do we need to say that, or is that understood?



Don has been very good at convincing me that some of our warning label was confusing, as in the word "eventually" , as "eventually causes cancer". We've eliminated that word. We also adopted "sensitivity to UV", which were Don's words. I believe the word "temporary" is a new addition, or I've missed it before.



We're open to your suggestions, although I'd like to have more details on the above items.

S

Sheila in Minnesota

Response~ Thanks for your quick reply Dr. Cyr:

The distinction between the warning words of "Over Exposure" and "Exposure" in relation to the skin type receiving the exposure is ultimately important, as is any statement that leads the reader to assume the appropriate level of danger or safety of a action or product.

One slice of cheese cake will not cause a heart attack . . . . 200 slices (over exposure to cheese cake) certainly may contribute to this health hazard. I am a firm believer in the English Language. Misleading statements either overly cautious or not cautious enough will not help in the matters at hand. We need to remove the confusion and state the facts.

One of the reasons I am so adamant about these services being provided in Professional Salons Only is that Gym Tanners, Home Tanners and those that have Tanning units available as coin operated units in apartment buildings are not being monitored by those trained to evaluate the proper skin type and follow a moderate program of exposure.

It also brings us to your next point regarding food and drug photosensitivity and the word "Temporarily". I believe that with any chemical changes within the human body ~ these sensitivity issues may in fact be only Temporary - - - both in longevity of the symptoms and in the actual continued occurrences. So, it is possible that with repeated moderate exposures and a consistent blood level of the Rx that a person may not need to discontinue the medication in order to be symptom free. A professional tanning salon uses the information to follow an appropriate course.

Again ~ I know there are issues that will escape my grasp, but on the need to avoid misrepresentations of the facts, I think we can all agree that working hard on these issues can only benefit us all.

Look forward to your thoughts on this.

Sincerely,

Sheila Mensching
Golden Tan Salon ~ Como
1021 Bandana Blvd. East #111
Saint Paul, MN 55108
651-645-9267

Don Smith

Sheila:

GREAT job! I am truly impressed!

Once you get pointed in the right direction, you are a force to be reckoned with!

I'll share a secret with you (no one else read this, please, because this is just between Sheila and I)(OK, Robbie, you can read this too).

State and federal regulators DO pay attention to letters, phone calls, faxes and e-mails from real, live tanning salon owners. And they pay MORE attention when they get LOTS of letters, phone calls, faxes and e-mails about the same subject from LOTS of tanning salon owners.

IF we can just "get our act together" and focus on "harnessing" our power, we can affect the direction that OUR industry is headed!

Good work, Sheila. I, for one, am proud of you!

Don

Gene

Here's what I sent to the FDA.

Dr. Cyr:

Your proposed wording of the sunbed warning label makes it sound like any exposure to UVR is bad. That's an extreme position. Encouraging total avoidance of UVR through fear of sunlight and it's attendant UV is unwise from a medical standpoint.

Clearly, this should say "WARNING - Overexposure to ultraviolet radiation (UVR) may contribute to skin injury, such as sunburn, skin aging and skin cancer.

I left out the eye warning on this line because I don't believe it makes sense it that context. Clearly we don't want tanners to avoid wearing eyewear because they don't consider their session "overexposure." This issue deserves a separate line--this is the toughest enforcement issue facing salon owners, especially with experienced tanners who are quick to say they have never used eyewer in the past, why start now? We need tough language.

I like the current wording: Wear protective eyewear; failure to do so may result in severe burns or long-term injury to the eyes.

Thank for your consideration,
Gene Brenner

It was only during the last meeting that push came to shove with Dr Cyr said what we all feared, that it is the FDA's opinion that any UV is too much (just like anti-tanning dermatologists preach). And Dr. Cyr
looked around the room and threw his arms up said, "Come on, everyone knows that!"

Imagine, God in his infinite wisdom made the sun, but the sun was bad. And he made man to tan to avoid damaging deeper skin levels but that was also bad and ineffective.

I don't buy it and I never will.