Is potassium sorbate a safe and effective preservative according to U.S. FDA and E.U. EFSA?
Denise Stephens, ZOI CEO (00:00):
So let's start with question number one, I would like to discuss potassium sorbate. There seems to be a lot of untruths stemming from the use of product preservatives. So will you please help our friends understand the myths surrounding potassium sorbate and why ZOI Global products use potassium sorbate as our product preservative.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (00:28):
Very good. And it's very good question. Yes. So we received this question frequently and we very, very glad to clarify, uh, regarding potassium sorbate, uh, why we use it and, um, how it is used, uh, in the United States, how it is used in Europe and try to, uh, we'll try to throw some light in some myths surrounding potassium sorbate. So potassium sorbate is one of the most commonly used preservatives for food, for wine, and for dietary supplements, because it is safe for human consumption and effective in protecting the food, wine, and dietary supplement formulations from a wide variety of microorganisms, including yeast and mold. In the food industry potassium sorbate is also used as a preservative in dried meats, in cheese products, yogurt, soft drinks, fruit juices, milk shakes. You can name it. Now, let's see what is the current status of the potassium sorbate use in the United States, first. In the United States, potassium sorbate is lawfully used as food and dietary supplements preservative.
As the United States food and drug administration, the FDA, has designated a GRAS status to potassium sorbate. GRAS is the acronym for Generally Recognized As Safe for a substance to be used within food or dietary supplement formulations.
Now the potassium sorbate specific 21 CFR number is 182. 3640. So this is the grass status of potassium sorbate in the United States. Now, the FDA has set the acceptable daily intake, um, usually this is referred us ADI (acceptable daily intake). So the FDA has set the ADI for potassium sorbate in the United States at 25 milligrams of potassium sorbate, per kilogram of body weight of the user per day. So clearly set, um, if you use it appropriately and you don't exceed this amount, then you are fine with your formulation. Potassium sorbate preserves your food or your dietary supplement formulation.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (03:45):
Let's see, what is the current status in Europe? Potassium sorbate is currently lawfully used as food and dietary supplements preservative in the European Union. The European Union Safety authority, the acronym is EFSA and EFSA is we can say the analog of the United States Food and Drug Administration, but for Europe. So in Europe, it is the EFSA. The EFSA has designated a letter “E” number, specifically E 202 for potassium sorbate. And the EFSA, as the FDA has done in the United States, the EFSA has also set the ADI for potassium sorbate in Europe at 11 milligrams per kilogram of body weight per day. Now, this was set, uh, in 2019. Now in this document, you can see the Food and Drug Administration, uh, GRAS status for potassium sorbate in the United States. While in this document, which is from CELIX, is the legislation in the European Union.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (05:21):
Um, this is from February, 2020 and specifically is about the potassium sorbate and it's ADI. Um, in the second page of this document of 2020, you can see these box there, let's magnify this, and we can read, um, that the ADI is now 11 milligrams per body weight for potassium sorbate per day. Now let's, uh, discuss about the history of potassium sorbate used in Europe. Now in 1996, the potassium sorbate ADI in Europe was set at the level of 25 milligrams per kilogram of body weight per day, exactly as it is today in the United States. And this ADI was in effect in Europe from 1996, up to 2015. So it was 25 milligrams per kilogram of body weight per day. Now in June, 2015, the EFSA established a new temporary ADI for potassium sorbate, very low three milligrams per kilogram of body weight per day.
Dr. Nikolaos Tsirikos-Karapanos, PharmD, MD, Cardiothoracic Surgeon (07:05):
And this is because back then in 2015, uh, some potential reproductive and developmental toxicity concerns were, uh, expressed to the EFSA. This temporary ADI, very low ADI of three milligrams per kilogram of body weight per day were established again on June, 2015 by the EFSA. And this was at the 2015 safety evaluation that the EFSA conducted for several substances. One year later, on June 10th, 2016, the EFSA recommended that their reproductive toxicity study needs to be conducted specifically for potassium surveyed in order to reconsider the temporary ADI for potassium sorbate again, back then, in 2016, it was set at three milligrams per kilogram of body weight per day. Now, the study that the EFSA recommended back on June, 2016, was conducted, and, uh, it was performed according to the standards that these studies must be performed. And the data were sent to the EFSA for the EFSA reevaluation of potassium sorbate as preservative. Now on the basis of the new reproductive toxicity data that were presented to the EFSA, the EFSA changed the temporary ADI for potassium sorbate that was three milligrams per kilogram, per body weight per day, and increased it to its current ADI of 11 milligrams per kilogram of body weight per day. And this was the safety reevaluation of 2019.
In this document, we can see the relevant EFSA Journal of 2015, um, where the reevaluation was presented. And in this document, we can see the EFSA Journal of 2019 with the current, uh, ADI, um, of potassium sorbate. This was exactly when it was presented to its current level of 11 milligrams per kilogram per day. Now, we discussed about the current status of potassium sorbate use as preservative in the United States. And in Europe.
Now let's discuss specifically about our formulations, the potassium sorbate used as preservative ClearDrops and in ClearSleep. Now, potassium sorbate is used in both ClearDrops and ClearSleep because is an excellent preservative system. But, it is used in very small, very small, but adequately to effectively preserve both formulations from various microorganisms and from yeast and mold. We have discussed, Denise, in the past that according to the CGMP standards, the preservative effectiveness test for both ClearDrops and ClearSleep, specifically, according to the USP chapter 51 requirements has confirmed that both ClearDrops and in ClearSleep are adequately preserved with the preservative system of potassium sorbate.
Now, to give some numbers and for our friends to have a better idea about how small quantity of potassium sorbate we’re using. Let's take as an example, uh, a male adult of 70 kilograms body weight that's 154 pounds. And that's because in, um, medical sciences and pharmaceutical sciences in physiology and in toxicology, the standard to discuss about quantities, uh, of several compounds is the 70 kilograms body weight for the male consumer. So for these reasons, let's take, uh, as an example, a male consumer of 154 pounds.
Now for this individual, to reach the ADI for potassium sorbate in the United States, this individual theoretically would need to consume 52 bottles of ClearDrops or 52 bottles of ClearSleep in one day. Denise, it’s that small of a quantity that we are using for the preservation of ClearDrops and in ClearSleep. There's another way also to see this. Now the daily dose of ClearDrops is 1 ML. It is the same for ClearSleep. It is 1ML. So this male adult of 154 pounds is using ClearDrops, is taking 1ML of ClearDrops per day. And on this day, this specific day, this individual is consuming 1,750 times less potassium sorbate than the ADI in the United States. It's, it's a minute quantity.
So, now let's suppose that this friend, um, again, is an adult male of 154 pounds of body weight let's suppose that this individual is consuming ClearDrops every day, 1ML, and also he's taking ClearSleep every day, 1ML. Now this individual by using ClearDrops and ClearSleep every day is also consuming potassium sorbate every day. How much? 875 times less than what it is the ADI of the potassium sorbate in the United States. Uh, potassium sorbate is a fantastic, uh, very safe and effective preservative system. And if you know what you're doing with your formulation, and if your formulation is made scientifically with all the scientific requirements in place, then you can use a minute quantity of this excellent preservative and still effectively preserve your formulation.
Now, after we discussed about the current status of potassium sorbate use in the United States and the current status of potassium sorbate use in Europe, uh, let's, let's, uh, discuss a little bit about some fake news that’s around for potassium sorbate use in Europe.
Recently, we have received some questions like, are you sure that potassium sorbate can be used in Europe, but it is banned in Europe? Well, Denise, uh, unfortunately in the dietary supplements industry, one can easily find a plethora of fake news. Now, this page, uh, is from a site and American site, https://www.honestweight.coop/ that misrepresents facts regarding the potassium sorbate used in Europe and claims that potassium sorbate is in the banned list. A careful reading though, on this site reveals that in fact, the banned list was created by the owners of this site and lacks any regulatory authority. It is practically a joke!
Just to give you an example from the real world, the equivalent Denise, is like ZOI Global can issue a banned list of cars and say, um, Chryslers, and, um, I don't know, Nissans and whatever other manufacturers cars are banned, or we ban them because that's what we want. Um, it reaches the level of ridiculousness.
So to conclude potassium sorbate is a safe and effective preservative system if used appropriately. And it is lawfully used in the United States and in Europe,
Denise Stephens, ZOI CEO (17:41):
Thank you so much, Dr. Nikolaos for that scientifically validated answer. And what that does is it keeps ZOI Advisors and ZOI customers, uh, having an ability to rely on science and not opinions because it's crazy the number of opinions that can totally create a pandemonium, almost in an industry that's not even needed. And it's just based on somebody's opinion, just like you clearly stated.