How Government Does Business And How It Hurts Us: Blocking You From Blocking The Sun's Rays
I have long worn the most protective sunblock available, Anthelios, with mexoryl, which offers strong protection from both UVA and UVB rays.
Europeans have been wearing it for years -- after mexoryl (aka ecamsule) was approved in 1990. Are Europeans dropping dead from its use? No.
But the FDA has long dragged its heels on approval of this and other highly protective sunscreen ingredients. So, I get mine in Paris -- in bulk, for about 12 eu a bottle -- while Americans can pay $30 or more for the same thing, and it's not widely available. (Here is one I found at Amazon for $23.)
Only the parent company, L'Oreal, of this product, is able to add it -- and only to this product and a few other high-priced ones -- because they are the only one who got FDA approval. The price would go down for sunscreens using it -- as it has in Canada -- if there was competition.
Brady Dennis writes in the WaPo about the FDA:
The agency has not expanded its list of approved sunscreen ingredients since 1999. Eight ingredient applications are pending, some dating to 2003. Many of the ingredients are designed to provide broader protection from certain types of UV rays and were approved years ago in Europe, Asia, South America and elsewhere....In the meantime, advocates for newer sunscreens have grown increasingly frustrated.
"These sunscreens are being used by tens of millions of people every weekend in Europe, and we're not seeing anything bad happening," said Darrell S. Rigel, clinical professor of dermatology at New York University and past president of the American Academy of Dermatologists. "It's sort of crazy. . . . We're depriving ourselves of something the rest of the world has."
Even some FDA officials have expressed frustration about how the applications have become mired in a complex regulatory regime, adopted more than a decade ago, that was originally intended to simplify approvals for over-the-counter products used in other countries for at least five years.
"This is a very intractable problem. I think, if possible, we are more frustrated than the manufacturers and you all are about this situation," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told lawmakers in November when asked about the agency's sluggish over-the-counter reviews.
Part of the holdup, she said, is that the agency must undertake a lengthy rule-writing process before it can add to the list of active ingredients approved for sunscreens. In addition, the FDA has found some applications lacking in safety data. And differing standards mean that an ingredient considered safe in Canada or Japan, for example, might not automatically get a thumbs up from U.S. regulators.
Since last year, a group of dermatologists, sunscreen ingredient companies such as BASF and advocacy groups such as the Prevent Cancer Foundation have lobbied lawmakers and rallied public support for changes to the approval process. Last week, a bipartisan group of lawmakers on Capitol Hill introduced legislation aimed at speeding up the FDA reviews. The FDA has planned a public meeting this month to seek input about overhauling its process for evaluating over-the-counter products.







Our new Constitution is now established, and has an appearance that promises permanency; but in this world nothing can be said to be certain, except death and taxes. -— Benjamin Franklin, in a letter to Jean-Baptiste Leroy, 1789
I think the last needs to be changed to:
but in this world nothing can be said to be certain, except death, taxes and bureaucracy.
Jim P. at March 26, 2014 7:09 AM
Part of the problem is that the FDA's regulatory regieme is still based on the precautionary principle, which basically states that there is no such thing as acceptable risk. This happens because people are squeamish about putting numbers on risk; you can just see the above-the-fold screaming headlines now -- "FDA SAYS IT'S OK FOR 10 PEOPLE PER YEAR TO DIE FROM THIS DRUG!"
And damn it, for all of the things that FAA does wrong, one thing it does right is that it puts numbers on acceptable risk. This provides a standard that can actually be met; you can calculate risks for airplanes and systems and see if you are meeting the threshold number or not. And the process is fairly objective; you do the math and either the number meets the standard or it doesn't. You can argue about how the number is calculated but there is only so much wiggle room there. Anything that's outrageously out of line is just not going to get through. Conversely, something that's on the straight and narrow, in terms of its development process, and can demonstrate that it's low risk, will have a relatively easy time of it.
With the FDA, the standard is impossible to meet because nothing in life has zero risk. So you get all kinds of kabouki theater about why something is acceptable and it meets the intent of the standard even though it really doesn't. There's no objective way to measure. And when you have a situation like that, you have an opening for politicking, backslapping and cronyism to creep in.
So, to put it bluntly, these suncreen ingredients aren't getting approved in part because no one is making a bunch of high-dollar political donations to make it happen. It's pay to play and if you don't have the money, you're just a spectator. And that's just the way the FDA works.
Cousin Dave at March 26, 2014 8:32 AM
Not surprising. Look at the incentives:
1) Not approved by FDA: work goes on as usual. Getting closer to sweet, sweet retirement at taxpayers' expense.
2) Approved, everything goes well: work goes on as usual. No extra thanks or rewards.
3) Approved, but someone gets sick: trouble. Pain. Might lose job and/or retirement.
Rationally, they're better off approving as few products as possible every year. They have little to gain and lots to lose.
V-Man at March 26, 2014 8:37 AM
Couple questions about this product (because I know you have paler skin, Amy, and I am shriveling up since moving to TX!):
Does it keep your complexion nice? I've found that a lot of drugstore sun screens prevent burn, but don't don't prevent my skin from going brown and aging me 10 years over the course of the summer. The physical (zinc oxide, usually) blockers I've tried keep my complexion nice, but stain my clothes.
I am willing to cough up more money on ANYTHING that keeps my complexion nice and doesn't wreck my clothes.
sofar at March 26, 2014 9:58 AM
In France, does this sunscreen come in an aerosol spray can? Cause if not, it's certainly not worth the expense of pushing it through FDA approval. Like it or not, Americans spray their sunscreen on now. I'm kinda not liking it since I throw away so many spray cans, but as a stubble-headed baldy I will say that spray sunscreen is Awesome.
smurfy at March 26, 2014 12:19 PM
"Rationally, they're better off approving as few products as possible every year. They have little to gain and lots to lose."
That's the story. Over the years of working with the government, I've observed that there are an awful lot of people who have the power to say no, but few who have the power to say yes. I think that's because most people don't want the say-yes jobs, so the system tends to create more say-no jobs. No one ever gets in trouble for saying no.
I look at the total government spending and I am amazed. I think, "Whoever is spending all of that money, how the hell are they getting it approved?" Of course, the answer is that most of it is being spent on entitlements and subsidies for which there is near zero oversight. It's a very different world from the one I work in.
Cousin Dave at March 26, 2014 12:26 PM
I'm sympathetic to both sides of the argument jere.
While the FDA is an army of overpaid nanny bureaucrats, on the flip side, all sunblocks even the approved ones, are made up of a bunch of chemicals, I will be absorbing through my skin if I put them on.
The long term effects of repeated chemical exposure, plus blocking the beneficial compounds in sunlight, to preserve youthful skin, may be counter productive for my overall health.
Im somewhat reminded of the French aristocrats who used powdered lead as makeup, to make their skin fashionably white. It did not work out well for them in the long run.
I limit my sun exposure to short periods, followed by putting on a hat, pants, and a long sleeved shirt, and applying sun block only to my neck, ears, and the backs of my hands, on those rare occasions where I need to stand in the sun for several hours.
For my limited purposes, American sunblocks work "well enough".
http://dermatologytimes.modernmedicine.com/dermatology-times/news/study-benefits-sun-exposure-may-outweigh-risks?page=full
Isab at March 26, 2014 1:40 PM
I wish they'd approve new types of sunscreen. I've found I'm allergic to all the standard ones available so I just don't use it.
BunnyGirl at March 26, 2014 5:37 PM
Sofar,
I have used it and its great. I use it on my hands and face. It doesn't stain or anything.
But it does have a high alcohol content. Alcohol isn't bad for the skin unless you are sensitive to it.
If you live in an immigrant Asian neighborhood like I did you will find they are super super super obsessive about sunscreen. They like being pasty pale and they mostly purchase skin care products (Americans purchase more makeup).
Shiseido makes great sunscreen, even an SPF 42 foundation. Plus there are those bb creams (the Korean ones, don't get the American ones) with really high SPF. Like I said Asians are obsessed with sunscreen.
MAC used to make a fantastic sunscreen called Prep and Prime SPF 50 that had physical sunscreen and controlled oil. They had to re formulate it so its not as good for oil control but its a good sunscreen. Plus it's Made in Japan.
If you see made in France, Made in Japan or Made in Australia (where their sunscreen testing is the best in the world) you know you are in good hands. American stuff isn't as good because Americans like to tan.
Ppen at March 27, 2014 9:13 PM
"I look at the total government spending and I am amazed. I think, "Whoever is spending all of that money, how the hell are they getting it approved?" Of course, the answer is that most of it is being spent on entitlements and subsidies for which there is near zero oversight."
On the other hand, we have lots of spending because of extreme levels of oversight. ~2 years ago, I tried to get an HP large-format printer repaired. A motherboard was needed, and several sources are clearly visible online. After five people were involved, it was determined that no one could fix it - and that was entirely because it was inside Savannah River Site boundaries. The regulatory requirements were just too lengthy. At one time, I was required to certify that repair would not cause proximity to high-voltage power lines!
So it sits to this day. Another new one, less capable but usable, was bought for just over $2500. (It broke immediately, and if an HP rep had not actually been in the area already it would have been lather, rinse, repeat.)
Radwaste at March 27, 2014 9:42 PM
2Radwaste: Entitlements and subsidies may lack oversight, but defense contracting costs three times as much _because_ _of_ oversight. The contractors have to keep very detailed records to prove that they aren't misusing the government's money in any way. To guard against counterfeit parts, they have to able to trace every material item used, often right back to the mine or oil well. They have to thoroughly document every decision, to the point that before a light bulb is changed, there is likely to be an engineering study of which bulb to buy. And the result is that for every man-hour on the actual job, there are at least two man-hours of forms, accounting, and QA. You have to at least triple the quotes to meet the contract requirements.
markm at March 29, 2014 10:42 AM
Leave a comment