Sucralose is found in thousands of low-calorie foods and beverages worldwide, and in the U.S. has the largest market share for artificial sweeteners and sugar substitutes. It first gained regulatory approval in Canada in 1991, with approval in the U.S. occurring in 1998.

The U.S. approval was based on early studies that suggested the majority of sucralose was not absorbed by the gastrointestinal tract but instead was excreted in the feces. As mentioned, this was also a major part of sucralose’s PR campaign in convincing the U.S. public that this unnatural sweetener is safe.

But as noted by the featured study, “The conclusions of the published data, from both rats and humans that ingested sucralose is excreted unchanged (i.e., not metabolized) appear to be premature.”

Indeed, Gary Ruskin, codirector of USRTK, said in a news release, “Are food companies deceiving consumers by telling them that sucralose doesn’t metabolize or bioaccumulate? That’s what we’re asking the Federal Trade Commission to figure out.”

“Tate & Lyle’s website sucralose.com states that ‘SPLENDA® Sucralose is not recognized by the body as a carbohydrate and is not metabolized by the body.’ Coca-Cola’s website claims that ‘The small amount of sucralose that is absorbed is not metabolized, but is rapidly eliminated in urine as sucralose. Sucralose does not accumulate in the body,'” Ruskin said. “These statements and others appear to be contradicted by the study in the Journal of Toxicology and Environmental Health.”

It remains to be seen whether the FTC will investigate sucralose’s potential deceptive marketing, or whether lawsuits will emerge as a result, but it’s clear that additional safety testing is needed.

This is particularly true since the dose used in the study (80.4 mg/kg/day) is sixteenfold greater than the acceptable daily intake (ADI) of 5 mg/kg/day set 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, the study noted. What’s more, their findings suggest the safe level of intake may actually be lower than what health agencies have set:

“If one were to apply a 100-fold safety factor to the biological effects reported in the present study, that is, metabolism and bioaccumulation at 80.4 mg/kg/day, this would lower the ADI for sucralose to less than 1 mg/kg/day … Data indicate that it may now be time to revisit the regulatory status of sucralose.”

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