So, I have an ingredient that’s superior than an existing ingredient. Currently, I am looking to do the clinical trial to back up this theory. So my question is
1. What is the fastest and most cost effective way to do the research in the cosmetic world (my initial reaction is to go back to the school I attended and pay the lab fees and do the research myself with the assistance of current interested students).
2. Once (I’m optimistic) we prove superior effectiveness of this new ingredient, can I just add it to my current formulation? If not, what’s the right course of action?
Many thanks!
H
Comments
What evidence will you show them that the ingredient is safe?
If you use an ingredient that has already been reviewed via the CIR, you can show them the toxicology tests, the animal testing, the carcinogenicity testing, etc. that others have done on the ingredient. You can show that you are using the ingredient at reasonable levels and you are following safe manufacturing processes that others have been following.
But if you don't use an ingredient that has a history of safe use you will be responsible for that. You will have to be able to prove...
1. It's not a carcinogen
2. It's not teratogenic
3. The level of skin irritation
4. Dermal toxicity
5. Oral toxicity
etc.
Look at this report on Lactic Acid. You will need to provide this level of studies to support your claim that the use of this ingredient is safe.
https://www.dropbox.com/s/dcw9n6jz1khdwvj/lactic-acid-safety.pdf?dl=0
And if you want to use the product in the EU there is a whole bunch more stuff you'll need to do in terms of testing and registering it with REACH. And you can't do animal testing so you may not be able to prove safety at all.
The fastest and most cost effective way is to hire a consultant to get the ingredient throughly safety tested. I suspect it can't be done for less than $1 million. But this isn't my area of expertise.
I appreciate your insight.
H
CPTC labs will do custom experiments, and they have already established tests including Ames Mutagenicity Testing, in vitro toxicology, skin sensitization.But like Perry said I'd imagine the cost to be pretty high
On the other hand, if you have a new material which will marginally improve the moisturization of a skin lotion, no one is going to be very interested even if you can show a statistically significant improvement.
It all comes down to whether the new benefit is monetarily significant or not.