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:

 

Teens and Tanning Beds April 28, 2011

Hopefully you don’t know a teen who uses a tanning bed, but the scary thing is that too many teens do use tanning beds since they are completely unaware of the dangers involved with their use.  Once a teen starts tanning it is really hard to get them to stop (it has even been proven that tanning is addictive which is very scary).  The US lags behind other nations in banning the use of tanning beds by teens; for instance the UK has banned the use of tanning beds by anyone under the age of 18.

According to The Skin Cancer Foundation:

Despite a link between indoor tanning bed use and an increased risk of melanoma, the deadliest form of skin cancer, 2.3 million teenagers visit tanning salons every year. In the spring, many tanning salon patrons are college students getting ready for spring formals, and high school students gearing up for prom season. So it’s no surprise that melanoma is now the most common form of cancer in young adults 25-29 years old, and the second most common form of cancer in adolescents and young adults ages 15-29.

“The damage caused by the ultraviolet (UV) radiation from tanning beds and the sun is cumulative and often irreversible, and the earlier people start to tan, the higher their risk of developing skin cancer in their lifetimes,” said Perry Robins, MD, President, The Skin Cancer Foundation. “In fact, melanoma risk increases by 75 percent when indoor tanning begins before age 35.”

If the threat of skin cancer isn’t enough to scare young people away from tanning salons, they should know that 90 percent of visible skin changes commonly attributed to aging are caused by exposure to UV radiation. Tanning accelerates the signs of aging, including wrinkles, leathering and fine lines, which can be seen as early as in one’s twenties.

Despite the fact that The American Academy of Pediatrics supports a ban on the use of tanning beds by minors it is still legal for teens to use tanning beds.  The Skin Cancer Foundation points out:

In the US, tanning is regulated by the states, some of which allow children as young as 14 to tan. The US Food and Drug Administration (FDA) classifies UV-emitting tanning machines as Class I Medical Devices, meaning that it considers them to “present minimal potential for harm to the user.” Last year, the General and Plastic Surgery Devices Panel of the FDA’s Medical Devices Advisory Committee unanimously recommended that the FDA upgrade its classification of tanning devices to better reflect the serious health risks tanning machines pose. The majority of the panel was also in favor of an age restriction to limit minors’ access to UV tanning devices.

So until the FDA and/or the federal government ban the use of tanning beds by minors what can you do to prevent teens from using tanning beds?  First and foremost, I think education is key.  If scaring a teen with the risk of cancer isn’t enough to get them to stop using a tanning bed appeal to their vanity by explaining that they are aging their skin tremendously by using a tanning bed.  If you want to do even more write to the FDA and/or your senator or congressperson asking them to support a ban on tanning bed use by minors.  Recommend to a teen who really likes how their skin looks tan to get a spray tan or fake a tan with a home applied tanning lotion.  There are a tremendous number of products on the market in all price ranges so there is really no excuse not to try one if you like the way your skin looks tan.

If any of the above tactics don’t stop the teens you know from tanning have them hear a personal story about the dangers of tanning beds.  I found this story on the FDA website:

Brittany Lietz Cicala of Chesapeake Beach, Md., began tanning indoors at age 17. She stopped at age 20 when she was diagnosed with melanoma, the deadliest form of skin cancer. The former Miss Maryland says she used tanning beds at least four times a week, and sometimes every day.

“Growing up, until I started using tanning beds, my parents were very strict about me wearing sunscreen,” says Cicala. Although she also tanned in the summer sun during her 3 years of tanning bed use, Cicala estimates that 90 percent of her UV exposure was in tanning beds during this period.

In the 4 years since she was diagnosed with melanoma, Cicala’s surgeries have left her with about 25 scars. Cicala gets a head-to-toe skin exam every 3 months, which usually results in removal of a suspicious growth.

 

Sources and Further Reading:

 

 

 

Challenging the EWG on Their Sunscreen Findings April 4, 2011

For the past few years The Environmental Working Group, a health and environmental watch group, has come out with an annual sunscreen report that casts an extremely damning eye on the vast majority of the sunscreens on the market today.  Last year the EWG recommended only 39 out of the 500 sunscreens that they reviewed.  The group called into question the use of retinyl palmitate (or vitamin A) and oxybenzone in sunscreens saying that retinyl palmitate could actually cause cancerous tumors if exposed to sunlight and that oxybenzone (which is so widely used in sunscreens it is hard to find a readily available commercial sunscreen without it) is an endocrine disruptor.  The report also went on to make harsh statements against The Skin Cancer Foundation for putting their seal of approval on sunscreens and the FDA for still not updating its sunscreen regulations, something they said they were going to do back in 1978 (yes, 1978 that isn’t a typo).   One more thing the EWG emphasized in their report was the fact that sunscreens’ were promising false security with exaggerated spf ratings.  I happen to agree with that last point wholeheartedly.  (For more on that issue please see my previous post – Spf 100 is a Joke.)

Last year’s EWG sunscreen report created quite a ruckus and got a lot of media attention.  In my opinion it also created a lot of unnecessary stress, worry, and aggravation particularly for parents who wanted to make sure that their children were properly protected from the sun.  Perhaps what bothered me the most wasn’t the debate about which sunscreens were best because I actually don’t think all sunscreens are created equal, but the lack of insight and the blind following that many people engaged in after reading (or just hearing) about the EWG report.  Instead of investigating the issue for themselves many people, and I knew quite a few personally, didn’t give the EWG’s statements a second thought and instead of doing some of their own investigating they simply became hysterical about buying the “right” sunscreen.  (I tried to cover different sides of this debate in my blog last summer is my posts: Sunscreen Woes – The EWG Releases Its Annual Sunscreen Report and The Debate Continues: More on the Sunscreen Controversy)  So I was pleased to see the recent article Shedding Light on Sunscreens in MedEsthetics Magazine which addressed many of the issues raised in the EWG report last year.

The article in MedEsthetics addressed the issues brought up by the EWG about retinyl palmitate and oxybenzone.  The article explains that the EWG reached their conclusions about retinyl palmitate causing cancerous tumors when exposed to sunlight:

based on initial, unpublished findings from a National Toxicology Program study released in late 2009 by the FDA.  The NTP is the federal government’s principal evaluator of substances that raise public health concerns.  In the study, lab mice were coated in 0.1% to 0.5% vitamin A cream and then exposed to the equivalent of up to nine minutes of midday Florida sunlight each day for one year.  The EWG says that tumors and lesions developed in up to 21% sooner in lab animals coated in the vitamin A cream compared to control animals covered in a vitamin-free cream.

The EWG’s interpretation caught physicians and the industry by surprise.  It wasn’t until November 2010 that dermatologists responded in a paper published in the Journal of the American Academy of Dermatology.  Lead author Steven Q. Wang, MD, from Memorial Sloan-Kettering Cancer Center in New York City, and colleagues disagreed with the EWG conclusions, saying that the number of malignant neoplasms in the two groups of mice were not significantly different in mice exposed to the higher doses of radiation.  They concluded that the evidence did not support calling the combination of retinyl palmitate and UV photocarcinogenic.

The EWG countered with its own online critique of the journal article, saying that it stood by its analysis of the data.  As we await a final report from the NTP, industry leaders weighing in on the evidence seem to agree with this statement from Tatiana Kononov, principle scientist at Revision Skin Care:  Although I applaud the stated mission of the EWG, the release of its report on sunscreens highlighted some harsh generalizations that I think were made solely for publicity purposes.  This specific act by the EWG was unfortunate and irresponsible.  I am sure that many future studies will show that retinyl palmitate is perfectly safe and even beneficial in sunscreen products.”

 As for oxybenzone, which the EWG labeled an endocrine disruptor, once again most experts disagreed with their findings:

The EWG bases its conclusion on studies in which mice were fed large amounts of oxybenzone.  “Oxybenzone has been around for 30 to 40 years, and there is no data showing that topical use is estrogenic in any way,” Dr. Lim says [Dr. Lim is the chairman of the department of dermatology at Henry Ford Hospital in Detroit].  “Since the original mouse studies, several groups have done human studies looking for hormonal effects but found none.”

Oxybenzone is a helpful ingredient because it has some UVA absorption characteristics,” says Kononov.  “It is approved for use in sunscreens by many other countries including Japan, Australia and South Korea.

I have to say that I was pleased to read these counter interpretations of the EWG’s conclusions.  Though I was initially inclined to think the EWG was on to something when I read their report last year I have since decided that their claims were way overblown.  Of course all this makes me wonder – what is the EWG going to say in their 2011 sunscreen report?  Only time will tell.

 

Quiz Yourself – How Much Do You Know About Cosmetics? December 10, 2010

So you consider yourself a savvy skincare consumer and perhaps you think you know all there is to know about skincare regulations and ingredients.  Now test your knowledge! 

The FDA has an online quiz called:  How Smart Are You About Cosmetics?   It will take you about five minutes to complete the quiz, and you’ll be much more informed after taking it. 

Good luck!

 

An End To Tanning Salons? April 5, 2010

There is no such thing as a healthy tan, and going to a tanning salon and using a tanning bed is one of the worst things that you can do to yourself since there is a direct link between tanning beds and skin cancer.  Unfortunately up until now physicians, estheticians, skin cancer survivors, and concerned citizens have had little support from the government when it came to educating and warning the public about the extreme hazards of tanning salonsand tanning beds.  Until now the FDA has classified tanning salons as Class I medical devices which means the FDA considers them to “present minimal potential for harm to the user.”  Of course, nothing could be farther from the truth.

Luckily, it seems that the FDA is going to upgrade their classification of tanning salons.  On March 25th the General and Plastic Surgery Devices Panel of the Food and Drug Administration (FDA) Medical Devices Advisory Committee met and unanimously decided that the FDA must change its classification of tanning beds and tanning salons.  Just what that new classification will look like is unclear.  According to The Skin Cancer Foundation:

The Panel unanimously concluded that this classification was not appropriate, with some Panel members favoring a designation of Class II with restrictions (“special controls”) to limit access by age, and/or skin type. Others thought tanning devices should be upgraded to Class III (the most strictly regulated category), but they acknowledged that the latter reclassification would be difficult to implement.The majority of the Panel was in favor of an age restriction to limit minors’ access to UV tanning devices, although some members preferred a parental consent option.

The Panel also approved of more disclosure to users — and better placement of labels warning users about the risks of UV tanning. While the FDA requires tanning beds to include instructions for the use of protective eyewear and a warning label about the potential for eye and skin damage, as Congresswoman Rosa DeLauro noted in a letter to FDA Commissioner Margaret Hamburg, MD, “In most cases the labels are located on the upper canopy [of the tanning bed], and out of sight of consumers prior to tanning.” The Panel also paid special attention to the possibility of eye damage from tanning devices, and discussed stronger protective eyewear requirements.

While the FDA is deciding just how the new regulations will look the American Academy of Dermatology Association asked the FDA to enforce the following restrictions when it comes to tanning beds: 

  1. Prohibiting access to indoor tanning for minors (under 18 years old)
  2. Educating all indoor tanning customers about the skin cancer risks and requiring their informed consent
  3. Implementing and enforcing labeling recommendations outlined in the Tanning Accountability and Notification (TAN) Act
  4. Encouraging enforcement of state regulations

The American Academy of Dermatology also supports the newly passed indoor tanning tax since it will hopefully discourage individuals from using tanning beds and tanning salons.

Hopefully sooner than later the FDA will change their classification of tanning beds.  Hopefully sooner than later people will come to their senses and stop using tanning beds!

Sources and Further Reading

  

 

There Is Nothing Wrong with a Fake Tan

 

If you love the way you look with a tan there are plenty of ways to achieve that look without exposing yourself to the risk of skin cancer.  There are so many self-tanners and bronzers on the market that anyone can find a product that they like.

 

 
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