Claims. Claims. Claims.

Cosmetic regulations are tricky. Really tricky.

If you’re casually visiting this page, you may not know this: Cosmetic regulations are voluntary.

Yup. You heard me right. You don’t have to.

Okay. ?. What’s the catch, you astutely ask?

The line between “cosmetic” and “drug” or “medical device” is really thin.

FDA.gov (of all places!) has a wonderfully illustrative page called, “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”

If you don’t have time to read it, that’s cool.

But remember, as soon as you say “helps promote [some attribute],” you are making a claim.

You may have unwittingly wade into Pandora’s regulatory, mandatory clearance, and other mythical boxes.

Wade carefully.

Or just contact me and ask first.

How many can you confidently answer?

My friend was pretty sure he knew the first answer. He was wrong.

Now you try:

1. Does FDA recognize the term cosmeceutical?
2. How do my claims need to change if FDA considers my product a drug instead of a cosmetic?
3. If my product is considered a cosmetic in other countries, how likely will it be considered a cosmetic here?
4. What are the requirements for color additives?
5. FDA cleared my claims. Am I set from an FTC standpoint? If not, what else do I have to do?
6. What is FDA’s position on the use the terms “cruelty free” and “not tested on animals?”
7. If I label my product “all natural” or “organic,” does it have to also be hypoallergenic?
8. Who is responsible for cosmetics safety?
9. Under what circumstances is additional testing required?
10. Which good manufacturing practices apply to cosmetics?

How’d you do?

I got a 10, Michelle! I get a ?!

I’m pretty sure I got 9 right, Michelle. I’d say that’s worth a solid ??.

I don’t know, an 8, maybe fewer and:
(a) That’s okay. I was just playing. We don’t make cosmetics.
(b) Maybe I should give you a ?. Where’s your calendar thingy?

Good. I’m glad we got that settled. ?

+ Michelle +