Astringents

[rockymtnaristocrat]

Hi there, wanted to ask you folks about selling a cosmetic that contains ingredients classified by the FDA as an astringent.

Will using an astringent (like witch hazel) in a cosmetic or soap force it to fall in the drug category? I intend for the labeling to make absolutely no drug claims for modifying the structure of the body.

Several hours of research has left me confused, and I'm wanting to talk with the FDA directly. Thought I gather your insight first, and see if you could point me to references.


Thanks!

 

[Hazel]

I'm not an expert at this so take it with a grain of salt. From what I've read, you can use any ingredients as long as you don't make any claims that the product will alter the condition of the skin.

 

[rockymtnaristocrat]

Thanks for the thoughts. Appropriate that you should chime in give your name

What you said is the sum of my current understanding.

What I think:

If you sell witch hazel, it's a drug. The definition of Witch Hazel is set by the FDA as a formula of 14% alcohol and 86% aqueous extract from the plant. So hypothetically, you could sell witch hazel, without the alcohol (remove the natural and post-production alcohols through an advanced extraction process), and it could be considered a cosmetic. It's pure witch hazel plant, but not witch hazel drug. How confusing is that?

I'm pretty sure any cosmetic or soap can contain witch hazel (or astringent), and not be regulated as a drug (so long as it's within a certain concentration).

Would love to hear others thoughts.

 

[Hazel]

But you're not selling witch hazel, you're selling...whatever. Are you thinking of putting it in soap or a lotion?

Yeah, I didn't even think about the title above my avatar.

 

[Genny]

I think that as long as you're not making any claims about what the witch hazel will do, then it's just a cosmetic.
From what I was reading on the FDA site they were saying if you use the ingredient, but do not say "for the purpose of", then it's a cosmetic.

 

[birdcharm]

I think if you are selling the product as having
astringent properties, you would first list the
witch hazel as an "Active Ingredient" ...
then, list your "Other Ingredients" (in order),
directly under the "Active Ingredient" declaration.

For instance, if you are selling something with
lavender e/o in it and you have made a claim
that the e/o helps to balance the skin, then,
from how I understand it, the e/o would need
to be listed as an "Active Ingredient" ... but,
if you are not stating that the e/o affects the
skin in any way, but it is simply for scenting
purposes, you would not show it as an
"active" and you can simply list the ingredients.

Kathy