GMPs

[jim mcdonald]

there was a guy in indiana who sold a huge selection of bulk botanicals and some isolated chemicals (all legal, but a lot of them considered "legal highs") who was busted right around 9/11. He not only made no claims about them, but also refered to *everything* in his catalog (even chamomile flowers) as "poisonous nonconsumables" and had the greatest waiver ever ("i understand I am not to eat, drink, inject, smoke, snort, snuff, huff, or otherwise put this material into my or anyone else's mouth, nose, ears, anus...").

Anyways, he got nailed, and convicted, based on presumed intent to supply or manufacture X, Y or Z. Now, nothing he sold was illegal. But you could use some of it to do or make illegal things, and that was all that it took.
_________________
jim mcdonald
~herbalist~
www.herbcraft.org

[kavawaka]

I think you summed it up accurately, Rebecca. Herbs sold to a consumer (the one ingesting the product) are either a food or dietary supplement. Right now, they are both subject to food GMPs. That means an approved kitchen and other requirements. When the dietary supplement (DS) GMPs are in effect, it becomes an issue of whether the herbs are food or a dietary supplement and then the appropriate GMPs apply. Under DS GMPs, herbs sold to manufactuers are ingredients, not supplements and are not subject to the DS GMPs - but still subject to food GMPs. Sold directly to a consumer, they become a supplement. One interesting exception i saw concerning Bioterror Act registration is that homes are exempt. Their rationale is that a named business will not be making foods in a home (back to the approved kitchen and food GMPs). Farms and wildcrafters are also exempt in most circumstances unless they start processing the plant material, which includes cutting/milling.

What the authorities in charge might do in the face of a violation varies. One small company with both physical and virtual storefronts was sent a letter reminding them that Bioterror registration was required and gave them 30 days to comply. In regards to the GMPs, FDA action for non-compliance could range anywhere from a warning to prosecution, depending on the circumstance. Anytime there is harm, or a claim of harm, one is at risk and any issue of regulatory non-compliance will have a far greater impact. Operating as a limited liability corporation can help protect your home and other personal property more than a sole proprietorship.

One point i brought up previously is that FDA is very busy and has limited resources and i'm sure that a lot of people/small companies will weigh the risks and continue to operate under their radar.

[Bear_Medicine]

that's a scary story, jim.

henriette, oooh, how american of me, sorry for the european generalization on my part, that was sloppy.

David, it seems you're most likely right, and for some of us tiny medicine makers that's a good thing... I feel bad for the small to mid level people. And I have to say that it's nice to have your very clear and reasonable voice on the forum, especially in such confusing matters. Thanks for taking the time to spell things out.
_________________
~*~ Kiva Rose
Anima Lifeways & Herbal School http://animacenter.org
Anima Healing Arts Health & Herbal Clinic:
http://animahealingarts.org
Traditions in Western Herbalism Conference: http://traditionsinwesternherbalism.org

[kavawaka]

Thanks for the kind words, Kiva.

Although definitions can vary, i agree about the small to mid-sized companies. They will be hit the hardest. Companies like Herb Pharm, Gaia and Herbalist & Alchemist will probably make it. Smaller companies that have developed some market visibility will either severely limit their inventories or eventually get out of the business, unless by some miracle things change.

[crabapple]

Sometimes we forget what "small" means in the corporate world.

I'm told that Avena Botanicals is really going to have a difficult time finding the resources to comply with all the requirements of the GMPs. Apparently they have only 10 employees, and thus are considered a very small company. (Any they sell tinctures in Whole Foods and places like that!)

"Tiny" is a good word for the kitchen-table tincture-maker. We aren't even "small." We're microscopic.
_________________
Rebecca Hartman
Crabapple Herbs: http://crabappleherbs.com/
The Herbwife's Kitchen: http://crabappleherbs.com/blog/

[kavawaka]

For comparison, Herb Pharm has 60-75 employees (including the farm).

[jim mcdonald]

...plus interns, or including?
_________________
jim mcdonald
~herbalist~
www.herbcraft.org

[kavawaka]

Not including interns, who work solely on the farm. The non-farm business is probably about 55-70 full time employees. By Federal standards, Herb Pharm is considered a small business.

[dreamseeds]

David, I too want to thank you and all the folks participating on this thread. These are things I dont know much about. Just wandering around this US trying to learn plants and work with them.
The government is the last thing I have thought of. Thank you
_________________
~Kristena~
http://www.dreamseedsorganics.com
Dreamseeds Organics Blog

[rosemarygoddess]

Greetings. I wanted to add another thread to this conversation: as I understand it these regulatations are in part being driven by an international movement called Codex.

As an aside I think the Traditional Medicines Congress, which groups of herbalists were protesting in the past couple of years, was trying to respond to this larger movement. And while I did not agree with their approach, I think they were attempting to maintain some level of input for herbalists and other natural health care practitioners.

Back to Codex, the international movement that appears to be driving a lot of this. Codex was started a long time ago and has intent to regulate the world's food and medicine supply. There is a watch dog group that is monitoring the international activities of Codex and as I understand it any thing we see happening with food, ie a recent piece of legislation passed without public comment in California to stop the legal sale of raw milk is related to this movement.

Of course this is all being touted as a way to protect the public, but we all know better, it is all about money, control and who knows what else. And as Kiva mentioned in a other thread, staying under the radar screen and/or outright activism is required. For more information about codex see: www.healthfreedomusa.org/index.php

As I understand it, in 3 years small companies will need to be in compliance with DSHEA Good Manufactoring Practices in order to legally sell anything for internal use. I have started to try to read these regulations, but have not finsihed, it would be wise to read them in order to be informed if you are a small herbal company selling products whether you continue to sell products or not.

Things are going to look very different in the near future. Glad for these threads and conversations.
Blessings
Linda
www.moonwiseherbs.com

[kavawaka]

A very detailed and informative perspective on Codex can be found on AHPA's website: http://www.ahpa.org/Portals/0/pdfs/05_0727_CodexAndDS.pdf