Does SunSafe RX Protect Skin from Sun Damage?

by Left Brain on August 2, 2012

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Jep Amanda asks…I’m curious about these supplements. Their claims are as follows — anything to this? “Sunsafe Rx™ is a natural, premium nutritional supplement, scientifically designed to promote skin’s natural defenses against the damaging effects of UVA and UVB rays. Research shows that the specific antioxidants in Sunsafe Rx™ safely and effectively: Help skin naturally defend itself against sun damage, Prevent unnecessary skin aging and wrinkles and 
Support the overall health of skin and eyes.

Note: Please see the our Forum for the response from Napa Valley Bioscience, the creators of Sunsafe Rx before reading our reply. 

The Left Brain responds:
I’ll preface these comments with an admission. I’m hyper-skeptical of all nutritional supplements as sold in the US. This is specifically because they are almost completely unregulated. See what I’ve previously written about the problem with supplements. Basically, a manufacturer can sell any product they want & make any claims (except medical ones) they want and they don’t have to provide any proof to the FDA. It’s the good ol’ 1994 DSHEA & it’s terrible if you ask me. Here’s what the FDA says…

FDA on supplements

“Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.”

So, a dietary supplement maker could (theoretically) create a pill from anything that they want, say that it helps protect you from the sun, and as long as it doesn’t poison you, it would be perfectly legal. I’m not suggesting that this is what the Sunsafe Rx people are doing, I’m just saying that there is no regulation that would stop them from doing that. But let’s look at the claims that were made.

Sunsafe Rx Claims

1. “Sunsafe Rx was created after enormous amounts of research.”

I say, who cares? Was it good research? Was it relevant research? It would be a rather simple matter to prove that this product protects you from UV damage. Create a placebo pill & one with all the “active ingredients”. Then do a double-blind study with a large group of people and expose them to a specific amount of UV radiation. Then have a dermatologist grade their skin. Oh yes, and there should also be a group that using sunscreen as a positive control.

Where is this research? Why isn’t this research published? Why is there only research posted about the specific ingredients?

See, the specific ingredients do not matter. You are not buying the specific ingredients. You are buying the supplement. Relevant research would be studies about the specific pills, not the ingredients. The lack of publishing such an obvious research study makes me suspicious. Why?

2. “every ingredient in Sunsafe Rx has been approved by the FDA for sale in the US”

This is true enough. As long as the makers are not bent on poisoning their consumers (and they would have no reason to do that) you can rest assured that the product is likely safe. That doesn’t mean it will help protect you from the sun or have any other notable improvement on your health. There is just no evidence suggesting it is dangerous to use.

3. “The Sunsafe Rx website doesn’t say that the product does not have FDA approval;”

The implication of this claim is that Sunsafe Rx DOES have FDA approval. It does not. The FDA does not approve ANY supplement. The DSHEA made sure of that. True, all supplements have to have the disclaimer that the claims are not evaluated by the FDA because they don’t have to show their data to the FDA.

4. “do mention this product to your dermatologist”

While dermatologists might know about treating skin diseases, this doesn’t make them an expert in determining whether a dietary supplement is going to protect you from the sun. And many dermatologists are easily swayed by irrelevant or even bad science. They also sometimes have a deal with dietary supplement makers where they get a % of sales of anything you buy. I wouldn’t automatically trust what a dermatologist has to say about this product.

5. “We don’t even call Sunsafe Rx a sunscreen.” 

That’s because it would be illegal to call the product a sunscreen. Sunscreens are OTC and regulated differently by the FDA.

The specific claims originally asked about are these:

a. “Help skin naturally defend itself against sun damage.” - This claim means nothing because the word “help” is used. ANYTHING can be said to “help” your body do anything.

b. “Prevent unnecessary skin aging and wrinkles” – Are there any “necessary” skin aging and wrinkles? There is no evidence provided that Sunsafe Rx will prevent wrinkles. I’d love to see data that showed this was true.

c. “Support the overall health of skin and eyes” – This claim is just like the first claim…meaningless. What does the word “support” mean here? ANYTHING can be claimed to “support” your overall health of skin and eyes.

The Beauty Brains bottom line

If you want to protect your skin from the sun, use a sunscreen. That’s what the American Academy of Dermatology says. Note also that in the section on the AAD website where they say “Q. Is sunscreen all I need to protect myself from the sun?” They do NOT list taking sun protection supplements. If and when an effective sunscreen-in-a-pill comes out, it will come from a drug company and will be approved by the FDA. It will have gone through drug trials for both safety and effectiveness. And initially you will have to get a prescription. Until such a pill comes out, I would avoid getting sun protection from a pill.

 

Nster.com

{ 5 comments… read them below or add one }

Kim West August 2, 2012 at 5:04 am

Thanks a lot for that information. I have long been wondering what it is really about and should I venture to such pills. After reading this, I guess I should just stick to our good ole traditional sun protection lotion!

Rozy August 2, 2012 at 12:27 pm

Can’t wait until an FDA approved sunblock pill is approved, I’d love to be able to take a pill to protect my skin!

Mer August 6, 2012 at 9:09 pm

Although I love your blog, I would like to point out that the double blind study you proposed would be impossible to do in real life. The randomized study would be illegal to conduct since you cannot intentionally expose people to UV rays which are known to be harmful in excess. Great idea but unfortunately it can’t be done in reality!

thebeautybrains August 7, 2012 at 6:10 am

@Mer: you’re probably not aware of this because you don’t work in the industry, but it’s actually quite common to test the effects of UV radiation on humans.

drrachel January 14, 2013 at 10:20 am

sunsafe says it contain polypodium leucotomos. The interesting thing is that another company has a patent on it as a photoprotectant. I wouldnt be surprised if they get nailed by a lawsuit. Im sure they will ignore it right up to the point when the complaint is filed in federal court. Its called denial in the pursuit of greed.

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