Can ClearDrops be refrigerated to extend the 30-day expiration date once I open my ClearDrops bottle?
Denise Stephens, ZOI CEO (00:00):
Ginny, we're going to come back to you, Sweet girl.
I am loving the answers to all these questions. I just keep messaging people like get on, get on. This is so awesome. Here's a question that we get, with the bottle and it says to use up your ClearDrops within the 30 day period. So if someone has maybe missed a day or two and they want to stretch it out a little bit, they have a question. Can clear drops, be refrigerated to extend the 30 day expiration date. And if not, why not?
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (00:34):
All right, Thank you for this question, Ginny. Okay. I go straight forward. Why not? Because it is the law. It is the law of the land. There's not work like that. Dietary supplements liquid formulations must support why you can use them 28 days after you break the seal, you must prove that these formulations, the liquid formulations of dietary supplements are adequately preserved. Okay. So, once you break the seal and they are now in contact with free air, remember the air has toxic compounds within it, particulate matter, and heavy metals. So how do you preserve it? How are you sure that your formulation is safe to be used for 28 days? The requirement the low is for 28 days, four weeks. So, you must conduct the appropriate and microbial effectiveness study and the way to conduct it is clearly stated at the United States.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (01:51):
Pharmacopoeia monography number 51. So after you conduct this study, you can show that your formulation is efficiently and preserved for 28 days after the day that you break the seal. We cannot extend that because we have not tested that. And we have not tested that because we are not permitted to test that there is not such a test that you can conduct and say, okay, our formulation passed the anti-microbial effectiveness study. So it is safe to use it for 28 days. What if we put it in the refrigerator and we get 10 more days, we are not allowed to do so after 28 days, it would go by the word of the, of the law. You must dispose it roughly after 30 days after you open the bottle, you break the seal, you can dispose it. I can tell you how I do it. If you're interested to find out the day that I crack the seal. And I open my ClearDrops I know what day of the month is. So I take a pen, permanent marker, and I write the same day of the next month. So if I started my clear drops on, let's say March 25th, I write on the bottle for 25. So I know that the 25th day of the next month, I have to dispose the bottle. Even if there are some droplets or drops of clear drops in the bottle. All right.
Denise Stephens, ZOI CEO (03:44):
Excellent. Thank you for that clarification, Dr. Nikolas, and you know, what what's interesting is that every liquid form, every liquid formulate dietary supplement formulation is held to the same standards. Whether or not that's disclosed or not to the consumer is another issue. You know, maintaining the integrity of the formulation is paramount at ZOI Global.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (04:09):
Yeah. Let let's think about this. We purchased milk. Okay. So milk after you open must be in the refrigerator and it's like best used before this date. So we cannot say, all right, this date is today. What if we put it in the freezer? And then we take it out tomorrow and use a little and put it again in the freezer and use a little, you know, that will be the equivalent does not work like that. Safety first.