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.