Features

Ensuring Integrity in the Herbal Supplement Market

In a self-regulatory environment, brands must manage supply chain risks, commit to cGMPs, and uphold high testing standards.

Ingredient Sales

Psyllium (Plantago ovata, Plantaginaceae) was the top-selling herbal supplement ingredient in U.S. mainstream retail outlets in 2022, according to the American Botanical Council’s 2022 Herb Market Report published in HerbalGram.¹ Consumers spent $269.6 million on supplements containing psyllium in 2022, a 9.8% increase from the previous year.

Elderberry (Sambucus nigra, Viburnaceae), which ranked first in mainstream sales in 2020 and 2021, fell 14.5% to $236.2 million.

Alongside psyllium and elderberry, the top 10 herbal supplement ingredients in mainstream retail outlets for 2022, as reported in HerbalGram, included:

Apple cider vinegar ($126.4 million, +26.4%),
Turmeric ($123.1, +6.9%),
Ashwagandha ($111 million, +20.1%),
Cranberry ($91.5 million, -1.9%),
Ivy leaf ($49.8 million, -1.6%),
Fenugreek ($43.2 million, -6.0%),
Echinacea ($42.0 million, 5.1%), and
Ginger ($40.8 million, -2.1%).

Meanwhile, sales for the top 10 herbal supplement ingredients in the U.S. Natural Channel included:

Turmeric ($35.8 million, -9.4%),
Cannabidiol ($33.7 million, -15.3%),
Elderberry ($28.9 million, -11.5%),
Wheatgrass/barley grass ($18.4 million, - 10.5%),
Ashwagandha ($17.7 million, - 1.3%),
Quercetin ($16.7 million, +3.3%),
Mushrooms (Other*) ($15.6 million, +11.2%),
Aloe ($13.4 million, +0.9%),
Psyllium ($10.6 million, +6.4%), and
Milk thistle ($10.4 million, -1.0%).

According to SPINS data for the 52 weeks ending May 19, 2024, top herbal supplement ingredient sales in the natural and multi-outlet channels, included:

Turmeric ($106.1 million, -6.6%),
Ashwagandha ($40.7 million, +34.2%),
Elderberry ($28.1 million, -26.3%),
Ginkgo biloba ($24.2 million, +51.9%),
Tribulus ( $22.1 million, -3.1%),
Garlic ($20.6 million, -6.0%),
Cinnamon ($18.6 million, +59.2%),
Valerian ($18.3 million, -2.3%),
Milk thistle ($17.5 million, -2.1%), and
Mushrooms (Other*) ($17.4 million, +52.2%).

(*Excludes Reishi, Cordyceps, Chaga, Maitake, Shiitake)

Market Challenges

In today’s dietary supplement market, ensuring product integrity is critical. Alkemist Labs has released a top-20 list of botanicals and fungi that most frequently failed identity testing during the first half of 2024.

CEO Elan Sudberg described the companies that test with Alkemist as “the best of the best,” so the contract testing lab may not see as many failures as some other labs. However, sharing the ingredients that are currently the most problematic is often valuable to the industry.

All were tested using High Performance Thin-Layer Chromatography (HPTLC) to assess identity and quality of botanicals and various ingredients. HPTLC, for which Alkemist holds a flexible scope ISO 17025 accreditation, is able to detect adulterants and contamination, such as containing incorrect plant parts, closely related species, and unknowns. This technique is applicable to crude raw botanicals from powdered to whole form, extract (powdered or liquid), and finished product/blends.

This list (Figure 1) is representative of the products Alkemist’s manufacturer clients are testing before they are included in their products as well as some finished products.

Several of the materials on this list are making a repeat appearance, including Eleuthero, Lion’s mane, apple, monk fruit, nettle, grape, ashwagandha, and the botanical that saw the most failures in 2023, elderberry.

“We encourage brands to be especially careful sourcing these materials, and make sure they are tested by the most competent labs,” Sudberg said. “We also suggest that anyone involved in raw material sourcing familiarize themselves with the Botanical Adulterants Prevention Program (BAPP) and have a policy in place for dealing with serious quality issues before they need it.”

According to Petra Erlandson, director of sales and marketing at Alkemist Labs, the failure rates among these 20 are all relatively similar, “but we have certainly seen repeat offenders.”

“Quality issues, particularly with excessive excipient dilution for extracts, continue to be a supply chain challenge,” she added. “Our HPTLC testing detects this and makes identity confirmation incredibly challenging in many cases. This is certainly not new; in fact, the American Botanical Council published a new article on this topic.”²

Brand Quality Assurance

Given the complexity of today’s supply chains and the reality of adulteration, how can brands ensure product integrity?

According to Len Monheit, executive director, Ingredient Transparency Center (ITC), brands must understand and test for possible adulterants, using best practices offered by third-party labs. “They should be familiar with programs such as BAPP, know what to look for, and in the case of supply shortages, areas where economically motivated adulteration could occur.”

BAPP’s Best Practices Standard Operating Procedure (SOP) for the Disposal / Destruction of Irreparably Defective Articles (aka "Burn It, Don't Return It") also offers a voluntary set of guidelines for suppliers, manufacturers, and distributors of herbal raw materials and other ingredients to protect against adulteration and ensure that irreparably defective raw materials and products are destroyed, appropriately disposed of, and thereby removed from the supply chain.

Travis Borchardt, vice president of product integrity and compliance at Nature’s Way, an herbal supplement industry pioneer, said the company has “an unmatched level of expertise in herbal supplement quality control and assurance.”

“We ensure products meet quality standards every stop of the way, from the source to the finished product,” he said. “Nature’s Way holds deep expertise in the complete supply chain, from planting to harvest to transformation into a supplement or vitamin.”

The company’s supply chain expertise, he added, includes “knowledge of global markets, an understanding of herbs and their risks for adulteration, strategies for geographic diversification and implementation of Good Agricultural Practices, and proficiency in herbal dietary ingredient manufacturing processes.”

As for procedures Nature’s Way maintains to ensure product safety and integrity, Borchardt said the company uses written purchasing specification documents as a contract of quality with suppliers.

“These documents detail the exact quality control tests to perform, the test methods to employ, and the accept and reject limits to maintain,” he said. “Tests include identity, bioactive potency, and contaminants such as heavy metals, pesticides, residual solvents, microbes and aflatoxins, as well as tests for moisture and particle size.”

Nature’s Way was the first branded herbal dietary supplement company to require all herbal ingredient suppliers to provide a representative sample of the whole plant starting material (including the root, stem, flower, and leaves) with each batch of herbal dietary ingredient powder or powdered extract, said Borchardt.

“We conduct macroscopic and microscopic evaluation of the starting material to ensure that the powdered herb was produced using the correct genus and species of the herb, as well as the correct plant part.”

Ximena Acosta-Molina, director of brand management at MegaFood, said the company’s commitment to quality and integrity is “unwavering.”

“Every formula we craft is tested for 150+ pesticides and meets the purity and potency standards we demand, and consumers deserve. Independent third-party verification organizations certify MegaFood compliance with a range of premium standards applicable to our company, ingredients, and products.”

MegaFood works with NSF, which audits facilities each year to ensure the company is following federal laws and industry standards.

“In fact, at our 2023 audit, NSF had no observations, meaning we got the highest possible score,” said Acosta-Molina. “The FDA also performs surprise audits of our facilities every few years.”

To maintain product consistency and ensure products meet label claims, all Megafood products undergo a variety of testing to ensure identity, purity, potency, and absence of contaminants like microbes, and heavy metals, Acosta-Molina added.

“Our rigorous internal standards ensure that our products meet label claims through our science-backed research and clinical studies,” she noted. “Additionally, MegaFood’s third-party certifications include B Corporation status, Certified Plastic Neutral, 1% for the Planet, USDA Organic, Non-GMO Project Verified, Certified Glyphosate Residue Free, Certified Kosher and Vegan. Our supplements are also made without the nine common food allergens: milk, eggs, peanuts, tree nuts, soy, wheat, fish, shellfish and sesame.”

Borchardt said every batch of each herbal dietary ingredient and dietary supplement is tested in a state-of-the-art ISO 17025 accredited laboratory.

“We achieve consistency by qualifying herbal ingredient suppliers, testing during the raw material and finished product phases, and validating manufacturing processes,” he noted.

“Every company should understand its impact on the climate by measuring its scope 1, 2, and 3 emissions. They can then make a science informed climate target and build a reduction plan to achieve it. Every business has a responsibility to keep global temperatures down, and one unique way food companies can reduce their impact on both people and the planet is the way in which they source their ingredients.”
— Stacia Betley, MegaFood

Supply Chain Management

The decline in herb wildcrafting collectors is accelerating, said Borchardt, with small herb farms being consolidated into larger ones primarily focused on growing commercial crops for human and animal food. “This trend is significantly impacting the availability and cost of numerous herbs,” he said.

Meanwhile climate change is impacting raw material growing, harvesting, and sourcing. “Botanicals rely on Mother Nature, which leads to volatility in availability, cost and quality,” said Borchardt. “In general, the heightened frequency and intensity of severe weather events, along with unusual weather patterns, can lead to certain harvest seasons yielding little to no harvestable herb material. This can cause an increase in prices and in many cases, the discontinuation of lower volume herbs altogether.”

Additionally, when demand exceeds supply, incidents of economically motivated adulteration arise, Borchardt noted.

“If we know that a particular herb crop is generally unavailable, it is unlikely that a supplier can deliver an authentic material. When an unavailable crop suddenly becomes available without any signs of adulteration, we approach it with caution. If it’s too good to be true, it probably is.”

Stacia Betley, director of sustainability and social impact at MegaFood, said a changing climate means “unpredictable temperatures, water availability, and increased extreme weather events.”

“Many of us have heard of the impact to the wine, tomato, and maple syrup industry, but farmers are seeing the impacts across various crops. Not only is a changing climate impacting yield, it impacts farmer’s health and wellbeing.”

These issues can affect the MegaFood business “in many unpredictable ways,” Betley added. “For example, in recent years our turmeric supply was impacted due to erratic weather in India. Ensuring we geographically diversify our suppliers and backup suppliers is just one prevention measure.”

Given the unpredictable consequences of climate change, what action can brands take?

“Every company should understand its impact on the climate by measuring its scope 1, 2, and 3 emissions,” said Betley. “They can then make a science informed climate target and build a reduction plan to achieve it. Every business has a responsibility to keep global temperatures down, and one unique way food companies can reduce their impact on both people and the planet is the way in which they source their ingredients.”

Everyone — companies and consumers — can swap out high-emission ingredients for low-emission ingredients (like replacing animal based foods for plant based foods), she added.

“They can also buy third-party certified ingredients like organic, fair trade, and regenerative organic for ingredients that might inherently have higher social or environmental risk (e.g., sugar, coffee, or cocoa). It’s important for both companies and individuals to understand how they can have impact at scale and pull the appropriate levers.”

It’s critical to have multiple supply sources for a brand’s most strategic herbs, said Borchardt. “And I recommend having geographic diversity within those multiple supply sources. Understand the risk involved with sourcing botanicals from their non-native geographies. For example, European elderberry is native to eastern Europe. With the spike in elderberry demand, sources from other parts of the world, such as China, became available. These were most likely to be adulterated and required a close review.”

He also recommended having strategic relationships within all sections of the supply chain, from seed to bottle. “It’s important to evaluate the opportunity to invest further back into the supply chain to secure a solid and safe inventory,” he noted.

About the Author: Sean Moloughney has been the editor of Nutraceuticals World since 2012. He can be reached at smoloughney@rodmanmedia.com.

References

1. Smith, T., Bauman, H., Resetar, H. (2024). “US Sales of Herbal Supplements Decline Slightly in 2022.” HerbalGram. Issue 139, Spring 2024, pages 52-69.

2. Gafner, S., Loffredo, L., Kababick, J., Wise, S., Upton, R. (2024). “The Undisclosed Presence of Excipients and Diluents in Botanical Extracts.” HerbalGram. Issue 140, Summer 2024, pages 44-51.