Calorie Control Council Response to U.S. Right to Know Request for Federal Trade Commission Review of Sucralose

(ATLANTA) November 20, 2018 — The Calorie Control Council (CCC) is responding to the request from U.S. Right to Know (USRTK) for a Federal Trade Commission (FTC) investigation regarding the advertising of sucralose. This request reports findings from a single study that asserts that “emerging evidence suggests, contrary to some advertising and marketing, that sucralose may metabolize and bioaccumulate”.

The study cited is deeply flawed and is scientifically unreliable for the conclusions used in the USRTK letter. Further, its assertions are not supported by a wealth of research that has been critically and thoroughly reviewed by regulatory agencies around the world, who confirm that sucralose is safe. The findings of this study do not warrant an overhaul of the regulatory status of sucralose, especially when it cannot be considered reliable for estimating effects on bioaccumulation and presents no new information about human metabolism.

Regarding the study cited in USRTK’s request, “Intestinal Metabolism and Bioaccumulation of Sucralose in Adipose Tissue in the Rat” conducted by Bornemann et al. and published in the Journal of Toxicology and Environmental Health, CCC would like to reiterate several limitations of the study.

• Study Used Excessive Intakes: Beyond the scientific flaws in the study design, the amount of sucralose used in this study was equivalent in sweetness to consuming more than 800 teaspoons of sugar per day every day for an average adult (150 pound person).
• Inappropriate Methodology: The study design does not include the elements necessary for evaluating bioaccumulation.
• Lack of a Control Group: The study did not include a control group (i.e., there was not a group of rats not given sucralose). As a result, there is no proof that their “findings” of “novel sucralose metabolites” were in fact the result of the administration of sucralose.
• No Evidence of Adverse Safety Effects: The fate of sucralose has been shown to be similar in all species previously evaluated, with very low levels of absorption.  The primary route of excretion is through the feces, unchanged. The findings do not provide evidence of any adverse safety effects nor do they indicate that sucralose builds up in tissue over time.

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 safety of sucralose and the Acceptable Daily Intake were established by regulatory authorities based on the demonstration of no adverse effects found in various animal studies and human clinical studies, using proper toxicology study design (such as including control groups), following long-term consumption of sucralose. The approval process includes the rigorous review of multiple types of studies, including both human and animal investigations, in order to establish the safety status.

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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