What is the difference in the FDA heavy metals testing standards and the EPA heavy metals testing standards regarding zeolite products?

Denise Stephens, ZOI CEO (00:01):

Okay, Lori.

ZOI Advisor  (00:04):

Well, this is a perfect lead in to this question. So as a practitioner, healthcare practitioner, Dr. Nicholas, this, this question is a very big deal for me because I have extremely high standards for any supplement. I will recommend to a patient out of safety always first, first do no harm, as we say. So, please explain to listeners the difference between the FDA standards for heavy metal testing, and then the EPA standards for heavy metal testing regarding zeolites, that is.   And then, if you will, add in what is the standards that ZOI zeolites is using? This is a key question. 

Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (00:50):

It is. It is. Thank you, Lori. Yes. This is a key question because we said before that zeolites are mined in minefields with heavy equipment and, and, and by with workers wearing boots and are full of elemental impurities. All right, let's start with the basics. FDA is the United States Food and Drug Administration. But, I want our friends first understand what is the FDA.  The FDA regulates or has jurisdiction over pharmaceutical products, food, and dietary supplements. Now, from the regulatory point of view, dietary supplements are there to supplement the food.  To put it in very simple words, to explain the regulatory component. If you get a pizza from Pizza Hut or any other pizza that is your favorite and a dietary supplement any dietary supplement… These two products, a pizza and the dietary supplement are regulated by the rules created at the Food and Drug Administration. Very simple. The EPA is the United States Environmental Protection Agency and it is responsible for the protection of human health as it pertains to the environment. Now, the EPA provides technical assistance to support recovery, planning of public health and infrastructure such as wastewater, treatment plants, et cetera, et cetera, et cetera.

Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (02:46):

The EPA and the FDA are both government agencies. Now they do different things. The Environmental Protection Agency has NO jurisdiction over dietary supplements in the same way that the Food and Drug administration has NO jurisdiction over, let's say the waste products of an industry. It is the EPA that will make sure that this industry manufacturing these products will not pollute this river.  It's apples and oranges. Both government agencies have the same goal to maintain human health, but through a totally different approach.  Dietary supplements are regulated by the FDA, not the EPA. Now the FDA standards, that means the standards that the FDA uses in order to regulate dietary supplements, are different from the standards and the metrics that the EPA uses in order to make sure that we, the people or the industry, we don't pollute the environment. The FDA, the Food and Drug Administration standards, mainly are based as it pertains to pharmaceutical products and dietary supplements, and are mainly based on the USP monographies.

What is the USP? USP is the United States Pharmacopeia. I want our friends to understand that the United States Pharmacopeia is where all information about all pharmaceutical products or chemicals used in the pharmaceutical industry is there. Many years ago before the internet, before computers, pharmacopeias were huge volumes like encyclopedia volumes with thousands of pages where you could go and say, okay, what's a pharmaceutical grade vitamin C, what is a pharmaceutical grade this chemical. And there were a pharmacopeias, several pharmacopeias all over the world.  The British Pharmacopeia, the Greek pharmacopeia, the Hellenic Pharmacopeia, the country where I trained and became board-certified pharmacist and board-certified medical doctor is one of the oldest ones because there are around 400 medicinal plants in Greece. So many, many years ago, pharmacopeia's were books, huge volumes of books with thousands of pages. Now days, the pharmacopeia is available to everybody at the USP, and it has certain monographies:  How you test the pH?

Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (06:25):

You follow what the United States pharmacopeia says.  You have to do this and that way. How you check about this?  How you check about elemental impurities? And it is the information that is contained in the United States pharmacopeia, the USP monographies, that is adapted by the FDA in order to regulate the industry. This has nothing to do with EBA. EPA has other standards and metrics in order to regulate the industry and human activities in order to make sure that we don't pollute the ground, we don't pollute the air, we don't pollute the rivers, et cetera, et cetera, et cetera. 

It's apples and oranges.