What FDA safety standards are used by Metron Nutraceuticals in all ZOI formulations?
Denise Stephens, ZOI CEO (00:00):
Great. Okay. So Dr. Nicholas now let's move into how the ZOI products, how did, how does Metron use the FDA standards to ensure the safety of the products that we build at Metron?
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (00:15):
Denise, I will be very glad to go there, and we are very proud of that Metron nutraceuticals, because we operate above and beyond the current standards set by the FDA, not the EPA, by the FDA for dietary supplements. And in some aspects above the standards used by the FDA for pharmaceutical products, you'll have a nice table so before you can put this table up and we can discuss how specifically we operate at Metron nutraceuticals. Now on the left, in under the orange table there, we see what the FDA standard is for checking for elemental impurities. These are free heavy metals, toxic heavy metals, bad heavy metals that can be in a zeolite. So, the FDA requires for any dietary supplement formulation, any not zeolite only, any dietary supplement formulation must be tested for arsenic, cadmium, mercury, and lead. It's mandatory and must be tested according to the USB 2232.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (01:43):
This is the USP monography that FDA requires dietary supplement liquid formulations to be tested like or under in contrast, the FDA requires all pharmaceutical formulations to be tested for 24 elemental impurities or free metals. According to the United States, pharmacopeia 232, 233. This is for pharmaceutical products for drugs. Within the 24 elements that every drug must be tested for exists. The four elements that every dietary supplement must be tested for, we are very proud at Metron nutraceuticals that will operate above and beyond of both standards. We test all final formulations available by Metron nutraceuticals, not for four elements as a dietary supplement, not even for 24 elements as a pharmaceutical product, but for 29 elemental impurities for 29 free elements. And Denise, we apply the exact standards as set by the FDA for 24 pharmaceutical products in order to test ZOI Global final formulations, that's unheard of in the industry and hurt.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (03:41):
Now, if we go further, if we go further, these testing that is conducted in every single final formulation, according to pharmaceutical standards and above for Metrons and ZOI Global dietary supplements is for the final formulation. Now let's not forget that we start with zeolite and zeolite has many elemental impurities that are not described in the shortlist of four, or even the Lazarus list of 24 or the 29 elements for this reason add measuring address certificates. It is part of our standard operating process. We test the concentrated form of our formulations for 69 elements. That's the maximum that we can test for and Denise and Carrie and Lori. We are very proud for this. We didn’t just do it once for research and development purposes. We have a commitment to Safety first as very boldly was stated by the great grandfather of all of us Hippocrates the Greek doctor Hippocrates 25 centuries ago.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (05:21):
Safety first, first do not harm how we make sure at Metron nutraceuticals that the ZOI Global formulations will not harm is that first we test the concentrated form of all ZOI Global formulations for 69 elements. And that's unheard of in the industry. And we test again, post-production the final formulations, all final of ZOI Global dietary supplements for 29 elements above and beyond current pharmaceutical standards as set by the FDA, Denise, this the major difference between how Metron nutraceuticals ZOI Global operate compared to any other player in the industry. This is far above and beyond the zeolite space of dietary supplements. This is the leading effort in the whole industry of dietary supplements.
Denise Stephens, ZOI CEO (06:48):
You know, Dr. Nicholas you're setting a new standard at global and Metro nutraceuticals as our supplier, we are truly setting a standard in a way that the industry has not ever seen, you know, for those that, that are performing ethically and are doing the minimum for heavy metals tests. That that's great, but you and I know that there are things that are happening and the whole dietary supplement industry that are unheard of.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (07:22):
There, there are let's stop here today. There's more to come on this very important safety issue. Absolutely.