ZOI Advisor: (00:00):
Thank you so much. Denise, Dr. Nicholas, we learned so much each time that we sit and absorb now. We've learned over the past months about nutritional supplements, and you've used a term, an acronym GRAS. And this is a status that a nutritional supplement is given and it stands for Generally Recognized As Safe. I believe that's by the FDA. Some years ago, I think it was 2012, maybe April 1st clinoptilolite zeolite was granted that status. I am correct. And knowing that not all clinoptilolite zeolites are the same, some are created in a laboratory. So, my question is can the clinoptilolite zeolite that is produced in a laboratory also claim that generally recognized as safe status as naturally occurring.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (01:25):
I see. Excellent, excellent question, Malcolm. Yes, GRAS is a designation that the FDA grants to natural products, products that you take from the nature. Okay. And it is absolutely very correctly. Said the acronym is generally recognized as safe and for these reasons it can be used as food additive and in dietary supplements. Now we we've said before that natural zeolite clinoptilolite sodium amino silicate is made when volcano lava meets the seawater. That's the moment that it is born. Now in contrast, synthetic zeolites are manufactured. This is an industrial product. They are manufactured in industry with the use of either raw materials from the nature or synthetic materials. Synthetic silicates, synthetic zeolites manufactured in the industry are supposed to be used only in industrial applications. There are several industrial applications that synthetic zeolites are used. Natural zeolite is GRAS status from the FDA and can be used as food additive. There's no comparison between synthetic and naturally occurring zeolites.
Speaker 1 (03:08):
That makes it very clear that and thank you for clarifying that. No, it's, it's a question that comes up very often.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (03:18):
Thank You for bringing this question.
Denise Stephens, ZOI CEO (03:21):
Thank you, Malcolm for bringing that question. I really appreciate it. Nicholas. Thank you for answering that question.