FDA cGMP compliance open source project

Our strength as herbalists is that we come together. We share processing tips and secret harvest spots (sometimes - depending on who's asking), discuss difficult cases, and generally help each other learn. This has been evident to me all the way from herbalist pot-lucks to the biggest herb conferences. Now I believe it is time for us to come together on another critical issue: the modern regulatory environment, enforced by the FDA, in which we find ourselves.
At Urban Moonshine (we make bitters and other tinctures and blends), I can't say we've come to a complete understanding with FDA. The issue of how to identify a liquid formula made from multiple herbs remains. But we have been through every step along the way, and have discovered successful strategies that FDA agrees are valid, and that rely on traditional methods for evaluating and identifying plants - the way herbalists have always done it. These strategies have been tested through multiple inspections. And now it's time for us to share them, share templates of the paperwork, share the research that justifies the specifications we've developed, and help explain what the regulations are, what FDA wants, and how to get there. Not because we've got all the answers, but because we want to open the conversation and create a forum where small-scale producers can get actual news they can use - not just copies of the rules, but actual examples in action. If we can have an ongoing conversation and herbalists across the country can share their collective wisdom, I know we'll have the tools to support anyone who wants to make tinctures for sale in their local communities or across the country.
I won't lie - this is a complicated task, and there are a lot of moving pieces. It's not something you can understand over a weekend and implement with a few days' work. This complexity may have deterred a lot of you, and in the future, may make it impossible for some to keep their heart-centered, small-scale herbal products on the market. FDA welcomes consolidation in the industry - hoping that herbal medicine will become concentrated in the hands of a few, and thus easier to control, easier to oversee.

**NOTE: all the information presented under the "FDA cGMP compliance open source project" is not intended to be legal advice, nor is it in any way guaranteed that my interpretation of the statute and system for compliance is going to satisfy any individual FDA inspector or compliance officer. These pages are a synthesis of my own understanding of the regulations and how to achieve compliance.

We reject the idea that our medicines can only be made by large-scale manufacturers. Despite the pressures today, there is a safe way forward for the community herbalist to make medicine, to  keep this vital and direct link between plant and health alive.
First, we must show that we herbalists – not physicians, not research scientists, not machines, but herbalists – understand the plants we use, and know the intimate details of their growth, their smell, their taste, their essence. We must show how herbalists have a clear, practical and safe way of successfully matching plants with people. Second, we must support a model that relies on customized, individualized medicine making for the local community: a practitioner-based, rather than product-based, economic relationship that focuses on plants, not pills; that encourages client self-care and self-resilience, rather than product-based dependence. And  third, we must reach out to our partners in all fields, to weave green tendrils into places where they’ve all too long been absent: in the halls of medicine, in the offices of urban planning, in the minds of FDA compliance officers, in the backyards of clients everywhere. 

So starting today, we are committing to unfold an ongoing open-source project to achieve FDA compliance for small-scale producers. Every Wednesday I will post information here, including some audio recordings, starting with an overview of the regulations in layperson's terms and a clarification of what FDA is after, then progressing through the moving pieces from documentation to batch records, all the while providing specific examples of documents that have worked for us and helping to tailor them to your needs. This is starting today, and will continue for as long as it takes. I urge you to take part in the conversation: post comments, questions, concerns, and examples. Ask for more detail, ask why, not just how. We will do our best to answer. But ultimately, we are doing this because everyone involved will get stronger as a result. Our collective experience, once open-sourced, will home in on amazing solutions with the ruthless efficiency of nature. This will help Urban Moonshine as much as it will help everyone else.

Posted below find an outline of the curriculum you can expect. Check back here in a week for our first installment and an overview of the compliance landscape. Contact us if you want to help. But before you go further, I ask you to please consider the idea that this could be done more efficiently than blog posts, uploaded documents, and audio recordings. We are trying to build a fully-interactive online classroom for just this type of conversation - where you can be present, ask questions and get answers in real time, and ensure this open-source process is a two-way street. In fact, we need you here contributing: how do you make medicine? How can we make FDA compliance work for you? It's going to be a lot less effective for this to just be an exposition of information - we all need to know what your experience looks like so we can build a truly resilient and adaptable compliance model for actual herbalists. 
This endeavor needs a lot of infrastructure, and we can't afford to do it alone. From fit-up costs for the space, to AV and telepresence equipment, we are relying on your help to make this a rich, interactive process. There will be a lot of other good stuff along the way, too - but what excites me most is the opportunity to create an open-source compliance conversation that happens every week, with intensive on-site experiences as required, and is available free of charge to anyone who wants to join up. But as you know, nothing is actually free. So please consider supporting Railyard - our herb center project. Hiring consultants for FDA compliance can cost thousands of dollars - even a weekend workshop can cost hundreds. If everyone from a group of engaged herbalists who want to maintain control over their own medicine-making contributed even half that much to the project, we can make Railyard happen. Think about it, and I hope to see you next week.

Tentative curriculum (we can customize it together):

Intro to federal regulations

A detailed breakdown of the federal regulations under CFR 21 part 111 (good manufacturing practices), part 101 (labeling requirements), and parts 174-186 (food contact surfaces and packaging requirements) will give the us the tools to critically evaluate a sound master manufacturing record, compliant dietary supplement label, and scientifically valid testing regime.

Herbal Product Manufacturing

The details involved in making a range of herbal products: research, formulation, safety considerations, process control steps required for compliance (FDA cGMPs), extraction, dosage forms, considerations of large-scale operations, packaging supplies.

Facilities and Equipment

We will become familiar both with the basic tools needed for manufacturing and larger-scale equipment such as floor scales, macerating vessels, presses. Maintenance and calibration requirements and tracking.

Records and Paperwork

We will cover the recordkeeping methodology for maintaining a cGMP compliant manufacturing operation, based on requirements from CFR 21.111, and grounded in specific examples currently in use. We will become familiar with creating: master manufacturing records and their associated batch production records; specification sheets for raw, in-process, and finished products as well as eccipients, solvents, and packaging materials; and valid testing methods and documentation.

Marketing, Sales, and DSHEA-compliant language

We will cover design and marketing concepts and suggestions, as well as thoroughly review what constitutes compliant language under DSHEA (regarding promotional material, labels, social media and websites, video, and product trainings).

Quality Control Laboratory

We will become thoroughly familiar with the requirements for identity testing under CFR 21.111, be able to access and compile relevant resources to aid in identity testing (voucher specimens, e.g.), and understand how to contract with third-party laboratories for identity, microbiological, heavy metal, pesticide and herbicide contamination testing.

Orientation to Industry

We will familiarize ourselves with the resources and connections in national professional organizations for the herbal products industry, such as AHPA, as well as legal and consultant resources that might prove useful. Additionally, we will talk about the requirements and practicalities of launching an herbal product: from interfacing with large retailers such as Whole Foods Market, to making barcodes for products, and more.


David said...

If the goal is "...a model that relies on customized, individualized medicine making for the local community: a practitioner-based, rather than product-based, economic relationship..." then regulatory compliance is fairly minimal. On the other hand, entry into commerce through massive chains like Whole Foods or selling on the web (very high exposure) is a different story altogether.

One thing I would strongly suggest from the outset is a very clear and prominent disclaimer to the effect that you are not offering legal advice and that any manufacturer selling into the broader marketplace should work with legal counsel to navigate the regulatory environment.

Guido Mase' said...

I do think that a practitioner-based model is a good and safe place to start in part because it does require less in terms of making a multi-botanical blend. However, the "fairly minimal" requirements rely on FDA maintaining Fabricant's position from a few years ago that the agency won't enforce cGMPs on practitioners who blend formulas - provided the ingredients of the blend are obtained from a cGMP compliant operation. If you are making your own tinctures, even for blending for clients, you are required to comply with the regulations regardless of the scale on which you manufacture.

And yes, I certainly am not a lawyer. I would welcome a lawyer to join the conversation - for their experience, not to provide general advice. But we also have to acknowledge that legal fees are often out of reach for small-scale producers, and we should not let the fact that our discussions aren't "legal advice" stop us from talking. And that, even without legal counsel, a small-scale manufacturer can move forward with effective compliance strategies. Part of getting herbal dietary supplements into a local coop or health food store needs to involve a sound compliance strategy; but due to financial reasons, legal advice often can't be a part of it. We have had the luxury of working with legal counsel to help us interpret the regulations. What we've learned can be shared. Waiting for the financial resources required for legal counsel often puts small-scale herbalists in a catch-22.

David said...

Yes, cGMP compliance is both required for practitioners who make their own extracts and some degree of good manufacturing practice is a reasonable, common sense idea. But the enforcement discretion for inspecting practitioners who see clients one-on-one (and some other requirements) seems to be intact, at least to my knowledge. Also to my understanding, this is not just concerning blending extracts but also making them. This area continues to be of exceptionally low concern.... Unless there are known instances of a practitioner (practice only, no retail) being inspected. If you know of any such instances, please share.

For those marketing their extracts, the easiest place to start is compliant labeling. I continue to see dietary supplement labels from national brands that bear improper claims or claims without the FDA disclaimer. Labels are your brand's face to the world and the first thing any regulatory body will see.

Guido Mase' said...

Agreed on both counts - I really don't think FDA has the resources to inspect even small-scale manufacturers who are marketing in limited local circles. And label compliance is relatively easy to accomplish, there are good available resources, and ample case studies that give good examples. Sounds like a good place to start - especially for folks who have websites or Etsy stores, which are an easy place for FDA to catch missteps.

I do have to say that, even if enforcement chances are low to nil, it bothers me that producers are being told to go ahead and work outside the statute because they will be "under the radar" - not because I don't believe in laying low and doing what you want, but because herbalists are essentially being told that what they do is illegal. It's the same story for the last thousand years. I'm tired of it. We can, with minimal financial strain, achieve what FDA wants of us. Especially if we work together. And then we can work without the threat, however feeble, that what we love will be taken away.

Unknown said...

This is SOOO needed! We are a community apothecary in Charlottesville VA and are work with the FDA GMP guidelines to be "out in the open". Have attended several classes on GMP guidelines and have crafted many forms for our use. However, it would be wonderful to work with people who have gone through an actual FDA inspection to see if OUR interpretation of the guidelines meets THEIR interpretation of guidelines for small herbal businesses.

David said...

I agree Guido. Not sure who is telling producers to work outside the statute, certainly not me. As I stated above, a degree of compliance is both achievable and is really just common sense (e.g., herb ID). However, sadly, I question how realistic it is for a small producer (well, actually any producer) to achieve *everything* FDA wants. It is realistic for a small manufacturer to follow basic GMPs and make great medicine. Raw material ID, MMRs, batch production records and traceability can be accomplished in a very small firm and go a long way towards compliance. These to me are fairly minimal practices compared to phytochemical fingerprints, heavy metal and pesticide testing, etc.

Natural Nurse said...

How do I join in this conversation? I have years of experience in this area, and have helped many companies understand and set up compliant practices.

Ellen Kamhi PHD, RN, AHG, AHN-BC

Unknown said...

Guido - this is so great you are doing this!! Such a needed conversation for us small scale herbalists (and big scale ones too). These FDA rules and regulations that I don't really understand have been hanging over my head for years holding a part of me back with worries if my business gets bigger than I will have to confront this FDA realm. What a service you are providing for us - to break it down, help us understand it, hear how others are dealing with it and ulitmately help herbalists feel more empowered and able to do the important healing work we have to do. Thank you!!!

Joan said...

This is a huge gift...huge!!! Thanks for finding a way for us to all move forward together. <3

Guido Mase' said...

David - it does seem that compliance has the potential to be a never-ending process for small-scale manufacturers, where efforts in one area reveal shortcomings in another. Microbiological and heavy metal contamination testing, two particular sticking points, probably will always require some degree of financial investment (one possible solution might involve cooperative testing facilities, we'd have to talk about how to set that up). But pesticide testing - particularly onerous and expensive due to the type of machinery needed - could possibly be bypassed by relying on certified organic herbs (an argument can be made that this is USDA jurisdiction and responsibility, not the manufacturer's). Regardless, these are the questions we need to puzzle through, looking at case studies and outcomes from folks who have actually dealt with FDA as manufacturers, and hopefully with the contributions of advocacy groups like AHPA (the American Herbal Products Association).

Ellen - glad you'd be interested. Would love to discuss your involvement further. For now, how does this sound: I'd like to give a brief overview of the landscape this coming Wednesday 12/2, in audio form, along with relevant links. You can certainly contribute at that juncture, but perhaps in the future we could set up an interview time so you can share more of your experience?

And just another shout-out to support the facility we're building for just this type of cooperative effort, check out Railyard:

Marie Frohlich said...

Thank you Guido.. So interested in all of this and a discussion around standardized formulas vs custom for practicing herbalists. Quality control concerns too-- the entire testing requirement and cost is fearsome. Looking forward to the conversation. Would like an option to contribute to Railyard monthly vs one time kickstarter. Consider membership options for continuing contributors?

Unknown said...

Thanks so much Guido for taking the lead in organizing this crucial FDA cGMP compliance conversation! Your words and vision ring true for us here at Avena Botanicals. Avena has been under the scrutiny of the FDA since the late 1980s. We were first targeted as "the sole manufacturer of drugs in the state of Maine" at a time when the FDA was unfamiliar with herbalists. After 27 years of dealing with FDA inconsistencies and their ever-changing regulations, I am relieved and grateful to no longer be so alone and isolated as an herbalist and community-based herbal apothecary. I am eager to join with you and others, supporting and learning from each other, and reminding each other to constantly stay true to our "radicle" roots as herbal healers. We MUST remember on a daily basis why we do what we do, stay spiritually rooted, Earth-connected, and heart-centered.

Natural Nurse said...

Hi Deb,
As a wildcrafting herbalist since 1964 I agree with your desires to stay spiritually rooted, Earth-connected, and heart-centered.

As a Professional Herbal Regulatory Specialist, although we may not like it, I believe it is best to maximize knowledge that will allow one to stay out of the FDA crossfire.... for example ... the word APOTHECARY brings an onslaught of rath and raises attention and red flags in many states "In some states there are state laws restricting certain words from being used in the name of the business, such as “apothecary”, “pharmacy”, “medicine shop”, etc. It is incumbent on you to educate yourself about state laws wherever you are practicing or running a business." (from AMERICAN HERBALIST GUILD website)

I think it is best to at least find out the Compliant Language, Manufacturing regulations, etc.... then if one chooses to 'go on with it' anyway, thats OK, or perhaps one might choose a less inflammatory pathway.

Its like not knowing you cannot go through red lights without potential consequences, or knowing but choosing to run the light anyway, since the coast is clear and there is no danger...

Nothing like knowledge to enhance the depth of personal choice.

Its so great that Guido has initiated this sharing conversation!

Ellen Kamhi PHD, RN, AHG, AHN-BC

Anonymous said...

Guido, I look forward to these sessions. Thank you for opening up this conversation!
In the clinic where I work, we do not make our own tinctures, but do formulate tincture blends for our clients. I am concerned about having to prove identity of those ingredients. To a certain extent, I'm counting on our established relationships with our vendors, and their GMP compliance. (That's an example of one detail that concerns me - there are oh so many more!)
@ David, I believe that Nicholas Schnell's clinic in Nebraska, Four Winds, has been through FDA inspection. I know KW Botanicals in California has been inspected, not sure if you count them as retail.
@ Guido, It is my understanding that GMP compliance is intended to be a never-ending process. Just like house cleaning! ;) You wash the dishes, you use them again, they are dirty, you wash them again - never ending, until you stop cooking & eating. Therefore, the FDA does not "approve" a facility that has been inspected.
I have learned a lot from Roy Upton's talks, available to AHG members on the archives. Erin Leary has been generous with her experience at Green Tree consultants, as well as Sarah & Amber & the other good folks at BioNetwork. (I wish our community college offered something like that - what a tremendous resource!) I've been inspired by Lorna Mauney-Brodek's FDA Pushback Dossier, pointing out areas of traditional herbal medicine making that will never comply with the current guidelines. And I've been disheartened to read about the latest episode in Urban Moonshine's drama with the FDA.
I am interested in cooperative strength for small-scale herbal medicine makers. Both Allison Loercher & I discussed the possibilities, at each of our talks at the recent AHG symposium. I envision a cooperative network of small medicine making facilities, modeled on commercial kitchens, that can take advantage of a central lab for the more expensive aspects like pesticide testing. There must be a way forward that is not large-scale industrial.

David said...

Sheila, if they sell products outside of the direct, one-on-one client consulting relationship then they step over into retail. Do you if that is not the case for either of these folks?

Guido Mase' said...

Sheila - I agree that FDA never "approves" a facility - I guess our goal could be restated as "an inspection that does not result in a form 483 being given out (a form that lists an inspector's observations of circumstances deemed out of compliance). Interestingly, a "no 483" outcome doesn't mean you are compliant - it just means nothing was found at that time. A whole other piece - in my opinion a crucial one - in this conversation is how to handle an inspection, what to expect, and what your rights are as a manufacturer (it's not a given that FDA inspectors will respect these rights).
Also, enforcement has not been uniformly applied nationally. Different FDA districts have different ways of doing things. This only adds to the confusion.
Thank you for mentioning Roy, who is a fantastic resource and advocate for true herbalism, the AHG, and I'd include AHPA (the American Herbal Products Association) and Michael McGuffin in there as well.
Finally, I believe KW Botanicals sells retail too. And Lorna is awesome.

Deb, thank you for adding your voice to this conversation and for reminding us that we are herbalists, not drug manufacturers. Does this mean we can't make medicine (to use a potentially inflammatory word you should never put on a bottle)? No, we can! And I believe we can do it in an FDA-compliant way that is still financially sustainable. But in order to do so, we are really going to have to think differently. The idea that you start a business, buy equipment, hire consultants and lawyers to guide you through the regulations, won't work for local, decentralized herbal medicine. But that local herbal medicine is precisely what we need more of. Local food, local medicine.
As I have seen herbalism as a healthcare modality integrate into modern medical practice (through my experience and in the experience of many others), I've noticed that our way, when practiced from a plant- and heart-centered foundation, changes the way things are done. Herbal medicine is grassroots and collaborative, seeks nature connection and thrives on a wild diversity. In this sense, it is a discipline that mirrors ecology - because it was invented by the ecology, not by people! If we can apply these tenets to manufacturing and collaborate in doing so, we will accomplish two things:
- support all herbal medicine makers, and
- define herbal medicine as inherently different from dietary supplements blended from vats of white powders.
My hope is that this will heal the wounds capitalism has inflicted on the practice of healing. In a roundabout way, FDA is giving us a huge opportunity here.

Natural Nurse said...

Its wonderful to have this exchange!

FDA registered- all manufacturers are required to REGISTER with the FDA

facilities are FDA REGISTERED, not FDA approved ( people often use this term incorrectly)

If any facility purchases herbs that have previously been created elsewhere (such as a large glass bottle of finished tincture or extract, or a powdered product of any kind) and THEN OPENS the bottle or package, to
create an herbal blend, or EVEN an herb tea blend, that facility has now crossed over into being considered a MANUFACTURER, and is then required to comply with the entire code of federal regulations ( 21 CFR Part 111) ( in some states licensed health care providers , such as a Naturopath, can do this on a limited basis for specific individuals and not be considered a manufacturer.

There are OTHER very specific codes and requirements for LABELING.

Labeling includes the label on the actual product, all literature that may accompany a product, and all statements in electronic form on any website..It also includes testimonials and even 'liking' a customer comment on facebook!

The labeling laws make it very difficult to communicate why an individual would want to use a specific herbal remedy.

It has been horrendous to watch the insidious rules being instituted by the FDA, creep into the sacred art of preparing herbal medicine. I have worked with great herbalists since 1964, including indigenous healers in Jamaica, Dr.Bernard Jensen, Ann Wigmore, Michael Moore, Mimi Kamp and many others.

I have been in a position of working with large herbal companies to help walk them though and successfully navigate this process, although to watch this process occur has been shocking.

Although the FDA says the basis of this over-regulation is safety and health, it definitely seems more like a government based attempt to decrease the ability of individuals to care for themselves through the use of natural remedies, to stop the significant inroads into profit margins that natural remedies have been making over the last few years. Its not just herbal medicine,,,, the FDA is now in the process of going after Homeopathics as well. Aromatherapy companies have also been included in this ongoing and escalating sweep.

So there are many issues here

Philosophical -in terms of supporting, promoting and continuing the art of herbalism( if we refer to history, this is NOT the first time demagogues have attempted to stamp it out)

Practical- this involved becoming deeply familiar with the rules that are now ACTUALLY in place

Political- coming together as a community to act on solutions, I so much wish others had been more willing to be AWARE of these rules as they were being instituted... Roy Upton and others have been sending out the warning for years... I was on several panels and shouted out about it for YEARS- however many herbalists were annoyed at the MESSENGERS for pointing out the horrendous rules that were being instituted. I often got reactions of dis-belief and overwhelm,,, which is understandable..

Ellen Kamhi PhD RN

Unknown said...

I have been reading this exchange with great interested. For the last year I have been in the process of setting up a company to blend animal herbal products. My background is in the chemical industry where all of the information that is in this discussion is completely integral. I feel like I bridge the two industries with my knowledge.

There are ways for us as herbalists to meet basic FDA and full cGMP requirements, but it is not something that most want to deal with. It is difficult, but it is a process that can be learned and used effectively. It can be implemented from the wild-crafter to the full-scale operation. Education is the key. There is a huge amount of knowledge with all the folks that have contributed to comments here as well as with those that are just reading and watching.

I am happy to contribute what I can based on my knowledge. If we can put together an effective program for those herbalists who wish to participate it would be amazing! We cannot ignore this issue for those that do ignore it will suffer, so we need to be encouraging for participation. Our European and British counterparts have also had to go through this.

Please call on me to help.

Jennifer Geib, WI

Unknown said...

@Ellen, thanks for sharing your thoughts as a Professional Herbal Regulatory Specialist. Avena Botanicals continues to work on being FDA and cGMP compliant. We have been working steadily with a professionally trained FDA consultant (recommended by Micheal McGuffin of AHPA) and a professionally trained QC manager this year. As Urban Moonshine, Heron Botanicals, Avena Botanicals, and other herbal companies have experienced, the dietary supplement regulations and cGMP’s are expensive and challenging. My comment came from a personal place, not so much from a professional place. I have been through several FDA audits since 1987. The audits each have changed as the FDA and GMPs have grown and developed to include herbalists.

I believe staying spiritually rooted, Earth-connected, and heart-centered is necessary for herbalists to stay true to our roots and these practices must be the foundation we stand upon as we navigate government regulations and learn to speak FDA compliant languages. Otherwise we will have sold out to an industry that does not place the health and well-being of the Earth as a priority.

Jonah Ruh Roberts said...

Thank you for doing this. I just supported the railroad kickstarter campaign and shared it with friends, i want to see this happen. I am in the beginning stages of setting up a local product making business and have an herb farm under development. I have been hesitant about even embarking on this for the past year because of the regulations, so I am starting with just selling teas which fall under food regs in my state. But i have a considerable apothecary at my own home of tinctures and am trying to understand all the ins and outs of how i can even begin to make steps in GMP direction. I am in western NH. I am passionate about making herbs more accessible to the public and believe there needs to be an herbalist in every town, making themselves known, sharing knowledge and helping people reconnect with the healing of plants.
Like you Sheila, I would love to see small producers pool resources for shared facilities. My goal is education, more than just making money selling products. I plan to sell at my local farmers market this year. Long term, i would love to help create a cooperative apothecary.

Unknown said...

Guido, thank you for continuing to speak with ecological eloquence and shining light on the fact that as herbalists we can do our work in an FDA-compliant way and remain true to our roots. I so believe that local herbal medicine is exactly what we need more of. It is time for the local food and the local medicine initiatives to join forces, both regionally, nationally and internationally. I agree with you that herbal medicine is inherently different from dietary supplements blended from vats of white powder. For many years I have seen how helping people connect with the medicine plants and trees in their community can be a doorway that opens into deep healing. I too so deeply hope that we can help heal the wounds that capitalism has inflicted on the practice of healing.

What do you and other herbalists propose we should do towards differentiating small-scale herbal remedy makers from dietary supplement mass-manufacturers that could result in some kind of regulatory change?

Jen, thank you for your comments and willingness to contribute to this conversation.

David said...

There were a number of us who pushed for exemptions for practitioners, herbalists and small companies during the comment period leading up to the final regulation. In none of these cases was an exemption granted. The only breathing room was for practitioners working with clients. Here FDA recognized that the risk of something hazardous being introduced into the food supply was extremely low and the practitioner/client relationship afforded quick feedback if any issue should arise. That is how the enforcement discretion on practitioners came to be. And until something changes with enforcement discretion, it is a valid option for practitioners to use. Still ID herbs, have written formulas and written batch records that follow the formulas, use proper sanitation and keep good records. But there is no shame in a practitioner not trying to be fully compliant and while full compliance may be the letter of the law, even FDA recognized the spirit of the law and granted the enforcement discretion.

David said...

For non-practitioners there was nothing other than a later compliance date (the smallest companies were required to be compliant in 2010). This was a difficult period as we were trying to carve out the regulatory niche that is being discussed here. But FDA's point is that even the smallest companies could cause harm. And in that, they are correct. FDA has no way to determine who is a genuine herbalist and who isn't. It is not just small versus big, it is quality and caring versus a 3-person company selling intentionally adulterated products. Now, years later, we see small, fly-by-night companies selling primarily weight loss and ED "supplements" that are laced with drugs. From the regulatory perspective, these are both classified simply as small companies. I don’t know how a massive regulatory agency would be expected to determine who is an herbalist and who is not, especially when this is not a priority for them.

David said...

I am almost sensing two conversations here. One is about maintaining our herbalist senses.... caring, making great medicine and care for the environment. Nothing is stopping us from doing that. The other conversation and the one where FDA enters in, is commerce. If the goal is truly small community-based herbal medicine, the issues with FDA will probably be equally as small and may remain that way for a long time to come. If, on the other hand the goal is to get products into broader distribution and hopefully get into Whole Foods one day, you can be fairly assured that you will be dealing with FDA along the way. And whether you get a really understanding field inspector or one who wants to crack the whip will make a world of difference. But getting into broad commerce means participating in a multi-billion-dollar industry where the regulators will not be able to discern your good intentions from those of the charlatan next door. But it doesn't mean you have sold out or that your integrity has been co-opted by capitalism. If you are participating in the marketplace.... well, like it or not, that's capitalism. It doesn't mean you can't manifest your spirit and intention in a good way, but it is capitalism.

I completely support herbal medicine making and all it stands for. And I don't have an answer as to how this might all be worked out to the good of true herbal medicine. Maybe it is just teaching more people how to make their own medicine. Maybe it is something low-key on a community basis that does not draw much attention. But I do not see a way to go back to those things we tried to achieve in the build up to final GMPs. If the regs are opened up to modification, I can say with fair certainty that it will not be in our favor. There are members of the government that would like to severely restrict all supplements, but most especially herbs. Herbs, due to the very complexity that makes them awesome medicine, are far more difficult to regulate than a vitamin or a mineral supplement. Once modifications to the existing regs are initiated, the fight will not be pretty. Testing methods may be prescribed rather than open to the manufacturers discretion as they are now. It is really quite heartbreaking for a lot of us who have been in this fight for a long time. Good intentions are wonderful, but I don't think they will fly in Washington. We all see how Congress operates and it is spooky.

For my part, I want to try to keep small-scale herbal pharmacy alive and well. And for the larger market, a handful of real herb companies are out there meeting the regulatory challenge. Whatever the next step is for community-based herbalism remains to be seen. I hope it thrives.

Unknown said...

David - Thank you so much for your comments. You got to writing exactly what I wanted to say. There is so much we can do to control the direction of herbalism in this country (and not loose our hearts), we just need to do it - or the government will do it for us. I have the knowledge of how to help accomplish that. I don't think any of you know me, but I come from a energy healing/esoteric studies/herbal/healing products (music, books) background (20+ years) and my life path led me to running two small chemical companies (antifreeze inhibitors and non-haz cleaning products) with my husband who is a chemical engineer. And, now I am so thankful for all of my knowledge as it can benefit the herbal community so very much. When there is a group ready to go know that I will help.

Guido Mase' said...

I unfortunately agree that, in the current environment, opening up the regulations to revision would probably yield a worse outcome for small-scale manufacturers. Part of the point of cGMPs is to harmonize the regulations in the US with those en force internationally, especially in Europe (believe it or not, US regulations and financial burdens of herbalists are relatively lax by comparison). So while I do support the idea of lobbying for a separate "herbal medicine" category under the dietary supplement regulations, I don't have a lot of hope that this will ever occur. It really is going in the other direction.

Regarding capitalism and the marketplace - agreed, participation in no way means "selling out". I'm a huge believer in changing systems from the inside: I've seen it in medicine, and I know it can happen in the herbal products industry, too. Think of structures like "B" corporations to see how corporate thinking is evolving. In fact, I'd go further to say it is important that herbalists participate in the larger market - because that is how capitalism will change. Part of that change, to me, means smaller, less centralized production and the lower real costs and greater local control that comes with that change. To make that happen, small producers need to operate in the current regulatory framework with confidence. That's what I think we can help provide through our collective experience.

Jen, I know I'd love to pick your brain at some point regarding quality control procedures and your experience in that field. Thanks for being willing. I'm trying to get a sense of how we can collectively organize the community resources that have surfaced from even this brief round of comments. If we could craft a well-defined agenda, might folks be interested in a panel presentation via, say, a live webchat (Google hangouts, e.g.)?

Natural Nurse said...

Hi All,

Wonderful comments !

I have been involved in all aspects of both European, UK and US phases of implementation of GMP's in the herbal industry and would be happy to be included in the Panel.

Guido, please let me know what would be useful.

The UK requirements were so intense that some of the major herb manufacturers who I worked with were forced to give up exportation to the UK of hundreds of skus even after having a solid market there for over 10 years..

It seems like having sound, usable information would be a wonderful start to any discussion.

One requirement I have not seen discussed here is the ADVERSE EVENT REPORT SOP's.

These can be accomplished by having an in house or consultant licensed health care professional, OR by outsourcing to an external provider to be responsible for filling out the 3500 A forms.

As herbalists we know that herbal medicine has an excellent risk benefit ratio when compared to pharmaceuticals... however the AER procedures are still required to be in place.

Thank you,
Ellen Kamhi PhD RN

Unknown said...

Thanks everyone for your clear comments. I am happy to participate in some kind of forum Guido and offer whatever I can from where Avena Botanicals is in this process.

David said...

I don't think the safety of herbal medicines really plays into AERs. These are by definition not based on causation, only association and are thus bound to happen. If foods were held to the same standard as supplements and someone who had been eating carrots got a headache and reported this to the producer, the producer would need to file a complaint report for their records. Any other complaints too, down to the print size on you labels if you get a customer complaint. If the person eating carrots had a heart attack the producer would need to file an SAER (severe adverse event report) with FDA within 15 days of the first call.

But to the point of SOPs, yes, written SOPs and written specifications for herbs and products are a very important and time consuming part of GMP compliance. Unlike some other aspects, the cost here is basically labor.... lots of labor.

Unknown said...

I am so happy that this group is really willing to look at facts, from the heart of course. If we can set up standards (this is difficult to explain in a forum) -- look at www.astm.org then we can have some leverage for production. Right now nothing standardized exists for herbalists to follow. I am not using the word standardized to mean strength of an extract. When industry standards are developed that is where the power comes in. They are developed BY THE people in the industry. Not by government. I know herbalists have issues with group collaboration and standardization... but really it is easy. Develop the standards then people can choose to follow them or not. This is how it is in the antifreeze/coolant industry. Many of our customer that we sell products to do not follow standards until they get sued, then they follow them.

YES I would very much enjoy being on a panel. Here is another resource for everyone to review. They help the animal supplement (including herb) industry with labeling, AER, etc. I did not join as it is absurdly expensive. I believe we could create something affordable and protective http://nasc.cc/

I can hardly wait to talk with Ellen and all of you!

Guido Mase' said...

I will definitely include a copy of our adverse event SOP (Standard Operating Procedure), which is important to have. But David, you're absolutely correct: what we've experienced is that FDA wants to see that you have a record of (alleged) adverse events, which we keep by filling out an (alleged) adverse event report every time we get a customer complaint or concern (which isn't very often because herbs are indeed quite benign). Then we review the forms, usually monthly, looking for patterns (i.e. same lots, same symptoms, etc...), go back and look at the batch records, and go back to the in-house retained sample of that lot to make sure everything looks and tastes correct. We record this review process. FDA has evaluated this way of doing things multiple times and has never found a problem with it.
A serious adverse event report (customer experienced anaphylaxis, cardiac event, stroke, or death) does indeed need to be reported immediately. Never had it happen - but we have a policy in place should it ever. Will share.

Only other comment: use neutral language when communicating with your customers around complaints - listen and record, don't speculate on causation. Refer them to a qualified healthcare provider if it involves a medical issue.

Anonymous said...

@ David, I'm not sure if Four Winds in Nebraska was inspected. I remember reading Nicholas' account in JAHG of the investment their clinic made towards compliance.
As for KW Botanicals, yes, Brian sells to other practitioners.

This is an area that interests me, because it seems intermediary. It is providing herbal medicine to another practitioner, who has the one-on-one patient consultation. It is not over-the-counter retail, with no practitioner consultation.
I hope for a world where an herbal medicine kitchen can exist, with reasonable due diligence regarding GMPs, specifically to serve herbal medicine practitioners. Not every herbalist wants to be a clinician. Not every clinician wants to make their own formulas, investing in the raw ingredients, the space to house that inventory, and the time to prepare formulations. (In the Western medicine professions, there are doctors and there are pharmacists.) And I don't think this is really the same as being a "manufacturer", or working in product development.

David said...

Hey Sheila, I think what you are talking about is considered a manufacturer. It's a smaller business model, but the same type of practitioner supplier as a company like Heron Botanicals and maybe Wise Woman Botanicals (not sure if they also sell wholesale/retail). The enforcement discretion was granted specifically because the practitioners, at least in theory, get direct feedback from their clients and so any harm or injury would be very limited and quickly detected. In the case of supplying practitioners, the manufacturer is now removed from the direct and immediate consumer communication. If you look at practitioner-only manufacturers like Heron you'll see they are very fastidious about their GMPs and even practitioner-only distributors like Emerson are very concerned about the GMPs of the manufacturers selling to them.

Natural Nurse said...

David, I believe you are correct..the intermediary provider of products to be resold would be a manufacturer and subject to all requirements.

If we read the FDA documents such as :

Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide


This document offers a useful question and answer that helps to clarify the FDA's position:

Am I subject to the DS CGMP rule if I am a practitioner (such as an herbalist, acupuncturist, naturopath, or other related health care provider)?

Yes. Practitioners such as herbalists, acupuncturists, naturopaths, and other related health care providers are subject to the DS CGMP rule. However, we believe that it would be appropriate to consider the exercise of our enforcement discretion in certain circumstances

Ellen Kamhi

Natural Nurse said...

AHPA just posted very helpful SOP documents on their website:


Happy Solstice! and Holy Days!

Ellen Kamhi

Guido Mase' said...

Happy Solstice Ellen! The new AHPA website is amazing - thanks for the quick link.

Maria Noel Groves said...

I’ve personally been passionate on the topic but haven’t had the time to really delve into it. I’m guessing I’m not the only one! Please do count me in on the conversation.

Personally, with our regulatory climate, I feel less than hopeful that the government will be willing to get lax or excerpt small herbal businesses (I still think it’s worth fighting for), though it may be possible to get some sort of agreement on a do-able set of standards for small businesses/community that still attend to the safety concerns that created a need for these regulations in the first place. We only need to look at farmers and FSMA to see that it’s not just an attack on herbalists but on grassroots small scale in general. Even as our local communities *want* more of the kinds of things we offer, our government is making it more and more difficult to do legally.

I’d love to see a collaboration of the American Herbalists Guild (perhaps most aligned to our needs but likely also on a shoestring budget, they will need passionate volunteers to help make it happen - they did have a GMP committee, but it was only able to pull together FAQ for the website, webinars, and some workshops at the symposium before it fizzled), American Herbal Products Association (they mostly work with the big wig brands but have been very supportive for the small companies and may ultimately create a lower level membership that is more affordable for us), American Herbal Pharmacopoeia (their main skill is identity, and Roy Upton rocks), and the American Botanical Council (servicing big wigs, but they might be a good spot for some kind of wiki, they’ve already begun one for identity and adulteration). *We* will need to take part, too. We can’t expect everyone else to do it for us. The challenge is that we are already so busy doing our own stuff and trying to make ends meet. But, I do see movement and potential here… both in training small-scale herbalists more easily in GMP compliance and hopefully also in creating a movement to encourage a do-able set of standards for smaller biz. The stories of Urban Moonshine and Avena Botanicals will hopefully help propel this.

One format that has made sense to me is a sort of "slow GMP" lesson of emails that takes one thing at a time every month or so and shares both "good ideas" and "for compliance." Many in our circles will never be able to be up to GMP specs entirely, but they may be willing to start with common sense changes and then work out from there. Things like pulling hair back, wearing an apron or "lab coat," properly cleaning and sterilizing surfaces, regularly cleaning the area... and then what else would need to be done to be truly GMP compliant (i.e.: cleaning logs with two sign offs, commercial kitchen specs, washing the ceiling, drain on the floor...).

Guido, thank you for sharing, and please do keep me in on the conversation! I'll check back in on the blog periodically, too.

Kate said...

I so admire your efforts! And as I'm working to open a community apothecary myself, it's been very frustrating to figure out how to read their regs, especially when it comes to building a lab from the ground up.

Unknown said...

Hey Jan, I am right over the mountain, in the Valley :)