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ABC Founder and Executive Director Mark Blumenthal discusses defense against adulteration and responsibility of contract manufacturers.
By: Sheldon Baker
July 30, 2024
Mark Blumenthal is the founder and executive director of the American Botanical Council (ABC), a leading, independent, research and educational nonprofit organization dedicated to disseminating accurate, reliable, and responsible information on herbs and medicinal plants, teas, essential oils, phytomedicines, beneficial plants, and edible and medicinal fungi.
Blumenthal is editor-in-chief and publisher of HerbalGram, ABC’s international peer-reviewed quarterly journal. He is also the founder and director of the ABC-AHP-NCNPR Botanical Adulterants Prevention Program, a nonprofit international consortium committed to extensively researching and exposing adulteration and fraud in botanical ingredients sold in the global market.
He has appeared on more than 400 radio and television shows and has written more than 500 articles, reviews, and book chapters for many publications. Frequently quoted in the media, for more than 50 years, he has been a leader in the global botanical and natural products community, promoting science-based herbal education and respect for scientific and clinical research, ethnobotanical traditions, sustainable and regenerative practices, and authenticity and transparency in the manufacture and marketing of herbs and phytomedicines.
Health E-Insights (HEI): What is the mission of the American Botanical Council (ABC) and how is it different than a trade association?
Blumenthal: ABC is an independent, tax-exempt, nonprofit research and education organization. ABC’s mission is to educate the public on the traditional and science-based responsible use of herbs, medicinal plants, teas, phytomedicines, essential oils, other plant-based ingredients, and medicinal fungi. Our mission is also to increase the quantity and quality of research and education on herbs, teas, spices, medicinal plants, phytomedicines, essential oils, fungi, and plant-based functional foods.
ABC was founded in 1988 and was based initially on HerbalGram, then a small 24-page newsletter dealing with research, regulation, quality control, market trends, conservation, and related topics in earlier days of the modern herb industry. ABC fulfills its nonprofit mission via its publications and programs, some of which pertain to industry and commercial issues, and quality control of herbal ingredients, particularly the identity and authenticity of botanical ingredients by educating industry and academia about adulteration and fraud.
Accordingly, because ABC deals with commercial and market issues in addition to scientific and clinical research, some people misperceive ABC as a trade association, and we frequently have to clarify the basic distinction between a tax-exempt organization like ABC under section 501(c)(3) vs. a trade association. The primary difference is a c3 nonprofit is tax-exempt because it operates for the public good. Hence, donations to a c3 are tax-deductible to the donor.
A trade or professional association has a different raison d’etre (reason for being). Trade associations exist mainly to promote and protect the economic interests of their members. And there’s another fundamental difference between ABC and a trade association. Trade association members have a vote via the officers of the organization. But ABC, as much as we appreciate our members, they do not have a vote. They do not vote for board members or ABC officers. However, that being said, all ABC members are welcome to make suggestions regarding ABC research and educational programs.
HEI: What does it mean to be a responsible member of the herbal industry?
Blumenthal: For many years I have frequently referred to the responsible members of the herb industry when asked a question like, “Mark, what does the industry think about the work that you’re doing on the problem of adulteration and fraud?” Or other questions that use the term “the industry” to denote the commercial sector of the herb and medicinal plant community. My answer usually states that there is no homogeneous “industry,” if the term “the industry” is meant to imply a monolithic group of companies and players in the commercial sector. As is the case with other industries, the herb industry is multi-layered, fractionated, and complex. My preference is always to engage with those individuals and companies whom I consider responsible actors.
So, the bottom line is that herb companies should follow all or at least most of the following guidelines.
HEI: We have recently heard a lot about adulteration of botanicals. In 2011, you founded the Botanical Adulterants Prevention Program (BAPP) among three respected research and education organizations (ABC, AHP, NCNPR). What is the mission of BAPP?
Blumenthal: The BAPP mission is essentially to enhance consumer health by reducing the amount of adulterated, fraudulent materials being used in consumer health products. This is done by employing research and education efforts internationally, directed towards responsible members of the herb and natural products industries. BAPP helps protect responsible companies by providing them reliable, authoritative, high quality, peer-reviewed information that helps responsible companies protect themselves from unscrupulous sellers of adulterated, fraudulent ingredients.
HEI: What are some examples of adulteration within botanicals and has this always been an issue or a recent phenomenon?
Blumenthal: Adulteration of herbs, spices, and botanical drugs is probably as old as human society. The first article that BAPP published, during its first year in 2011, was by the late botanical expert and noted photographer and author Steven Foster, called “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs.”
This article traces cases of herb adulteration back to Greco-Roman times. The reason I commissioned this article is because I wanted to show people in the industry and the public at large that herb adulteration and fraud isn’t just something that has come on to the scene recently. It’s been with us for millennia. Fraud is not something new or particular to the modern herb and dietary supplement industry.
A quick look at the Botanical Adulterants Prevention Bulletins section of the BAPP homepage provides almost 30 popular herbs that we have determined are subject to adulteration and fraud. Salient examples include using banned red food dyes in St. John’s wort extract to artificially provide the red look that is characteristic of SJW.
Then there’s ginkgo leaf extract, one of the most-adulterated herbal products in the world, adulterated with compounds from lower-cost plants. And bilberry fruit extract, adulterated with anthocyanidins from lower-cost plants, and, in some cases, with artificial dyes that can deceive some of the more simplistic and not fit-for-purpose analytical methods that may be used by some companies.
Then there’s the adulteration of turmeric with lead chromate to give the powdered rhizomes of the popular spice a brighter yellow color, and then the addition of synthetic curcuminoids to some turmeric extracts. Unfortunately, the list is long, too long to be comprehensive in the space of this interview.
HEI: What role do contract manufacturers play in the adulteration process and why is it important that they engage in the BAPP Program?
Blumenthal: This is a key question. Two of the most vulnerable links in the supply network for botanical products, whether they be dietary supplements, teas, cosmetics, or others, are the actual suppliers and producers of the botanical raw material, extract, or essential oil and the contract manufacturer (CM) that frequently produces the products for the company who will be marketing and selling the finished product. With respect to the actual supplier of an adulterated raw material, where the adulteration is intentional (economically motivated adulteration), it’s obvious that they are engaged in fraud, and illegal activity.
With respect to the CM there’s considerable vulnerability. The CM is the middle-man, so to speak. The CM obviously has many fixed costs and overhead. Depending on the volume the CM has, the price for bottles, caps, labels, product seals, capsules, and other packaging and processing materials are relatively fixed, costs subject to quantity discounts.
Where the CM might be able to obtain extra margin is the actual ingredient. If they can obtain a low or lower price on one or more ingredients, they might be inclined to go for the lower or lowest price and pocket the savings. This is where problems can arise, because the price then becomes the primary specification for the ingredient(s) in the intended product.
While there are many reputable, ethical, responsible companies that operate in the contract manufacturing sector, I have to wonder where the source is for cheap, adulterated products that we see in the marketplace. They have to come from somewhere, and that somewhere is from CMs that are more concerned with price and profit than they are with quality, integrity, and ultimately, the consumer’s best health experience.
HEI: All this work requires a lot of effort. What can companies do to support BAPP and help fund this critical work?
Blumenthal: First, they can access the information we provide and determine which of the 88 peer-reviewed publications we’ve produced to date (July 2024) are relevant to their particular business. The information is free to anyone and everyone in the world; all people have to do is register on the ABC website, www.herbalgram.org. BAPP publications are free-access thanks to the dozens of forward-thinking and responsible companies that have funded BAPP for the past almost-13 years.
Second, they can donate funding to support current and future BAPP research and educational activities like the publications and various BAPP Best Practices SOP for the disposal and destruction of irreparably defective articles (BAPP SOP). BAPP is totally dependent on donations from responsible members of the herb community and beyond.
Third, they can publicly endorse the BAPP SOP, as have various industry trade associations and industry companies, and not only endorse the SOP, but also utilize it by incorporating it into their GMP processes. The BAPP SOP is designed to empower responsible companies to be able to remove from the supply network any adulterated or contaminated ingredient, botanical or nonbotanical, that is irreparably defective. It’s defective to the point that it cannot be lawfully remediated or reconditioned for its intended use (or a finished product containing such an ingredient). The BAPP SOP is in effect a consumer-oriented process that helps ensure that herbs and other health products in the market contain authentic ingredients.
HEI: If you were to provide the top best practices when it comes to mitigating supply chain adulteration risk, what would those be?
Blumenthal: These are virtually self-evident to almost anyone with any experience in the botanical industry, although I suspect I’m probably overlooking some obvious and/or not-so-obvious items that warrant inclusion.
1. Do the appropriate research and set specifications for each ingredient that acknowledges the various types of ways that a specific botanical ingredient might be adulterated, especially if the research indicates that the herb is known to be subject to adulteration. In order to do this, the potential buyer of the proposed ingredient should access reliable, authoritative sources. These include monographs from the American Herbal Pharmacopoeia, monographs from the United States Pharmacopeia, the European Pharmacopoeia, and/or relevant quality control monographs from other pharmacopeias in China, Japan, and India, to the extent that the botanical material is the subject of a monograph in those compendia. 2. Properly qualify the supplier for each ingredient. This is self-evident and is also required in the GMPs for dietary supplements, assuming that the ingredient will be used in a dietary supplement. But it doesn’t really matter what kind of product the material will be used in. The buyer should appropriately qualify the supplier.
3. Don’t allow price to become a specification. Someone can get into trouble when and if price becomes the primary specification. While pricing is obviously important in commerce, it should not become a primary factor in decision-making.
4. Ensure that the QC team utilizes appropriate analytical testing methods that are fit for purpose and robust enough to accurately identify and authenticate ingredients and that have not been “gamed” by unscrupulous suppliers.
What does this mean? We know that the producers of intentionally adulterated, fraudulent extracts are aware of the prevalent analytical methods used in industry and third-party analytical laboratories. They then can adjust, spike, or adulterate an extract with a specific marker compound(s) that might be derived from a lower-cost plant (or it may be synthetic) so that that marker compound can fool or deceive the targeted analytical method.
Both ABC and BAPP have published an extensive scientific paper on this fraudulent practice, and it was published in a highly respected peer-reviewed scientific journal, Journal of Natural Products. This paper represents 12 years of BAPP’s research. Every company should obtain a copy of this paper and refer to it in its QC process, depending on which herb(s) it is purchasing. A review of the paper and access to it are available here.
5. Adopt and utilize the BAPP SOP, as noted above.
Sheldon Baker is a full-time freelance writer who covers health and wellness and other fun topics for Nutraceuticals World, Rodman Media, and other publications. He’s based in Northern California near Yosemite National Park, and enjoys exploring worldwide destinations, especially New York City, Mumbai, India, and Sydney, AU. He’s also happy to hang out at home with his wife and the many young foster children in their care. Follow him on Twitter @SCB3128 or send him an email at sbaker@bakerdillon.com.
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