Call it the Eleventh Commandment: “Thou Shalt Not Commit Adulteration!”
Though it may not quite be a divine decree, the elimination of contaminants and adulterants is an imperative that conscientious herbal supplement companies are taking very seriously these days.
Several industry-wide initiatives over the last year show that leaders in the herbal medicine field are determined to clean up the global supply chain.
It is no secret that herbs unintentionally contaminated or intentionally adulterated sometimes make it into finished botanical supplement products.
Like any agricultural product, medicinal herbs are at risk for contamination with environmental toxins (heavy metals, pesticides, fumigants, petroleum derivatives) and biological contaminants (microbes, mycotoxins, endotoxins, helminthes, insects).
Heavy metals and other industrial or agricultural chemicals find their way into plants via polluted water, soil, and air. Some plants are particularly good at absorbing toxins---rice, for example, has an affinity for arsenic, and tea plants are good at concentrating fluoride.
More than any other category of supplements, medicinal herbs are also vulnerable to deliberate, economically-motivated adulteration. Because of the intrinsically complex biochemical nature of plants, adulterants can be difficult to detect.
A Global Issue
Herbal medicine is big business these days. According to the latest data from Nutrition Business Journal, herbs generated $12 billion in total sales in 2017, representing 28% of the total $43 billion in total supplement sales, and growing at roughly 8% per year. And that’s just in the US.
Worldwide, the global herbal supplement market could reach over $86.7 billion over the next 4 years, predicted Zion Market Research, an industry analytics firm based in Pune, India.
Such high demand puts intense strain on growers and raw materials processors. Sustainable agricultural practices, careful processing, and continuous quality assurance are not easy, and not cheap. The temptation for raw materials companies to cut corners—and for supplement makers to turn a blind eye—is ever present.
Some unscrupulous ingredient suppliers use cheap plant materials as substitutes or fillers for costly or rare herbs. Others intentionally spike herbs with pharmaceutical ingredients—a particular problem with herbal supplements for weight loss, performance enhancement and sexual health (Kosalec I, et al. Arch Industr Hygeine & Toxicol. 2009; Tripathy V, et al. Phytochem Letters. 2015).
How widespread is intentional adulteration or substitution? It’s hard to say.
Several years ago, Canadian researchers used DNA techniques in a blinded analysis of 44 consumer-facing herbal products representing 12 brands. They found 32% contained DNA from plants not listed on the labels, indicating species substitutions or dilutions. Several had potential clinical significance, like Senna alexandrina—a strong laxative--in a St. John’s Wort product. Juglans nigra (black walnut) found in several Ginkgo and Echinacea products, could be problematic for patients with nut allergies.
Further, 21% contained undisclosed plant-derived fillers (wheat, rice, alfalfa, and soy), which could trigger reactions in people with allergies or sensitivities (Newmaster S, et al. BMC Medicine. 2013).
Many experts in botanical analytics have questioned the validity of DNA-based techniques, but none dispute the reality of intentional adulteration.
Tackling a 2,000 Year Old Problem
Mark Blumenthal, founder and executive director of the American Botanical Council, an internationally renowned non-profit herb research and education organization, estimates that anywhere between 35% and 45% of the best-selling medicinal herbs—including things like Echinacea, Milk Thistle, Ashwagandha, Maca, Oregano, Black Cohosh, Cranberry, Saw Palmetto, and Aloe Vera--are subject to adulteration.
“That’s not to say that they are adulterated, but these herbs are potentially subject to adulteration.”
The US Pharmacopeia defines Economically Motivated Adulteration as: “The fraudulent addition of non-authentic substances or removal or replacement of authentic substances without the purchaser’s knowledge for economic gain of the seller.”
It’s not a new problem. Dioscorides, Pliny the Elder, Galen and other medical authors of antiquity described the adulteration of medically valuable herbs over well over 2000 years ago, says Blumenthal, a seasoned veteran in the long fight to clean up the herbal supply chain.
“Back in the late 1970s, there was an ersatz Ginseng product in health food stores in the southwest. It was sold as “Wild Red American Ginseng” which had no biological, chemical, botanical, ethnopharmacological or functional relationship to Ginseng whatsoever. Clever marketers were selling at as “wild”…which somehow must be “better” than cultivated. And the word, “Red” equaled “stronger” in some peoples minds.”
The plant they sold—known to herbalists as Canaigre (Rumex hymenosepalus)--is from the Dock family, and its roots contain high tannin concentrations. “It’s great for making a gargle for sore throats, which is its traditional use by Native Americans and Hispanics in the southwest. But it is not Ginseng,” Blumenthal told attendees at Holistic Primary Care’s 2018 Practitioner Channel Forum.
At the time, he was head of the Herb Trade Association, a group that preceded ABC. “We published this 8 page reviewed white paper on the adulteration of Ginseng using Canaigre. He’s been calling out this sort of malfeasance ever since.
Since 2011, ABC has issued 41 peer-reviewed publications on adulteration of medicinal herbs, as part of its Botanical Adulterants Prevention Program (BAPP). The series includes five lab guidance documents and 14 herb-specific adulteration bulletins.
The latest, issued in June, looks at Turmeric (Curcuma longa), one of the top selling herbs worldwide. Authored by Ezra Behar, PhD, a botanical researcher at San Diego State University, with input from 18 analytical experts, the bulletin details—among other things—the increasing use of cheap synthetic curcuminoids in place of those derived from Turmeric root.
Stefan Gafner, PhD, ABC’s chief science officer says use of undisclosed artificial dyes is also an issue. “Many yellow or orange colorants, such as lead chromate or metanil yellow, may represent a health risk. Since daily dosages of several grams of turmeric powder are recommended for health benefits, use of adulterated turmeric products may lead to an intake of excessive amounts of these colorants.”
All of ABC’s adulteration reports are freely accessible on the group’s website.
The organization has more such reports in the works, looking at herbs like: Ashwaghanda (Withania somnifera), Frankincense (Boswelia serrata) Kava (Piper methysticum), Lavender (Lavandula), Tongkat Ali (Erycoma longifolia), Pomegranate (Punica granatum), Siberian Ginseng (Eleutherococcus), and Black seed (Nigella sativa).
Blumenthal says there’s a constant cat-and-mouse game between unethical ingredient suppliers and the scientists and quality assurance officers working to detect them. Analytical techniques improve over time, but adulterators evolve accordingly, growing ever more sophisticated in their deceptive methods.
Holly E. Johnson, PhD, the chief science officer for the American Herbal Products Alliance (AHPA) noted the following example: Several years ago, when Ginkgo hit peak popularity and demand was extremely high, some raw materials suppliers began to cut corners.
They knew that US Pharmacopeia guidelines recommended high performance liquid chromatography, keyed to detect three specific reference compounds, as the optimal test for identifying Gingko. They figured out they could use leaves from Sophora japonica –a tree unrelated to Gingko—that produces the same three molecules, and pass the USP’s recommended analytic test.
“You really have to know what to look for,” says Johnson, who also serves on ABC’s scientific advisory board.
Members of ABC’s BAPP team are about to publish a paper titled, Botanical Ingredient Adulteration—How Some Suppliers Attempt to Fool Commonly Used Laboratory Analytical Techniques, in an upcoming edition of the journal, Acta Horticulturae.
ABC’s “Search & Destroy” Initiative
ABC’s mission is primarily educational, but this year, the council took a major step beyond merely raising awareness about adulteration: Blumenthal and his team want the industry to adopt new purchasing procedures that will stop the problem.
He explained that most major supplement companies have strong commitments to quality control: they do extensive analytical testing on raw materials and routinely reject substandard, contaminated, or adulterated herbal ingredients.
But what happens to those rejected materials?
All too often, suppliers simply resell them to lowest-bidding buyers looking for a good deal. “It’s the dirty little secret that’s not such a secret. It doesn’t get thrown away by the supplier. It just gets resold to someone else,” Blumenthal says.
To combat this, ABC has proposed a new industry-wide Standard Operating Procedure (SOP) which would include contractual clauses mandating complete destruction—at the ingredient supplier’s expense—of any raw materials proven to be adulterated or irreparably defective.
“I’ve been involved with this industry since 1970. Many of us have gotten fed up with the ways that people are selling substandard material, fraudulent material, and some companies either look the other way or don’t seem to have the analytical methods to recognize they are buying junk,” says Blumenthal. “It occurred to me that it would make sense to try to develop an SOP and get it accepted by industry, to find a way to remove some of this bad raw material from the supply chain.”
ABC worked closely with other industry groups, leading botanical experts, and legal counselors to develop the new SOP.
Michael Levin, a veteran industry consultant, quality control advisor, and contributor to HPC’s 2017 Quality Counts report, developed the concept of “irreparably defective materials” at the heart of ABC’s proposal.
This term differentiates between materials rejected because they do not match a company’s particular specifications or preferences---for example a Ginkgo leaf powder that was not ground to the buyer’s requested particle size—and materials that are contaminated, adulterated, or fraudulent, such as Gingko powder containing plants other than Ginkgo biloba, or cut with non-Ginkgo flavonols.
Levin developed 4 key questions to help ingredient purchasers make the distinction: 1) Does the raw material meet specifications of the buyer? 2) Is it adulterated or misbranded? 3) Can it be remediated by the buyer? And 4) Can it be remediated by the seller?
“Defective” materials can be defective for various reasons, says Blumenthal. In some cases there’s no malfeasance, and the materials can be remediated by the seller. But an “irreparably defective article” cannot be remediated.
“Adulterated materials, with few exceptions, cannot be remediated. You can’t fix red dye #2 or other illegal red dyes in a St. Johns Wort extract. Once it’s in there you can’t get it out. That stuff needs to be destroyed.”
ABC’s new SOP includes contract language templates that companies can use and customize; materials destruction templates; analytical testing guidelines; lists of qualified 3rd party testing labs; conflict resolution pathways; and procedures for safe and legal destruction of irrevocably tainted materials.
The proposal is still under legal review, but Blumenthal says early industry response has been very positive.
Ultimately, this SOP puts responsibility for supply chain integrity precisely where it belongs: on the manufacturers who purchase ingredients.
“The buyer is key. The buyer wears the pants,” Blumenthal told HPC. “With this type of contract, the buyer is saying to the would-be seller, “Here’s our new contract. It contains the Botanical Adulteration Prevention Program language. From now on, it’s a priority. It’s a requirement. If you want to do business with us, you need to agree to these things.
AHPA: Good Ag = Good Health
ABC’s efforts dovetail with other initiatives aimed at preventing adulteration and improving supply chain integrity.
Last year, the American Herbal Products Association issued a landmark guidance document, Good Agricultural and Collection Practices & Good Manufacturing Practices for Botanical Materials (GACP). It is a greatly expanded update on an earlier paper jointly published by AHPA and the American Herbal Pharmacopoeia in 2006.
AHPA holds that the purity and potency of medicinal herbs—and ultimately their clinical efficacy—is highly contingent on how (and where) they’re grown, harvested, and processed. Simply put, healthy soil and healthy farming practices produce healthy products.
AHPA’s GACP guidance fills major gaps in US and international regulations. As the authors note, there are no formal GACPs prescribed by either the USDA or the FDA for the vast majority of medicinal herbs. The minimum guidelines that do exist focus on microbiological testing, and have little to say on general herb quality, environmental toxins, or intentional adulteration.
Likewise there are no formal Good Manufacturing Practices (GMPs) specific to herbal products beyond the basics outlined in DSHEA, that apply to all dietary supplements.
GACP provides templates that growers, harvesters, and processors—large and small-- can adapt to their operations. The goal is to help the industry ensure that herbal raw materials are grown in a healthy sustainable manner, are accurately identified, are not adulterated, and are free from risky contaminants.
“A lot of companies proffering botanicals now are totally disconnected from the farmers and growers and suppliers, they don’t have botanists on staff. They’ve lost touch with reliable old methods ofdefining botanical identity based on macroscopic features—the leaves, the branching patterns,” says Dr. Johnson.
She adds that there’s a strong interest among committed herbal medicine companies to reconnect the industry with its roots in the soil.
“Sourcing and quality assurance going all the way back to the farm is something that AHPA pays a lot of attention to. Sustainable, ethical agriculture is definitely important to our membership. If companies are in touch with their plants at that level, a lot of the adulteration issues disappear,” she told HPC.
Though written for industry use, Johnson believes the AHPA GACP document—available free of charge on the group’s website--can provide medical practitioners with an excellent roadmap for assessing botanical supplement companies.
More specific to practitioners, AHPA also recently issued a white paper on Good Herbal Compounding & Dispensing Practices, also accessible without charge. This document recognizes the fact that some medical practitioners—especially acupuncturists, some naturopaths, traditional herbalists, and practitioners of Chinese medicine—make their own custom herbal formulations for their patients.
FDA regulations do permit this, provided that, “practitioners have adequate professional training and dispense supplement products on the basis of one-on-one consultations, and the supplements dispensed have no known or suspected safety concerns.” (FDA cGMP regulations, 21 CFR Part 111).
In the hands of well-trained and experienced clinicians, this is personalized herbal medicine at its best. But the various schools and healing disciplines all have their own methods and protocols, and historically there have not been any widely accepted, trans-disciplinary consensus on best practices for clinic-based herbal compounding.
Enter AHPA. The Herbal Compounding guidelines provide practical recommendations for ensuring quality and safety of individually formulated decoctions and liquid herbal extracts, powdered herbal formulas, poultices, pastes and linaments.
The white paper has been accepted and promoted by a number of major practitioner groups, including: the American Herbalist Guild, American Association of Naturopathic Physicians, American Association of Acupuncture and Oriental Medicine, and others.
AHPA also publishes The Botanical Safety Handbook one of the most valuable, comprehensive, and practical guides to herbal medicine ever published. It’s a reference that belongs in the library of any practitioner who recommends or dispenses herbs.
The recently revised edition—available at $95.00 for AHPA members and $119.00 for non- members—compiles the properties, clinical benefits, potential adverse effects and supporting clinical research for over 500 of the most commonly used medicinal and culinary herbs.
Among its many useful features, the Handbook divides herbs into three classes:
- Generally safe herbs with minimal potential risk that can be widely utilized without practitioner guidance.
- Herbs with specific contraindications or restrictions, such as those with potentially hepatotoxic, neurotoxic, or teratogenic effects
- Herbs with serious potential risk that should only be used under close guidance of a qualified herbal medicine expert. This includes those with very narrow therapeutic ranges, and those with well-documented, life-threatening adverse effects.
The Handbook also includes a separate classification system, based on what is known about interactions between herbs and pharmaceuticals, that distinguishes actual clinically relevant and well-documented adverse interactions from ones that are plausible though hypothetical.
It provides a balanced and rational perspective, dispelling the popular consumer sentiment that all herbs are intrinsically safe simply because they’re “natural,” while at the same time avoiding the alarmist tone of some reference guides that place disproportionate emphasis on the danger of herbs which—given how many people now use botanical products—is quite small.
Johnson believes clinicians who are well-informed about herbs—even if it is only a few of the most commonly used ones—can play an important role in pushing the herbal industry toward further improvements.
“You, as a practitioner, can use AHPA’s documents to ask questions of companies. Ask them about their compliance with FDA’s cGMPs. Ask them what analytical methods they’re using for the different herbs. Ask them for their specs.”
These industry-directed efforts at supply chain improvement are aligned with the broader implementation of the Food Safety Modernization Act (FSMA) of 2011, a far-reaching set of new regulations aimed at preventing and controlling contamination across the food industry, at all points along the global supply chain. Since all supplements, including herbs, are considered “foods” by the FDA, FSMA applies to this industry as well.
Among other things, FSMA includes a set Foreign Supplier Verification Programs that put increasing responsibility on food and supplement companies to ensure that ingredient suppliers outside the US are manufacturing in accordance with all US safety standards.
In June, the FDA issued draft guidance for a new Intentional Adulteration Rule under FSMA, intended to help manufacturers mitigate the risk of intentional adulteration or contamination.
One could certainly argue about the adequacy of US standards or the efficacy of FSMA in enforcing them. But US-based supplement companies are taking the regulations seriously, and the new rules will no doubt create some much-needed “upstream” pressure on raw materials suppliers.
The effort to eliminate, or at least minimize, herbal adulteration will be a long one,
“The botanical supply chain is global. Adulteration is a global challenge. The solution requires a global effort,” says ABC’s Mark Blumenthal. That effort will be a long one. But with industry, government, the clinical community, and health conscious consumers all pushing for it, real and meaningful change is on the horizon.