FDA Overhauls Sunscreen Ratings As Part Of Continuing War Against The Sun

A recently issued rule from the FDA would overhaul and expand the agency’s fight against the sun’s radiation. The proposed regulation would require sunscreen makers to test for effectiveness against UVA rays, which unlike UVB rays, do not burn the skin; UVA instead gives us an attractive bronze that can cause cancer.

The agency also plans to spruce up the existing sunburn protection factor (SPF) system by rating sunscreens on a one to four-star scale. sunscreen_labels.jpgJust in case consumers misunderstand the star scale and think fewer stars are better, the agency will also rate sunscreens as “low, medium, or high.” As a final resort, sunscreens will bear reminders that cowardice is the best protection against the sun; consumers will be encouraged to wear protective clothes and limit their exposure to the sun.

The proposed rule is subject to a 90 day comment period. If approved, sunscreens sporting the revised labels should appear on shelves in time for the summer of 2009.

F.D.A. Plans New Labeling for Sunscreen [NYT]
Docket Management Comment Form [eRulemaking]
(Photo: mtoz)

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  1. Christovir says:

    Personally I’m a little skeptical of the common wisdom that simple exposure to the sun really causes malignant skin cancer. It’s definitely known that sunburns, particularly in childhood, can cause cancer in adulthood, but there is very thin evidence for any ill effects from sun tans and moderate exposure.

    I believe that the positive effects of sun exposure outweigh its negative effects. Stress is probably the greatest cause of illness, and worrying too much about if we go out in the sun or what we eat may be more harmful than the action itself.

  2. Nicholai says:

    You say “War Against The sun” like it’s a bad thing…..

  3. duncanfj says:

    @ CHRISTOVIR :

    I’m a skin cancer researcher. Trust me, moderate exposure will still give you cancer. The health benefits so many people try and tout are achieved with 15 minutes of sun exposure, which most people get walking to and from their car each day. Once you get over that, there are no added benefits. And the damage you are causing your skin just adds up. Skin cancer is the most diagnosed cancer in the world. It may have a relatively low mortality rate (other than melanoma), but it can be disfiguring and painful. Which of course translates into expensive to treat.
    It is even worse if your immune system is out of whack. Oh, and all of the “literature” out there about tanning beds not causing cancer? Guess what we use in our research?

  4. ptkdude says:

    Aren’t people who think one star is better than 4 also going to think “low” means low risk and “high” means high risk? I mean, seriously, if they don’t understand that more stars is better, aren’t they too stupid to understand more challenging things with letters in them (i.e. words)?

  5. Christovir says:

    @duncanfj:
    I would appreciate it if you would post some citations of studies finding moderate sun exposure in adulthood causing malignant tumors.

    I’m not just talking about basic biological/cellular health benefits of the sun, which I’m sure are fairly limited. I’m talking of the holistic benefit of being able to enjoy the outdoors actively without stressing too much about all of the potential hazards. We are predisposed to biological illness through psychological stress, and I think staying indoors for fear of the sun is a net loss. Sure, we should take some precautions, like using decent sunscreens, but our lifestyles are healthiest when well balanced, and staying indoors/covering up from head to toe all summer is not my idea of balance.

  6. Amy Alkon says:

    Thanks, Duncanfj. I’m always amazed by people like the first poster who speculate, based on zero data.

    Can you address whether the new additives that have come out in the USA are as good as Mexoryl, which has been available in Europe for maybe a decade. (I’ve been wearing Anthelios XL #50+ or 60 from France for years.)

    I’ve written about Anthelios from time to time on my blog, and I’ve contacted Jennifer Jones, a spokesperson at L’Oreal, Anthelios’ parent company, to find out when Anthelios will be approved by the FDA in more than SPF#15, but she wouldn’t/couldn’t say. She did seem to be hinting that it’s in the process, but I can’t say that for sure.

    P.S. Beyond the cancer issue, avoiding exposure to sun means you’ll look a lot less like an old leather handbag.

  7. TeraGram says:

    Hurray for the FDA! Protect us from ourselves while really doing NOTHING! Hurray! HURRAY!

    Seriously! This is another one of those “look over HERE! LOOK OVER HERE!” distractions by an governmental agency under control by the Bush Whitehouse. Instead of working full-force on a real and dangerous problem (food safety) they’re distracting the public with another quick-fix P.R. stunt that not only doesn’t solve any real problem, but in fact will cost manufacturers a good chunk of change to comply.

    It’s a load of CRAP.

  8. Amy Alkon says:

    The FDA has “protected” us for years from protecting ourselves from skin cancer, and it didn’t just start with the Bush administration (which I’m not a big fan of, for what it’s worth).

    From research I’ve read, Mexoryl has been the best protection against UVA and UVB for quite some time, and although people in Europe weren’t dropping dead from using it, the FDA has not allowed it to be sold here.

  9. Amy Alkon says:

    Here’s Stossel on Mexoryl:

    [abcnews.go.com]

    Our suntan lotions are good at screening out the sun’s UVB rays — the ones that cause sunburn and skin cancers — but most people don’t realize their sunscreens don’t offer much protection against UVA rays, the ones that put wrinkles in your skin.

    “Ultraviolet A light ages your skin. And the reason it does that, it’s a longer wavelength, so it can penetrate deeper into the skin, and instead of attacking the upper layers of the skin where skin cancer often forms, it attacks the layers that give your skin its tone, its elasticity, as we call it. & You get the lines, the wrinkles, all the things associated from aging,” said Dr. Darrell Rigel, clinical professor of dermatology at New York University.

    But there’s good news. Lotions that contain the ingredients Oxybenzone, Titanium Dioxide or Parsol 1789 block out some UVA rays.

    Doctors say a chemical called Mexoryl offers even better protection.

    “It produces a product which gives us almost perfect protection against sunshine,” said Dr. Vincent DeLeo, chairman of dermatology at Columbia University.

    People are happily protecting themselves with Mexoryl on the beaches of Rio de Janeiro, the streets of Paris, in Canada, Mexico and Australia.

    Mexoryl “is the No. 1 individual ingredient in terms of protection from Ultraviolet A radiation,” Rigel said.

    But even though dermatologists say Mexoryl is the best, you cannot legally buy it in the United States. It’s illegal, because the Food and Drug Administration won’t approve it. They won’t even say why. The FDA is charged with making sure no drug is sold unless the government is convinced it’s safe and effective. Dermatologists think it’s just stuck in the bureaucracy. It routinely takes 12 to 15 years for a drug to get approval. After an approved drug — Vioxx, for example — gets bad publicity as a health risk, the FDA gets particularly cautious.

    But is there no common sense here? All drugs have risks as well as benefits. Mexoryl has been in use in other countries for 13 years. It’s passed many safety tests. Why won’t our FDA even talk about it?

    Although buying or selling sunscreens with Mexoryl is illegal in the United States, that doesn’t mean sunscreens with Mexoryl aren’t bought and sold here. We found it at some pharmacies. It was expensive — $30 to $50.

    That’s the same stuff I get for $10-$12 a tube in a Paris pharmacy. Thanks, FDA!

  10. SOhp101 says:

    @Christovir: It really all depends on your own skin. Some people burn easily and therefore should use sunblock more frequently, while others can be in the sun nearly all day without getting a shade darker.

    It’s common knowledge (now) that most sunscreens are bad at blocking UVA rays, but there are some that are being marketed as “broad spectrum” but I don’t know how accurate that term is. It’s a shame that the FDA hasn’t already fast tracked a way for that stuff in Europe to come stateside.

    Having moderate/heavy sun exposure is no guarantee that you will get cancer (as does smoking, bad eating habits, etc.) but it does increase your chances. Just remember to put some sunblock on if you’re going to be outside for an extended period of time. Will you die if you forget? Probably not.

    @Amy Alkon: Most cosmetic products, if they do have sunblock in them, only have SPF15. Seems like it’s the industry standard. I have no idea why, but I would guess it would have to do with it still maintaining its ‘beautification’ qualities without smelling and feeling like sunblock.

  11. duncanfj says:

    @ Christovir: I could post 20-30 citations in just the last six months alone. Very few researchers use more than a moderate dose. People rarely go out and purposely get burnt. Most people go out and stop when their skin feels warm or a little sensitive. Or people go out and put on what they think is enough sunscreen. When researchers plan experiments, they try to do so in a way that would mimic what people would do. I agree that it feels great to be outside, but there is no reason to not be safe also. Wear a hat, put on sunscreen that has physical blockers (zinc dioxide, etc) and wear a long-sleeve shirt, if possible.

    @ Amy: The best protection will always be a physical barrier, such as zinc oxide. Chemical barriers can work very well, but the problem is that they break down. Most of them have to be reapplied very often, alot more often than people do so. And people usually try to be thrifty and use what they used last year, or the year before. By then, all that is left in the bottle is moisturizer or something else that is worthless as a sun screen.

    @ Sohp: Using skin darkness isn’t really a good way to predict susceptibility to skin cancer. The reason that most sun screens are bad at blocking UVA rays is that many of them are chemical barriers that begin to break down as soon as sunlight hits them. There is a brand from Australia available here in the US that is very good, Blue Lizard. Forget Europe when it comes to sun protection. Australia knows what it is doing. Look up the “Slip, Slap, Slop” campaign started backn in the 80s.

  12. phoenixcat says:

    Another question for our experts- I use Bare Escentuals face makeup- which has zinc oxide and titanium dioxide ( I think ) I dont seem to get much color in my face when I apply a good amount- am I still needing a sunscreen on top of this? ( I live in Phoenix, and we just cook here…

  13. SJActress says:

    This rating thing is stupid. Isn’t the SPF a rating already? And am I the only one who reads the bottle to see if it protects against UVA rays?
    I love that our government wastes time on things of no importance. If you can’t figure out how to use suntan lotion, you deserve to burn to death.

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  15. Amy Alkon says:

    I also have a clear screen on my car windows to block out UVA and UVB.

  16. JMH says:

    @duncanfj: I’m willing to listen, what is it about Blue Lizard that makes it better than, say, a sunscreen that contains Mexoryl, as was mentioned above?

  17. kimsama says:

    @duncanfj: Wow, it’s great to hear from someone who studies this for a living. I was so terrified of skin cancer when I was a teenager that I wore long sleeves and a hat all the time in the summer. I was pale as a ghost. Then I heard about the fact that 15 minutes a day actually has cancer-preventative effects (like you mentioned) and that most women who develop osteoporosis get it because of insufficient vitamin D (not lack of calcium). So, now I get 10-15 mins a day, and that’s about it. Sunscreen for longer outdoors times (I’ve used the Neutrogena stuff with UVA/UVB, hope that works!).

    Any other insider advice you can give us on how to limit skin cancer risk? And what did you mean about immune disorders? I’ll bet plenty of other people here have allergies/eczema (which are essentially immune derangements), so let us know…

  18. jeff303 says:

    @Christovir: Thank you for bringing this up. I’d be very interested in seeing some archaeological evidence that many (most?) of our ancestors died of skin cancer, given the non-existence of sunscreen until the 20th century and the almost certainly higher levels of exposure in a pre-industrialized world.