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

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

6 Responses to “Quick comments on the GMP’s (Good Manufactoring Processes)”

  1. Mo Horner says:

    Thank you for your thoughtful response, 7Song, especially the comments ‘these rules … push this category of herbalist out of the picture’ and ‘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’.

    I’m sure we herbalists are all for consumers getting safe herbal products that are what they claim to be. But, as you suggested, why isn’t anyone asking ‘when was the last time you heard any news of an herb seriously harming someone?’ Must we have a file cabinet full of paperwork to avoid one possible misuse or misapplication of a plant?

    No answers here, either. Making ‘custom formulas’ is going to be a thing of the past for community herbalists under these regulations. It will force community herbalists into the supplement seller category and this just rubs me the wrong way. Thoughtful people disagree on these matters. Thanks for being part of the dialogue, 7Song.

  2. Mama Wu says:

    I agree with your questions and concerns. I think one key is getting back to community- face to face direct interaction with your practitioner/supplier (or at least their reputation in the community). This insures good practice and integrity more effectively than any licensing or credentialing ever will.
    As teachers we endeavor to inspire some impulse towards honesty and integrity but then it is up to the individual.
    Licensing is only minimally about consumer protection. It is more about who can practice, make the money and puts an additional layer of protection around the practitioner should they be charged with malpractice (it is not a criminal charge that is usually brought but a charge against their licensing rules) End of my rant on licensing.
    This dilemma seems similar to the ones affecting agriculture- issues of scale- large farms vs the small, diverse, local organic grower. The rules need to be different. They are different businesses.
    I always appreciate your thoughtfulness on so many things, 7 Song!

  3. I completely agree with you 7Song. I’ve been very frustrated with similar legislation here in Canada, and I’ve also had a hard time putting my finger on exactly what was bothering me about it. On the surface, the regulations seem “reasonable,” but when you look at the repercussions of this kind of legislation, it’s disheartening.

    Here in Canada, the majority of the herbal products on the shelves are now either imported from Europe, or pharmaceutical companies who have “gone alternative.” There are only a small handful of herbal companies who have been able to keep up with the mountain of bureaucratic paperwork required to get the coveted NHPD number.

    One might say this is “survival of the fittest,” but after working for the NHPD for a brief stint, I have to say that the rules, exceptions to the rules, regulations, and paperwork are extremely confusing. I’m university educated, I have good critical thinking skills, and I still had a difficult time understanding how to correctly file the paperwork. Everything has to be done in a very specific way – one error and the file gets sent back to the owner and then bumped to the end of the (very long) cue. There are some files that have been in circulation for years.

    Eventually, I came to learn that the large companies actually hire a professional firm that specializes in filing govt claims so that they get processed quickly and accurately. So now there’s an additional barrier to entry for smaller companies who want to bring their products to market.

    In Canada, the CCHA (Canadian Council of Herbalist Associations) successfully petitioned for the govt to allow herbalists to continue compounding for their patients which is a huge bonus because it allows community herbalists to craft medicines on a small scale. I think herbalists have to be increasingly creative with how they bring their herbs to market, and “thinking outside the tincture bottle,” so to speak, is now mandatory.

  4. 7Song says:

    Hello there Melanie
    Thank you for your thoughtful reply. Canada seems to have adopted much of the UK types of rules with similar results. One being, far less small herbal companies. Thank you again for writing.
    ~7Song

  5. Kate Sinon says:

    I think the dissonance you’re feeling is very important. The way the issue is framed intentionally makes it difficult to argue against… Who doesn’t want to make sure that products have a high level of quality? However, if you remove the artificial boundaries of the debate and look at the bigger picture, you might ask who’s driving the requirements and, historically, who they have served? Who do they choose to regulate, why now, and who benefits?

    Think about the push to regulate organics in the 1990s (USDA, not FDA but, between the two of them, they control almost everything we eat). I think it can be argued that the push to “protect public safety” came at a time when traditional corporations realized that there was a growing market in organic foods (all those folks getting tired of being poisoned). Those regulations also put a huge financial and red tape burden on the producers so it was not surprising to see most of the small producer get bought up by major corporations. At the same time, the regulations started to get watered down, for example in 2004 when USDA passed new rules that allow USDA-certified organic farms to use fertilizers and pesticides that contain “unknown” ingredients, and USDA-certified organic dairy cows that have been administered antibiotics or fed non-organic fishmeal – made with synthetic preservatives and potentially contaminated by mercury and PCBs (a known carcinogen). I should add that much of this was retracted because there was such a huge outcry from the public but the point here is that there is this quiet battle going on to make the organics industry more appealing to corporations and their bottom line practices. That is also why you see the adaptation by the real organic community in that they stress sustainable practices and buying locally rather than just the “Organic” label.

    Also think about who these agencies go after… They’ve been waging a war on producers of “raw” dairy products and they site food borne illness – scary stuff. I would wager that illnesses associated with these products takes a substantial backseat to the illnesses (and disease) caused by our conventional food supply.

    While I agree that we should be concerned with regulating ourselves that is not what is going on here… I frankly believe we are being led into a canyon with no exit route. I think it is important that the herbal community start to discuss the larger perspective rather than just respond to the frame that the FDA has provided and that we start to develop viable strategies that protect, not only public safety, but also the quality and intent of herbal practice itself.

  6. I consent with your concerns and issues. I think one key is getting returning to community- experience to deal with immediate connections with your practitioner/supplier (or at least their popularity in the community). This guarantees sound exercise and reliability more successfully than any certification or credentialing ever will. As instructors we try to motivate some reaction towards loyalty and reliability but then it is up to the person.

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