FDA Compliance and MOCRA

FDA Compliance and MOCRA

If you are here you are probably interested in Neons in the USA. I am going to keep this one short since we have already beaten this dead horse on the Worldwide Compliance blog HERE.

GTX Facepaint is a fully FDA Compliant line of cosmetic face paint. What does this mean?

This means that we are in compliance with the FDA guidelines for cosmetics. We are registered with MOCRA (the FDA's new online registration system implemented in July 2024.) 

This means that all of the products we sell are in the FDA's system, including all of the ingredients within our neons. When we submit a cosmetic product to the FDA's system, it takes some time to think, then if the product is approved, the system sends us a cosmetic number for each product. 

There is some conflicting information out there about neons. This is because the rules for ingredients in cosmetics differ from country to country. If you look at our worldwide compliance blog you will see that some countries allow chemical brighteners in cosmetics (Canada and Australia specifically allow all ingredients in our neons.) Some countries are not so clear (UK/EU,) and some countries say if this ingredient is not listed, it is not allowed. 

In the US, ALL of our colors are registered with the FDA, (You will see the round FDA Registered Logo on all labels) and the labels will eventually (once we cycle into the newest inventory) show a cosmetic registration number like this one for Budgie, highlighted in yellow: 

 

However, in the USA, to be EXTRA safe, we are also labeling the neons as non-cosmetic. WHY?

Because the US doesn't list a couple of cosmetic brighteners as "colorants" (that are in our neons) that other countries DO allow. Since we want to do everything right, we have registered the neons as cosmetics with the FDA, and received a cosmetic number. We did this since people WILL be using them on skin and if there are ever any skin reaction issues, they need to be traceable. So as far as the FDA is concerned, all our neons are registered cosmetic products. I spoke at length with an agent from the FDA on the phone as I was registering. I asked the agent on the phone why the neon cosmetic products were approved by the system if these certain ingredients were not allowed. She didn't seem to know much about specific ingredients, and was unconcerned about the cosmetic brighteners, so she wasn't much help. One thing I did learn on the phone with the FDA is that if the system registered it and gave us a number it, it is a cosmetic.

Even with all of this, we at GTX still have to be as careful as possible as the brand putting product out into the market. So, we are labeling with the Special Effects sticker just to let people know that these do contain ingredients that are not on the list of colorants for cosmetics in the US currently. 

Why are they not allowed?

Because the FDA has no interest in testing these ingredients. (Canada says they are fine, Aus says they are fine.)  The FDA is in charge of so many things now, food, drugs, medical devices, that neon pigments don't even make the list to test or approve. They simply don't care. Because of this we are in a holding pattern until they do test or change their minds about these ingredients. 

Again, in the US, UK, and EU you will see a "Special Effects" sticker on the Neons. In Canada and Australia, they are perfectly legal cosmetics and will not have a Special Effects label. 

What should you do?

Our products have been tested skin-safe and some countries allow all of the ingredients for cosmetic product. It is up to you to decide if you want to use them on your clients. We are doing everything we can to make sure we are above board in all countries. 

As always please email with any questions! hello@gtxfacepaint.com

Thank you!!

Amber

 

Back to blog