FDA proposes new sunscreen rule

Yesterday FDA proposed a new sunscreen rule that did two things.

1) It set out rules for measuring UVA protection (currently SPF only measures UVB protection. UVB causes burns but UVA is a greater risk for skin cancer). Finally! The new system will give you SPF for UVB (now up to 50+, as far as is technically feasible), and a 4 star sytem for UVA protection. It's sad it took this long to get here but thankfully, now consumers can figure out what the real protection is.

2) It asks for comments regarding nanosized materials in sunscreen. You already know what I think about this!

You can comment on any part of the rule if you get it in by 26 Nov 2007. The Docket # is 1978N-0038 and can be accessed here

I've got to add this - In the FDA news release there is this paragraph:

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

You dolt, everyone understands that if you spend less time in the sun or wear more clothes you get less skin damage. Just because we don't do it doesn't mean we don't understand. Who approved this communication? Way to sound both condecesding and out-of-touch, FDA.

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The bigger problem, dolt, is that people are perhaps spending too much time in the sun because they are wearing sunscreens and falsely reassured the risk of skin cancer is decreased. The opposite may end up being true because the usual screens don't block all UV rays. And the risk of cancer may well be independent of the risk of burning. And there's nothing wrong with addressing people as if they're stupid. Lots of people are stupid. Should we abandon them?

David, I think you missed the point of the post. The new standards are good for taking into account the likely more harmful UVA rays and many people should stay out of the sun more as opposed to relying on sunscreen. However, FDA's tone of communicating is rediculous.

But if you think it's okay to address people like they are stupid, then we have a huge difference of opinion. Usually when we say people are stupid it's because they didn't understand or follow what we said. Almost invariably this is because either it wasn't explained properly, or they understand but just don't care/disagree. I think in the sunscreen area it's probably the later; people understand the risk of being in the sun w/o protection but just don't care.

It's complete pig-headed arrogance to think that people who don't do what we think is best are stupid. Your "Should we abandon them?" sounds like pity, not concern. How nice of you to think about those idiots who don't make the right decisions. You can keep your pity, nobody wants it. People will do much better when informed properly.

See, David, AT just provided an example of how to speak to a stupid person without being overtly patronizing.

By Fnord Prefect (not verified) on 28 Aug 2007 #permalink

The idea that David inexpertly introduced actually has a name: Risk homeostasis.

You can have a successful treatment or device introduced and widely used by the population (in this case sunscreen) and yet a few years later the outcome your trying to minimize (i.e. skin cancer) still hasn't dropped. That's the homeostasis bit, the risk stays the same because there is a compensatory factor keeping the risk high. Here people might be putting sunscreen on, so they feel safer in the sun, but they then stay outside for much longer periods because they perceive themselves protected. So the overall dose of UVA stays about the same or even goes up. A few years later and the skin cancer rate hasn't changed much. This is where the Slip Slop Slap campaign changed to add a rider about staying out of the sun during the hot part of the day in addition to the original message.

The same risk homeostasis effect has been blamed for why it has been so hard to show that bicycle helmets reduce head injuries or deaths. People with helmets may ride in a riskier fashion than if they didn't have helmets and it turns out that motor vehicle users will give more room on a road to a person without a helmet than a cyclist with a helmet. So whilst the severity of each individual crasj may be lessened by a helmet the number and severity of all of the crashes may be going up which causes the observed homeostasis.

So. Does this mean that sunscreens and helmets should still be made as safe and effective as possible? Absolutely. In this environment the stupidest thing we could do would be allow a risk countermeasure that the public generally trusts (like Sunscreen and helmets) to actually be ineffective. If that were to happen the risk of skin cancer and bicycle injury would probably markedly rise because people would still engage in the riskier behaviour but would not longer have their risk lowered by the helmet/s.screen.

As one who spends much time in the tropics, I am delighted I will get to be able to protect myself better from skin cancer (one small bout so far), in fact that is rather what I throught I had been doing by applying sunscreen! Now I learn I was just preventing burn.
Yes clothing is good but also not entirely protective. I go down with white skin, cover myself with sunscreen and wear long sleeve shirts. Within a few days I am brown through the sunscreen and shirts!

Did they also mention what protection you can expect from clothing and just what "protective" clothing actually is. I was really shocked when my doctor told me how much protection I can expect from a white t-shirt.

AT, there is nothing pigheaded about recognizing the incidence of intelligence amongst the hoi polloi, nor is there any pity. How can you indict the FDA for aiming for the lowest common denominator, most of whom lack ologist as a suffix? Do they not sizzle in the sun?
Nat, Inexpertly perhaps but far more accessible and digestible. I was near a quarter way through your epistle when oooh donuts!

thought I'd weigh in. There has been a recent large study conducted at the Creighton University School of Medicine in Nebraska. The study involved 1,179 healthy women from rural Nebraska. Turns out that the lack of Vitamin D is a major factor in cancer, including skin cancer, breast cancer, etc. The study showed a whopping 77% reduction in the instance of cancer in the group receiving vitamin D and calcium. Major source of Vitamin D? The Sun. What do sunscreens block? The Sun. What do most sunscreens contain: how about highly carcinogenic substances that are absorbed through the skin. WHO says that 70% of all cancers can be prevented by dietary and lifestyle changes, including sun time (w/o sunscreen).

By david0217 (not verified) on 29 Aug 2007 #permalink

So David's argument is that because he thinks like Homer Simpson all other people think like Homer Simpson.

I was wondering when someone would mention Vitamin D (not really a vitamin at all, actually a very important multi-function hormone precurser formed in the skin that relies on adequate cholesterol levels, later converted in the liver). There is more info on Vit D at the Vitamin D Council, a group of Vit D researchers ( http://www.vitamindcouncil.com/ ).

Cancer rates are higher as one goes farther from the equator. The sun/melanoma issue isn't as cut and dried as it seems. Melanoma risk seems to be lower in those with adequate Vit D levels (easily testable, but rarely done). Melanoma often occurs on skin with little sun exposure.

Most of the gain from sunscreens and sun avoidance is the reduction of skin aging (collegen/elasticity breakdown) and basal/ squamous skin cancers. As someone who had MOHS surgery/reconstructive skin graft for a basal cell carcinoma on my nose at age 37 (all those teenage summers rusting, I mean trying to tan like my friends in upstate NY, I guess), I can say having a basal cell carcinoma is not fun, the reconstruction takes as much as a year to completely heal, and can be tricky if it occurs in difficult spots like the eyelids, etc. But generally speaking, these kinds of skin cancers are more cosmetic and nuisance issues, and preventing them with sunscreens and reducing sun exposure is beginning to look like it also raises the risk of far more serious cancers.

I complied with my dermatologist's instructions to use strong sunscreens and avoid the sun, especially the midday hours. Living in So California now, that advice seemed so wise. But I should have also been advised to supplement with Vit D3 (cholecalciferol) which is not found in many foods (the synthetic D2 added to milk is not the best source). Now I use sunscreen only if I am out in the sun for extended periods (I try not to over do it) and protective SPF clothing to reduce sunsreen use, but I also try to get at least a few minutes of strong, unprotected sun every day (without burning) and I feel much better for it (I hadn't realized how draining lack of sunshine is until I started "taking the sun again"). If I can't get the sun everyday, I take Vit D (cholecalciferol) or cod liver oil. Sure, my skin may show its age, but I feel much better for it. I'll never keep up with all the cosmetic "procedure" junkies here in So Cal anyway :-). There are worse things than looking my age.

This control seems like a great tool. The problem I am having is that I cannot get the jpg to render. I followed the instructions from version 1.1 and the postcomment.aspx as well as the DLL from version 1.2. There was no readme

As for as concern with the deficiency of vitamin D as factor which triggers skin cancer it seem not appropriate.
Because it is a clear fact that 90% of the skin cancer is caused by the uvb light and uvb light is famous source for the production of vitamin D.
So here is conflict.
Although it is possible that deficiency of Vitamin D may cause depigmentation problems in skin.

This just goes back to the very smart idea of prevention instead of curing. Anne I think that, as with most things, you need to find that moderation of getting some sun without getting too much.