In Defense of Good Herbalista Practices (GHP’s), or

Healthcare Practitioners are not Manufacturers

The current Good Manufacturing Practices (cGMPs)[i] were created by the FDA to regulate the growing industry of dietary supplements, including herbs. As the name implies, these standards and protocols were created with the mass manufacturer in mind and not with an eye towards the specific needs of the practicing herbalist. Despite their obvious bias toward the manufacturing model, the FDA has written these regulations in a way that binds the herbalist, forcing them to adhere to inappropriate and often economically unfeasible requirements. In an effort to soften the blow, the FDA stated that it would “be appropriate to consider the exercise of our enforcement discretion, on a case-by-case basis.”[ii] This offers no respite; they have most assuredly reserved the right to apply this rule to the ordinary herbalist. These regulations interfere with our ability to provide affordable herbal care to our community and most certainly infringe upon a patient’s access to quality healthcare. And while the effects of these regulations may not yet have made themselves felt to the larger community, it is still important to speak out and make our objections known.

In the mass-production manufacturing model, the success of any company is measured by their growth and by their profit. The goal must be to create larger and larger batches, destined for an ever greater number of shelves, in increasingly distant lands. These remedies must survive multiple transits and transactions, making the manufacturer and ultimate recipient strangers to each other and accountability quite difficult. And so the cGMP’s were penned, in defense of a vulnerable public from the possible negligence of a faceless manufacturer.

In contrast, our success is not measured in dollars, but in quality of life– in the vitality of our patient, in the health of our community. Most clinical herbalists make small batches of medicaments with their community in mind, maintain a modest sized apothecary, and dispense herbal remedies that have been custom compounded for their patients. These remedies are then delivered directly to the patient. There is no middleman involved. The relationship between herbalist and patient can be well established and accountability quite possible.

Herbalists are not manufacturers; we are healthcare practioners. Our relationship with the public exists in an entirely different realm from that of manufacturing. Our aim as herbalists is to provide patient focused care. And this means working with quality herbs. With this in mind, we are often involved with our remedies from their harvest until they lay in our patient’s hands. Sometimes we even plant the very seed of our future medicaments. We are intimately familiar with the qualities of the herbs we use and are trained through time and experience to differentiate plants and understand the variety of quality or action that can result from fluctuation in rainfall, sun, location, or harvesting time. We wear many hats – grower, wildcrafter, medicine maker, apotheker, educator, practitioner, and more. It is becoming clear that to require herbalists to adhere to cumbersome criteria intended for mass manufacturers is an insult to our vital craft and will result in the degradation of the practice of herbalism. The more the cGMP’s force the practitioners away from the making of their own medicines by creating these prohibitive requirements (in cost, time, and infrastructure), the less herbalists will handle the materials of their craft. We will lose our herbal intimacy, dulling our understanding of the very tools we use to heal. This is like asking a violinist not to tune her own instrument or a cook to never do prep work. And while these comparisons are a bit clumsy, one thing is quite clear – under these current GMP regulations, the making of herbal medicine has been handed over to the manufacturing industry in the realm of commerce, whose bottom line (as time has repeatedly shown) is profit, and NOT the health and wellness of people. The FDA has no business lumping the herbalist with the natural products manufacturer. This is a misstep.

For all of the years leading up to now, on the land mass we call the United States of America, the people have ALWAYS maintained the right to practice and utilize herbal medicine. We have never before been restricted when making medicines from the earth to support our vitality and wellbeing. The health of this nation has been on a slow decline, with chronic disease ever on the rise. This is the time to empower the local healer, not to hobble them.

I cannot accept FDA guidelines, which require me to exclude “dirt” (Section 111.15) from my premises. What do they think herbs grow in? I will not abandon making medicine under sky in the open air where the plants grow because those premises do not “include floors, walls, and ceilings.” (Section 111.20) I will neither apologize for washing my bottles in merely a double (instead of a triple) basin sink, nor for making medicines in a kitchen where I also prepare my personal meals.

As a practicing herbalist, I have made a pledge to my patients, to my community, and to my planet to heal and serve. This means that I hold to certain standards of practice, such as cleanliness, transparency, sustainability, environmental protection, quality, and affordability, all of which guide my daily practices in the clinic and apotheke.

I have created varied documents over the years, which guide our work at Herbalista Headquarters, as we strive to create vital medicaments to share with our community. They are but a continual work in progress, as our practice and procedures certainly change over time; just as flexibility is a sign of good health, we need to be able to adjust with integrity to the changing needs of our community, to the resources at hand, and developments of our own understanding of health. These documents now form the beginnings of what I will tongue and cheek refer to as our current Good Herbalista Practices (cGHP’s) and I invite you to read, share, modify, and utilize as you desire. We hope to add more documents to the database on the Herbalista website over time in the hope that they support the craft of the practicing herbalist and help us continue our traditions in healthcare.

~ Herbalista Lorna
December 6, 2014
Atlanta, GA

Endnotes

[i] CFR Title 21 – Food and Drugs; Chapter 1 – Food and Drug Administration Department of Health and Human Services; Subchapter B – Food for Human Consumption; Part 111 – Curruent Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements.

[ii] Comment 32 from Final Rule Page 34793 of Vol. 72, No. 121 June 25, 2008

(We update this post as we develop our cleaning procedures.)

One thing’s for sure– herbalists go through a lot of bottles!  For a profession where environmental impact rates high on the list of our concerns, the last thing we want to do is add to a bunch of bottles, caps, and droppers to the mountainous landfills.   We clean and reuse bottles as best we can at Herbalista and wanted to share with you the methods we have found safe and efficient.

We try to keep separate the bottles that are used by people (meaning they go home with clients) from the stock bottles that don’t go near a person’s lips.  We store them separately until they go through the first phase of cleaning.

PHASE I

REMOVING LABELS

When a bottle is returned to us, we pour out any leftover tincture, oil, etc into the compost and place the bottle in a box until we gather a few together.  We then place them into a very hot, soapy bath.  Leaving them to soak for a time allows the labels and any  residue to loosen.  The labels will practically fall off, and for the more stubborn parts, simply use the label bits that did come free and rub that over the remaining adhered label.  That will usually work it free.  If parts still don’t come free try a wee bit of soap on a copper pot scrubbing pad.  As a last resort we might use some Goof off.

BOTTLES

We have a number of different sized bottle brushes with which we can scrub the inside of each bottle.  Once they are thoroughly scrubbed and rinsed, they are placed on the bottle wrack for drying.  When completely dry we hold them to the light to check for any obvious organic material or residue that may remain.  If we see any, we put it through the same initial soak and scrub all over again.  Once it appears clean WHEN DRY AND HELD TO LIGHT, we place the bottle into a box for Phase II.

DROPPERS & CAPS

We completely dissemble the droppers– separating the pipettes, the squeeze bulbs, and the plastic rings from one another.  We also separate the internal plastic phenolic cone from the caps with the use of a pointed set of tweezers. These bits and pieces are all then immersed in a soapy, hot bath for a soak.  We use either a mascara wand (purchased from a beauty supply store) or pipe cleaners to clean the inside of the pipettes, squeeze bulbs, and other hard to reach places.  After this prewash we place everything into a bin for Phase II.

PHASE II

In order to feel like the bottles and tops have received a complete wash and sanitation for reuse, we use a dishwasher and program it for with the highest heat setting.  Since Lorna is not gifted with a dishwasher at Herbalista HQ, the next step involves schlepping all the bottles and various accoutrement to her mother’s house (is there ever a time we stop needing assistance from our folks) to run them through her machine.  We don’t use any detergent at this phase, as it could leave a residue and the purpose of the dishwasher is actually to sanitize through STEAM heat.  After they have been run through, we schlep them back to HQ for the final stages of this “ever-so-time-consuming-but-totally-worth-it” cleaning protocol.

FINAL CHECK

The bottles are lined up against the west facing window bank to allow for any last bits of moisture to escape.  When the bottles appear completely dry (usually in a matter of hours) they are again checked against the light and if clean, they are placed into the bottle cabinet for reuse.  If not and seem to still have schmutz on the inside, we put it back into the initial box to go through the entire cycle again.  

The tops are laid out on a clean flour sack towel on the table.  The blue bottle in the picture here  is filled with 70% alcohol.  We spritz and wipe them down with a thin cotton towel, fine tuning the bits and pieces.  This is a chance to have your eyes on everything and do some good quality control.  Anything that seems icky, too scratched up, or loosing its integrity, it goes to be recycled.  Finally, all is reassembled to be used once more to dole out sweet, sweet herbal medicine. 

For any bottle or top that doesn’t pass muster (using organoleptic evaluations of sight and smell) they are put back into the bin for another round of cleaning or put into the recycling bin.  You will find that over time, the squeeze bulbs loose their integrity (notice in the photograph that some are starting to look a bit grey) and they will eventually get pulled.  This is a bit frustrating, because the pipettes and ring are still completely fine.  We have searched and have yet to find a distributer of just the bulbs.  So we’ve taken to keeping  the extra pipettes in a cup for tastings of herbal concoctions, which feels like a fine way for them to spend their retirement!

-Herbalista Lorna

updated on 08.20.21