02-28-2023
To Our Customers:
We are aware of a recent scientific study by Marc Witkowski et al. that has been published in a high-profile journal, Nature Medicine. The paper claims to show an increased risk of major adverse cardiac events (MACE, usually heart attacks or strokes) with the consumption of erythritol, one of the minor flavoring ingredients of Sweetamine.
Erythritol is one of the most widely used natural low-calorie sweeteners in the food industry. It has been recognized by the FDA for over a decade as "Generally Recognized as Safe" (GRAS). In fact, according to definitive research from 1996, the maximum safe level to consume is 1 gram per kg body weight. Those results mean that it has been viewed as safe for an 80 kg person (176 pounds) to consume 80 grams (16 teaspoons) of erythritol per day. For comparison, each full daily serving of Sweetamine contains only 0.8 grams (less than 1/4 teaspoon) of erythritol. According to these numbers, it would be safe to consume up to 100 times the erythritol per day as is contained in one daily serving of Sweetamine. [1] [2]
In the authors own study they also gave erythritol to healthy volunteers and reported that there were still blood levels capable of increasing platelet aggregation two days later. Trouble is, they had the volunteers eat 30 grams of erythritol, 37.5 times the amount in a daily serving of Sweetamine; more than the erythritol in an entire month’s supply of Sweetamine!
It is unfortunate that such an alarm has been raised by the recent study because the science involved is methodologically flawed. Specifically, the authors of the latest study (Witkowski et al.) neglected to include blood glycine as a confounding variable, even though glycine is known to be a protective factor for major adverse cardiovascular events. https://www.webmd.com/diet/health-benefits-glycine
Moreover, two of the co-authors of the present study (one being the corresponding author, Stanley Hazen) also co-authored one of the studies that established this protective effect of glycine. [3,4]
It is also important to note that the recent study says that the way in which erythritol would increase the risk of thrombosis, the main type of MACE, is by increased platelet aggregation. In contrast, the way in which glycine protects against thrombosis is by decreasing harmful platelet aggregation. [5]
Witkowski et al., were therefore negligent in that they knew or should have known that a valid statistical model of the variables they were examining (MACE among those with chronic cardiovascular disease) would have to include adjustment for blood glycine concentration, a confounding factor with a known mechanism of protective action. By only adjusting for the "usual suspects", (sex, age, BMI, diabetes, hypertension, current smoking status, plasma cholesterol levels, etc.), and not adjusting for glycine, the authors of the study were ignoring the confounding effects that patients' glycine consumption would have on their heart health. I am certain that, if glycine measurements had been included in the set of relevant variables, glycine would have emerged as a protective factor in the recent study.
There is also a lack of transparency in the Witkowski et al. study, because important information reported from the clinical trial they cite (the actual amounts of erythritol consumed by test subjects) is unavailable.[ NCT04731363]. There is further confusion added to the information available to the public because the authors incorrectly referred to erythritol as an "artificial sweetener". In fact, erythritol is a natural sweetener, found naturally in many edible plants.
I am convinced that the present formulation of Sweetamine, which includes about 0.8 g of erythritol per serving (less than 1/4 teaspoon), will decrease the risk of MACE overall.
We at Natural Food Science LLC will continue to research the effects of the ingredients of Sweetamine, to ensure that Sweetamine will always be a supplement that can only improve well being by providing nutrients that will increase the overall level of wellness of its consumers.
Joel Brind, PhD
President and CEO
Natural Food Science, LLC
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