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Too Bad There's No Such Thing As FDA-Block
As I've written before, if you could block out the FDA, you could block out the wrinkliest, most cancer-causing rays of sun -- and without the additional cost of a trip to Paris.

bouganvilleadusoleil.jpg

Laurel Naversen Geraghty writes, in The New York Times, about Anthelios XL 60, my sunblock of choice, with the most protective ingredient on the market, Mexoryl:

So far the Food and Drug Administration has approved only three ingredients protective against UVA: zinc oxide, titanium dioxide and avobenzone (trade name Parsol 1789).

But Mexoryl seems more effective than any of these at protecting against UVA light. In 2000, Canadian and French researchers slathered six brands of sunscreen and sunblock on the backs of volunteers and exposed their skin to a UV sunlamp for 15 minutes. The product containing Mexoryl (along with avobenzone, titanium dioxide and other ingredients) was more than twice as effective in protecting against UVA light as any of the others. The study was published in the Journal of the American Academy of Dermatology.

...The difference between UVA and UVB light is a matter of wavelength. UVA rays come in longer wavelengths (320 to 400 nanometers), so they pass through the outer layer of skin, rather than burning it as do the shorter UVB rays (290 to 320 nanometers). UVA rays penetrate deep into the dermis, or lower layer of skin, where they can break down collagen and other proteins that keep the skin plump and firm.

"That deeper penetration and deeper damage is what we think is really associated with premature aging in the skin," said Dr. Clay J. Cockerell, a Dallas dermatologist, who is president of the American Academy of Dermatology.

The UVA rays can also damage cells and DNA in the dermis, decrease the skin's immunity and generate harmful free radicals. Though the exact mechanisms remain unclear, doctors assume these actions explain why UVA exposure is also associated with skin cancer.

Unlike UVB light, prevalent only when the sun is high in the sky - between 10 a.m. and 4 p.m. during summer - UVA light is virtually inescapable. "It's present in the same amount from sunup to sundown, 365 days a year, totally independent of climate conditions," said Dr. Katie Rodan, an associate clinical dermatologist at Stanford University.

That means it not only penetrates car windows and T-shirts, but it also reaches the skin during fog, rain and even blizzards.

...It is hard to tell whether Mexoryl will make it to the United States market anytime soon. A L'Oréal spokeswoman would say only that the company has "initiated a process of discussion with the F.D.A. regarding Mexoryl and is continuing to work closely with the F.D.A."

Luckily, Botox is perfectly legal. Unfortunately, it tends to stymie all but the most Stepfordlike facial expressions.

Posted by aalkon at June 13, 2005 8:59 AM

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Comments

Hi, Amy. I understand your frustration and I totally agree that this marvellous sunscreen should be permitted in this country, but please. Blocking out the FDA as a whole??? I'm sure the Bush Administration would love to do the same thing, as it is the FDA who regulates meat inspection, for instance. Without the FDA, kids will be ordering their burgers with the unseen additional topping of E. Coli.

Posted by: Patrick at June 13, 2005 9:30 AM

>Without the FDA, kids will be ordering their burgers with the unseen additional topping of E. Coli.


Actually that's mostly the USDA. La Coquette thinks I'm a "pedantic old fart" for correcting her vulgar french and maybe she's right ;-)

Posted by: Stu "El Inglés" Harris at June 13, 2005 12:40 PM

After reading your previous post on this, I ordered it and I [and my dermis] love it. Thank you!

Posted by: ema at June 13, 2005 7:12 PM

Oh, fab! Thanks for telling me!

Posted by: Amy Alkon at June 13, 2005 7:50 PM

I'm all for keeping the E. Coli out of the food supply. It's just that we could use a little judgement on their end in cases like this.

Posted by: Amy Alkon at June 13, 2005 7:52 PM

Elmer's Glue has been on the market for years, and it has all sorts of off-label uses.

Posted by: Lena-doodle-doo at June 13, 2005 9:55 PM

One proposed reform is the "split label" system. Under this system the FDA would not be able to prohibit products, but products under their purview would have to carry statements by the FDA in addition to the manufacturer's information. That way anyone who wants the FDA's "protection" will have it, but those of us who prefer to think for ourselves will have the full range of options.

Which brings me to my rant:

Dr. Milton Friedman and others have harshly criticized the FDA. In a nutshell, the FDA's policies unnecessarily delay the release of new drugs, and the expense of the drug approval process encourages companies to introduce only the most profitable products. The process favors the richest corporations, thereby stifling competition and holding back the progress of medical science. In addition, they have a history of making politically motivated decisions, playing regulatory power games at the expense of the American people, and even defying scientific concensus at times.

The only reason Americans aren't organizing demonstrations against the FDA is because the suffering and loss of life they cause is invisible. When a drug causes a mere hundred deaths, it's news. But when a hundred thousand Americans die because the FDA prevented the release of a lifesaving drug for no scientifically valid reason, most people never even hear of it.

Unfortunately it's been years since I read up on this issue, so I can't provide a lot of details. It's an issue I feel strongly about, however.

All the Best,
Charles

Posted by: GodlessRose at June 14, 2005 1:47 AM

By the way, a pet peeve of mine is the way people in the skeptics movement often quote statements by the FDA as if they are infallible. That isn't my idea of skepticism.

Dang - I misspelled consensus. Forgot to use my spell checker.

All the Best,
Charles

Posted by: GodlessRose at June 14, 2005 1:59 AM

What Charles said.

Posted by: Amy Alkon at June 14, 2005 4:42 AM

It's annoying that this has been approved in Europe but not in
the U.S. That's not the FDA's fault, though. It could just as
easily be the opposite way. It's two separate sets of tests and
bureaucracy to get the two different approvals.

How about a little injection of facts? Here's a link to a
research paper about the FDA/EMEA approval process.

http://www.pubpol.duke.edu/courses/pps255s/2003/m-team-c/policy_europe.html

Posted by: Ron at June 14, 2005 7:12 AM


One reason that drugs get approved a lot faster and easier in Europe than in the U.S. is that European adults understand that life is full of risks, and they make their decisions accordingly. Which means they don't try to sue the drug manufacturers because new side effects were discovered when the drug was put into wide use - or worse, because the drug manufacturer warned of a particular side effect, but didn't put it in bold enough print.

Their system is built on the premise that it's better to have the drug available and let individuals accept both known and unknown risks (or not) than to try to warn or guard against everything bad that might happen, which isn't possible anyway.

Imho, we'd be a lot better off on oh-so-many-fronts if we adopted the UK system where someone who brings a lawsuit and loses has to pay the other side's legal fees. That approach would cut the cost of dealing with nuisance suits (which we all pay) and also cut manufacturing costs, so companies didn't have to put stupid labels to try to limit their liability, like "don't use electrical hairdryer in the shower."

Like the tag line I read on an e-mail - "I'm not saying we should have capital punishment for stupidity, but how about if we just remove all the warning labels and let the problem take care of itself?"

Posted by: Melissa at June 14, 2005 4:37 PM

Has anyone read
http://www.cosmeticscop.com/bulletin/092905-full.htm
Was 20/20 Blinded by the Light? by Paula Begoun
She makes some interesting claims against the Mexoryl bias:

"Despite the enthusiasm of L'Oreal and some dermatologists, independent, peer-reviewed research supporting L'Oreal's claims for Mexoryl is lacking. Almost all of the studies pertaining to Mexoryl's UVA-protecting prowess have been funded by L'Oreal (or a L'Oreal-owned company such as La Roche Posay). A small-scale, double-blind German study showed Mexoryl to be effective when paired with avobenzone and titanium dioxide (this combination is used in many commercial sunscreens featuring Mexoryl). But this study begs the real question: How do we know the Mexoryl is responsible for the positive results? Rather than spotlight Mexoryl's individual ability to protect skin from UVA damage, the study demonstrated that Mexoryl works best when combined with other active ingredients, and that variances between active ingredients can affect how well a sunscreen protects skin (Source: Photodermatology, Photoimmunology, and Photomedicine, December 2000, pages 256–259).

In contrast to the information about Mexoryl, several studies show that titanium dioxide and zinc oxide are capable of providing significant UVA and UVB protection when used alone, and that they have no risk of skin irritation. However, the 20/20 report made no mention of that whatsoever (Sources: www.abcnews.com; Skin Therapy Letter, volume 2, number 5, Table 1, 1997; Journal of the American Academy of Dermatology, January 1999, pages 85–90; The British Journal of Dermatology, August 1999, pages 250–258; and Photodermatology, Photoimmunology, and Photomedicine, October 2003, pages 242–253).

There is no official confirmation on the FDA's Web site (www.fda.gov) that L'Oreal has submitted Mexoryl for approval as a sunscreen active. However, media reports, including one from www.washington post.com, have alluded to the proceedings but mention that the FDA is not commenting on Mexoryl's application. The media-relations folks at L'Oreal are also remaining tight-lipped, commenting only that "All we really say about Mexoryl is that we have initiated a process of discussion with the FDA about Mexoryl and are continuing to work closely with the FDA." Where ABC got the notion that Mexoryl was the be-all and end-all of sunscreen ingredients is unknown, because there is no research showing that to be the case, and no one else in the industry (aside from L'Oreal) believes that is the case.

The bottom line is that U.S. consumers are not being shortchanged in meeting their sun-care needs just because Mexoryl is not widely available. While it would be nice to have another UVA-protecting sunscreen ingredient in the U.S. market, research does not support the media stories that proclaim Mexoryl as "the best" sunscreen agent, although I bet L'Oreal is loving the free publicity!"

Posted by: Rezl at June 29, 2006 12:58 PM

i have suffered from polymorphus light erruption for 17 years...how would you like to walk from your house to your car..average walk 40 seconds...and get an intense red angry itchy rash..where ever your skin was exposed to the sun? and not to mention how do you block the reflective light? and by the way..it takes WEEKS to go away..oh..IF you stay out of the sun completely...i have tried every product..(nope cant go to the ball game, nope cant go fishing, nope cant go...ANYWHERE..unless its winter..sorry kids..i cant go to your baseball game) this has been horrible...i own no stock in L'Oreal..or La Roche-Posay..but this product is the ONLY product that protects my skin..i beleive it is the mexoryl..i've tried other products with the parasol and it doesnt do enuf at all...so the proof is in the pudding folks...i pay alot for this and i would even pay double that if i had to...you have no idea..and i love the sun! i would be paying for anti-depressants eventually without it. just try staying out of the sun..for 6 months of the year..its awful.

Posted by: nyj at July 5, 2006 8:22 AM

How horrible that these idiots at the FDA are sitting on the approval instead of letting us have the product. My sympathies.

Posted by: Amy Alkon at July 5, 2006 9:01 AM

Hi there!
The GOOD NEWS is that Mexoryl XL/XS have made it finally to the US!!! July 24. 2006! There is a God there! A big fan from Norway, Europe

Posted by: eva at July 27, 2006 7:26 AM

I cannot believe that it takes so long to get something that is so needed to the U.S.!
I live in south Florida and I need the best possible coverage.
I do use a good sunscreen but why can't we have what everyone else can get?
I'm not getting any younger.

Posted by: Gloria at May 30, 2007 8:00 AM

I agree with Rezl, I am extremely fair and i have freckles - this is the only product i have found thus far that prevents my freckles from darkening!
I have ordered it from Canada before but was not happy with the website i bought it from - does anyone have a site that they can recommend?

Posted by: Emma at June 6, 2007 2:59 PM

i have been ordering anthelios from canadian websites and specialty pharmacies in new york. the highest spf that is sold legally in the us is only 15. does anyone know why that is?

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Posted by: lfyjhezq vchkiyub at July 16, 2007 1:39 PM

One thing I've noticed, although FDA approved Mexoryl XL, Europe still have different products, different concentration and higher filters. Has anyone seen that too ?

Posted by: Zaneta at October 28, 2007 2:52 PM

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