Using an innovative ingredient not listed on CIR

Hewitt

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

EVchem

https://cptclabs.com/ < they will not be the cheapest option but I'd trust their results and they can probably set up a trial for you comparing your ingredient to one that performs similarly

Perry

If you're selling the product in the US, you have to be able to prove that your ingredient is safe.  So, how would you prove your ingredient were safe?  Imagine this real scenario. You make this product using your new ingredient. You start selling well and it's popular.  Then some consumer gets a rash (maybe not even related to your product) but they sue you or the FDA sends inspectors to your manufacturing facilities.  

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.

Hewitt

Thank you both! @Perry, I understand the need for accountability and would never just add an ingredient. We certainly can’t afford $1 mil at this point. Would it be possible to do the research outside the EU and US to cut costs? In the end researches get published on common journals and I don’t see why it matters where it’s done.

I appreciate your insight.
H

EVchem

Is this a new material never used in any other products (skin care or otherwise) that you could pull  some data from?  You could also try to partner with an ingredient supplier and have them do some of the heavy lifting.

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

Perry

@Hewitt - I guess it comes down to the degree of benefit you can demonstrate with the ingredient. For example, if you had an ingredient that grew hair. You could easily find a raw material supplier who would pay for all the required safety testing to get exclusive rights for using the ingredient.

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.

Hewitt

@EVchem, the ingredient isn’t found in any skin formulation to my knowledge and research extent. However, based on what’s actually in it and personal experiment, I am convinced it’s got superiority in mineral and vitamin content compared to its counterpart that’s in the market. I like your idea of partnering with suppliers. Besides detailed contract terms, how do you suggest I protect myself to not lose proprietorship? 

@perry, it isn’t as exciting as growing hair but I think it fills the unmet need in the market. 

I appreciate you both very much! 

H