CCC Responds to Shil et al on Neotame

In Vitro Study on Neotame and Gut Bacteria Cannot be Inferred to Humans

A recent study evaluated the effects of neotame on model gut bacteria and intestinal epithelial cells using in vitro laboratory models. CCC noted that the findings cannot be readily inferred to humans. Importantly, global regulatory agencies continue to support the safety of neotame at approved consumption levels.

Study Examined Neotame and Model Gut Bacteria

The study was published in the Frontiers in Nutrition journal. Led by investigators out of Jahangirnagar University and Angela Ruskin University, the objective of this study was to better understand how neotame impacts gut bacteria and how they interact with the intestinal epithelium. The authors utilized two model gut bacteria, Enterococcus faecalis and Escherichia coli , which are predominantly identified in the microbiota and a human cell model of the intestinal epithelium. The bacterial growth curve, biofilm formation, bacterial adhesion and invasion, as well as cytotoxicity following exposure to neotame were assessed.

The authors concluded that their findings demonstrate that neotame can damage the intestinal epithelium directly, through the sweet taste receptor, T1R3, and indirectly, through stimulating pathogenic changes in model gut bacteria.

Study Limitations Reduce Real-World Relevance

The investigators’ use of in vitro bacterial models limits the findings of the current study, as such models cannot mimic the complex environment within the human body. It also may induce interactions that do not occur in vivo. Further, the responses seen from the exposure levels measured are not predictive of that of real-life exposure (i.e., 24 h exposure to neotame vs 5 h intestinal transit time). As noted by the researchers themselves, in reality, it is unlikely that human epithelium and gut microbiota would be exposed for the length of time studied in the current investigation.

Existing Research Supports Sweetener Safety

Safety has been well-documented on low or no-calorie sweeteners and the gut microbiome. It has been determined that there are no safety concerns at their currently approved levels.

CCC Statement on Neotame Safety

In response to this study, the Calorie Control Council has issued the following statement:

“Given the use of lab controlled models, the results of the current study cannot be readily inferred to humans. Further, considering the small amount needed to achieve the desired level of sweetness in food and beverage products, people are unlikely to consume levels of neotame that would affect the gut microbiome. Low- and no-calorie sweeteners, including neotame, have been continuously proven safe by global regulatory agencies including the FDA and EFSA,” said Carla Saunders, President, Calorie Control Council.

Learn more about sweeteners and the gut microbiome.

Learn more about neotame.

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