Herbal ingredient adulteration in 2020

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We all like to know what we’re getting. That holds true whether we’re buying a healthcare plan, shares in a mutual fund, or a dietary supplement.

And to its credit, the dietary supplement industry has gone out of its way to ensure that consumers know exactly what they’re getting with each purchase.

But despite industry’s best efforts, shenanigans occur. So, the American Botanical Council (ABC; Austin, TX), in collaboration with the American Herbal Pharmacopoeia (AHP) and the University of Mississippi’s National Center for Natural Products Research (NCNPR), established a Botanical Adulterants Prevention Program (BAPP) to address the shenanigans that occur in the botanicals space.

As chief science officer for ABC and technical director of BAPP, Stefan Gafner, PhD, has a unique perspective on botanical adulteration. And with the COVID-19 pandemic threatening to make adulteration a more common occurrence in the supplements space, Gafner’s perspective, and the work of BAPP and its partners, becomes all the more valuable.

This Is What Adulteration Looks Like

“Botanical adulteration comes in many forms and shapes,” Gafner says.

At its most innocent, human error is to blame, as when a wildcrafter misidentifies a plant and collects the wrong species, or an employee at a processor unintentionally mislabels a drum in the warehouse with no ill intent.

“But more often,” says Gafner, “adulteration is economically motivated.” In these instances, an undisclosed, lower-cost material with a similar chemistry or appearance may substitute for the labeled ingredient or a portion thereof.

“For example, powdered turmeric (Curcuma longa) sold in the local herb shops in rural India or Bangladesh may be adulterated with yellow dyes—some of which are made with lead—or corn or tapioca starch,” Gafner explains. “In Europe or North America, substitution with other Curcuma spp., or the use of synthetic curcumin or curcuminoids, appears to be the main problem.”

Published data indicate that most adulteration occurs at the harvesting and ingredient-processing levels, Gafner adds. “But that doesn’t mean there aren’t finished-product manufacturers who intentionally adulterate botanical ingredients.”

Adulteration Temptation

Malefactors at any point in the supply chain have no want for motivation, whether from sudden increases in demand, supply shortages, sharp and unexpected price rises, or competitive pressure, Gafner says. Lax government oversight, as well as shipping delays requiring pricey air-freight costs, also increase the temptation to adulterate.

Even a lack of appropriate test methods or suitable analytical markers can increase adulteration’s economic appeal, as was the case with African mango (Irvingia gabonensis) and cordyceps (Ophiocordyceps sinensis), Gafner says.

Given the supply-chain upheaval brought about by COVID-19, there’s reason to believe that the strain it’s put on the botanical market could encourage some degree of exploitive adulteration in response.

That said, Gafner declares, “It’s too early to determine if there will be an increase in adulteration due to increased demand, supply shortages, and less oversight, as FDA temporarily suspended onsite inspections.” While history suggests that such crises open the doors to adulteration, “we haven’t received confirmation that this is actually happening,” he says.

Nevertheless, BAPP monitors the situation closely, especially in the case of ingredients seeing “extraordinary increases in sales” thanks to COVID-19. Those include elderberry(Sambucus nigra subsp. nigra and Sambucus nigra subsp. canadensis), echinacea (Echinacea spp.) roots or aerial parts, and ashwagandha (Withania somnifera).

Other ingredients worth watching at any time include mushrooms (lion’s mane, reishi, and cordyceps), astragalus (Astragalus membranaceus and A. mongholicus), ginkgo (Ginkgo biloba) extracts, and berry extracts such as bilberry (Vaccinium myrtillus) and cranberry (Vaccinium macrocarpon). And as Ayurveda’s popularity has grown, so, too, has adulteration of its top-selling botanicals, not least of which are turmeric, ashwagandha, and boswellia (Boswellia serrata), Gafner says.

Risky Business

What’s the risk to those on the receiving end of botanical adulteration?

Fortunately, consumer safety is at low risk, Gafner says, except in instances where, say, lead chromate replaces turmeric, or the hepatotoxic germander (Teucrium spp.) takes the place of skullcap (Scutellaria lateriflora).

More often, adulteration harms the botanical sector’s image.

“The negative headlines about botanical-ingredient adulteration damage the reputation of the whole industry and are used by some industry critics to ask for stricter regulations,” Gafner notes. “Importantly, the lower prices at which adulterated ingredients can sell also put high-quality suppliers at a competitive disadvantage. For many industry members, this is more of an economic issue than a safety one.”

Frontline Defense

That’s still an issue worth militating against, and the industry has mounted multiple initiatives to curb adulteration.

Gafner considers the mightiest so far the establishment of BAPP, which conducts research and educates botanical-sector members about herbal-ingredient and dietary-supplement adulteration. As of June 2020, BAPP had published 57 papers and newsletters documenting adulteration cases and highlighting detection methods for raw materials.

Gafner also credits the American Herbal Products Association’s (AHPA; Silver Spring, MD) Botanical Identity Reference Compendium, which, he says, provides access to images from analytical tests to identify botanical ingredients.

For its part, BAPP is completing its standard operating procedures on the disposal and destruction of irreparably defective articles, which Gafner describes as a self-regulatory effort to inform receivers of adulterated material on how properly to dispose of or destroy what they can’t lawfully recondition, rather than send the adulterated material back to the supplier, who might then sell it back to another buyer.

BAPP is also discussing establishing a “mailbox” for anonymous company reporting of adulteration incidences. “The goal is to alert industry members in a timely fashion about new, or old, ways of botanical-ingredient adulteration,” Gafner says.

“On a positive note, I’m thrilled about the positive impact that the ABC-AHP-NCNPR Botanical Adulterants Prevention Program has had on the supply chain,” he concludes. Companies that read and use the group’s documents generally have “very robust and solid quality-control protocols,” he believes.

But even the most well-intended manufacturer or supplier can be caught unawares, which is where the program has offered significant help improving test methods and detecting fraudulent ingredients before they reach consumers.

“Ultimately,” Gafner says, “this is what the program is all about.”

Here’s a look at how adulteration may be affecting the botanicals you work with today.

Ginkgo Leaf: A Case Study in Adulteration

Ginkgo biloba may be the poster botanical for “the many ramifications of adulteration,” Gafner says. Competitive pressure pushes some companies to ask for ever-lower prices, initiating what he calls a “race to the bottom” that encourages dilution of ginkgo extracts with foreign flavonoids, like those from Japanese sophora (Sophora japonica, syn. Styphnolobium japonicum) leaf extract.

“This has gone so far that it’s become quite difficult to obtain authentic ginkgo leaf extracts on the market,” Gafner notes, “and those companies that sell quality extracts find themselves at a big disadvantage because they can’t sell their products at the same low price as others.”

Adulteration of Saw Palmetto with Ingredients Derived from Animal Fat

In this case, Gafner says, bad actors adulterated the popular botanical in such a way that the tampered-with ingredient mimicked the fatty-acid composition of authentic saw palmetto (Serenoa repens) extracts.

“What I found surprising was the extent of sophistication that went into this to avoid getting detected by current analytical methods,” Gafner observes. “It makes me wonder just what types of adulteration we may not catch because the adulterators have found ways to cheat without getting caught.”

What to Do with Weak Chromatograms?

Recent studies on analyses of commercial herbal dietary supplements frequently report occurrences of “weak chromatograms”—from, say, HPTLC or HPLC-UV analysis—reflecting low concentrations of the labeled ingredient.

“Unfortunately,” Gafner says, “some manufacturers cut costs by selling excessively diluted ingredients,” considering the resultant mix of excipient and extract the actual botanical ingredient. But as far as he’s concerned, that’s textbook adulteration: “The products don’t provide what the consumer expects based on information on the label.”

Unfortunately, it isn’t always easy to detect, as some products simply contain a highly diluting ingredient, or, as Gafner puts it, “just a low-quality extract.”

Extract Doping

Gafner and colleagues are also noticing more cases in which suppliers appear to have doped herbal extracts with single molecules, either synthesized or naturally sourced, to increase the extracts’ strength.

Addition of ellagic acid to pomegranate extracts; curcumin to turmeric extracts; and vitamin C to acerola (Malpighia spp.), baobab (Adansonia digitata), and other vitamin C-rich extracts are all examples, he says, as is the addition of caffeine to cola (Cola nitida) and guarana (Paullinia cupana) extracts.

“Depending on the chemical marker in question and the dietary intake, there can be potential safety concerns with such ingredients,” Gafner cautions.