Askanesthetician's Blog

An esthetician explores skincare issues and concerns

33 Years In the Making: The FDA Unveils New Sunscreen Regulations June 15, 2011

It only took 33 years but the FDA is finally finalizing new and improved rules to regulate the labeling and sale of sunscreens in the United States.  Here are the highlights of these new rules:

  • Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
  • Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
  • “Waterproof, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
  • Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

The above changes will become law in a year.  Interestingly one important change has, for the moment, been left out of the new rules:

The proposed rule, if finalized, would limit the maximum SPF value on sunscreen labels to “50 +” because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

 Additionally, the FDA is going to study spray sunscreens to determine what level of protection they provide and if they could be toxic if inhaled.  The FDA is also going to reexamine 17 sunscreen ingredients.

Though this has been a long time coming I applaud the FDA’s new rules though I would love for there to be a ban on SPF 50 or higher when the new rules go into effect in a year.

 

Sources and Further Reading:

 

Nothing New: The EWG’s 2011 Sunscreen Report May 31, 2011

The Environmental Working Group (EWG) has issued its annual, damning sunscreen report for 2011.  Here’s the thing – besides changing both its product recommendations and the products that they hate there is nothing different in this report from the 2010 report.  As always the EWG uses scary language and offers even more disturbing “facts” (more on that later on in this post) to the consumer about sunscreens.  Here’s a sample of the EWG’s scare tactics:

Is your sunscreen actually protecting your family as advertised? Or are some of the claims just marketing hype?

Of the more than 600 beach and sports sunscreens analyzed by Environmental Working Group for our 2011 Sunscreen Guide, we can only recommend one in five. The sunscreen industry continues to load store shelves with bottles listing misleading, sky-high SPF ratings that may protect against UVB rays that cause sunburn but leave skin at risk for UVA damage. And nearly one in three products in the guide are still laced with vitamin A ingredients that accelerate the growth of skin tumors and lesions according to recent government studies.

Last year I took my time reading through the 2010 EWG sunscreen report and writing a response here in my blog.  Throughout the year I posted updated information in this blog on the EWG report.  Below I’ve listed my other posts about the 2010 EWG sunscreen report.  Needless to say, the 2010 EWG sunscreen report got a ton of media attention and, in my opinion, created a ton of unnecessary hysteria. 

In my humble opinion it comes down to this – just as you shouldn’t believe every skincare claim by beauty and cosmetic companies you also need to take what the EWG says about sunscreens with a grain of salt.  All their scary claims are controversial.  For example many experts completely disagree with the EWG’s claims about Vitamin A in sunscreens.  If you prefer to follow the EWG’s recommendations than go for it, but please keep in mind that they are one opinion among many about sunscreens.  Having said that there two parts of the sunscreen report that I do agree with.  The first one is about how high spf numbers (like spf 100) are ridiculous and ultimately create more harm than good.  Secondly I agree with the statement that the FDA’s new regulations on sunscreen are LONG overdue. 

Lastly, one of the things that bothers me the most about the EWG’s sunscreen reports is the fact that they are all doom and gloom and frankly, I am afraid that people might stop using sunscreen because of all the doom and gloom in their report.  So until they actually come out with that sunscreen pill I’ve read about keep using your sunscreen every day – no matter what.

 

Further Reading:

 

Sunscreen Woes – The EWG Releases Its Annual Sunscreen Report May 28, 2010

 

This week the Environmental Work Group, a non-profit watch dog organization made up of scientists, engineers, policy experts, lawyers and computer programmers that researches and reports on issues concerning public health and the environment, released its newest report on sunscreen.  And the report is a doozy.  According to the standards that it sets for safety and effectiveness of sunscreens only 8% of the 500 beach and sport sunscreens that the EWG tested, that means only 39 out of 500, are recommended by the organization.

The report is extensive and long, I’ve been reading it over the last few days, and if taken at face value – scary.  As with all past EWG sunscreen reports there is much bad news and little good news about sunscreens (none really).  I looked up all my favorite sunscreens (the ones I use personally and the ones I recommend to clients, family, and friends) and all of them got poor ratings from the EWG.  What’s an esthetician to do? 

Here are the main points of the report:

  • Sunscreens do not offer enough UVA protection which then exposes people to cancer
  • Spf ratings have gotten out of control.  Spf ratings of 50 and higher aren’t much more effective than spf 30 and furthermore, the high ratings cause people to both stay out in the sun too long and use too little sunscreen
  • When Vitamin A (look for retinol or retinyl palmitate in the ingredient list) is added to sunscreen it will breakdown in the presence of sunlight and thus speed up the development of skin tumors and lesions
  • As sunscreen ingredients breaks down in the precense of sunlight it causes free radical damage
  • The FDA takes too long to approve new and effective sunscreen ingredients (ingredients that are already used in European sunscreen formulations) and to publish new regulations regarding sunscreen
  • Oxybenzone, a very popular chemical sunscreen ingredient (try finding a sunscreen without it – it’s close to impossible) is a hormone disrupting compound.  This chemical penetrates the skin and enters the bloodstream causing damage or worse to the body.

All pretty upsetting things, right?  My fear every time I read the EWG’s sunscreen report is that people will stop using sunscreen because of it.  The EWG even states that the best ways to protect yourself from sunburn and sun damage is not to apply sunscreen but rather to seek shade, wear protective clothing, and avoid the sun in general especially mid-day.  All great advice – but realistically – how many people can maintain a lifestyle like that?

Two other issues brought up in the report interested me in particular.  In the section of the report called Hall of Shame the EWG gives a great big thumbs down to powder sunscreens.  Anyone who has read this blog knows that I use powder (brush-on) sunscreens daily and highly recommend them as a convenient way to reapply your sunscreen throughout the day particularly if you wear make-up.  The EWG objects to powder sunscreens because they say that the titanium dioxide and zinc oxide particles can be easily inhaled and settle in various parts of the body causing damage and irritation.  Another point from the Hall of Shame section of the report is about The Skin Cancer Foundation and their seal of approval on sunscreen products.  According to the EWG all a company has to do in order to receive this seal of approval is to donate $10,000 to the foundation and prove basic claims about their sunscreens and its spf factor.  The company’s seeking approval for their products do not have to prove if the product provides adequate UVA protection, and the company can even make claims about their products that violate FDA regulations.  Since I continually mention The Skin Cancer Foundation in this blog and ways to support their work this information was very interesting to me.

 

So Should You Worry?  Should You Throw Out Your Sunscreens?

Opposing Opinions to the EWG Report

  

 

First and foremost, please keep using sunscreen daily and keep reapplying it especially if you are spending the day outdoors! 

Now should you only use the sunscreens that get the best ratings from the EWG?  Truthfully I don’t know.  First off, all the sunscreens that the EWG recommends are rather obscure, for lack of a better term, for the most part.  These are not the brands that you can readily find on the shelves of Target, Walgreens, and CVS for the most part. 

So is it right to err on the side of caution and only use sunscreens that the EWG recommends?  Perhaps.  But you should know that not everyone agrees with the EWG’s findings.

I found a report on the Cosmetics and Toiletries website that quotes John Bailey, chief scientist of the Personal Care Products Council, views on the EWG report.  The Personal Care Products Council  is the trade association representing the cosmetic, toiletry and fragrance industry in the United States and globally.

I would like to quote the response in full since it addresses all the issues mentioned above:

John Bailey, chief scientist of the Personal Care Products Council, has released a statement in response to the 2010 Environmental Working Group (EWG) Sunscreen Report.

Bailey finds the report unscientific and unsubstantiated, noting that the American Academy of Dermatology, the Skin Cancer Foundation, the Center for Disease Control, the US Food and Drug Administration (FDA), physicians and other health care professionals have all emphasized the safety of sunscreen use. Bailey is concerned that the group’s report will needlessly cause consumers to avoid using sunscreens, when that use is critical to prevent skin damage and skin cancer.

“Sunscreens in the United States are regulated as OTC drugs by the FDA and must undergo pre-market approval that involves rigorous scientific assessment including safety and efficacy substantiation according to FDA standards,” noted Bailey. He furthered, “The FDA testing and regulatory process for sunscreen products is the most rigorous in the world.”

According to Bailey, EWG did not use the established scientific and regulatory safety assessment process for sunscreen products and ingredients. The following topics are those proposed and questioned in the report.  

Vitamin A: In their report, EWG questioned the safety of vitamin A in sunscreens, referencing the National Toxicology Program’s (NTP) announcement in 2000 that it would study the potential of retinyl palmitate to enhance UV radiation-induced photocarcinogenisity. Bailey noted that the study is ongoing (scheduled for late 2010 or early 2011) but is not designed to study retinyl palmitate in the presence or absence of sunscreen formulations. He notes that retinyl palmitate has been reviewed by the Cosmetic Ingredient Review (CIR) expert panel and found to be safe in cosmetics.

Skin cancer: EWG questions the ability of sunscreen to fight skin cancer based on increased skin cancer rates. Bailey maintains that skin cancer rates are the result of excessive unprotected sun exposure from several decades prior and on our ability to better track, monitor and report occurrence of the disease.

Oxybenzone: In response to the safety of oxybenzone, Bailey notes, “When used as a sunscreen ingredient, oxybenzone, also known as benzophenone-3, protects the skin from harmful UV rays. Oxybenzone is also used to protect cosmetics and personal care products from degradation by absorbing UV rays.” Benzophenone-3 is approved in the United States, Canada and the EU as a safe and effective OTC sunscreen ingredient. In addition, it has been found safe for use as a photostabilizer by the CIR. Finally, Bailey added that there have been no available scientific data supporting a link between UV filter exposure to endocrine-disruptive effects in humans.

Nanotechnology: Nanoparticles have been found to pose no risk to human health, according to Bailey. In addition, when used to protect against UV damage, nanoparticles are required to go through an extensive FDA pre-market review process to prove they are safe and effective.

FDA sunscreen monograph: Finally, Bailey added that the FDA is not intentionally delaying the release of the final sunscreen regulations. He noted that establishing sunscreen safety standards is a long and vigorous process, and that the FDA is considering a number of viewpoints before establishing final guidelines.

So who to believe?  Frankly and honestly, I just don’t know.  I wonder sometimes if the EWG is hysterical or if they are right and we are all just sticking our heads in the sand.  This question made me think of Silent Spring by Rachel Carson.  When the book was first published in 1962 and warned of grave health and environmental issues that were affecting everyone and being ignored by the government and industry, many people didn’t want to believe Carson.  Of course, it turns out that Carson was right, particularly when it came to the horrible effects of DDT on the environment and human health.  So I ask myself – is the EWG right?  Should I follow all their instructions?

Truthfully, at the moment I am not going to change anything.  But when I run out of my current sunscreens I think I will look at the EWG’s recommendations again and perhaps try one of the sunscreens that gets a best rating from them.   As for The Skin Cancer Foundation, I still think their website is an excellent source of information about skin cancer prevention and issues, and I will continue to recommend that people look at the site.  I’ll also keep using my brush-on sunscreen.  I just think that concern might be overblown.

I would be very curious to hear what my readers have to say about the report.  If anyone has tried any of the sunscreens that the EWG recommends I would like to hear what you think about them.

Here is a link to another blogger’s take on the EWG report.  You can find the American Cancer Society’s comments on the EWG report here.

Here is one of  The Skin Cancer Foundation’s response to the EWG report.  This is a more comprehensive response by The Skin Cancer Foundation.

And here is a comment from Allure magazine about the issue of Vitamin A in sunscreens.

P.S.  – About two weeks after writing the above post I went to the dermatologist for a skin cancer screening.  While there I asked her what she thought of the EWG’s sunscreen report.   Her response was that she didn’t agree with the findings in the report and that the group’s conclusions were misguided and even silly.  Though my initially my thoughts about the EWG sunscreen report had been more borderline, that I was inclined to change my sunscreens to recommended brands by the EWG eventually, now after more thought I am beginning to think that the dermatologist is right.  Since the EWG is the ONLY group saying the things that they are saying about sunscreens I want validation for at least another source before agreeing with them.  The dermatologist told me that she recommends La Roche Posay Anthelios 45 Ultra-Light Fluid for Face and Vanicream SPF 30 (which by the way the EWG thinks is ok) as good sunscreens for her patients to use. 

For more opinions on the sunscreen controversy see my post The Debate Continues.

For Dr. Leslie Baumann’s opinion about the EWG’s sunscreen report see this blog post by her.

The American Academy of Dermatology disagrees with the EWG’s findings on retinyl palmitate (vitamin A) in sunscreens.

 

 

 
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