EFSA decision upholds years of research that shows safety of sucralose

May 8 2017

The European Food Safety Authority (EFSA) decision upholds years of research on sucralose - the sweetening ingredient in the original SPLENDA Sweeteners - that shows it to be safe and does not cause cancer. The decision was published as an open access Scientific Opinion in EFSA Journal, and rejects allegations made by a small Italian lab regarding a study in mice that they conducted. EFSA concluded that "the available data did not support the conclusions of the authors (Soffritti et al., 2016)."

EFSA noted numerous issues with the Ramazzini Institute study on sucralose, including:

• Researchers used an unconventional design leading to inconclusive, unreliable results and were unable to prove any probable effect of sucralose on tumor development.
• Mice naturally get tumors as they age. In this study, mice were dosed until they died, which compromises reliable data interpretation.
• Researchers drew conclusions that were not supported by data.

Ramazzini Institute has been criticized previously by the regulatory and research community for not complying with recognized research standards in its sweetener studies. The U.S. Congressional House Committee has also expressed concerns that funding of this lab may not meet adequate scientific integrity standards.

The recent EFSA opinion further reinforces the importance of considering recommended research standards when reviewing scientific studies and their results, particularly when the research, as in the case of this latest Ramazzini study, utilizes unconventional methodology and employs scientific practices that have already been found to be problematic for data interpretation.

It's important to remember, for food ingredients, industry does not set the guidelines for what type of research must be done. These are set by health and safety research authorities from around the world. The safety of sucralose has been demonstrated by a wide body of research. FDA and other regulatory agencies reviewed more than 110 scientific studies designed to meet the recommended research programs set by expert health authorities for investigating the safety of a new food ingredient. Reviews of these studies have led to consistent conclusions that sucralose is safe, including for women who are pregnant or nursing and for children. SPLENDA Sweeteners are a safe choice.

The science EFSA just dismissed has been used by some, such as the Center for Science in the Public Interest (CSPI), to put sweeteners on their "avoid" lists. As EFSA's review confirms, this is not warranted and is particularly bad counsel when it comes to sucralose-sweeteners like SPLENDA. SPLENDA is one way consumers can safely reduce their added sugar and calorie consumption, which we know is important to long-term health. It would be prudent for CSPI to reconsider their advice based on the latest science and determinations from leading food safety authorities.

EFSA's decision puts good science first, and it is consistent with the movement to bring greater scrutiny to poorly designed studies that draw false conclusions and unjustifiably alarm consumers. This is a topic we are particularly passionate about at SPLENDA. We invite others to commit to evaluating research using rigorous scientific judgment and apply sound research findings before making recommendations or sharing opinions.