Essential oil blend help?

[PaprikaFaa]

I really don't know how to word this, so please be patient with me... I have spent the last couple of decades working on an essential oil blend that would help me personally with fibromyalgia, which is apparently now classified as an autoimmune nerve disease, so, in my search for a natural, holistic, sustainable method of controlling the constant agony, I have come up with a concoction that not only reduces my pain, but I can apply it as often as I need to, and it has a cumulative effect.
Now, the problem lies in the fact that I have given this concoction away to volunteers who understood the experimental status of the oil, and were VERY willing to try it and report back. They have provided me with a list of the things they used it for, and how it affected them.
And then OTHER people started asking me for it, people who were not part of the volunteer program I set up. They said they'd be willing to pay as much as $50 per half ounce bottle of the essential oil blend. It doesn't cost me that much to make it, and I can blend approximately 8 ounces in each batch, but I refuse to blend it with anyone watching because I know what happens to holistic health practitioners in the US, so...
Anyway, please forgive my wee rant, but I want to be able to sell this blend on the internet, but I have done some research and I would have to either be exempted from most drug requirements, or conform to them. So how do I get the information I need to access the "permission slip" or the requirements of a basic essential oil recipe without making claims I know the product can back up with ease? I have looked all over theFDA website and I cannot find it.

Please, someone, help?

Also, my domain name is
miracleoil.works, but I haven't set the hosting yet because I am broke and on a fixed income. Yay.

 

[paradisi]

You cannot, legally, in the US. Medical claims such as that make the product a drug.

 

[PaprikaFaa]

You cannot, legally, in the US. Medical claims such as that make the product a drug.

Yeah, that's why I need to find more information about the process of getting either approval or exemption.... and I know that both can be done. As I previously stated, I have spent decades on this mixture

 

[AliOop]

There is no exemption for labeling of products that make medical claims. They must be FDA approved after rigorous testing.

Of course, many folks out there are making claims about their non-approved products, but they do so at their legal peril.

What you could do is sell your mix without making any medical claims whatsoever. For tips on what terms to avoid, take a look at Marie Gale's website.

If you avoid making medical claims, then you would only need to comply with the labeling requirements for essential oil sellers. Another thought is to also contact some sellers like Hopewell Oils, Plant Therapy, etc., and see if they are interesting in licensing the blend from you. That way, they would be responsible for all the compliance, and you would still receive compensation for your hard work to develop the blend.

 

[paradisi]

Yeah, that's why I need to find more information about the process of getting either approval or exemption.... and I know that both can be done. As I previously stated, I have spent decades on this mixture

Approval only comes after extensive testing for safety and effectiveness, meeting FDA standards for new drugs. That requires significant investment, it's not something one can do at home. And there is no exemption.

 

[PaprikaFaa]

Thank you, AliOop, for your help... my greatest concern is now in finding out the specific details of how to market products that are NOT soap and CAN be used for cosmetic purposes because I have ZERO knowledge of cosmetics... I don't even wear makeup and my sister's the real soaper in the family.

If I did license the blend to another company, would they have to have the recipe? I have no wish for genericizing this stuff.

 

[AliOop]

Thank you, AliOop, for your help... my greatest concern is now in finding out the specific details of how to market products that are NOT soap and CAN be used for cosmetic purposes because I have ZERO knowledge of cosmetics... I don't even wear makeup and my sister's the real soaper in the family.

If I did license the blend to another company, would they have to have the recipe? I have no wish for genericizing this stuff.

They would probably want to produce the recipe using their oils, and putting their brand name on it. That's usually how licensing works. But honestly, I'd just reach out and have a conversation with them about it. It doesn't cost anything or put anything at risk to talk.