tanTALK - View Single Post - Final FDA Version

Don Smith · 05-08-2002, 07:51 PM

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 ]

05-08-2002, 07:51 PM	#1 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,597 Rep Power: 10	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 ]