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Old 04-25-2002, 06:16 PM   #1 (permalink)
 
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Listed below you will find (1) the "warning label" language proposed by FDA on 2/8/02, (2) the alternative proposal that I have made to FDA,(3) the "proposed" Health Canada "lauguage" for our neighbors up north, and, the "new" Australian language.

1. FDA Version.

* 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. 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.

3. Health Canada version.

DANGER - ULTRAVIOLET RADIATION
* Follow instructions. * Use protective eyewear.
* Overexposure causes skin and eye burns.
* Long term use contributes to skin cancer (sometimes fatal), wrinking and sagging of skin.
* Drugs and cosmetics may increase UV effects.
* The use of this device is prohibited for minors.
* Health Canada recommends against tanning.

4. Australian warning notice.

* Exposure to ultraviolet radiation such as from a sun-tanning unit contributes to the skin ageing process and may cause skin cancer.
* People with fair skin and who are unable to tan shall not use a sun-tanning unit.
* Intentional exposure to sunlight or sun-tanning unit should be avoided for 48 hours after sun-tanning unit exposure.
* Protective gogles must be worn at all times while undergoing sun-tanning unit exposure.
* No person under the age of 18 shall use a sun-tanning unit without parental consent.

Some questions/comments for Canadian salon owners.

1. Is a person 18 considered a "minor" in Canada? What is the age at which a person is no longer a minor?

2. The last sentence "Health Canada recommends against tanning." implies that Health Canada is recommending "against" UVR exposure, either indoors or outdoors. Do they realize the legal position they are putting themselves in? IF it read "Health Canada recommends against OVEREXPOSURE to UVR, either indoors or outdoors", it would be acceptable. As it is, it is CLEARLY something that must be contested.

3. The term "sagging skin" is not precise enough to be used in this language and, therefore, it is a "scientifically unsubstantiated" statement.

4. "Skin aging" (solar keratosis) is more scientifically correct) than the use of the word "wrinkling".

5. Why doesn't Health Canada "warn" against sunburning since that is the most likely adverse effect to be expected?

6. Health Canada HAS used the word "contributes" and that is good.

I'll cover some other similarities and differences in future posts.

Some questions/comments for Australian tanning salon owners.

1. Evidently there is no 48-hour prohibition against tanning outdoors like there is indoors. Doesn't make sense!

2. How do they plan to enforce the prohibition against skin type 1 individuals using a sun-tanning unit since they don't mandate the use of a skin typing/subtyping format?

3. Why wasn't there a "warning" about sunburning since that is the most likely adverse event to be expected?

I'll have more to say (much more!) about the Australian/New Zealand Standard later.

Don

Added later. If you want to print out a "formatted" copy of the warning label comparison, go to the link shown below.

http://www.naatso.org/frameset_tso.htm
[ This Message was edited by: Don Smith on 2002-04-25 18:59 ]
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Old 04-25-2002, 08:20 PM   #2 (permalink)
 
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Is there a European version? EU or individual countries.

Globally harmonize on the DLS version.
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Old 04-26-2002, 04:22 AM   #3 (permalink)
 
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Steve:

The European (IEC) version was the one that FDA proposed on 2/8/02 = #1.

Don
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