It’s no wonder that the botanical industry has fixated on fears of adulteration in these challenging times.
With prices reaching extortionary heights and the global supply chain being run to all appearances by a demonic supervillain, it’s no wonder that minds in the botanical industry have fixated on fears of adulteration. Human nature being what it is, bad actors will invariably respond to trying times like ours by trying to manipulate the authenticity, identity, and even safety of botanical ingredients.
Yet while current circumstances seem uniquely dire, “This issue’s been around for as long as humankind,” declares Stefan Gafner, PhD, chief science officer, American Botanical Council (ABC; Austin, TX). And it won’t go away, either: “On the contrary,” he maintains, “suppliers and manufacturers have to be especially vigilant in times of short supplies and price hikes, as industry is now experiencing.”
Fortunately, a whole cadre of herbal professionals have made it their work to ferret out what shenanigans they can, and they’re leaving the whole sector more secure for their efforts.
Behind the Spike
Surveying the supply-and-demand dynamics in the botanicals space, John Travis, technical manager, NSF Certified for Sport, NSF International (Ann Arbor, MI), draws this lamentable conclusion: “High prices and increased demand make for a dream scenario for unscrupulous suppliers.”
Holly E. Johnson, PhD, chief science officer, American Herbal Products Association (AHPA; Silver Spring, MD), agrees, offering a recent anecdote from the elderberry space as a case study in how these dynamics play out on the ground.
“As consumer demand for the herb’s immune-support benefits skyrocketed during the pandemic,” she explains, “companies were keen to deliver new formulations containing elderberry—putting pressure on existing supplies.”
So when a leading supplement manufacturer was motivated by the dearth of raw material to subject a number of elderberry CPGs and ingredients to analysis, it surprised no one that some of the materials under scrutiny failed HPTLC and HPLC testing, Johnson says.
And elderberry is hardly alone. Gafner notes that ashwagandha and even Echinacea extracts—“for which we just received the first industry reports of a new kind of adulteration,” he says—are also seeing the very degree of increased demand that makes them subject to foul play, too.
Easy Marks
But while the threat of adulteration seems perennially to hang over expensive and otherwise scarce botanicals like cordyceps, ginkgo, St. John’s wort, and bilberry—not to mention such essential oils as lavender, rose, bergamot, neroli, and mandarin—Gafner doesn’t believe that botanicals are “uniquely vulnerable” to the threat.
Consider, for example, that olive oil, fish, oregano, pomegranate juice, and other foods all frequently find themselves in adulterators’ crosshairs, he notes.
That said, what does set botanicals apart is that they now change hands mainly in the form of extracts, or formulated into products like tablets, capsules, gummies, and liquids—platforms in which the botanical ingredients “can’t be identified just by looking at them,” Gafner says.
Complicating identification even further is the intricacy of their chemical composition, he adds, which creates a situation that “unethical botanical suppliers and manufacturers may take advantage of.”
Adulteration’s Changing Face
How do they do it?
They’ve come up with some creative methods, but Travis notes that adulteration often occurs as “outright ingredient substitution or dilution with less-expensive, inferior ingredients,” the latter of which “of course gives the supplier a considerable price advantage, assuming it doesn’t trip whatever identity test is used to catch it—as it often doesn’t.”
Gafner adds that an even newer tactic rearing its head is the undisclosed “fortification” of a botanical with chemically synthesized or fermented constituents, or constituents purified from natural sources—so, for example, the addition of synthetic curcumin to turmeric extract, or the fortification of ginkgo extract with rutin or quercetin extracted from Japanese sophora.
“It’s important to emphasize that such practices are undisclosed,” Gafner stresses. “This is an essential component of adulteration: The seller is trying to create a false sense of identity and value for their economic benefit—and to the buyer’s economic detriment.”
Caught in the Act
As vexing as the cat-and-mouse game may be, Johnson is in no hurry to throw in the towel. “Botanical adulteration may indeed be a centuries-old problem,” she admits, “but we now have a plethora of modern regulations, guidance, standards, and methods to ensure quality of botanical materials, supply-demand pressures aside.”
And they are making a dent. Remember that supplement manufacturer who ran the passel of elderberry products through the testing gauntlet? “Interestingly,” Johnson notes, “while more than half—14 out of 25—of the raw materials failed testing, only two of the finished products didn’t pass. What this indicates to me is that many product companies are indeed compliant with the cGMPs in 21 CFR Part 111 and have strong ingredient-qualification programs to evaluate, and then reject, poor-quality or adulterated ingredients before letting them reach consumers.”
But here again, botanicals’ oft-noted chemical complexity can confound even fine-tuned tests, some of which aren’t up to the task—or even validated for the purpose—of identifying them.
And as Travis is quick to note, “Actors in this space understand this and know how to fool the tests.” A brand may deploy, say, near-infrared (NIR) spectroscopy to identify goldenseal extract, he posits, but “can this method distinguish goldenseal from its common adulterants? Can it detect if the ingredient was diluted with Coptis chinensis extract?”
He even notes that a 2018 study on this very issue underscored the lack of “apparent, visible spectral features of the species that permits differentiation between adulterants and goldenseal,” according to the study’s authors.1
Industry Intervention
In the face of such analytical limitations, Gafner suggests that industry members “respond by adapting their test methods, or by adding qualified suppliers as backups if quality is below expectations.”
And whatever they do, he says, they shouldn’t feel like they’re flying solo in the process, as industry organizations and others recognize the challenges facing the botanical sector and are here to help.
“Some trade groups have information resources about adulteration and how to detect it,” he points out, citing AHPA’s Botanical Identity References Compendium as one such guide. But “the most prominent effort” to his mind is the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP), which provides resources and in-depth assessments of how well various analytical methods perform at authenticating those botanicals at documented risk of adulteration, he says.
“Also, BAPP will soon release its Best Practices SOPs for the Disposal/Destruction of Irreparably Defective Articles,” Gafner adds, which he describes as “a strategic tool” to help companies work with certified third parties to ensure that “irreparably defective” botanicals—that is, material that can’t lawfully be reconditioned to remove adulterants—exit the supply chain via proper destruction or disposal.
All About Relationships
Beyond that, Travis cautions brands to “be alert when encountering a ‘good deal’ and attentive when qualifying incoming materials to avoid being duped by inferior adulterated ingredients.”
And Johnson’s “best advice” for brands is that “now is the time to review internal company policies and procedures related to sourcing botanical ingredients, setting specifications, and qualifying suppliers to be in a strong position to acquire high-quality ingredients into the future. Brands that have longstanding, trusting relationships with suppliers, as well as rigorous quality systems in place, are best positioned to continue delivering safe, authentic ingredients and products to consumers.”
Those relationships, Gafner admits, “are usually built over many years,” but when well-tended can prove “especially valuable once supply situations become more challenging.” And to prepare for the adulteration crises to come, he encourages brands “to join a trade organization or nonprofit like the American Botanical Council to tackle any future problems together.”
Reference
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