Episode Summary
Herbs and spices have been part of commerce for thousands and thousands of years, and so have bad actors that substitute less expensive plant material for authentic plants. This practice known as botanical adulteration, has impacted the dietary supplement supply chain. But an industry initiative led by three leading nonprofits has developed a large scale program to reduce ingredient and product adulteration. Learn more on this episode of CHPA Chat.
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Botanical Adulterants Prevention Program
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Anita Brikman: Coming up in this next episode of CHPA Chat, we're talking about something that's been a part of commerce for thousands and thousands of years, herbs and spices. But just as long as those have been sold, there have been bad actors out there trying to cut corners. Today's episode focuses on something called Burn it, Don't Return It, the Botanical Adulterants Prevention Program, or BAPP. Let's listen.
Speaker 2: Welcome to CHPA Chat, conversations in the consumer healthcare industry with Anita Brickman.
Anita Brikman: Welcome everyone. Herbs, spices, they've been part of commerce for thousands and thousands of years, and so have criminals that substitute less expensive plant material for authentic plants. This practice known as botanical adulteration, has impacted the herbal dietary supplement supply chain over the years. An industry self-regulatory initiative led by three leading nonprofits has developed a large scale program to reduce ingredient and product adulteration. To tell us more about this important initiative and the problems it aims to address, I'm happy to turn the discussion over to CHPA's own senior vice president of dietary supplements, Duffy McKay. Duffy, take it away.
Duffy McKay: Thank you, Anita. Really happy to be here to discuss this important topic. And Anita, I welcome you to join the conversation today, with Mark Blumenthal, the Founder and Executive Director of the American Botanical Council, sometimes referred to ABC. And ABC is one of the spearheads of this important initiative. We also have Stefan Gafner, who's the Chief Scientific Officer at the American Botanical Council, and he's the one that really has his fingers on the day-to-day of this project. So before we get into the specifics of the Botanical Adulteration Prevention Program, which you guys have started, I want to talk just a little bit about the American Botanical Council and a little bit about you guys. We'll start with Mark, and I know the story is long, so we'll keep it brief, Mark, just a little bit about who you are and a little bit about the top line mission of the American Botanical Council.
Mark Blumenthal: Well, thank you, Duffy, and thanks for including us, and thank you for the CHPA, for taking on this question about adulteration. The American Botanical Council is an independent nonprofit research and education organization. We were founded almost 35 years ago by myself and two reputable scientist, Dr. James A. Duke, the late Dr. James A. Duke, who was the chief medicinal plant expert at the United States Department of Agriculture, and therefore was probably the most knowledgeable medicinal plant expert in the entire federal government. And Professor Norman R. Farnsworth, the late Farnsworth, who was a internationally renowned professor of pharmacognosy, which is the study of drugs from natural origin, usually from medicinal plants. He was at the University of Illinois, Chicago.
And Professor Farnsworth, Dr. Duke and I started the ABC as a nonprofit organization, to increase the quantity and the quality of information being disseminated to academia, to industry, to regulators, to journalists about herbs and medicinal plants. So we're a science-based organization, at the same time, we honor and report on historical use, anthropology and ethnobotany, but we tend to focus on controlled clinical trials as a scientific way to help establish the substantiation for many of the benefits and the safety of these medicinal plants that have been used safely and effectively, in many cases, for hundreds or thousands of years.Duffy McKay: So you are a science-based organization, so a critical staff member is your chief scientific officer. So Stefan, tell us a little bit about yourself.
Stefan Gafner: Well also thanks from my part for the invitation and for being part of this discussion. My background started out as a pharmacist, so I got training as a pharmacist in Switzerland, which you may hear by my somewhat heavy English accent. And upon coming to the United States for a post-doctoral position, I went, after the post-doc, to work in the industry for 14 years. The company is Tom's of Maine. So we had, at that time, a dietary supplement line, which I developed quality control methods for. And then in 2013, joined ABC at their chief science officer.
Duffy McKay: That's excellent. Tom's of Maine, I hear they have a lot of herbal toothpaste, so it makes sense why they would need a strong herbalist on staff. So I understand American Botanical Council has partnered with the esteemed American Herbal Pharmacopeia, as well as the University of Mississippi National Center for Natural Products Research, which is the US FDA's Center of Excellence when they have questions about botanicals. So you have two of the biggest experts in botanicals, you've partnered together on this initiative around adulteration. So before we talk about how that initiative works, what is botanical adulteration? Maybe Stefan, you can help me with that.
Stefan Gafner: Well, it's a really good question because there are a number of definitions out, for example, by the Food and Drug Administration or by the USP. We use the USP or United States Pharmacopeia definition, which is an ingredient that has been substituted in part or entirely by a non declared ingredient of lower quality and altogether different ingredient, without the knowledge of the buyer or the consumer, if it's a finished product.
Duffy McKay: Got it. So I just bought 100 kilos of spearmint and someone put something else in there instead of spearmint, because it was less expensive and so it's an adulterated ingredient. Is this a new problem?
Stefan Gafner: It certainly isn't, and I would like to raise awareness of the first publication that the American Botanical Council, the American Herbal Pharmacopeia on NC NPR, have published as part of the Botanical Adulterants Prevention Program, an article by Steven Foster, entitled, The History of Adulteration, in which he shows that alteration goes back probably to the beginnings of humankind, where people started to cheat and substitute grains or food with lower quality products. So there is a long, long history of cheating in the food and also at the herbal medicine arena.
Mark Blumenthal: And if I may, we published that article as our very first article that we published under BAPP, we published it in our peer review journal, HerbalGram, because we wanted to send a message to industry and people outside the industry, to inform that adulteration is not just a problem and does not just occur in the botanical dietary supplement industry, but it occurs in all kinds of industries, and it's been going on for at least, with the article that we published, at least 2000 years and beyond. And the actual title of the article, I think it's called A Brief History of the Adulteration of Herbs, Spices, and Botanical Drugs, that's the actual title. So it covers herbs and spices and drugs that are made from medicinal plants. So it covers the wide spectrum of the use of plants in the ethnobotany and herbal medicine field.
And this goes back, and our article, it goes back 2000 years to Greco Roman time. And the point was this has been around a long time, this is not just a problem with the dietary supplement or the herbal industry. It happens in the wine industry, it happens in the olive oil industry, it happens in the seafood and fish and conventional food industry. There's people out there since the beginning of human social economy, people cheat, unfortunately, some people cheat, and this has been with us historically. And so our point is that this is a historical issue, what are we going to do here and now to reduce the amount of adulterated material and to help educate people so they know how to avoid purchasing adulterated material.Duffy McKay: So the real target of the program is to educate a company, correct? So it would be the purchaser or the lab, the head of the lab, and you're providing them tools to avoid adulteration. And I know there is an example, wasn't there an example where, I forget, bilberry was a great example of where this really started, at least that's where I really started to hear good analysis where bilberry was being adulterated with a dye, because bilberry's a very rich pigment, it's a very hard ingredient to harvest, it's a very expensive ingredient when it's authentic, and you could just add a little dye and a little starch. And of course if you're going to use a test that's just really looking at pigment, you might be fooled.
So I believe you guys are involved in really unraveling that in a very transparent way, to help the lab say, "Hey, you got to test this way in order to not get duped by people who are just adding dye." I mean, that's one of the examples that really strikes me. Are there other kind of classic examples that you guys have helped fix within the supply chain?Mark Blumenthal: Stefan, why don't you take that one, since you're the PhD in analytical chemistry.
Stefan Gafner: Happy to, but that could be a lengthy conversation. So there are just so many examples that we have published on over the past 10 years, but maybe two that I want to point out because these are examples where industry members actually have contacted us and told us, "In our in-house lab, we've seen that issue." One of them is the issue of dyes in St. John's wort, which is, for me, an interesting case because basically what the fraudsters tried to do is fool an analytical method into believing that there's a constituent hypericin at certain levels in their using dyes.
So the method that is used in labs measures absorbance and the dye absorbs at the same wavelength as hypericin. But in order to make the powder visually similar to St. John's wort, the dye to adulterate is blue, they had to add yellow and other dyes to make it green, so that just not looking at it, the powder would look blue. So at the end, yes, it's one of these things that we got information from industry and that was then written up in our newsletter and raised the awareness, and there have been a number of subsequent papers on the topic later on. So that's one example.Duffy McKay: That's great, really just helping the industry get it out in the open so that everyone can activate and not keep the problem going. And that brings us up to a really important part of this program that I think has been the most conversation starting piece of this, is as this was moving along, the question comes up and I've participated in a lot of these thought leader conversations and CHPA has been gracious enough to support the BAPP program over the years, because we also believe that this is a very important priority. But the question, Anita, you might find this interesting, the question came up was, okay, I'm at the lab, I've been using the BAPP program, they've trained me how to identify when I might get fooled. So all of a sudden I've tested this material and it isn't what it says it is, now what do I do?
Anita Brikman: I was wondering the same thing. What are your recourses if you get something that is adulterated and not what you thought you were buying?
Duffy McKay: And so this was a real big question and a lot of people had different answers. And so Mark, what did you guys decide to do?
Mark Blumenthal: Before I answer that, first of all, let me acknowledge, Duffy, I want to acknowledge CHPA and Barb Kochanowski and Scott Melville for the excellent support that you've given us over the years, understanding that there's a problem out there and that we are part of the solution. So we really appreciate your trust and confidence in ABC, and BAPP, in supporting our nonprofit research and educational work. I asked the same question a number of years ago to various colleagues. I had a herb company back in the '70s and '80s, almost 50 years ago I started a company in the middle '70s wholesaling herbs. So I came into this through the herb industry originally, and I'm very open and transparent about that and very grateful for that. Met a lot of great people, learned a lot about medicinal plants, and I'm still learning about it. But now of course, the last 35 years almost, we're just working off a non-profit platform.
And I kept asking the question, what happens to the stuff that has been documented to be adulterated, especially stuff that cannot be lawfully reconditioned? Under GMP rules, you can lawfully recondition certain foods and certain ingredients within certain parameters, but what about something like Stefan just mentioned, the St. John's wort with a red dye in it, which is an illegal food dye in some cases. You can't get that out, there's no chemical or other way to lawfully recondition that's St. John's wort extract. So that chemical compound that's been added or the group of chemicals, the colorants have been added, you can't get it out. It cannot be lawfully reconditioned for some kind of safe use as a food anywhere or as a dietary ingredient. Well, what many companies do historically is they send the material that they reject, sometimes they reject things that are reconditionable legally, they send it back to the supplier for either a reshipment of something else or a different batch of what they're ordering or they want to get a refund.
The question then comes up, what does the supplier do with that material? Especially if it's what we call irreparably defective, if it cannot be lawfully reconditioned. And unfortunately, and it's the dirty little secret that a lot of us know about, but not everybody guesses this, that some suppliers, if they sold the bad material in the first place, which legally they should have tested it before they shipped it and known what they were shipping. If they're selling stuff that's really bad, they'll often, if it's returned, they'll sometimes sell it to somebody else who has maybe not as good a robust quality control regime or might look the other way, I don't know. So it goes back into commerce somehow, it gets into the supply chain. So I started putting together an article for our journal, HerbalGram, about this subject, but I wasn't satisfied with the way the article was going, I felt like something was missing.
And I called my good friend Michael Levin, who's a respected GMP and regulatory consultant in the industry. He says, "Well, we can write an article about this, but it's too early for this. What we really need is a new SOP to deal with the return of this material or the lack of returning the material." Because what happens is we know that sometimes it's resold and it gets back into the supply chain. So we put together, over several years, what we call the BAPP Best Practices SOP for the Disposal or Destruction of Irreparably Defective Articles. By using the word articles, it could be ingredients for cosmetics, for foods, for dietary supplements, whatever. And we created basically a new regulatory term of art, irreparably defective, because there's actually a hole in the GMP rules, there's information about rejection and quality control.Because after all, quality controlled testing, the first test has to be for identity, you have to confirm the identity, then you deal with the purity. But if the identity's not right, if it's adulterated, you don't even go to purity, it's irrelevant because it's not what it claims to be. And so what happens is we have situations where we are helping people understand that when they have it in quarantine in their warehouse or in a separate warehouse just for quarantined incoming materials, depending on the size of the company, they have a moral obligation, possibly a legal obligation, not to return it to the supplier for credit or for reshipment of something else. They have a responsibility to have it destroyed, disposed of in a landfill, by a competent, certified third party. We created this SOP, and it's based on a platform where there's a contractual agreement.
The customer says to the supplier, "We want to have a contract with you or amend our contract, if they're already a supplier. In order for you to sell to us or to continue to sell to us, you have to now agree that we're going to adhere to the guidelines of the BAPP Best Practices SOP." And so it's a mutual agreement. And the supplier agrees that if a third party lab, that they can help choose a priori, using appropriate analytical methods, that they can help stipulate a priori. If a third party lab determines that whatever they shipped was irreparably defective, A, they're not getting paid for the material. B, they're not getting the material back. C, they have to pay for the extra cost of testing. And fourth, they have to actually pay for the third party certified company to come take it to the landfill or to the incinerator.
And that should be the stipulated terms of agreement or terms of engagement with any company in the herb business or the spice business or any other business, because this applies to a number of different kinds of products, with their suppliers. I mean, it seems reasonable, it seems appropriate, it seems ethical, and it would help reduce the amount of material that might be going into the supply chain.
Anita Brikman: Mark, that makes so much sense, that that would be a major disincentive to keep doing this bad stuff, right?
Mark Blumenthal: Yes, it would be. And by the way, let me just share, Anita, that it also applies to contaminated material. It doesn't have to be adulterated either by accident or intentional adulteration, which we've pointed out is a big problem, economically motivated adulteration, something that is contaminated by accident, either with chemical contamination or even microbiological contamination. If it's irreparably defective, it could be subject to the same SOP guidelines.
Anita Brikman: And how widely adopted are those?
Mark Blumenthal: Well, we just rolled this out. We just rolled it out in November at the SupplySide West Show after four years of working on this, and by the way, two rounds of public comment. This SOP that we've produced went through two rounds of public comment. Anybody that was an ABC member, a non ABC member, it was publicized in a lot of the industry trade media, anybody in the world could have commented. And we received, I think, over 108, I forget, different comments. And we have been very careful about how we, and very transparent on how we accepted or didn't accept various comments and amended the documents appropriately and accordingly. But basically this material, this SOP can apply to almost any material, it doesn't have to be botanicals. And it applies for a wide range, not just adulterated material, but contaminated. And it helps fill that hole, that gap in the GMPs that currently doesn't have any guidance on this matter.
Duffy McKay: So let me try to piece this together. We have the Botanical Adulteration Prevention Program that provides education and information to help buyers and laboratories identify and avoid adulterated or contaminated material. So that's one part of this, laboratory methods, awareness over trends and patterns. But then the second part of this is the best practices SOP. And for people who don't know what SOP is, that's standard operating procedures and GMPs. So that means that you've got it in writing, you're committed to it, it's part of your standard way you operate. So as soon as you identify that you have irreparably damaged adulterated material, you would follow that SOP. So you would go to read paragraph one, paragraph two, and that would instruct you to keep it in quarantine, dispose of it correctly.
And I think if I recall, I was part of the process, a lot of this required exhaustive legal review, people wanted to be comfortable that nor the supplier or the manufacturer each were sharing the responsibilities here, that the seller of the material assigning this to say, "I'm going to do my due diligence to ensure I'm not selling you this material. Because if I do, I'm going to be paying for disposal, I'm going to be paying for extra lab fees. So I'm now motivated to sell authentic and verified material once I've signed this thing."
And then as the manufacturer, I'm protected because I can now purchase from you. I can do my due diligence of verifying and if I find anything that's junk, there's not going to be a whole bunch of extra costs because I'm going to pay for some labs to prove it's junk, but I'm going to get paid back for that. I'm going to pay for some disposal, proper disposal, I'm going to get paid back for that. So a lot of moving parts, but a lot of it's really built around common sense and ethical practices. My understanding is the documents have just been finished after the two rounds of review, I's have been dotted, T's have been crossed, and now it's time for the companies to really look at this and assess at what level they want to embrace the program. Either way, the information is clearly valuable. Now, Anita, something that you'll appreciate, I think, is they've come up with a pretty catchy tagline. Tell us about that, Mark.
Anita Brikman: Oh yeah, let's hear it.
Mark Blumenthal: One afternoon when I'm taking a walk, I came up with the idea, burn it, don't return it.
Anita Brikman: Love it, love it.
Duffy McKay: It captures the whole thing, you're just going to burn it, don't return it and-
Anita Brikman: Don't return it. Now on the burning issue, is there any pushback? Because I know we've seen that on other environmental issues, as far as burning stuff in landfills. Has there been any thought to that?
Mark Blumenthal: That's a conversation that we really didn't do a deep dive in. We're not, first of all, concerned ... presumably this is not going to constitute a large amount of material that's going to be happening very frequently. So this is not like we're really going to be producing a lot more problems for the greenhouse effect and putting more carbon in the atmosphere. But in principle, that is a case. It can be put into a sanitary landfill without being burned, but the burn it, don't return it sounds better than put it in a sanitary landfill, don't return it, it just doesn't have the same catchiness.
Anita Brikman: Yeah, it is a little catchier, I'm going to have to agree with you. And it's something that hopefully will stick with our listeners.
Mark Blumenthal: Right. Exactly. Exactly.
Duffy McKay: So how would you describe success? Tell us a little bit now, in your vision of this, if you're looking back 10 years, you guys have been working on this, how would you describe success?
Mark Blumenthal: We've been doing it 10 years since Stefan joined us, we've been doing it 12 years, we started the program, and I'll let Stefan answer some of this, but we have almost 80 extensively peer reviewed documents published, number one, they're all available on our website, which is available to anybody in the world who wants to access our material. It's free information, underwritten by the generous support of our various industry members and underwriters, including but not limited to CHPA. Thank you again. So anybody in the world, a small laboratory anywhere or a company or a regulatory agency can access our material.
I think the best success in my view is that quality control managers of various companies have told us they use our publications in helping set specifications for ingredients that they purchase or they're looking at purchasing. And in some cases, because of those specifications that have been revised based on our publications, they've had to find different suppliers than the one they're currently using. And so that means hopefully, presumably better quality herbal material is going into millions of capsules and bottles because the people are adhering to better specifications. Stefan, you might have a different way of looking at how you measure success.Stefan Gafner: I look at it now from a point of view as a pharmacist, to have somebody coming in and buying an herbal dietary supplement. So I want that the consumer or the patient gets what he wants to buy. So for me, success would be that the dietary supplement on the shelf contain what is on the label, so that the consumer gets the expected benefits from the product they purchase.
Anita Brikman: And that's something we are so focused on at CHPA as well. The foundation is rebranding, for our consumer facing website, to include a lot more on dietary supplements and the ideas of what are the benefits, but also what to look for and watch-outs and those things. And the idea that this effort is underway to really improve the quality and integrity of the ingredients, that is a win for consumers and it's also a win for industry, as far as their products, and also reputation, don't you think?
Mark Blumenthal: I agree. And let me just say and just make sure that we're clear about this, there are many, many high quality companies that do a lot of responsible activity, that are run by ethical, responsible, and highly committed management who really care about the quality of the ingredients going into their products and care about the experience of the consumer on the end, whether it's a cosmetic ingredient, whether it's an herbal preparation that people are putting in their mouth and swallowing, whatever it is, there are a lot of good companies. The problem is, proverbially speaking, there's always been a bad apple in the barrel. And in our case, there are many barrels out there, so we have to do our diligence. And I would rather be here talking about the plethora of clinical trials that keep getting published, that keep documenting the safety and many of the benefits of herbs and medicinal plants.
And we have a whole database and website based on that kind of information. But at the same time, we have to be real and we have to be realistic, there are people out there who don't play by the rules. There's people out there who don't care about the consumer experience, all they care about is making money at whatever cost, and they're going to take shortcuts and they're going to sell X as Y or X cut with Y, but it's undisclosed and Y is something much cheaper, and so they can make a few extra dollars at the consumer's expense.Anita Brikman: Duffy, any final comments?
Duffy McKay: Well, I just want to say how much I appreciate the work you're doing, as myself, previous roles working with botanicals, and when you're in the company and you're sourcing material, you're so busy in thinking about the next quarter, that no one is going to stop and do this kind of work. So it's really great that you guys as a nonprofit, have stepped up, first of all, went through the painstaking process of collecting support. I mean, I remember 12 years ago, you going around with this grand idea and just having to get the monetary money to start the process, and then you're able to get all this work done and offer it to the people who need it most for free.
And I think that's really what makes this a potent initiative, is you're putting the information out there for an academic, a regulator, someone in another country where they might not have as much of this kind of lab work going on, and you're making it globally available. And I think that's going to have a real impact, whether it's on the olive oil industry, the cosmetic skincare industry, or our personal dietary supplement industry, this is really, really filling a gap and rising tide floats all boats. So I appreciate and I want to send my gratitude back to you guys for really sticking with us for all this time.Anita Brikman: Stefan, Mark, thank you for joining us on CHPA Chat and enlightening us. Good luck, I know this is a fledgling initiative, but I'm sure there are great things to come. Thanks for being with us.
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