Distributing a niche moisturizing cream product - possible to be shutdown?

[talentedavatar]

Situation: I used an amazing niche moisturizing cream product that helped my baby with their eczema. It was recommended to me by a friend who had used it with their daughter and it was the ONLY thing that worked for them.

It's an extremely hard to find this product, we had to go searching for it and found it at a small ethnic pharmacy. The person who recommended it to me said that though it is mainly an herbal cream from Asia it was said to contain one ingredient that was a type of steroid and had thus been restricted from being imported, so it disappeared a few years ago.

The cream we found with the same name and branding, now does not list the steroid in the ingredients and is now made in the US.

What I'd like to do: This cream has no marketing done on it and can't be found online. No one sells it online, like I said, I had to track it down from an ethnic pharmacy. I'd like to figure a way to distribute this item online, it really does work.

Does anyone know about these types of products and if there needs to be some sort of FDA clearance or if it's possible that they could try to shut me down if I start selling this product online?

Thanks for any advice in advance.

 

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[5holiday]

approval

I did a quick search about when a product needs FDA approval (i'm from the UK though), and found this tool:

http://www.fda.gov/newsevents/productsapprovals/default.htm

it seems to suggest that if is marketed (labelled) as merely a 'cosmetic product' rather than an actual pharma product, then it doesn't need FDA approval to go on the market. But the FDA will regulate how it is branded and whether it is safe: http://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/CosmeticsQA/ucm135709.htm

distribution

Do you have experience in this area? (if you do, please teach me everything )whilst it sounds like a great product, successful distribution online and offline exactly a walk in the park. As above, you wouldn't really be able to use any strong medical results based USP if it was merely marketed as a cosmetic.

having said that, it could still work! distribution is somewhat cool, especially when you later leverage your existing distribution contacts by offering them other new products you've found!

 

[talentedavatar]

Thanks for the response and info.
I've been trying to figure a few angles on how to find out more and this is all pretty awesome info.
Feel a little dumb not looking in the most obvious place.

Right now, I'm trying to figure out the need for the product and also my ability to market it, like you said, not exactly the easiest thing in the world, especially with a product that almost no one has heard of.

Thanks again!

 

[SGBoise]

I don't have any experience in distribution but I would recommend you talk to a insurance agent for E&O insurance. See how much it will cost even if they are willing to give you the insurance.