Michael McGuffin has been at the forefront of the herb and dietary supplement industry since 1974 and for the last 21 years has been leading the American Herbal Products Association. He speaks to Joy Beckerman from Hemp Ace International about providing regulators with best practice recommendations for hemp cultivation, manufacturing, retail dispensing and lab practices. Produced by PodCONX https://podconx.com/guests/michael-mcguffin
Michael McGuffin has been at the forefront of the herb and dietary supplement industry since 1974 and for the last 21 years has been leading the American Herbal Products Association. He speaks to Joy Beckerman from Hemp Ace International about providing regulators with best practice recommendations for hemp cultivation, manufacturing, retail dispensing and lab practices.
https://podconx.com/guests/michael-mcguffin
Joy Beckerman: [00:00:09] Welcome to today's Hemp Barons podcast, everyone. Host Joy Beckerman. And so happy to be a great show with a special guest today. And first, let's talk for a moment about updates from what's going on in our country.
Joy Beckerman: [00:00:21] Movement of compassion, a movement of human rights and movement of justice. All four officers in the death of George Floyd have now been charged. The lead murderers charged Eric Chauvin have been upgraded to second degree murder, and the other three officers have now finally been charged with aiding and abetting of different types. There are some details around that night. I find that even the main news organizations don't have all of the details correct or sync. But that's the bottom line is justice is on its way for those four officers. And in terms of the protest, the malevolent, destructive infiltrators appeared with abated. And we're seeing growing protests now in hundreds of cities in all 50 states and a groundswell of grassroots organization that's taking place very quickly with synagogues, mosques and churches. Are spiritual community really beginning to anchor the movement as it did so effectively in the 1960s? And remember, in the 1960s, we had phone trees, word of mouth and Xerox copying machines had only basically just been invented in 1959. Now we have all of these powerful tools at our disposal to organize people, to relay information, to fact check. This movement is on fire and it's not going away. We're going to take it all the way home. For example, entities and communities are starting petitions and movements on their own to remove known racist law enforcement leadership personnel into and contracts with police departments. The revolutionary words to live by, think globally, act locally are finally screaming in our ears because the reality is there's no magic government or magic law that's really ever going to solve our challenges.
Joy Beckerman: [00:02:00] There is no magic amount of money that's going to solve our challenges. It's us. It's people, one by one, taking responsibility for an acting on what we can heal and what we can change in our own neighborhoods and then our own neighborhoods, taking responsibility for and acting on what we can heal and what we can change in our own communities. So neighborhood by neighborhood, community by community, it's people power that will heal this world. We are the change we wish to see in the world, and we are the ones we've been waiting for. And we're going to heal this world. We'll talk about healing. Michael McGuffin, our guest today, president of the American Herbal Products Association, or APA, as they are so well-known throughout the Hemp and dietary supplement communities. He's been active in the herbal industry since 1975. He's a genius. He's a guru. He's a standard and ethics and code of federal regulations, expert and oppas contributions over the last decade, ten full years. They've had a Cannabis Committee to the advancement of the cannabinoid industry is immeasurable. When Michael starts talking, I listen. I take it down. He's just an absolute treasure. A legend and also a formal legend as named by New Hope Natural Media. So get ready for a great interview with Michael and I'll see you again next week.
Joy Beckerman: [00:03:20] In the meantime, I'm wishing everyone in your family's good health. Inspiration to find your purpose, to get out there, to join this movement and to get active.
Joy Beckerman: [00:03:38] Well, hello, Michael, thank you so much for being with us on Hemp Barons today.
Michael McGuffin: [00:03:42] Well, you're quite welcome, Joy. I greatly appreciate the opportunity to talk to you and your audience about this. Erbe Hemp. It's something that's very much on our minds for the last decade now. And I like. Again, appreciate the opportunity to talk to you.
Joy Beckerman: [00:04:02] Well, we are the beneficiaries of the true expertize that you are about to share with the listeners and with this promising emerging industry. As I often say, when I introduce you at conferences or elsewhere, I say when Michael McGuffin speaks, I will grab a napkin to write down what he's saying and that and nothing could be more true. So, folks, if all you have is a napkin recipe, start writing on it. Or, of course, go to our Web site to replay this episode, because Michael is an expert upon experts in the herbal industry, in the dietary supplement industry, and very much as it relates to Hemp dietary supplements. Now, Michael, off of the American Herbal Products Association is playing such an important role in the development and standards and ethics. And we're so blessed on the on the U.S. Hemp authority to have Holly Johnson, your chief science officer's brain. As as we move together as an industry that you took this on, you have been in herbs and in dietary supplements now since 1974. This was before there even was a legal dietary supplement industry. And offer then was formed in 1982 again, even before there was really this legalized dietary supplement industry. It was the Dietary Supplement Health and Education Act, which, as you well know, started out as the Health Freedom Act and then evolved into this. Schey, the Dietary Supplement Health and Education Act, changed in the early 90s, during which time you were a member of the Board of Trustees for Oppor for a full decade before you became this important association's president in nineteen ninety nine. So you're now celebrating 21 years and oppor. If we could start out with the Cannabis committee that APA created some years ago. Really one of the first. I think the first. And you'll correct me if I'm wrong on that Michael mover in in recognizing this opportunity, recognizing the need for the industry to start to lead the CBD and cannabinoid industry. And you created the Cannabis committee. Let's take it from there, Mr. Shaw.
Michael McGuffin: [00:06:21] We we chartered our Cannabis committee in in June of 2010. So it's been 10 years now. And then there are also activists, but more on the medical marijuana and adult use marijuana activist organizations that long preceded and that are very important players like Normal and the marijuana policy project that we brought to the table in 2010. And what we thought was needed was a unique experience that Oppor had at that time was already decades of engagement with federal regulatory agencies on proper practices for oral dosage, herbal products. And we recognize that the emergence of Hemp products in the marketplace was inevitably going to go to tablets and capsules and tinctures. And we already knew a lot about how to interact with the Food and Drug Administration, how to address labeling issues, how to work together in an industry to create self-regulatory models where necessary, and some of our earliest outreach. I'll remember this for years to come. When I first met, step here with the Americans for Safe Access, another real leader in the medical marijuana side. What steps said to me? She thanked me for recognizing for oppas recognition that our tent, our herbal tent was big enough for this earth to live here too, because she was really a strong advocate for recognizing Hemp in the community of botanical ingredients rather than some isolated herb that was somehow a discovery of natural medicine or natural products. And I thought that was very important and and I appreciated the recognition of that. It wasn't really how we started. In our initial discussion of forming this committee, but soon as she said that, it kind of clarified that we would be able to bring the resources that we've developed over that. She said Apple was formed in 1982, so it was already that nearly 30 years in we could bring all those resources and share them with the developing Hemp community and product marketplace. And that's what we tried to do in the interim.
Joy Beckerman: [00:09:09] She's incredible. And, you know, of course, that's exactly what Cannabis preparations were. They were botanical preparations, as we well know, as the golden age, really, of the United States or Cannabis Apothecary between 1830 and 1937.
Joy Beckerman: [00:09:26] So everything old is new again. And and Steph is just an incredible leap into exercising that and and for recognizing really the future of what all of these tremendous properties with their different wellness and other benefits can bring from this plant. AIPA has created a number of guidance documents for the for the industry. And we at the US Hemp Authority definitely refer to some of these guidance documents. Could you take a moment to explain the guidance documents that you've created for this industry and watch whether or not certain of them are available publicly and to reveal others available for being a member of APA, which is one of the most valuable trade associations? That person, a company and industry leader, can be involved with. If you are talking about dietary supplements, herbal medicine.
Michael McGuffin: [00:10:29] Well, thank you very much for that. Again, right at the beginning, we formed the committee and we looked at the needs of developing marketplace. And remarkable was that so many companies were coming into this business that had no prior experience of selling an FDA regulated product. They were entrepreneurial. They were true believers. They were strong advocates. They were committed to sharing their personal experience, all of which I think are great reasons to bring products to the marketplace. But what they were lacking was hands on real world experience. And we had been developing guidance documents for our members for quite a number of years. And so we just borrowed that model and created four different. We call them recommendations to regulators that addressed best practice for cultivation, for manufacturing, for retail dispensing and for lab practice. And there the documents, if you could just about go in and substitute any other botanical. With the exception of that, we had issues like THC to deal with on the non products that are intended to remove the THC or limit the level. We had security issues in the marijuana medical cannabis side. So there were some specific elements, but largely we were borrowing what we had learned over the prior decades and sharing that with this community. But we also and this is just our process for any kind of guidance. We didn't try to make that up.
Michael McGuffin: [00:12:23] I didn't sit with my colleagues, with Jane Wilson and Holick Johnson and and makeup. Well, what do you think would best? Instead, we brought the community together and we met with the people that were growing. We met with the people that were manufacturing, the people that were running the labs, the dispensary. And we created a forum for them to share their knowledge and experience and then put it in the context of our broader botanical experience. And we still do that. You mentioned the Hemp authority and Holly Johnson's involvement there. We're very collaborative. And so when the Hemp authority first came into being and they decided to create a standard, we were asked to participate and we did so. And we we think we contributed both with ideas and with criticism. And then when they when the first draft standard came out, when version one came out, the authority then came back out and said, we invite further criticism. We want to make this even better. And we again, engaged and have. Continued to make our contributions in terms of supporting that standard, ensuring that any company that complies with that standard also meets the expectation of a regulator. Once we get to a transition in the way that FDA deals with these products, which is a topic that I hope we get time to talk about here today.
Joy Beckerman: [00:14:00] Yes. Excellent. I absolutely want to make that a focus. And in fact, I think probably a good segue way to that is and we spoke about it earlier, another lobbying call for other groups that we're we're involved in about how we read the cottage industry and those enthusiastic entrepreneurs of which you just spoke, who were really moved by and inspired by it and passionate about these products, really created this industry and started to make these products available, whether it was with Hemp seed food or other cosmetics moving forward. And we're talking about Hemp is Hemp Barons. So just keeping it sort of focused on Hemp derived kanab and weights.
Joy Beckerman: [00:14:45] And and when we talk about you as Hemp authority version one point. Oh, I often describe it as. The industries wanted to be able to not freak everybody out. These folks, as you say, did not even have an awareness over what the code of federal regulations are for current good manufacturing practices, for substances that are going to be ingested or applied to someone's skin. And current good manufacturing practices, of course, goes far beyond the actual manufacturing. And I say the timing issues that we're talking about holding, distributing, complaint management, packaging, labeling, all of those aspects are a part of current good manufacturing practices. And so we wanted in version one point oh, to sort of I guess the best way for me to describe it was GMP Lite. And maybe you need to be sort of eased in to what GMP actually is. Well, that way of thinking, and it very clearly became very obvious, obvious to us. I'm sorry if this is going to shock you guys. These are the rules. This is the code of federal regulations for the businesses in which you are engaged. You are manufacturing dietary supplements, Sutin Cosmetics and so quickly went up to baseline GMP compliance with the Code of Federal Regulations.
Joy Beckerman: [00:16:09] And then, of course, the additional standards and guidelines specific to specific to cannabinoids. Now, when it comes to trade associations, particularly when you are stewarding dietary supplements, are not the best friend of the FDA. I often describe dietary supplements as sort of the ugly stepchild of the of the FDA. And we're piling on now with Cannabis, whether it be Hemp or other forms of Cannabis. But folks need to comply. And if they're going to be a part of the trade association, there does need to be policy around that compliance and some type of monitoring. And I'm seeing that that's where a lot of various trade associations are, are popping up everywhere. And even some existing that are not really monitoring the compliance of of their membership. And members are coming in, you know, ad nauseum. How does ApoB I know that oppor has a clear policy if you are a member. You are following these regulations, mock up a monitor at all or attempt to deal with members who are not compliant.
Michael McGuffin: [00:17:26] We spend very little of our time or focus on policing. That's not our task. That is the regulators task. We have a procedure when you apply to us, we will review sales literature, review your Web site specifically looking for drug claims, claims that your product can cure, treat, prevent, mitigate disease or disease symptoms. And we will let companies join. If we see those kinds of claims, what's remarkable is the number of times that happens, at least ten or twelve times every year, we call an applicant back and we say, with all respect, we can't allow you to join because you're making these drug claims. And 10 or 12 times out of those ten and twelve times, the company says, what? What are you talking about? Really? I didn't know that they fix it. They thank us and then they join. It's really remarkable that we provide this plane membership service to and go going back to a lot of companies that are coming into the trade because they're excited. They're passionate. But they they're not familiar with laws and regulations. And we provide that really as a service that I think the first few times we did that, we thought we were going to be attacked. The challenge. Who who are you? You're not FDA. And that's not at all what we hear. What we hear is a recognition, the acknowledgment that the company was not aware of that restriction and an immediate willingness to fix it. So that's the main way that we are in the enforcement side. We pretty much rely on the Food and Drug Administration or the Federal Trade Commission or, you know, the Occupational Safety Administration. We don't we don't act as regulatory enforcers. We do provide educational services to our members so that they're on the right side of that regulatory inspection, which is fantastic.
Joy Beckerman: [00:19:50] And the wage and the way to operate and. That is also my experience for the most part, folks want to comply. Appreciate the feedback. It's very rare when when somebody pushes back and it's generally just a good little good little red flag or a warning when someone does. But it is very rare. I find that folks want to be a part of this industry, not just because of their financial investment, because they want to be good stewards of this amazing plan and the promise and all that it has to offer.
Joy Beckerman: [00:20:25] It's it's very, very exciting and uplifting and encouraging to be a part of.
Michael McGuffin: [00:20:32] So now let's talk about the FDA. As we're aware, the FDA has been saying for a number of years now. It's just that in the last couple of years, it would seem that state departments of Health and State Departments of Agriculture were all of a sudden being becoming aware that the FDA guidance position is that it is a violation of federal law to market CBB as a dietary supplement or food additive, and that that is because at the end of your investigational new drug preclusion. So there isn't a regulatory framework right now at the FDA, of course, understands that it got its marching orders from Congress, the prior acting FDA commissioner, Scott. Dr. Scott Gottlieb, of course, immediately testified in right after the 2008 farm bill was signed that. Yes. Here we've got our marching orders from Congress. They want there to be a legal pathway for these CBD products to be sold. Yet here we are a year and a half later and we're not very far down that path. So from your perspective. A. The regulations that you want to see and B, any feedback or your impressions on this process of creating the regulatory framework?
Michael McGuffin: [00:21:51] Sure. I appreciate that question because I think it's what those of but very involved in industry governance are talking most about. We have a class of goods in the marketplace being consumed by. You probably know the numbers better than I do. Hundreds of thousands or millions of people that FDA has interpreted the law to say these products are not allowed in these products. So they're not regulating those products. They are. Their regulation is focused on drug claims. They will go after companies for drug claims, but they're not inspecting their manufacturing facilities for compliance with GMP. They're not demanding submission of serious adverse effect reasons reports. They're not reviewing nutritional information on product labels, all of which should be happening. So and you're right, Doctor Gottlieb, I believe it was on the day that the farm bill passed in December of two thousand and eighteen, issued a statement that sounded very optimistic that will we understand we'll need to create a pathway and we'll get there within two months. His testimony had moved to within three to five years. And that's not what we need because consumers are using this product now. I appreciate Dr. Gottlieb is gone. Doctor on is the current FDA commissioner and his statement just a couple of months ago, in February, I guess it was.
Joy Beckerman: [00:23:26] People are using these products. We're not going to be able to say you can't use these products. It's a fool's game to try to even approach that. I appreciate that, Dr. Hahn. What?
Michael McGuffin: [00:23:37] What we really need to see is for FDA to create it has the authority to create the pathway. And what we have argued is that.
Michael McGuffin: [00:23:50] Although we empathize with the difficult challenge that the agency faces, they still need to do something because the the right the priority is the Food and Drug Administration is protecting public health. And that falls away if they're not regulating the good. So even though it will be difficult to create the pathway, we're asking FDA to complete that difficult task so that we can pull these products into a well regulated, regulated structure. And and then from our point of view, that's not particularly complicated.
Michael McGuffin: [00:24:34] Regulated exactly the same way that every other botanical dietary supplement is regulated. We don't need a whole new set of regulations for Hemp.
Michael McGuffin: [00:24:44] We've got we've ironed that out over the last quarter century. It fits very neatly in the regulatory structure that governs vaccination, camomile and ginkgo and aloe, and that's where it belongs.
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Joy Beckerman: [00:25:44] Of the many public comments that I have drafted and submitted, it's basically in a nutshell, if it ain't broke, don't fix it. There's a wonderful existing regulatory scheme here for botanical extracts. Here's what we need to deal with for CBT or other cannabinoids. THC limit labeling, potential warnings that may be different at testing, even even those limits. Of course, we are already using existing guidelines for heavy metals, residual solvents like a toxin, et cetera, et cetera. So it's a very little tweaking or supplement, as it were, supplementation to the existing regulation that we're asking for. And an arbitrary enough. It was in that February of 2019 testimony because he did that that December 20th was it was an interesting day. The farm bill was signed December 20th, 2015 was an interesting announcement from the FDA. And also today, of course, that they approved for the first time ever, Grauwe status generally recognized that state status to Hemp seed oil and protein powders and hold Hemp seeds. But it was in that same three month later or so February congressional testimony that Gottlieb said, we got our marching orders and yet we think we're going to need 60 million dollars in three to five years, et cetera, et cetera.
Joy Beckerman: [00:27:11] So I and I, too, while we are using these really fantastic quotes as look here, folks who are confused about the legal status of CTD, look with the commissioner just said he said it's a fool's game to even try to approach getting people to stop these things.
Joy Beckerman: [00:27:31] Having said that, as you say, we still have the lack of clarity. We still have State Department of Health and State Departments of AG opining and this absolute patchwork of state regulation and law where we have some states that are not allowing any CBD products at all. Others just cosmetics, others with no oversight, while yet others have labeling requirements that are so onerous that a national distributor can't possibly create a label that would comply with all of the different 50 states. So it's pretty untenable and we need to move forward with that. Any prediction, Michael?
Michael McGuffin: [00:28:10] Well, certainly from the perspective of industry, we need a single unified regulation all across the country. We want to support interstate commerce.
Michael McGuffin: [00:28:22] We don't want to play some requirement that if you want to sell it in Rhode Island, you have to grow it in Rhode Island and make it Rhode Island. And nor do we want a nationally sold brand to have to have different labeling in different states. It just doesn't make sense. I want to use an example of how the current regulation works and the one that is often cited as well.
Michael McGuffin: [00:28:49] How could we regulate this? The same as Michael just said, Eckard Asia Alo. We can use the same rules. But but this one has THC in it. OK. So there's a part of the GMP rule that good manufacturing practice rule for all dietary supplements, that the manufacturer is required to establish a specification for any contaminant that may adulterate the finished product. Well, THC is a contaminant that may adulterate the finished product. So the regulation already requires you set a specification for that and your specifications can be not more than zero point three percent THC. And then there's the next part of the same regulation for all specifications, not just these specifications on contaminants that know that you set the specification you have to ensure that you met them. And the FDA inspector has to be able to see that you had the specification and you met it. So it's really not that complicated. It's not at all complicated. It's apply the existing rule to this particular botanical in terms of predictions.
Michael McGuffin: [00:29:59] The FDA will eventually create the regulatory pathway, I wish I could say when the there is no a lot of pressure on having Congress do FDA job for it.
Michael McGuffin: [00:30:16] Having Congress force the issue. I'll take that as a backdrop. But it's certainly not the preference. The preference would be for the Food and Drug Administration to complete the task. It has the authority that has the Know-How. There's some really smart people that work at that agency. They've got resources. That's our preferences. That FDA recognize that this should be resolved like by by just acknowledging that the herb is treated like any other. Again, they the agency does have that interpretation that because CBD is now an approved drug, there's a prohibition against our inclusion of CBD and any dietary supplement or adding it to any food. And we could agree or disagree with that interpretation for the sake of argument. Let's say FDA is accurate. They have the authority to just set that aside. They have the authority to grant an exception. They need to do that. They can never meet that first priority of protecting public health until they do that. And that's what we've been asking them to do for almost two years now. When will they do that? My crystal ball is just not that good.
Michael McGuffin: [00:31:37] But I but I would close with the statement that you and I have both made in in acknowledging that what Commissioner Hahn has said is these products are not going to go away.
Michael McGuffin: [00:31:53] People are using them. OK, then let's figure out how to properly regulate them. That has to happen.
Joy Beckerman: [00:31:58] It surely does. And what's interesting, and I imagine this is going to come up and you mentioned, you know, that zero point three percent THC. The issue is that the Agricultural Improvement Act of 2009 18 defined a plant. It didn't define a finished product. Right. So it's a zero point three, not greater than this Cannabis to keep a plant. We don't get into the tax nominal errors of that. But a Cannabis a cheaper plant that does not contain greater than zero point three percent Delta nine tetrahydrocannabinol on a dry weight basis. So not a finished product. Not a liquid product. A plant. So like most developed countries, Canada and so on and so forth, we're more than likely because it's a necessity going to be going into PCM parts per million of THC. So, for example, can't have a maximum of 10 p.m., I believe, in Canada, which, of course, only just this year started extracting hemp legally for cannabinoids through these very intricate more medical marijuana program. The Hemp folks can do that. But up until this last year, since 1998, when candidates started regulating as an agricultural commodity this crop with federal crop insurance. And Canada quickly became and hopefully will catch up soon. The world leaders in bulk Hemp grain food ingredient processing. It's always been PDM and I think that there is no way around that because this this reference to zero point two percent keeps me on a dry weight basis, just does not involve finished product.
Joy Beckerman: [00:33:34] So I think that there's going to be another set of arguing over that. For example, the EU wanted to set a limit of five p.m. And as is the case, most of us International Trade Association folks and in industry leaders speak with each other globally. And so the European Industrial Hemp Association wanted support like that. We want your support, America. We want you to write in public comments that says five TPM is correct and good and four for me and for the leading trade associations here. They didn't participate and we can't always support each other's initiatives. We tried very, very hard. It feels bad like, well, we can't, but we don't even believe there's scientific evidence to limit it to 10. PTM, THC, we don't think there is any chance of intoxication even at 10 p.m. So we certainly weren't going to support five TPM. How do you think your vast experience in the dietary supplement industry and how these things go with rulemaking? What would you what is your prediction around that? I hate to use that word. None of us have a crystal ball. But what do you what are you thinking that might look like?
Michael McGuffin: [00:34:44] Certainly the tools available to trade associations know how to address those issues that we can build on our experience with self-regulatory. Models and self-regulatory positions to add.
Michael McGuffin: [00:35:05] Come to an agreement on what is an appropriate limit for a finished product.
Michael McGuffin: [00:35:10] And the best way to do that is through an open conversation and transparent discussion with people in the trade. People concerned about health issues. And I think that can be accomplished.
Michael McGuffin: [00:35:26] And and if it is accomplished internationally, that is certainly better. But we would want to be looking at exactly what you just inferred. Is it. Let's say choose an artificial number. What is the number? What is the limit in a finished product? That would be below. Any possibility of a physiological effect on a sensitive person.
Michael McGuffin: [00:35:52] And could we agree to establish that as an industry standard at the same time that I'm advocating for a basic regulatory structure as supporting this plant?
Michael McGuffin: [00:36:08] That doesn't mean there. There still is room for self-regulatory standards. You mentioned earlier heavy metal limits. There are no federally required heavy metal limits for foods or supplements, with a few exceptions. FDA has a lead limit for. Likely to be consumed by children.
Michael McGuffin: [00:36:30] And it has some for shellfish. There are a few limits out there. But largely, we rely on industry standards that again, this wasn't Jane and I. Jane and Holly and I are sitting around saying, well, these numbers would be good, rather. We met with the the big ingredient producers. We looked at what's pragmatic. We looked at what's actually in the market. We studied and evaluated toxicological information. And then we arrived at recommendations that should companies choose to establish limits for their product. We recommend these limits so that the same kind of process can occur here as needed.
Joy Beckerman: [00:37:17] Absolutely.
Joy Beckerman: [00:37:17] And for the US sense authority, that is precisely who we point to, heavy metals, pesticides, microbiology and mycotoxins are. Is that is that a guidance? So it's interesting to see, you know, regulators and industry working together and and creating that self-regulation, plugging those holes. Where were the regulators aren't providing that guidance or that standard. Let me ask you this, Michael.
Joy Beckerman: [00:37:45] The FDA and as you mentioned in a previous response, of course, it would be much more ideal if the FDA would come up with their safety guide to come up with a determination and create its regulations. They don't want to be forced in even the subcommittees or the committees at U.S. Congress within which these these debates would otherwise fall. And I believe that's us. And I'm gonna botch it a little bit because it's a much longer title. But the Senate Committee on Health, the House Committee on Energy and Commerce, oddly enough, also deals with these types of things. And those committees are even saying, listen, we we wanted a chance that there is going to be legislation on this issue. We wanted to come to our committee. We want to be a part of this process. But again, ideally, it would be that the FDA acts, they continue the FDA to state that they have concerns over human liver toxicity. And I'm just gonna throw out a few stats and and then I really want to hear your your thoughts on this and for the listeners to get the benefit. Because I. I prefer and have always preferred to walk in partnership with our lawmakers and our regulators. That's just how you get things done. And it's just a wonderful way to be able to be joint, good collaborative stewards of these opportunities.
Joy Beckerman: [00:39:07] And I try very hard not to be suspicious. I have a little bit of PTSD around the Drug Enforcement Administration, which we've just been battling with for decades and decades. And they oftentimes seem to me to be the biggest addicts in the world in terms of being addicted to prohibition. But the FDA, I get concerned because when we talk about human liver toxicity and we even just discuss acetaminophen so commonly available at almost every store, I don't think there's any age limit to buy acetaminophen. And yet we see that there are some hundred thousand plus calls to the poison control center annually over at 56000 emergency room visits, which result in twenty six thousand hospitalizations than an average of four hundred fifty eight deaths per year on intentional and unintentional overdoses of acetaminophen that have caused causes liver toxicity, in many cases fatal. And that those are numbers directly from Pop Machol. And we've got all of this talk and apparently there were several deaths during the clinical trials to prove the safety of a in acetaminophen. And we have none. We had the opposite of those statistics here. So is really going on in your view of this concern of human liver toxicity with CBD? When the World Health Organization has said that it has a good safety profile and generally well tolerated.
Michael McGuffin: [00:40:33] Great question. I think there's there are a couple of factors. So maybe 30. And I can think of a couple. One is that I think that just institutionally, the Food and Drug Administration considers drugs to be well regulated. They've got a very strict framework, especially new drugs. Over-the-counter drugs is a little looser. But nonetheless, it's pretty well controlled. The over-the-counter drug monographs are very definitive.
Michael McGuffin: [00:41:04] These are the substances that you're allowed to use. So I think that FDA just has a greater comfort with it. The framework under which it regulates drugs than it does for the statutory control of dietary supplements.
Michael McGuffin: [00:41:23] And some of that goes back to the. You mentioned the Dietary Supplement Health and Education Act. That was not something that the Food and Drug Administration asked for, nor did they support it. They strongly opposed that. But it was what the American consumers, American citizens and the industry work together to get it passed, because prior to that, the Food and Drug Administration was actively working to create obstacles to the ready marketing of vitamins, even though it had been maybe a decade earlier. But at some point, the Food and Drug Administration established through regulation quantitative limits on the amount of vitamins that were allowed to be in a supplement form product that I think was one hundred and fifty percent of the RDA.
Michael McGuffin: [00:42:19] So that at that point, the FDA had a regulation that would have not allowed any more than 90 milligrams of vitamin C. Well, that's not what people want. People want to be able to take a thousand milligrams or more. And so that law got that regulation was pushed aside through legislative action. But my point being that there's been an ongoing, shall we just say, disagreement between the Food and Drug Administration and the people of the United States and their demand for natural products, that that explains some of why there is this tension now or why there's been such difficulty in resolving it. I think another piece is that there's been a false narrative created that we've heard numerous examples of. I've heard this at least two or three times. Well, what are we going to do to control cumulative consumption throughout the day? Here's the narrative. So it's you know, it's almost 3:00 in the afternoon here. So I probably already had my CBD coffee this morning. And then I put some CBD soy milk over my CBD cereal. And then I had a CBD snack mid-morning and then I slathered some CBD sauce on my party is at lunchtime and I hadn't even taken my CBD supplement yet. Well, that's just not true. That's a false narrative. I mean, maybe there's one or two people out there, maybe one or two. Your listeners are saying, yeah, that sounds like me, but most of them know that's not what we do.
Michael McGuffin: [00:43:57] We have a CBD product that we like to take, whether it's in food or in supplements. But almost nobody is. Beating CBD, eating a Hemp product throughout the day, over and over and over. But the FDA has called that out as something that they need to resolve before they can get this regulatory pathway. Another example is the. I think the liver talks, we know that that's based on a very high dose and rarely seen and does not in any way imply a likelihood of liver damage from taking the kinds of Hemp products that are in the market place. And and so I I'm concerned, too, that the FDA is asking questions that they're asking us to prove a negative before we can go forward. Another of the narratives we've heard is these these terms have come into the marketplace. It was largely Hemp products trying to differentiate themselves from pure CBD, from CBD. Isolette came into the marketplace first called full spectrum extract, which, by the way, is a synonym for extract. And then there was a differentiation, a broad spectrum extract meant to be a full spectrum extract from which the THC has been reduced or some other compounds been removed. Well, I keep saying, you know, what we call vanilla extract. We call it vanilla extract.
Michael McGuffin: [00:45:27] We don't call it vanilla full spectrum extract because it just vanilla extract. But now we've heard FDA say they need to understand the difference between full spectrum extract and broad spectrum extract in order to understand how to regulate all of these goods. And, you know, we're working on that. We're trying to come up with some definitions. If it if it were today, what I would tell FDA is neither of the terms mean anything. They need extract and we don't really need to resolve that. They mean an extract that's made when you put a plant biomass in solvents and make it simply extract it. It's not it's really not different than vanilla extract. Unless you start controlling for one or another the compounds and then those kinds of products do need to be differentiated. So, you know, back to the comment that you made or the the direction that you've taken the conversation here, I think we have all of these issues that the agency has identified as if they have to be 100 percent resolved before this regulatory pathway can be created. And I think there there are parts of this that we just need to take full responsibility for. It's satisfying to see companies that are moving forward with their free market safety work through grass affirmation or through new dietary ingredient notifications or preparation for those.
Michael McGuffin: [00:47:00] Right now, FDA won't accept those at the same time that they're currently.
Michael McGuffin: [00:47:06] We need to push back a little against some of these false narratives and then make it clear that what we're all looking for is the same thing, a product that is safe and readily available and of good quality, which, by the way, are the same priorities that FDA carries for all of this class of goods.
Joy Beckerman: [00:47:29] Well, I can tell you this Hemp extract and Cannabis in all of its forms and in all of the ways that it can improve our lives and improve the lives of the animals. We are very, very blessed to have Michael Magoffin and the American Apple Products Association onboard helping to lead the lead the way and really steward this this incredible crop and all that it can be to improve our lives and and our general well-being. And and, of course, all of the promising research that's going on. Michael McGuffin, thank you so much for being with us on Hemp Barons today. I cannot wait to have you back and I'll be very excited when we're traveling again and I get to enjoy you in person. You are a delight, sir.
Michael McGuffin: [00:48:11] Thank you. Thank you very much. And if I can, I'll leave us here at the end with a little humorous quip if we don't get this resolved soon, Joy. We're going to have to rename the plant. I'm thinking we need to call it Cannabis fatigue. I think it's exhausting, right? It's exhausting. We should be able to get this resolved. It's just another urb. Let's let's create a good regulatory pathway so that we can put our fellow citizens who really want good quality Hemp products available in the market.
Joy Beckerman: [00:48:46] Aymen Cannabis fatigue. Wonderful. Thank you so much again, Michael. And enjoy the rest of your healthy. We enjoy. Thanks again for the opportunity. Thank you.
Larry Mishkin: [00:49:10] I'm Larry Mishkin. I'd like to invite you to join Jim Marty and me on our weekly podcast, the Deadhead Cannabis Show. Each week we explore the latest Cannabis and Jim, then to reminisce with other Cannabis industry, Deadheads and jam band aficionados, not to read musical acts we've seen and heard. Check out a new episode every Monday at MJBulls.comor wherever you listen to Budget's.
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