Let's talk about the safety of our sunscreens, because they're safe, right?
To answer that question, you need to know that sunscreen is regulated as a drug in the
U.S.
Then you're going to need to know a little history.
Time machine, take me back to 1962.
Up until this point, non-prescription drugs were sold in the U.S. without having to provide
any data proving they were safe and effective.
(1) The answer to your question might have been no.
However, things were about to change.
In the late 1950s, a non-prescription drug called thalidomide entered the worldwide market.
(2)
The drug was used to treat morning sickness in pregnant women that caused a tragedy when
insufficient testing led to over 10,000 babies born with severe abnormalities.
(3) To avoid this and similar tragedies, the U.S. Congress passed the 1962 Kefauver Harris
Amendments (4).
Among the rules the amendments introduced was that manufacturers needed to conduct well
controlled clinical studies, run by qualified experts, and that all the ingredients already
used in non-prescription drugs must be evaluated for safety and efficacy (5), meaning how well
a product works.
It sounds like we're safe, right?
Well, when the Kefauver Harris Amendments were passed, more than 100,000 non-prescription
drugs were already on the market (6).
Reviewing each one for safety would take decades, so in 1972 (7) they decided to make the process
faster by assigning these drugs to therapeutic categories.
Anti-acne was grouped together in one category.
Antiperspirants were grouped into another.
Skin protectants into a third and so on.
Today, there are over 80 categories (8), and the FDA calls each one a monograph.
The monograph acts as a recipe book telling formulators what active ingredients can be
used in what concentrations and what tests need to be conducted to prove safety.
It even covers efficacy and labeling requirements (9).
These monographs make sure that nonprescription drugs also known as over the counter drugs
are safe by listing everything a manufacturer can use in order to sell its drug to the public.
(10)
Once a final monograph is approved for a category, manufacturers don't need any sort of preapproval
from the FDA to release their products as long as they follow the guidelines in the
monograph (11).
That's the kind of useful information that subscribers to my channel can expect to learn,
but back to the topic.
Does this make our sunscreen safe?
As an over the counter drug, sunscreen gets its own monograph.
Like all others, it has go through a three-stage process the FDA calls the over the counter
drug review.
If you want to read about each step, it all gets documented in the federal register.
We're all dying to read that on the internet, right?
To start out, an expert panel reviews the ingredients, determine if they are currently
recognized as safe.
The results are published to allow for public comment.
Then a tentative final monograph is produced and published.
Based on that feedback, once law makers and the public have had sufficient time to respond
to the ingredients, uses, warnings and acceptable claims listed, the final monograph is published
and hopefully enacted into law.
This process has helped remove a lot of ineffective and unsafe products.
The question you're probably asking yourself now is, "Why are we debating about the safety
of sunscreen in 2019 when the FDA has had the over the counter drug review in place
since 1972 to make sure everything's safe?"
Well, it turns out our final sunscreen monograph has it never been put into effect.
The process for sunscreen started way back in 1978 when your mama was still wearing bell
bottoms and groovy hair.
The tentative final monograph wasn't published until 1993.
Well, that took a while.
In 1999, they enacted a final monograph, but it was staid, meaning it was paused a couple
of years later.
Now, we have this Sunscreen Innovation Act that says the FDA has to have a final monograph
by November 29th, 2019 (12), but I'm taking bets on whether they'll miss that too.
Another reason we're having the safety conversation is that the 16 ingredients that are generally
recognized as safe and effective were decided in 1978 (13).
Times have changed and so has our sunscreen is gone from the opaque stuff.
Beach goers occasionally dab on their noses to transparent creams you're told to wear
every day.
I mean, come on.
When they approved the 16 ingredients we have now, an accurate way of measuring skin penetration
for these ingredients didn't even exist yet (14).
It's no wonder that the FDA is re-evaluating the safety of sunscreen ingredients.
The FDA has reached out to cosmetic companies and said, "Hey, can we get more data?"
What they heard was...
(15) Still want to take that bet?
Just because the FDA is questioning the safety status of the currently approved sunscreen
ingredients, that doesn't mean you should stop putting the stuff on.
Even the recent study conducted by the FDA, which shows some sunscreen ingredients can
make it into your blood, only suggests caution (16).
We have insufficient data and we need more, which is how science is supposed to work after
all (17).
Meanwhile, we know for sure that sun exposure increases the risk of skin cancer, so keep
slathering it on.
How much?
You'd be surprised.
Check this video for more.