TEPRSSC Report: Warning Labels

Don Smith · 05-23-2002, 06:58 PM

In some ways the discussion that took place after Dr. Cyr proposed the changes FDA wanted to make for "warning labels" were some of the most interesting of the day. In fact, it was this issue that elicited the most constructive comments from TEPRSSC members.

What do we do now? Now, we must work with FDA to "revise" the "warning label" until it is acceptable to all parties.

Here is what Dr. Cyr proposed:

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

And, here is a "revised" warning label that I prepared on the flight home that incorporates most of the the various and sundry points brought up during the discussion period.

WARNING
* Ultraviolet radiation (UVR) may cause acute injury to the eyes and skin like:
- sunburning
- (will add this later)
* UVR may also contribute to the development of chronic conditions like:
- skin aging
- skin cancer
* Read all instructions carefully.
* Wear the compliant eyewear (goggles) provided.
* Certain medicines and cosmetics may increase sensitivity to UVR.
* Avoid overexposure to UVR.

Comments to this "revised" version?

Don

solarmeter · 05-23-2002, 07:44 PM

Don,

I don't like the word 'acute' at all, unless it pertains to the fairer sex.

Should specify 'unprotected' eyes, as I believe Brenda mentioned to Sharon Miller.

Good that 'overexposure' was put back in.

Do you have to 'add more later'? Darn label keeps getting longer.

Brenda at Eye Pro · 05-23-2002, 08:12 PM

Don,

Did you write down the changes that the pre-ITA meeting came up with and that Joe Schuster proposed to TRPRSSC? I don't see any of our changes in your new label.

I'll contact Joe and get the revisions we all worked on.

Brenda

Don Smith · 05-24-2002, 09:51 AM

Brenda:

I tried to focus on the "directions" that TEPRSSC members gave FDA and the industry. IMHO, they had some good suggestions.

Feel free to put forth any ideas that you and/or Joe have.

Don

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05-23-2002, 06:58 PM	#1 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,526 Rep Power: 10	In some ways the discussion that took place after Dr. Cyr proposed the changes FDA wanted to make for "warning labels" were some of the most interesting of the day. In fact, it was this issue that elicited the most constructive comments from TEPRSSC members. What do we do now? Now, we must work with FDA to "revise" the "warning label" until it is acceptable to all parties. Here is what Dr. Cyr proposed: * WARNING - Ultraviolet radiation may cause: - injury to the eyes and skin - skin aging - skin cancer * Read instructions carefully. * Wear protective eiyewear (goggles) provided. * Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation. And, here is a "revised" warning label that I prepared on the flight home that incorporates most of the the various and sundry points brought up during the discussion period. WARNING * Ultraviolet radiation (UVR) may cause acute injury to the eyes and skin like: - sunburning - (will add this later) * UVR may also contribute to the development of chronic conditions like: - skin aging - skin cancer * Read all instructions carefully. * Wear the compliant eyewear (goggles) provided. * Certain medicines and cosmetics may increase sensitivity to UVR. * Avoid overexposure to UVR. Comments to this "revised" version? Don

05-23-2002, 07:44 PM	#2 (permalink)
solarmeter Join Date: Nov 13 2001 Location: MI Posts: 515 Rep Power: 7	Don, I don't like the word 'acute' at all, unless it pertains to the fairer sex. Should specify 'unprotected' eyes, as I believe Brenda mentioned to Sharon Miller. Good that 'overexposure' was put back in. Do you have to 'add more later'? Darn label keeps getting longer.

05-23-2002, 08:12 PM	#3 (permalink)
Brenda at Eye Pro Join Date: Jun 29 2001 Location: Fort Wayne IN Posts: 231 Rep Power: 8	Don, Did you write down the changes that the pre-ITA meeting came up with and that Joe Schuster proposed to TRPRSSC? I don't see any of our changes in your new label. I'll contact Joe and get the revisions we all worked on. Brenda

05-24-2002, 09:51 AM	#4 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,526 Rep Power: 10	Brenda: I tried to focus on the "directions" that TEPRSSC members gave FDA and the industry. IMHO, they had some good suggestions. Feel free to put forth any ideas that you and/or Joe have. Don

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