Expert panel report on a study of Splenda in male rats

Regul Toxicol Pharmacol. 2009 Oct;55(1):6-12. doi: 10.1016/j.yrtph.2009.06.013. Epub 2009 Jun 28.


A recent study in rats investigated the retail sweetener product, Granulated SPLENDA No Calorie Sweetener (Splenda) (Abou-Donia et al., 2008. Splenda alters gut microflora and increases intestinal P-glycoprotein and cytochrome P-450 in male rats. J. Toxicol. Environ. Health A, 71, 1415-1429), which is composed of (by dry weight) maltodextrin ( approximately 99%) and sucralose ( approximately 1%). The investigators reported that Splenda increased body weight, decreased beneficial intestinal bacteria, and increased the expression of certain cytochrome P450 (CYP450) enzymes and the transporter protein, P-glycoprotein (P-gp), the latter of which was considered evidence that Splenda or sucralose might interfere with the absorption of nutrients and drugs. The investigators indicated that the reported changes were attributable to the sucralose present in the product tested. An Expert Panel conducted a rigorous evaluation of this study. In arriving at its conclusions, the Expert Panel considered the design and conduct of the study, its outcomes and the outcomes reported in other data available publicly. The Expert Panel found that the study was deficient in several critical areas and that its results cannot be interpreted as evidence that either Splenda, or sucralose, produced adverse effects in male rats, including effects on gastrointestinal microflora, body weight, CYP450 and P-gp activity, and nutrient and drug absorption. The study conclusions are not consistent with published literature and not supported by the data presented.

MeSH terms

  • Animals
  • Body Weight / drug effects*
  • Data Interpretation, Statistical
  • Evaluation Studies as Topic
  • Intestines / drug effects*
  • Intestines / microbiology
  • Male
  • Product Surveillance, Postmarketing / standards*
  • Rats
  • Research Design / standards
  • Sucrose / analogs & derivatives*
  • Sucrose / pharmacology
  • Sucrose / toxicity
  • Sweetening Agents / pharmacology*
  • Sweetening Agents / toxicity


  • Sweetening Agents
  • Sucrose
  • trichlorosucrose