Research Claims of Accumulation of Sucralose in Lab Rats Fails to Establish Safety Concern

August 31, 2018

FROM THE CALORIE CONTROL COUNCIL:

The study in question — “Intestinal Metabolism and Bioaccumulation of Sucralose in Adipose Tissue in the Rat” Bornemann et al. — was published in the Journal of Toxicology and Environmental Health.  The objective of the study conducted by researchers at NC State University was to determine if sucralose is metabolized in the rat intestine with repeated dosing and to examine whether sucralose might accumulate in rat adipose (fat) tissue.

There were several drawbacks to the study:

1. Used excessive dosing: The mean sucralose dosage in this study was essentially 16 times greater that the acceptable daily intake (ADI) of 5 mg/kg/day determined by the U.S. Food and Drug Administration and 5.3 times higher than the ADI of 15 mg/kg/day approved in the European Union. In a 68 kg human (150 lbs.), the dosage used would be equivalent to 137 8oz servings of diet cola. Excessive dosing is typically found in animal studies, therefore limiting the extrapolation of the findings to humans.
2. Performed on rats, not humans. Given that rats are not biologically equivalent to humans, animal studies are used only as guide for future research in humans.
3. Limited study with 10 rats. Regulatory approval of sucralose is based on pharmacokinetic and metabolism studies that suggested that the majority of orally ingested sucralose was not absorbed from the gastrointestinal tract (GIT) but rather excreted unchanged in the feces. While this study uses new methods on ten rats indicating that sucralose may be metabolized and not just excreted, it does not indicate that there are any concerns over the consumption of sucralose.
4. Showed no evidence of adverse safety effects: The dosage in the study marks the level at which sucralose metabolites were detected. While this finding contradicts data which previously reported that sucralose passes through the body and is excreted unchanged, the findings of the NC State study do not provide evidence of any adverse safety effects.
5. One study does not replace over 100 other studies: While animal studies are typically the starting point for toxicity studies, clearly the findings of a single study do not warrant an overhaul of the regulatory status of an ingredient, especially when there is a large body of evidence (over 100 studies) substantiating the safety of sucralose. The approval process includes the rigorous review of multiple studies, including both human and animal investigations, in order to establish the safety status.

Sucralose has been approved by the U.S. Food and Drug Administration (FDA) for use in food since 1998. FDA reviewed more than 110 safety studies in approving the use of sucralose. The Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO)’s Expert Committee on Food Additives (JECFA) has determined sucralose to be safe for human consumption along with other regulatory bodies including Health Canada, the Japanese Ministry of Health and Welfare and Food Standards of Australia and New Zealand.

More recently, in a scientific opinion published in 2017, the European Food Safety Authority (EFSA) reconfirmed the safety of sucralose at current use levels.

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