In Defense of Good Herbalista Practices (GHP’s), or
Healthcare Practitioners are not Manufacturers, or
The Rejection of Rules Written in the Name of Mass Production by a Practicing Herbalist
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
[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