distillation of medical herbs

15 years ago

I've been working with medicinal herbs for many years and have recently gotten deeper into trying to extract the active ingredients via distillation. Does anyone know how pure the extract can be and still be legal to sell without a pharmacology license? It hasn't been an issue before when I was either selling tinctures or raw herbs but this may be crossing lines into selling "drugs" so does anyone know the relevant US laws on the subject? Thankss

Comments (4)

brendan_of_bonsai
15 years ago
Welcome to Gardenweb, and happy birthday If you entered it right.

I don't think its a matter of purity, I think it depends what chemical and what strength.

If you leech out a controlled substance (like saffarole or cocaine) then no amount of impurity makes it legal. Also if you are making a claim to treat anything but self limiting symptoms then they will need a prescription to buy if from you and you will need to be a pharmacy to sell it to them.

Have you ever thought about going back to school for pharmacology? If you do you can actually learn how the active compounds work, and sell what ever you like to boot.
janellelee
15 years ago
Hi I also took a class on medicinal herbs and have gotton to the place where Im interested in distilling (or trying to distill) some herbs. Id like to keep in touch with you just to follow how it goes for you.
Do you incorporated herbal teas along with the use of the oils?
THanks Jan
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janellelee
15 years ago
For a home distiller...
How much of the herb would be needed to make an 8th of an oz?
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simplemary
15 years ago
A LOT. Distilling herbs yields two compounds: 1) the distillate water (hydrosol) which contains the hydrophyllic (water loving) properties of the herb & 2) the essential oil which contains the concentrated plant oils. A special still is required-- one that can be sealed completely & which has the additional apparatus to separate the hydrosol from the e.o. Small stills run around $400 for home use & yield only an ounce of e.o. at a time, if that. They get kinda pricey for large scale production (even if you do it yourself) & are most suitable for people who have herb farms & can do mass production.

Since you are getting only hydrosols or essential oils from distillation, I don't see why you need any permits or pharmacology licenses. Other methods of extraction --like freebasing (same methodology used to make crack as to extract caffeine)-- which may isolate specific compounds may involve permitting, but those procedures are not "distillation".

Depending on your local health codes, you may need a permit that shows you follow good manufacturing processes-- clean areas, appropriate plumbing, no animals in production & storage areas--check and see.

BTW, for those confused by the term distillation, think about distilled water-- it's simply water that's been evaporated & collected again, leaving all its impurities behind. Herb distillation is similar and it does not yield any alcohol (which comes from the "mash" or fermented corn/grains in moonshining).