Why do ZOI products have a 30-day lifespan after opening the product bottle?
Denise Stephens, ZOI CEO (00:00):
Tom, we're coming to you, my friend.
ZOI Advisor (00:04):
Good evening. Hi, Dr. Nicholas, thank you for taking my question. It's going to be kind of about the product and will you please explain why ZOI products have a 30-day lifespan after opening the product bottle?
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (00:23):
Well, Tom, Thank you for this question. It's very important. Well, yes, let's, let's explain this. It's very important and you will see immediately why Tom it the law is. It is the law of the land. Let me explain all dietary settlement formulations that are liquid formulations cannot exceed this lifespan after you break the seal of the product. So, if you don't break the seal of the product, if you purchase it, you're going to see in the bottom, the lot number of the batch of the product, of this lot of the product. And you're going to see the expiration date, which is two years from the day of the production. Now we link this period of two years. If you break the seal of the product, then this moment you expose the product to the environment right now, ZOI Global formulations ClearDrops and ClearSleep adequately preserved in the preservative system is potassium.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (01:36):
Sorbate. It's not that we just want to do it this way at Metron. It is the law. You must preserve a liquid dietary supplement formulation. Now not only you have to preserve it, but you must prove that the preservative system within this liquid formulation, adequately, preserves eat for a certain period. So you have to conduct what is called the anti-microbial effectiveness test. A E T. Sometimes this test is called in every days language in the industry as preservative effectiveness test, or sometimes it's called the challenge test. Well, these test, which is a requirement, it is an FDA requirement is performed within 28 days. They take the product, they break the seal. They load it on day one with a certain quantity of microbes. And then they follow the concentration of these microbes to see if the concentration of the microbes drops in a certain pre-set fashion within four weeks.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (03:13):
And then the FDA is using the United States, pharmacopeia USB 51. Monography that describes how this is done. And then you, you meet or you don't make certain criteria. You must meet all the criteria within these 28 days of continuous testing and then and only then the USB 51, or anti-microbial effectiveness test or challenge test or preservative effectiveness test is okay. And you pass it then and only then you can claim that your liquid formulation is a adequately preserved for 28 days. For this reason, we say that roughly after 30 days after you open the product, you have to dispose it. There's a very simple trick that you can do. I do it with ClearDrops myself. Whenever I open a new bottle. It's not necessarily the first of the month. I may open a new bottle the 17th of the month. So what I do, if I open the bottle on the 17th, let's say of April, I would say, I take a permanent marker. And I write on the bottle May 17th. Then I know that the May 17, this bottle needs to be disposed, even if it has some droplets of product within it. So it is 28 days. Roughly one month, there is not, I repeat, there is not any option to extend this 30 days more. That's the maximum. And we have tested ClearDrops, and it passes USB 51. For this reason, we gave it the maximum of 30 days. I hope this explains why. Yes.
ZOI Advisor (05:27):
Thank you, doctor. It's, you know, we hear about ClearDrops and why it has a 30-day lifespan is now very much clearer. And I, I appreciate that clarity. Thank you again.