Erythritol has been approved as a food additive by the FDA (1997), EFSA (2003), Health Canada, and FSSAI in India. It occurs naturally in many foods: pears, grapes, mushrooms, watermelon, and fermented products like wine, beer, and cheese contain measurable amounts of erythritol produced during natural fermentation.
In 2023, a study published in Nature Medicine (Witkowski et al.) received significant media attention for suggesting a potential association between elevated plasma erythritol levels and major cardiovascular events. This study generated widespread consumer concern — and requires careful scientific context.
The study was observational in design, measuring existing erythritol levels in blood samples from high-risk cardiac patients — a population that already had metabolic dysfunction. Critically, the study could not distinguish between erythritol consumed as a food additive versus endogenous erythritol produced by the body itself via the pentose phosphate pathway. People with metabolic syndrome, diabetes, and pre-existing cardiovascular disease produce significantly more endogenous erythritol than healthy individuals — making the observed correlation a probable marker of metabolic disease, not a cause.
No interventional study to date has demonstrated that erythritol consumption causes cardiovascular events in healthy individuals. A 2024 reanalysis published in Nutrients (Regnat et al.) found no significant cardiovascular risk signal in randomised trials where erythritol was administered as a dietary supplement. The European Food Safety Authority's 2023 re-evaluation confirmed erythritol's safety profile and maintained its ADI as 'not specified' — the highest safety designation.
In practical context, a typical serving of Off Sugar (1 teaspoon = 4g) contains approximately 3.6g of erythritol — well within the range of naturally-occurring erythritol in a single pear (0.5–1.9g per 100g). Moderate consumption as part of a varied diet poses no evidence-based risk for healthy adults.