Beyond the myth of a monolithic herb industry

This article was originally published in Nutrition Business Journal's Market Overview Issue.

During the past few decades, I have responded to inquiries from both trade and mainstream media using the term industry when referring to the herb and supplement industry at large. I am often asked questions like, “What does the industry think about...?”

My response almost always includes the qualifier “responsible industry” or “responsible elements of the industry.” I seldom, if ever, use the term “industry” by itself. 

I do not consider myself to be a spokesperson for “the industry” because, in my view, the term industry is something of a myth. It erroneously implies the industry is homogeneous or monolithic, but it is not. The herb and dietary supplement industry is multi-layered and fractionated. Different types of herb and dietary supplement companies have different commercial agendas and varying degrees of commitment to the values that, I believe, are essential to a robust and responsible herb industry and extended medicinal plant and natural health community.

When I refer to the responsible elements of the herb community, I am referring to companies that exhibit a number of the best practices criteria listed below. While I am not suggesting responsible companies must meet all these criteria, responsible best practices should include at least several and, preferably, as many of them as possible.

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Trade association membership

Trade association membership is a good business practice. Adhering to the policies of one or more trade associations is good business. Trade associations exist to promote and protect the commercial interests of their members, and most generate policies and/or trade recommendations that promote ethical and responsible sourcing, manufacturing, labeling, marketing, etc.

In many, if not most, cases, non-members benefit from the collective work of one of more trade associations, which are essential for the healthy growth and responsible functioning of the herb and supplement industry. Trade associations and nonprofit research and educational groups have been planting seeds, watering them, and fertilizing them for decades, and new companies and investors entering the herb and supplement market are able to harvest ad libitum from the garden they have not supported. All too often, private equity investors’ ROI-based policies result in cost-cutting that excludes support for some of the key groups that have helped that company grow and prosper.

Clinical research

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Herbs had demonstrated safe and effective use for centuries before the advent of the controlled human clinical trial. But in commerce, health-related claims are more credible when supported by clinical research. As the founder and executive director of a science-based nonprofit research and education organization, I have been banging the research drum for over 35 years. The staff and Board of Trustees of the American Botanical Council (ABC) believe herb companies should invest in conducting human clinical research on their proprietary ingredient(s) and/or their key finished consumer products when it is reasonable to do so. To perhaps a lesser extent, in vitro research that documents the mechanism of action of observed clinical outcome is also welcome and warranted. 

Noteworthy in this context are those supplement companies that support the Botanical Safety Consortium (BSC), which strives to determine whether in vitro assays are suitable to predict botanical ingredient safety in humans, without having to rely on conventional animal testing.

Ingredients of pharmacopeial quality

Including botanical raw materials and/or extracts that conform to one or more official pharmacopeial monographs can (at minimum) provide a more reasonable assurance that the product contains ingredients that are properly identified, authentic and reasonably free of contaminants. Pharmacopeial quality herbs provide minimum standards for reproducible quality and efficacy. However, as the Botanical Adulterants Prevention Program (BAPP) demonstrates, adulteration techniques change much faster than published monographs are revised; for that reason, companies following best practices will constantly monitor reports of supply chain fraud and revise their ingredients specifications and testing methods as conditions warrant. (This is a regulatory requirement under the Food Safety Modernization Act [FSMA], defined in 21 CFR 117).

Appropriate qualification of ingredient suppliers and contract manufacturers

DSHEA requires supplement companies to adequately qualify suppliers of raw materials, extracts, and other ingredients and components and to test the ingredients for ­identity, purity, and strength. 

A large but possibly elusive portion of the herb and supplement industry’s finished products are manufactured by contract manufactures. One knowledgeable industry veteran told me there are over 200 contract manufacturers in North America producing various forms of supplements. According to industry estimates, more than 50% of supplements sold in the U.S. are made by contract manufacturers. Some companies may be abdicating their regulatory requirements and relying solely on these contract manufacturers to set specifications.

While many contract manufacturers employ high levels of responsible best practices, problems arise when supplement companies accept ingredient specifications based on what the contract manufacturer has on hand. It frequently, the primary specification for ingredients is—you guessed it—price. Because ingredients may be adulterated in one or more ways that have been definitively documented by BAPP, companies that use contract manufacturers must define all specifications associated with a purchase order, perform audits, and have oversight, representations and warranties that these specifications are met.

The BAPP Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles stipulates that, if a buyer receives a shipment deemed by its quality unit to be “irreparably defective,” it should not return the material to the seller but should have it disposed of or destroyed by a certified third party. Responsible companies should incorporate this SOP into their existing quality programs. 

Use of validated and fit-for-purpose analytical methods for proper quality assessment

There’s a reason for the small “c” in front of the term cGMP. The “c” refers to current good manufacturing practices. One of the many ways herb and supplement companies can and should stay current on GMPs is to ensure their analytical testing labs, whether in-house, third-party or both, are current on which analytical methods are fit-for-purpose for the specific ingredients being tested.

As BAPP has demonstrated in many of its publications, fraudsters design and develop adulterated botanical extracts to deceive the prevalent analytical testing protocols. Certain analytical methods—unless they are simultaneously coupled with other analytical methods in what is referred to as orthogonal methods—can be deceived and end up falsely authenticating adulterated materials. Quality Unit managers must constantly monitor developments regarding documented adulteration and make updates to analytical methods specifications. A BAPP-produced, peer-reviewed article that comprehensively explains fraudsters’ adulteration strategies and how manufacturers can avoid being fooled can be found here. 

Safety labeling data based on AHPA’s Botanical Safety Handbook

Many, if not most, of the herbs used in the U.S. are safe, as documented by the relatively low number of overall adverse event reporting records. Nevertheless, new research data, changes in dosage or the targeted population for a product may warrant additional literature research or safety testing. A thorough safety evaluation of a large portion of botanicals in commerce is provided in the second edition of the American Herbal Products Association’s Botanical Safety Handbook. Responsible industry members should comply with the safety guidelines for product labeling provided in this book. In addition, herb companies should strongly consider engaging with an adverse events reporting service, like SafetyCall International for the relatively unlikely event of a need for such.

Appropriate benefit claim language

Responsible industry members comply with dietary supplement labeling claim requirements (per CFR 101.93). Brand holders are not allowed to make any claims on the label that suggest their product can diagnose, treat, cure or prevent any disease. Many, perhaps the majority, of supplement companies comply with these requirements, but FDA enforcement actions show that not all of them do. Some manufacturers make direct or implied claims that their products may be useful for treating conditions such as diabetes, Alzheimer’s disease, COVID-19, or even cancer—none of which are allowed for supplements.

Third-party certification

Responsible companies adhere to all appropriate cGMPs, which are required by federal law. One way to demonstrate compliance is to submit to GMP audits—of the company, an ingredient, and/or specific finished products—by third-party organizations like NSF International and United States Pharmacopeia (USP). Quality improvement is a process, not a destination.

Sustainable practices

One of the most important aspects of responsible companies is adhering to sustainable practices. Commercial herb and supplement companies can exhibit their commitment to sustainable practices by obtaining B Corp status (not an easy or trivial process), as well as supporting the collaborative work of the ABC Sustainable Herbs Program. In addition, companies can access herbal raw materials that have been sustainably harvested and for which fair prices have been paid to the producers by sourcing from groups like FairWild Foundation (a Swiss nonprofit that promotes sustainable, traceable and ethical trade of wild plant ingredients and products) and/or FairTrade International (a consortium of farmers). This is a compelling existential issue and an emerging area of concern and focus for the entire global herb industry.

Support of BAPP, ABC and AHP

Supporting nonprofit research and educational organizations and some of their key programs is part of responsible industry participation. One of the major initiatives in this area is BAPP, a large-scale program to educate the herbal and dietary supplement industry about ingredient and product adulteration, which has developed a best-practices SOP as a solution intended to remove irreparably defective articles from global trade. Over the 13 years of its existence, BAPP has been supported and/or endorsed by more than 220 industry members, including trade and other organizations.

ABC produces a wide variety of science and clinical trial information on hundreds of popular botanicals, and AHP publishes exquisitely researched and produced monographs that provide a significant amount of information on quality control, history, traditional use, and modern scientific and clinical research on numerous herbs sold in commerce.

Proper training of technical, scientific, R&D staff

Sending key employees to various scientific and professional conferences and providing access to online webinars, trainings and other ways to enhance staff knowledge and professionalism are essential for the robust growth and community involvement of a responsible herb company. Developing collegial relationships with professional and scientific peers is a healthy practice for key employees’ enhanced productivity and overall company success.

Fortunately, many responsible companies care about the quality and authenticity of the botanical ingredients they source for the consumer health products they produce and market, as well as wanting to ensure a positive experience for the end customer. These responsible players are at the table, so to speak, discussing ways to help ensure authenticity in botanical supply/value networks, and much more, as noted above.

Unfortunately, there are many more companies that are not at the table or even in the room. These companies—which could care less about cooperating with their suppliers, customers and even their competitors to produce industry-wide agreements and standards—might be considered the irresponsible elements of the herb and supplement industry. For them, it’s just about making money.

Mark Blumenthal is the founder and executive director of American Botanical Council and the founder of ABC-AHP-NCNPR Botanical Adulterants Prevention Program.

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