Free shipping on all orders over $50  |  Play smart. Play safe. Non-toxic suncare

FDA Passes on New Sunscreen Ingredients

by Will / March, 11 2015 01:30

Back in November Congress passed the Sunscreen Innovation Act. Its aim is to speed up the approval process for new sunscreen ingredients. In particular, it's been 25 years since any new ingredient was approved and eight ingredients have been waiting over 12 years for review. Many of these eight ingredients, including ecamsule and enzacamene, are already in use in Europe, Asia and elsewhere. Slam dunk for these new sunblock ingredients, right?

Not so fast the US Food and Drug Administration (FDA) says. New sunscreen ingredients have to go through an approval process that requires a lot of safety and testing data. We're not sure exactly what the required data is but we'd guess it involves a number of clinical trials and long-term studies.

What Does the FDA Say?

Essentially the FDA said there is not enough scientific data around these eight ingredients to prove they are safe for use despite the fact they are available in other countries and have been for a long time.

Here's an illustrative quote from the FDA:

On January 7, we met the first requirement of the SIA. In doing so, we announced our tentative determinations that six of these ingredients are not GRASE [Generally Recognized As Safe and Effective] for use in sunscreens because we need more data from the manufacturers to help establish the safety and effectiveness of these products.

Today, we completed another requirement by taking initial action on the last two pending ingredients, ecamsule and enzacamene. We tentatively determined, as we had with the other six ingredients, that we need more data to decide if these ingredients are, in fact, GRASE for use in OTC sunscreen products.

Hmm...seems a bit perplexing and many sunscreen and consumer advocate groups are upset with the FDA. Everyone, including us, thought these ingredients would pass pretty quickly. But here's the thing, the FDA has not said these ingredients are unsafe, rather they've said they need more safety data and tests from the groups proposing the new ingredients.

This next quote from FDA really explains their point of view:

There is apparent confusion as to why ingredients that have been on the market for years in other countries cannot be used in the U.S. without further review by FDA. While information on marketing history in other countries is helpful, what we can learn from it is limited. For example, such information doesn’t tell us anything about the long-term effects from use of the ingredient or how much is absorbed. Because of the widespread daily use of sunscreen products by a broad population, including babies and pregnant women, FDA has proposed data requirements that will allow us to determine that sunscreen ingredients are generally recognized as safe and effective.

What Does Block Island Organics Think?

Reading that, it makes sense but still leaves us a bit conflicted. On the one hand we completely agree that new ingredeints must be proved safe before using them. Ensuring that is the FDA's job and we applaud them for it. Plus, these 8 ingredients are all chemical UV filters and at Block Island Organics we believe in the natural / mineral filters zinc and titanium for our sunscreen as they are considered safer and better. On the other hand we are all for advancing sun protection and if these chemical UV filters are better than the current chemical UV filters, that's a positive in our book.

Some also question whether the FDA is right, that more data is needed. It's a legitimate concern. Is this all just a bunch of red tape? Unfortunately that is a question we aren't equipped to answer. We can say the FDA knows drug / ingredient approvals much better than we do and what's needed to prove they are effective and safe.

It would be interesting to hear the counter argument from a doctor, scientist, researcher or other accredited health authority. Someone who is an expert in this area.

In the end we have to believe the FDA knows what it is doing and we definitely err on the side of safety. We'd love to see these (and other) sunblock filters approved but only if they are deemed safe by someone or some group (the FDA in this case) that knows what it's doing, has the public's interests in mind and has the legal authority to do so.

Your Turn

What do you think? We always like to hear from others. We think it's important to have a wide range of opinions to fully understand a topic. Let us know in the comments below.

Tags: , , , , , ,

blog comments powered by Disqus