FDA cGMP compliance project update

This week saw an excellent development in the quest to provide open-source resources to the herbal community in our efforts to achieve compliance with FDA cGMP regulations: AHPA (the American Herbal Products Association) has posted hundreds of document templates, including manufacturing record templates, testing method templates and specifications, policy templates for almost anything you could imagine (and more) that might be involved in making an herbal dietary supplement. This is a great resource (thank you Ellen Kahmi, http://www.naturalnurse.com for bringing this to my attention the day it was released). Find it here:


As you can see, the list of available documents is quite extensive. It is available for members of AHPA (base-level membership for a small-scale manufacturer is $1,000 per year. AHPA is a fantastic organization. $1,000 is a lot of money).

Another development is that I will no longer be posting updates and documents at this site, but rather at a new dedicated site where you can find all previous information and also future updates. Find it here:


Hopefully this will be a more practical way for us to communicate about this. Over the next few weeks, I will be reaching out to folks who have expressed interest in helping, to make them contributors to the site and allow them to edit and add material as they see fit. There are a few items I might suggest putting on our agenda and to-do list for this project:
- live online forum discussion to help us meet, define the work, and agree on goals
- working through explaining the pieces of cGMP compliance (more documents and voice-overs of why they are structured the way they are, and how to customize them for your own business)
- the problem of testing, and its cost: even a testing program that takes random annual samples (which requires some baseline level of confidence in raw materials and in-house manufacturing, and data to support it) still can run hundreds or thousands of dollars, depending on how many products you make
- the lingering uncertainty around defining identity and strength specifications, and testing for those specs, for a multi-botanical herbal dietary supplement.

I'm taking next week off. Stay tuned at https://sites.google.com/site/gmpopensource/home for further updates in the new year.


FDA cGMP project - raw material identity specifications and testing

**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.

When manufacturing any dietary supplement (herbal or otherwise), the guidelines on current good manufacturing practices (cGMPs) require that specifications be established for everything that goes into what you're making. This essentially means that you have to define a few things and set a standard that you find acceptable, and then test the relevant material and record the results of that test. The regulations under 21CFR111 tell us what specifications we need - sort of. Let's take a look.

A great outline of all of 21CFR111 is here:
and, for the details on specifications, see section 111.70:

The key pieces are identity (what is it?), purity (for a raw herb, is it all the herb in question? Is there dirt and/or foreign non-herbal matter?), strength and composition (for a raw herb, this is full-strength 100% raw herb), and contamination.
The identity, purity, strength and composition for whole or cut-and-sifted (NOT powders, which require a microscope) can be assessed through organoleptic testing (using sight, smell, feel, and taste) if conducted by a qualified herbalist. The contamination, unfortunately, requires help. This is even if you get a certificate from your vendor telling you that there is an acceptably low level of contamination, if any. This is one of the big pieces that we still have to solve as herbalists: the cost for contamination testing of each batch of raw material can get steep. Is there a way to consolidate results on lots of herbs so all can benefit and/or spread the costs?

Identity specifications are established in an herb monograph, and there should also be a voucher sample of the herb in question, as well as a sample of the cut-and-sifted material if that's how you purchase it. Additionally, details should be included about potential adulterants, if an herb is known to be adulterated (goldenseal and yellowroot for instance). Rejection criteria - meaning, if you find this you mail the herb back to sender - should also be included.
AHPA has begun to collect excellent information on botanical identity, including microscopic identity. You should visit:
Purity specifications can include details on adulterants, but also a way to assess (and reject if necessary) how much filth and foreign matter is present in a sample.
Contamination specifications include:
- microbiological testing. What's an acceptable total bacteria count? What about yeast and mold? Note that in many cases, bacteria, yeast and mold are a normal part of, say, a fresh berry. Without them there would be no wine. But sometimes there's too much. And certain specific bacteria, like E. coli and salmonella, should never be present.
- heavy metal testing. How much arsenic, mercury, lead, cadmium are in the sample? It's tricky to determine what an acceptable level could be for a raw herb. Additionally, there is good evidence that tincturing actually removes heavy metals from the final product (because most, if there are any, remain in the discarded marc).
- pesticide testing. Our argument so far has been that using certified organic herbs shifts the burden of responsibility to USDA, and that we are not required to test for pesticides. We do use only certified organic herbs. This may or may not be enough - the jury is still out. I'd be curious to hear of other's experience here, especially if there has been pushback from FDA even for those who use certified organic raw material.

AHPA has put out great guidance documents to help define these specifications. For an overview, see:
And, for much more details on heavy metals specifically:

The above is good, but the heavy metals specifications refer to daily total maximum intakes, not how much can be in an herb you're planning to use. This is a complex question that has to do with the weigh-to-volume ratio of your tincture(s), the dose, and how much heavy metal is left in the tincture from the original raw herbs. Working backwards from the daily limits, you can make a case for how much should be present in a raw herb. Here is an example of how to make such a case, and includes the final heavy metal limits:
Heavy metals contamination rationale.

Again, the problem isn't necessarily defining the specification, but testing for it. These tests can get quite expensive. There are ways to reduce the amount of testing you do, especially once you have some data to go on - but getting there can be an overwhelming financial burden. We need to find a way to collaborate on these types of tests - to spread the financial burden and somehow, effectively, share results if we want to support small-scale manufacturers.

What follow are a couple of examples: the first is a raw material monograph (the specifications) for Echinacea purpurea root. The second is a specification sheet, where the results of testing are recorded to ensure they comply with the specifications. A voice walk-through is below as well.

Full document .pdf file

Full document .pdf file

One note: these are "controlled" documents. They must be signed, dated and approved by whomever is in charge of quality control; revision numbers must be advanced if any changes are made; and they should be "secure" (i.e. not easily tampered with or alterable). Filled-out spec sheets must be in hard copy, filled out in ink, and stored. Until this documentation exists, and is signed off at the bottom, you cannot use the herbs for manufacturing and they should be stored in a designated "quarantine" area (blocked off by fencing, walls/doors, or even tape on the floor to distinguish the area from one of active use).

Finally, one cannot necessarily rely on organoleptic testing unless the person conducting the test(s) is qualified to do so. While you don't have to convince me that you know what dry, cut-and-sifted Echinacea purpurea root looks, smells, and tastes like, you will have to convince FDA. Plus, herbalist qualification does raise some interesting questions: could you tell the difference between E. purpurea and E. angustifolia? Perhaps. What about Actaea racemosa and Actaea pachypoda dry, cut-and-sifted rhizome? It's not always so straightforward. Again, AHPA is doing a great job putting together a lot of the specifications and images necessary for herbalists to conduct these tests (see, for instance, the detailed Actaea racemosa monograph), but unless you are a botanist or pharmacognosist with a degree, you will have to prove to FDA that you can competently identify herbs. Essentially, you have to find a way to "test the tester", or qualify the analyst, who is ensuring that the organoleptic specifications are being met. Here are two document that give an example of how one might do this:
Analyst testing method (how we test our testers)
Analyst testing record (where we record the test results)
Ideally, you will build a testing record that shows you can competently identify all the herbs you use. Now, the question remains: how do you know that the sample you're using as a way to certify the herbalist's skill is actually what you think it is? This requires either the purchase of a validated sample, the assistance of a qualified botanist or pharmacognosist, or validation through an external lab test. This can add extra cost. Is there a way for us to centralize this somehow? Could analyst certification be offered at herb conferences?
Any additional training seminars, certificate programs, or herb schools that you can attend (and collect certificates!) serve to bolster your case that you are, indeed, qualified to conduct these tests. Build a strong case, and identity of raw (non-powdered) herbs can be tested using our senses and good reference materials.

So, specifications need to be developed for everything - including packaging and labels - and you have to maintain a record that you checked everything that comes in against those specifications before using material to make any kind of product that will go to the public. This is a big undertaking. In the coming weeks/months we'd like to share as much of what we have as possible. Hopefully these documents can be edited, improved, and custom-tailored to adapt to different individual situations. But the scope of the project has already outgrown this blog: we need a platform that allows for collaborative sharing, posting, and discussion. So next week, I will provide links to a separate website that will hopefully be more interactive and allow us to leverage the excellent experience and advice, as well as offers for help and contributions, that have been coming our way. Thank you for supporting the FDA cGMP open source project and stay tuned!


FDA cGMP project - labels and language

Though not technically part of the regulations that govern good manufacturing practices, product labels, websites, and social media pages and the language they contain are also regulated by FDA and are, unfortunately, a ripe potential target for government agents who enjoy browsing the internet at their desks. Lately, warning letters have been issued just for unapproved website claims (for example, here). Regardless, it makes good sense to start by having compliant packaging and marketing materials: anything else invites scrutiny.

**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'll look at the label itself in a bit. First, what about claims on labels? There are two types: ingredient claims (this much Vitamin C, for instance, or these many calories), and structure/function claims ("supports healthy immunity" and other such language). It's rare that herbalists will need to make nutrient claims - but I've included a label for a product that contains some honey, so you can see how to articulate the carbohydrate count on a label. But structure/function claims are a source of perpetual befuddlement. What can be said? What cannot? Are there code phrases or tricks?

I will start by saying that there really aren't tricks. You can't get away with saying "this statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease" and then making any claim you want. You can't say "traditionally used" in front of any claim you want, and think this exempts the language. You can't get tricky and say things like "useful during the cold and flu season", because colds and flus are diseases, and herbs can't be useful during disease season because "useful" can only mean "medically useful" in this context. You can make a claim that a supplement supports the normal, healthy function of an organ, system, process or function of the physiology, provided those processes and functions are part of the normal, healthy course of life. You can also use language that FDA doesn't understand, or considers meaningless - like "enhancing yin" or "unblocking stagnant liver qi".

This is the tricky part. It really is up to FDA to decide what a normal, healthy course of life looks like and I have to say that, based on my experience, it appears FDA (and/or their medical consultant squad) spends a little too much time sitting at desks on the computer, eating a questionable diet, feeling stressed and not sleeping too well. This is in part because anxiety, tension and stress, occasional heartburn, gas, upset stomach, PMS and insomnia are all considered part of a normal, healthy course of life. But I digress.
Blood-based parameters - like blood sugar, cholesterol, pressure etc... - are fair game as long as it is clear that the herbal product "supports healthy blood sugar levels that are already in a normal range" (emphasis mine, and is required). Anything else would imply disrupted blood levels, which means disease. Certainly can't mention diabetes.
I have found the following document very helpful:
It gives a good background on how we got here (namely, the Dietary Supplement Health and Education Act, or DSHEA), which is interesting to read if you like context. But you can also search the document right in your web browser. Try typing in "heartburn". Or "blood pressure". Or "insomnia". Then, try "potency" (improving sexual potency is not an acceptable claim, but improving sexual performance is - poor performance is apparently part of a normal, healthy course of life).
These searches give you ways to approach herbal actions from an acceptable structure-function perspective, and more importantly, if you spend a little time reading, you can get a good sense of what will be acceptable, and what might get you into trouble. There are some tricks - "occasional" heartburn and sleeplessness are fine, but without that qualifier, they are diseases (though of course this wouldn't work for "occasional" migraines). Best of all, FDA explicitly says "this is acceptable" after a good many statements, and you can use these statements as you see fit. Beyond this, you have to prove that a claim refers to supporting something that happens anyway as part of being a healthy human if you want to use it.
All claims - even mentioning the word "immune" in a product name - must have an asterisk next to them. This asterisk must point to the FDA disclaimer somewhere on your label, which must be enclosed in a hairline box: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

These regulations around claims apply to print and internet material, too. Brochures, business cards, shelf talkers and sales sheets, catalogs, websites, and social media pages - even, perhaps, audio and video - must all comply (and must include the FDA disclaimer). You can't control what others post on your sites - but don't "like" or acknowledge them. Testimonials, if not properly worded, aren't acceptable either. Personally, this is a big loss: I remember back in the day herb companies often had some of the best information on herbs, their pharmacology and applications, in their print and web media. Now, you can't even post a study that references one of the herbs you use because it's seen as implying that the herb can actually do what it does in the study.
One way around this is to set up, or ally yourself with, a few personal social media pages and weblogs. You can link to these from your product pages, even if these external sites say outlandish unacceptable things like how herbs prevent heart attacks. Some warn that such sites must be "two links" away from your herbal company's website - I haven't seen this distinction in action yet.

Once you have defined what acceptable claims you want to use (and I do recommend connecting with ahpa.org to find a lawyer to review these, if you have the financial means), you are required to submit them to FDA, just to let them know that you're saying herbs do things, within 30 days of beginning sales of the product. Here's an example of what such a letter might look like, including the address to send it to:

Herb Pharm Liquid Herbal Extract Vein Health Letter.

Furthermore, you are required to have files that substantiate the claims you're making: if, for example, your elderberry syrup says it supports the immune system, you should have a file that references actual research and dosing, and/or traditional sources (such as 19th century texts), pointing to elderberry's effectiveness (you just can't ever share any of that information with the public on your website).

How to build such claim substantiation files? In the near future, I'd love to start sharing some of what we've put together and would welcome anyone else's support in this. Perhaps a shared online repository? To a certain extent, some of the files are customized for a particular formula or extraction - but there is still the possibility for substantial overlap. For now, start at Health Canada (in many ways more enlightened on this particular regulatory topic), where monographs on many plants are included with references that back up a range of claims. Note, however, that most of these claims are unacceptable to FDA - such as Ashwagandha's effect as a sleep aid - but you can rephrase it as "helps with occasional sleeplessness" and use the Health Canada reference as part of your claim substantiation.


Now, we can look at the specifics of label regulations themselves. There are rules for how a food label generally, and a dietary supplement label specifically, must be structured. There are also variations in requirements depending on the label size. And there is a specific exemption: if there are no nutrient claims or structure/function claims on the label, and there are no wholesale sales, and total annual sales are less than $500,000 or there are less than 100,000 units of a product sold, then having a supplement facts label is not required. If you want to sell your products through a store or distributor, this exemption is not an option. It really only applies to herb shops, farmer's markets, and direct-to-consumer sales.
General rules on food labeling, including the details on exemptions (found in subsection (j)) are in the Code of Federal Regulations (CFR), Title 21, Part 101, subpart 9 (abbreviated as 21CFR101.9). Find the whole thing here:
Specific rules on dietary supplement labeling are in 21CFR101.36, which is available here:
I'll go over these regulations while looking at some specific label examples, which makes it much more clear. But a few pieces to note:
- less that 12 square inches on a label allows you to use 4.5 point font. Anything bigger than 40 square inches requires 6 point at a minimum for text, and 8 point at a minimum for the serving size text in the supplements facts box.
- note the requirements for hairlines, lines, and columns in the supplements facts box. There are some good examples included in 21CFR101.36
- list plants by common name and include the part (root, rhizome, leaf, seed, flower, etc...)
- many herb supplements only need a proprietary blend listed, along with a symbol pointing to a footnote that says "% Daily Value not established". If you add honey or other sweeteners, you may need to list the carbohydrates/sugars, and perhaps the calories, per serving (if the amount per serving exceeds 1g of carbohydrates, and/or if it exceeds 5 calories). The website nutritiondata.com gives good carb/sugars counts for various foods (and a whole lot of other stuff, here's an example for honey: http://nutritiondata.self.com/facts/sweets/5568/2). Just remember, if your serving is 2ml, and there's less than 1g of carbohydrates in there, you don't have to list them on the supplements facts panel.

So, with a little of the background information available, let's take a look at some example labels for two different sizes of a dietary supplement that also contains a little honey. Because writing it all out would take too long, here is a voice walk-through identifying all the important pieces of a (in this case liquid) herbal dietary supplement:

And here are the labels: first, a larger size with a complete supplements facts panel.

Next, a small size with a "linear" supplement facts declaration (only for labels smaller than 12 square inches, though you could make a case to use this way if it's under 40 square inches and there's no room for a big panel).

Next week we'll start to talk about the ingredients and packaging that go into making dietary supplements: from herbs and other ingredients, to your labels, bottles, closures and seals. We'll look at specifications and hopefully get to some ideas on testing. Another piece to cover (if we can get to it) is getting to know your vendors and "qualifying" them to help streamline future work. As always, questions and comments are welcome and I will do my best to include your experience in the conversation. Anyone who has had labels vetted by FDA inspection or legal counsel is really encouraged to send examples to guido at urbanmoonshine dot com. Thank you!


FDA cGMP project - overview

**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.

The landscape of FDA compliance may seem vast, and, indeed, it is. I will tell you, however, that it is not as vast as the landscape of human health and disease: it is much easier to understand than medicine and healing are, and certainly easier to learn. If we are to approach this landscape, which includes forms, research papers, logs and checklists, documentation and reference samples, specifications and lab journals, scales and thermometers, and more, I contend that the best way to begin is to do what herbalists do best: start by finding broad patterns, understand intent and intention, and look at the landscape from high above.

Being an herbalist means you can really improve a friend's condition without fully describing the fine details of their pathophysiology: you can observe the state of their tissues, address imbalances using macro-level energetic descriptions, dovetail them with safe herbs, and achieve excellent results. As you gain experience and deepen your study, you add detail and complexity. It can be a similar process - thought much simpler - to understand what goes into FDA compliance. Bringing that understanding into action can be more difficult - but less so if you know the big picture all along. Essentially, complying with regulations isn't a proscribed set of steps - you have to have a, b, and c done in exactly this way. Unfortunately (or fortunately, depending on how you look at it), FDA expects manufacturers to think for themselves within established parameters. So we can't just "copy" something and expect it to work for us (though having examples is really useful). There isn't a "secret formula" to achieve compliance. We've got to understand the patterns and intentions behind the regulations.

If there is a central point to FDA compliance - something akin to the herbalist's understanding that a living being will attempt to nurture and increase life if given the chance - it would be that one must present proof. You can do almost anything if you can present proof. Ask yourself: how do I really know that this is the case? Where's the proof? It isn't that lab tests are what you need to ensure your dandelion tincture is dandelion. You just need proof: an herbalist looking at that tincture, savoring it, shining light on the dropper may be just as good (in fact, like any good sommelier will tell you, the human palate is way better than a machine). If, that is, you can prove the herbalist is competent. Part of why labs are used so often is that it's actually cheaper than to train a competent herbalist. But for those of us who have followed plants from seed to harvest, who have intimate knowledge of how the veins branch in the leaves, how he flowers change when they dry, how the flavor changes with age - identifying plants is a skill woven into our very fabric. We just have to prove it. Do you have a journal where you record your observations of the plants you harvest and use? Having one will improve your skill, but also serve as an important piece of the proof.

When you make and sell an herbal product, there are four key areas that require attention to proof.

First, what goes in to your product? We need to know about everything - from herbs, to bottles, to your chopping surfaces, to labels. It all must be controlled from start to finish: not used until it's proven to be the correct component, secured, sanitized if appropriate, accounted for, and tracked. If you harvested four pounds of Echinacea root, how do you prove it was four pounds? You weighed it? Really? How do you know your scale is accurate? When did you last check? How do you know it's Echinacea? Because you're an herbalist who grew it from seed? Really? Who says? What seeds? 
You get the idea. It may seem daunting, but once you've got the basic pieces together (we can share examples), you don't have to do it again: you calibrate the scale daily with a standardized weight at a standard temperature. You studied herbs for over 10 years - here's the conferences you attended, the field work you did, the teachers you studied with and when, and furthermore, you conduct blind taste tests on yourself a few times a year and you're consistently accurate. These are all examples, but you get the sense of the work. Lay a solid foundation, and you can get to making products confident that what you're using is what you think you're using - and you can prove it to FDA.

Next, how is the product made? If you're going to build a cabinet, you won't just go get some wood from the lumberyard, make some cuts, and put it together. Hopefully, you will make a plan first. Ideally, the plan will cover everything you need to make that cabinet: materials, cuts, tolerances, specialized processes. Making herbal products requires a plan, too: to ensure consistency of execution and also to prove that product consistency exists, and that no errors were made. How do you know this gallon jar of Echinacea tincture, made from 2 of your 4 pounds, is the same as the next gallon jar made with the other two pounds? There are some specific requirements here, mostly related to the possibility of human error. For example, one part of the plan should be to gather all your ingredients first, then mix them. This may seem obvious, but let me give you an example: when I was first starting with tincture making, I'd want, say, a pint of 50% alcohol. So I'd take a pint-sized measuring cup, measure out 8oz of grain alcohol (let's assume, just for simplicity, that grain is 100% alcohol), then pour water into the alcohol until I got to 16oz, and there you have it. Do you see a problem with this? If you do, you are correct. We'll need to cover the checkpoints necessary to prove that the product is made consistently and accurately. 

Then, what is the product - and what is it not? We have to describe and define what our tinctures are so that we can check to make sure, once they're pressed and ready to go, that they turned out right. We have to prove that the Echinacea tincture actually is Echinacea tincture. If you've ever tasted Echinacea tincture, you might think I'm silly. But try watering it down 10%. Come back a few days later and taste it again. Is it Echinacea tincture? How do you know? You need some kind of reference standard. We'll cover ways to make one, and in our experience with FDA, this way works - without expensive lab tests. Part of the solution relies on covering your bases in the two previous steps. 
But you will also need to define what your product is not: not contaminated with bacteria, not loaded with heavy metals, not laced with pesticides. These are harder questions to answer, and may require a lab. One of the big questions I have is how to create a way to reduce these costs for small-scale herbalists. We know some things that don't work (for example, believe it or not, FDA doesn't buy the argument that 60% alcohol basically kills all bacteria in a tincture. At least not in blanket fashion. Has anyone made such an argument successfully? I'd love to know). 

Finally, where does your product go? You need to establish a way to trace specific lots, with a granularity of each bottling run, to where they go: what stores, what customers. If you bottled half your pressed Echinacea tincture in 2oz dropper bottles on one day, and the other half a week later, they should have different lot identifiers. FDA wants you to be able to account for each and every bottle. Records of bottling = sold product + what's still on the shelf (no more, no less). You sold some product? Really? To whom? Prove it.
For many businesses, this will be part of an already-existing inventory control and invoicing system. But you can do it using modern e-commerce tools (like Square) too, as long as you enter the lot of the product for each sale. Part of what FDA inspections involve is a mock recall: they'll pick a product and a lot, and ask where every single one went.

The areas where we need proof are, to the best of my understanding, described above. It's pretty broad, but if you keep those four key areas in your mind, you will stay mindful of the intention behind the current good manufacturing practices (cGMPs). Once we start getting into specifics, don't lose sight of those overarching areas of proof that are needed. 
But before that, there is an important area which, as has been suggested, has well-defined guidelines (mostly) and just requires following rules: labeling and language. As David said, "Labels are your brand's face to the world". And, increasingly, so is your website and social media presence. Compliance on this front can be easily achieved, because the rules are fairly clear, especially if you refrain from saying your product does anything at all. Since that's pretty ridiculous, there is a law that says we can make "structure/function" claims about our herbal dietary supplements. What this means is less clear - but there are good resources available to help. Next week I'd like to start here: what does a label need? what is a supplement facts panel and how must it be formatted? what kind of language can go on a label / website / facebook page? If folks have experience and resources, please share them next week and I will add them to the page for everyone to reference. I will start out with some detailed examples (vetted as compliant and FDA-tested), links to the relevant pieces of the statute, and a voice walk-through for both to help navigate the examples. 

Thanks for reading, feedback always welcome, stay tuned.