CARMEL, IN (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 Journal1, 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)2."
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.
We invite people to learn more about the safety of sucralose. A review of the regulatory and scientific rationale in determining the potential for sucralose to cause cancer is available here.
Overconsumption of added sugar is a rising health concern, and low calorie sweeteners like SPLENDA® No Calorie Sweetener help millions of people every day lower their added sugar intake for healthier eating without sacrificing the sweet moments in life. We support people in taking small steps to live a little healthier each day - whether that means cutting back on empty calories, managing weight, staying active and more. For information on how to make simple changes for a healthier you, visit Splenda.com.
For more information on EFSA's review of the Ramazzini Institute study of sucralose, visit the report in the EFSA Journal.
About Heartland Food Products Group
Based outside of Indianapolis, Heartland Food Products Group is a global leader in the production of low-calorie sweetener products, creamers, beverage concentrates, coffee, and nutritional drinks. Visit Heartland at http://www.heartlandfpg.com. The SPLENDA® Brand is the most recognizable and iconic low calorie sweetener ("LCS") brand in the world, having sold more than 100 billion yellow packets since its launch in 1991. Today, the SPLENDA® Brand is the clear #1 LCS brand in the $72 billion global sweetener market with market shares that are more than twice those of its nearest competitor. Since the acquisition of the SPLENDA® Brand in 2015, Heartland Food Products Group has launched SPLENDA ZERO™ Liquid Sweetener and now SPLENDA® Naturals Stevia Sweetener, expected to be the greatest innovation in the brand's history.
1. EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food) et al. (2017). Statement on the validity of the conclusions of a mouse carcinogenicity study on sucralose (E 955) performed by the Ramazzini Institute. EFSA Journal 2017;15(5):4784, 14 pp. https://doi.org/10.2903/j.efsa.2017.4784
2. Soffritti, M., et al. (2016). Sucralose administered in feed, beginning prenatally through lifespan, induces hematopoietic neoplasias in male swiss mice. Int J Occup Env Health, 22, 7-17 http://dx.doi.org/10.1080/10773525.2015.1106075.