Archive for October, 2012

Quick comments on the GMP’s (Good Manufactoring Processes)

Tuesday, October 23rd, 2012

Contentious Herbal Issue, about the GMP’s (Good Manufacturing Processes). These are new enforceable FDA legal standards for retail supplement products, including internally taken herbal medicines.
While I was at the American Herbalist Guild (AHG) Symposium, I went to a class about the GMP’s and how smaller companies can become compliant. I appreciated the presenter’s information and real-life details trying to help people get through all the confusing mandates and details that are necessary to be up to GMP code.
Before I get into how I feel about this issue, I want to say a few things for clarification. First, I am FAR from being any kind of expert on this issue and so some of my details may be wrong. I am lightly knowledgeable at best about the subject, but my opinions are based on the gestalt of this thing not the minutiae.
Second, I am not really looking to start a flame war here, though I invite others thoughtful opinions for, against, in the middle or otherwise about GMP’s.
I left the above class frustrated (not at the informative presenters) and tried to figure out why. On the face of it, GMP’s are a ‘reasonable’ idea, that is, products are what they say they are, and so consumers know what they are getting.
The problem is all rules and contrivances necessary to get there. While it certainly seems ~possible~ to achieve being GMP compliant, there is A LOT of paper work and other details necessary to keep the FDA at bay.
But here’s where it gets more maddening for me. When I talk to some of the makers of herbal products, some of those who are GMP compliant make it sound easy for anyone to get there. It is surely not. If one is primarily a product maker, then perhaps they can devote the ongoing time and resources necessary to stay compliant. However, if you are a generalist herbalist on your own, and also see patients, gather and/or grow some of your own medicines, teach classes, etc, then it is not easy at all. So what these rules do in my mind is push this category of herbalist out of the picture (insert visual photo of a fuming Michael Moore here). So for small batch herbalists who may just sell locally, these rules will take a needed source of income away from people helping their community and making it more difficult to help keep herbal medicine local, affordable and accessible.
Okay, for those of you who are saying, yea 7Song, but what about the consumer?, I say to you “Please show me some documented or anecdotal stories that make these rules necessary for these kind of herbal producers”. How many times have herbalists sickened or poisoned their neighbors with their products? I am sure that it has happened, but as we all well know (need I say ‘steroid shots’) that no amount of rules will stop the occasional unfortunate accident. And generally the herbalist will be accountable, maybe not legally, but people will talk.
It is difficult for me to hear from those who are compliant and have the resources (money and people) but don’t see how these rules affect this category of shall we say, community herbalist?
Here is my analogy. To me, it is like licensing herbalists. At this point I personally would get licensed as I have been practicing long enough and have enough connections to make sure my name gets passed on as a Qualified Herbalist. And for others who are not, I would say ‘don’t you all see, it is for ~consumer protection~ that we need to be licensed. Otherwise how we would we parse those who have passed the tests from others who have not gone through the hoops we have?’ Well, I say F# that. There will always be people, licensed or not who are in it strictly for money or other reasons that are not about helping people or making quality products. And I don’t mind being associated with riff-raff. If there were simple ways that made distinctions between different levels of herbalists and did not exclude, I guess I might be open to it. But generally, it is about the integrity of the individual herbalist to let potential patients know their abilities
Okay, I don’t mean to really get into a licensing rant for herbalists debate here, I am just trying to make the point that our ready acceptance of GMP’s is similar as it will turn away ‘herbal people’ who might contribute to their neighborhoods and larger communities.
I don’t have any answers to this predicament; I just want to give voice to some of my feelings from this weekend. I hope we as a community of plant-loving, human-supportive people can do as best we can to help support others to be engaged in the old and new traditions of herbal medicine. ~7Song