GMPs

[crabapple]

I'll try to get in touch with Tracy on Monday. And I'll invite him to participate on the forum. You never know...

I've been mulling over the "taking it back" and "going underground" issues a lot as well. I'm not sure I've come to any good conclusions.

Emphasizing teaching is important. People need to know how to make things for themselves.

Public education about the consequences of regulation is also important. People in general don't know about this issue, and about the larger questions of licensing, etc. We need to get the word out about why we don't want to emulate the European model of regulation in this country.

I sometimes also wonder about the definition of "dietary supplement." It's very wide and vague. I'm not sure, but perhaps there's a way to get around it with herbs in a form that really is just food. (Remember, these GMPs don't apply to straight-up food.) What about herbal honeys? I think it depends on how you present them. If you make any label claims at all, or mention "medicinal," etc. it becomes a dietary supplement. But if it's just really tasty lemon balm honey.... I don't know. It is indeed frustrating.

(If anyone wants to rant in private about this, I made a private forum -- "The Kitchen Table" -- at jim's suggestion. I'll try to add everyone whose real name I know, but I know I will miss people. Just send me a message if you want to be added to that group.)
_________________
Rebecca Hartman
Crabapple Herbs: http://crabappleherbs.com/
The Herbwife's Kitchen: http://crabappleherbs.com/blog/

[kavawaka]

It's good to be thinking of all options. One could go the route of foods, but then you are limited only to herbs approved as foods (GRAS). Otherwise your food is now adulterated.

A couple of weeks ago in an online FDA GMP presentation, FDA revealed that they are now in the process of rewriting the food GMPs, no doubt to make them more restrictive. I fear for all of the small kitchens making brownies, breakfast burritos and other tasty treats.

[crabapple]

Food, too?

Mass corporatization, isn't it.
_________________
Rebecca Hartman
Crabapple Herbs: http://crabappleherbs.com/
The Herbwife's Kitchen: http://crabappleherbs.com/blog/

[jim mcdonald]

regarding "food, too?":

here in michiagn, the big cherry growers lobbied for rules that said that if you washed off or dried something, that was considered processing, and you need a state licensed & inspected kitchen (and all the costs that entails).

Why?

Because the larger growers wanted the roadside stands out of business.

politics
root words:
poly = many
tics = disease causing blood sucking pests
_________________
jim mcdonald
~herbalist~
www.herbcraft.org

[kate]

I'm curious from the bottom of the globe, where similar but different issues are being debated:

Are the proposed regulations for manufacture rather than just sale? In NZ I think the debate at this stage is around products that are for sale, so technically one could give away herbal medicines and not fall under the regulations (although I haven't seen a legal opinion about that).

(the debate here is more about if NZ should be covered by the Australian regulatory body which has much stricter criteria, and centres on medical and health claims on products but this will affect small manufacturers too. The good news is that lobbying stopped the legislation from going through, so far)

[kavawaka]

The Dietary Supplement Health and Education Act of 1994 (DSHEA) regulates the marketing and manufacture of herbal (and other) dietary supplements in general as food. These include 'herbs and other botanicals' (except for tobacco) that are ingested and intended to supplement the diet, rather than provide primary nutrition. Prior to 1994, most of the herbs we use fell under foods, but any that were not approved as food were essentially unapproved food additives. This was problematic and set most products up as potentially adulterated food products and there was a general fear that herbs would be banned in the marketplace.

Part of FDA's authority under DSHEA was to establish good manufacturing practices (GMPs), which are a major issue here, especially for small manufacturers. The GMPs will not be enforced on any practitioners that are specifically given a pass by FDA. In other words, it appears that FDA will determine whether they consider a practitioner to be qualified and then not hold them to the GMPs. No one here is certain how this judgment will be made.

Under DSHEA, any herb in the marketplace as of October 1994 can be sold as a dietary supplement. Exceptions are tobacco (regulated separately) and any herb that FDA feels they have proven to be unsafe (other than tobacco?!) or are otherwise banned as foods. Herbs introduced into the marketplace after October 1994 have to go through a complicated 'new dietary ingredient' (NDI) application.

In theory, we cannot do anything as medicine. DSHEA does not allow for that. Products are only allowed to make claims that support the structure or function of the body and that are 'truthful and not misleading.' We are not required to make a claim on a product, but any substantiated and truthful structure function claim can be made as long as the product also bears the FDA disclaimer...this product is not intended to 'diagnose, treat, cure or prevent any disease.' My personal disclaimer is that this stuff doesn't have anything to do with how i view medicine.

The biggest crunch for us right now are the GMPs, as you've probably gathered from this thread. These are new and the conformity date is still a ways off. The GMPs require so much, from paperwork, facility requirements and a potential for microbial (and possibly other) testing that most small manufactures have not figured out how to survive them. There was great hope originally that very small manufacturers would be exempted from the requirements. FDA chose not to go that way and has instead drawn the line at approved practitioners as discussed above. We are not currently, however, wrestling with anything as oppressive as the Australian regs.

OK, sorry for taking such a long way around to your question. I think the answer, if one was strictly adhering to the law, is...
An FDA-approved practitioner could make a cup of chamomile tea for a client during a consultation as long as it was only claimed for something like, let's say, supporting digestive function and a healthy nervous system.

[jim mcdonald]

a student of mine was talking with one of thier old teachers, a well known and well regarded herbalist whose name I'll not mention because I'm reporting this second hand, who suggested the possibilty of practitioners simply charging for consults and giving the herbs away. The idea here being that, since the preparations are not being sold, the GMPs woudln't apply.

Do you have any insight into the feasbility of this approach, or perhaps into the also suggested idea of setting up "herbal shares" where groups can buy into a share of a herbal operation, making all the members technically "co owners" rather than producers and consumers?
_________________
jim mcdonald
~herbalist~
www.herbcraft.org

[kavawaka]

Can't say for sure Jim, but what i see in the rule is manufacturing without stating that the product is intended for sale in commerce. Where they do mention sale, they usually use the phrase 'sales and distribution.' The definition of who is subject to the GMPs does not state anything about selling the product (see below). Could be wrong on this, but that is my read.

FDA is looking at how they want to handle free samples distributed at trade shows. Given the stated goal of consumer protection, i think they would look at any type of manufacture or (non-retail) distribution as being under the authority of FDA. A theoretical example that comes to mind: food given away in a shelter or soup line still must meet FDA requirements for food safety.

From the rule:
§ 111.1 Who is subject to this part?
(a) Except as provided by paragraph (b) of this section, you are subject
to this part if you manufacture, package, label, or hold a dietary supplement, including:

[the rest of this is just legaleze that excludes retailers from the rule, but is included here for clarification]

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and
(2) A dietary supplement imported or offered for import in any State or
territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
(b) The requirements pertaining to holding dietary supplements do not
apply to you if you are holding those dietary supplements at a retail
establishment for the sole purpose of direct retail sale to individual consumers.
A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.

[pacificschool]

In response to jim's question about the legality of giving herbs for free:
I have heard many people raise this question. Working for free, or giving out herbs for free does not offer any legal shelter to the person or organization working for free. The technical legal word is "gratuitous." This has been examined legally, and there is ample case law on this topic.
It is an important confluence of law and ethics, and can help us think through these issues more thoroughly. To hold a practitioner free from liability, free of responsibility for creating harm simply because he or she didn't charge the person that he or she hurt makes no sense. It would imply that those poor people who can not afford anything other than free care or donated medicine deserve to have no recourse for dangerous treatments.
If a person runs over you with their car, but you didn't pay them to do so should they not be liable for damages?
The viewpoint that gratuitous care should have no liability-no responsibility for providing quality care that at least does no harm prioritizes the practitioner when the client should be the priority.
see for example CAL. BUS. & PROF. CODE § 201, TEX. REV. Civ. STAT. ANN. art. 4510a (Vernon 1976), People v. Saunders, 61 Cal. App. 341, 345, 215 P. 120, 122 (2d Dist.1923), People v. Vermillion, 30 Cal. App. 417, 418, 158 P. 504, 504 (2d Dist.
1916.
Adam Seller
Pacific School of Herbal Medicine
www.pshm.org

[kavawaka]

Those are good thoughts on liability of practice, Adam. I think this issue, however, is a broader one concerning manufacture and distribution of products under the new GMPs. FDA-approved practitioners who follow certain consulting guidelines will be given a pass on the GMPs, even though the liability issue would still apply if they caused harm. It is the unapproved practitioners and small manufacturers who are still in the cross-hairs.

FDA commented that they do not believe the intention of Congress was to give a company a break just because they are small, so i find it interesting that they have made this one exception. I wonder if this will even hold up once FDA begins allowing some practitioners to bypass GMPs and hold other practitioners to them. The sad part is that this would probably mean everyone would be subject. On the other hand, it could be a foot in the door. Congress also didn't intend for hundreds of small manufacturers to go out of business.

The only thing i can think of is to petition FDA regarding ultra-small business. I doubt they would do anything, but it's all that i have come up with. AHPA has already petitioned them on some other issues...
http://www.ahpa.org/Default.aspx?tabid=69&aId=411&zId=1

[crabapple]

David -- what do you know about the petitioning process? It seems like an interesting option, but I'm not sure what it would take to actually have an influence this way. (Adam? Do you know these details?)

The answer to the "give it away for free" question seems quite clear, legally, as David and Adam have pointed out.

But the "share" / "co-ownership" model is intriguing to me. I live in a state where the sale of raw milk is illegal. However, some farmers offer a "cow share" program -- people buy a share of a cow and pay the farmer a small fee to milk it for them. Thus there is no change in ownership. Nothing is sold, and nothing is given away. This model could be applied to herbs as well.
_________________
Rebecca Hartman
Crabapple Herbs: http://crabappleherbs.com/
The Herbwife's Kitchen: http://crabappleherbs.com/blog/

[jim mcdonald]

I don't think that the ethics of liability in cases where harm is done gets to what I was trying to flesh out. Of course you can and should be held liable if you cause harm. But do the GMPs assume harm, a priori?
_________________
jim mcdonald
~herbalist~
www.herbcraft.org

[kavawaka]

Taking clues from AHPA’s petition, i would think that the process is fairly straightforward. What will carry the most weight are the signatories. My approach would be to leave the entire practitioner issue out of it and request an exclusion for very small companies under 10 full time employees. Having a clear idea of the number of non-practitioner businesses that would need to shut down because they cannot afford to conform to the new regulations would also be very powerful. (i am leaving practitioners out because we do not yet know what criterion FDA will use to approve/not approve practitioners and therefore cannot speak to it.) This endeavor would take an enormous amount of work, communication and cooperation. To really drive the point home, district representatives and state senators should also be contacted. They are the ones who make the laws and should also, hopefully, be concerned about small business. They need to know about the people in their district/state who are concerned about losing their livelihood. Sadly, if i can generalize here, Republicans act to protect small business and Democrats act to ‘protect’ the public.

With all of that said, there is the greater issue of exposure for small business. I am guessing that most small manufacturers of herbal dietary supplements (in other words products that are ingested) have not registered their company as required under the Bioterror Act. This Act and the registration required by it are why there is no registration requirement in the GMPs. FDA is already using this registration to identify dietary supplement manufacturers. So, before considering the coordination of such a huge undertaking is the overall consideration of exposure for small manufacturers.

Any thoughts from the small manufacturers who make dietary supplements for general sale outside of consultations?

On the issue of shares or co-ownership, i’ll see if i can found out anything. In general, i would default to my comments to Jim’s post. The rule states that the regulation applies to those who manufacture or hold/distribute dietary supplements and i do not know of any stated conditions of sale or mode of distribution.

[jim mcdonald]

well, its nice to know the AHPA is doing something, though I've always objected to the fact that they themselves exclude small scale medicine makers, as their dues (the lowest: sales of $500,000 & under = $1,000) are outside of what many small medicine makers can afford. It'd be nice if they offered a reasonable membership option for small operations.
_________________
jim mcdonald
~herbalist~
www.herbcraft.org

[crabapple]

It seems to me that AHPA's interests (and the interests of their members) are different from the interests of very small tincture-makers. Maybe very small medicine makers need to have their own organization? (Of course, who has time for that? But it may be necessary.)
_________________
Rebecca Hartman
Crabapple Herbs: http://crabappleherbs.com/
The Herbwife's Kitchen: http://crabappleherbs.com/blog/