Why does ZOI Global NOT USE fulvic acids and humic acids in their formulations?
Denise Stephens, ZOI CEO (00:00):
This let's discuss humic acids and fulvic acids. There seems to be a mystery in the zeolite dietary supplements market surrounding humic and fulvic acids. So will you please help demystify the zeolite dietary supplements market regarding humic and fulvic acids, please?
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (00:21):
I would be glad Denise. First of all, humic acid and fulvic acid, uh, it's a wrong expression. Fulvic acids in humic acids is a group of acids that are produced from the degradation of dead animals and dead plants in the soil. So practically it's a natural fermentation material and it's coming out in the soil from the cycle of life. Dead animals, dead plants degrade and create several, uh, chemical substances. Some of them are named humic acids and fulvic acids. Interestingly lately, um, humic acids and fulvic acids are used in dietary supplements, but there are many, many questions surrounding humic acid and fulvic acid, uh, and they are very, very controversial as you very well know, we have received a question at ZOI Global on why we don't use humic acids and fulvic acids in our formulations. Now let me start with a short story.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (01:53):
As we know with Metron’s professional strength formulation was in the market from May 2015 under the commercial name CytoDetox. The commercial name CytoDetox was not the property of our company, that was owned by our distributor at the time a company called 180 Degree Solutions. Now from 2000 from May, 2015 and the October, 2017, 180 Degree Solutions was distributing Metron’s professional strength, detox formulation under the name CytoDetox within this period of time, 180 degrees solutions breached the relevant distribution agreement between Metron and them. And for these reasons in October, 2017, Metron Nutraceuticals terminated the distribution agreement between Metron and 180 Degrees solutions and never produced again, CytoDetox for 180 degrees Solutions. Now after October 2017, two things happened Metron’s professional strength, detox, dietary supplement, which is available through ZOI Global, only two licensed health healthcare professionals, medical doctors, Dentists, and licensed practitioners is in the market under our name ClearDetox Pro the Metron’s produced side to detox since 2015, up to 2017 and ClearDetox Pro are identical only the name changes.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (04:16):
The second thing that happened after October 2017, we're Metron Nutraceuticals. Terminated the distribution agreement with one 180 Degree Solutions is that 180-degree solutions created the knock off product under the same name site of CytoDetox. And this knockoff product contains zeolite suspension among other ingredients, and also conveyance. Guess what? Humic acids and fulvic acids. Which is very understandable to us? If you don't have the real thing, you want to add little star dust, a little Hocus Pocus, a little snake oil to create a product and keep have the profit that you use to have with the real product which was made by Metron and patented in fact, triple patented product. So, this is how Metron became aware of the use of humic acids and fulvic acids in a knockoff product formulation. That used to be the real thing when Metron Nutraceuticals, who because was producing it right now in general.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (05:44):
Um, we have been asked why we don't use humic acids and fulvic acids in our products. And our position is very clear. There's no science to support the use of these products in our formulations. And in fact, in any dietary supplements’ formulation, we are at where that these products are available in the United States markets. One of the companies that is making this product seems to be a company called Black Oxygen. And this is a Canadian company, not an American company. It seems that manufacturing is done in Canada. Now from Black Oxygen side, we see a lot of, uh, nice faces there advertising these products. But, uh, again from the Black Oxygen site, you click on one of these individuals that, uh, advertising this product in what you get these testimonials. So, the advertisement is based on testimonials and Denise. We have discussed in the past that unfortunately we live in the era of marketing over science, and we have analyzed on why testimonials, uh, used by companies to promote products practically have absolutely zero value.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (07:25):
If you have a science for the product, you present your science in the patent or in a paper published in a peer review journal that you present your science testimonials say nothing. Especially if this, testimonials are not followed or don't follow proven science in peer reviewed science as presented in patents or peer reviewed papers. So this company is based everything on testimonials in order to promote humic acids in fulvic acids formulations. And we see here that there are allegedly 14 great reasons to take black oxygen for the rest of your life. Um, I would like to read directly from this highlighted, um, part of this, uh, marketing effort of this company. It says that due to its Nano size, black oxygen moves easily into cells, including the blood-brain barrier. And he's, that's a very bold statement. Um, as we very well know, we have three patents, not one or two, but three patterns for our water-soluble zeolite we have conducted the appropriate study to so that it is capable in crossing cellular membranes.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (09:05):
And we don't even claim crossing the blood brain barrier. We did a search regarding this claim and there is absolutely zero scientific evidence that humic acids and fulvic acids can cross the blood-brain barrier and permit me to say, as a board-certified pharmacist and board certified medical doctor that most likely it's great that humic acids and fulvic acids cannot create, cannot cross the blood brain barrier. Uh, it doesn't seem right to me, that substances that come out of the degradation of dead animals and dead plants cross the blood brain barrier and get into our central nervous system. So, I continue reading it bonds to nutrients, guiding up to 60 times its molecular weight in nutrition into the cell fulvic acid, also bonds to waste inside the cell or removing up to 60 times its weight in toxins, heavy metals and pesticides.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (10:28):
We were unable to find any scientific publication or a patent that has been peer reviewed by the us PTO or anywhere else in the world, supporting these claims for this reason, we simply don't believe these claims. Now we looked more into the side of this company, and we find that a very key person is Mr. Marc Saint-Onge in Canada. And we look a little better and found in the Canadian securities exchange, um, information related to this gentleman. So, he was related with a company called Golden More incorporated in, as we see from the, as we see here in the Canadian securities exchange, Golden More began in 1987, it was founded by Marc Saint-Onge of Canada initially send on, started the company in his home using a washing machine to mix ingredients. All right, after an extensive search of 63 bugs, mark discovered the bug in Castleman for which.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (11:58):
He has the 25 year contract for extraction rights. The quality of the more in this area is higher quality than any other more used elsewhere in the world. I have no reasons not to believe what it is stated here, but again, um, dead animals and dead plants, degradation substances to be used as ingredients in dietary supplements. Um, there are many red flags here now in good faith. I believe that there is a list of questions that one can have regarding humic acids and fulvic acids and dietary supplements. Number one, there's no GRAS status from the, from the United States food and drug administration for humic acids and fulvic acids. So I'm wondering how these ingredients are used in dietary supplements unless we are wrong. And there is a Gras that in that case we would like to see what the Gras status is and when the FDA has designated GRAS status to humic acids and fulvic acids, number two, we couldn't find any diet data ingredients that new dietary ingredients stats from the FDA.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (13:37):
If there is any new dietary ingredient status for fulvic acids and human cascades from the FDA, what would like to see it? Number three, there's no published papers on safety of this products. And by published papers, I don't mean the usual white papers that companies, write and present them in their sites. I'm referring to peer reviewed publications in peer review journals, number four by many licensed health care professionals, physicians and practitioners. The safety of use of humic acid and fulvic acids in dietary supplements is questionable maybe because there's no published studies on safety. It remains questionable.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (14:42):
Number five, we are not aware of any publication regarding the efficacy of these substances. We are aware about the claims of the substances, but we're not aware of about any publication regarding the efficacy of humic acids and fulvic acids. Of course, we understand that our testimonials, but testimonials cannot and should not replace scientific information that you can find in peer reviewed documents like patents or papers published in peer review journals. Now we'll have some specific questions regarding humic acids and fulvic acids. That are in the market, not specifically from this company from Canada, but from any company now is manufacturing done within the United States for dietary supplements that contain humic acids and fulvic acids. And if yes, is manufacturing done at the FDA registered facility, if not, if manufacturing for dietary supplements, having humic acids and fulvic acids is done outside of the United States, what is the name of the company of the entity that is importing these dietary supplements in the United States? Is they important entity and FDA registered importer of dietary supplements?
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (16:26):
Finally, what would like to see what the CGMP are established criteria for the entity, the composition, the purity, and the strength of this product as the identity, the composition, the purity and the strength of this product are mandatory. It's not at your discretion to present it or to have it. You must have it. These are the requirements, at least in the United States for dietary supplements and the food and drug administration has jurisdiction over this, we think with the last red flag or regarding the substances related to several warning letters issued by the FDA. Recently for these absences, what we see here is a warning letter from the FDA issued on April 8th, 2020 to a company called M RP organics LTD because this company was claiming at their site that the dietary supplements, containing humic acids and fulvic acids had several medical users including treating or preventing COVID-19.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (18:11):
I am not aware of any study showing that humic acids and fulvic acids can prevent or treat viral infections, including, COVID-19. So, Denise for all the reasons that, I present you a lack of scientific information about safety, lack of scientific information, about efficacy, lack of a GRAS status from the FDA, unless we are wrong. And we would like to see this GRAS status, lack of an NDI application with the FDA approved by the FDA, unless we are wrong. And we would like to see this NDI approval from the FDA. I'm wondering how dietary supplements with humic acids and fulvic acids are even circulating in the United States. I understand that the Hocus Pocus, the stardust the snake oil salesman approach, give some high revenue to companies and to individuals that were convinced to invest their time and effort in promoting these products.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (19:35):
But this will not happen with Metron nutraceuticals, and ZOI Global. We cannot go there none of the elements that should be in place to make a safe and effective dietary supplement are in place. And for this reason, the ZOI Global formulations, we cannot, and we don't use humic acids and fulvic acids. Again, if something is wrong of what we said today, and if there is a Gras status would like to see it, if there is an NDA application, NDI application with the, with the FDA, for fulvic acid and humic acids that has been approved by the FDA, we would like to see it. And if not, all our red flags remain in place again, uh, I understand that very good individuals that like to help people, uh, may promote these products, being convinced by companies about the safety and especially the efficacy of these products based on testimonials, but, uh, all these friends that have been convinced in promoting these products, I believe that, uh, it would be good to have all these questions that we asked answered first before they put their name, their reputation, their money, their time, and the efforts behind these highly questionable substances and prominence
Denise Stephens, ZOI CEO (21:32):
Dr. Nicholas, I can't even begin to explain a set it in the very beginning, you know, ZOI Global operates, and our tagline and we proudly say, this is Zero Barriers. So, when something creates a barrier for our customers to understand, or our advisors to understand, we're able to bring it front and center and present it to people and you again have just exemplified why I said in the beginning, you are one of ZOI Global unprecedented assets being a triple board, certified formulator. So as a ZOI Global customer or ZOI Global business owner, we don't have to question the science because you are questioning, and you are in place to make sure that was ZOI Global delivers to the market as something that is safe, effective, and proven the things that we say. If we say it it's been proven.