Response to the Letter to the Editor by S. Schiffman and M. Abou-Donia: Additional information to clarify the evidence of sucralose safety

Regulatory Toxicology and Pharmacology

Volumn 63, Issue 3, 2012, Pages 509-513

  Grotz, V Lee ^a   Brusick, David ^b  

^a McNeil Laboratories Inc   (United States)

^b Independent Consultant   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2D1; CYTOCHROME P450 3A4; SUCRALOSE;

ABSORPTION; EXCRETION; FECES MICROFLORA; GLUCURONIDATION; LETTER; METABOLISM; NONHUMAN; PH; PRIORITY JOURNAL; PRODUCT SAFETY; PROTEIN EXPRESSION; PYROLYSIS; RADIOACTIVITY; TEMPERATURE; TOXICITY;

EID: 84863880807     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.05.001     Document Type: Letter

References (21)

1. Abou-Donia M.B., et al. Splenda alters gut microflora and increases intestinal P-glycoprotein and cytochrome P-450 in male rats. J. Toxicol. Environ. Health Part A 2008, 71:1415-1429.
2. Barndt R.L., Jackson G. Stability of sucralose in baked goods. Food Technol. 1990, 44(1):62-66.
3. Brusick D., et al. Expert panel report on a study of Splenda in male rats. Regul. Toxicol. Pharmacol. 2009, 55:6-12.
4. Bernstein J.A., et al. Double-blind, placebo-controlled trial of reformulated azelastine nasal spray in patients with seasonal allergic rhinitis. Am. J. Rhinol. Allergy 2009, 23:512-517.
5. Deferme S., Augustijns P. The effect of food components on the absorption of P-gp substrates: a review. J. Pharm. Pharmacol. 2003, 55:153-162.
6. Eckford P.D., Sharom F.J. The reconstituted P-glycoprotein multidrug transporter is a flippase for glucosylceramide and other simple glycosphingolipids. Biochem. J. 2005, 389:517-526.
7. Eckford P.D., Sharom F.J. Interaction of the P-glycoprotein multidrug efflux pump with cholesterol: effects on ATPase activity, drug binding and transport. Biochemistry 2008, 47:13686-13698.
8. Freedman S.B., et al. Assessing the palatability of oral rehydration solutions in school-aged children: a randomized crossover trial. Arch. Pediatr. Adolesc. Med. 2010, 164:696-702.
9. Grotz V.L., et al. Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes. J. Am. Diet. Assoc. 2003, 103:1607-1612.
10. Grotz V.L., Munro I.C. An overview of the safety of sucralose. Regul. Toxicol. Pharmacol. 2009, 55:1-5.
11. ILSI Europe workshop on 3-MCPD esters in food products, 2009. Brussels, Belgium. Available from: http://www.ilsi.org/europe/publications/final%20version%203%20mcpd%20esters.pdf.
12. Jenner M., Smithson A. Physiocochemical properties of the sweetner sucralose. J. Food Sci. 1989, 54:1646-1649.
13. Liew K., et al. AAPS Pharm. Sci. Tech. 2012, 13:134-142.
14. Lillicrap A., et al. Bioconcentration of the intense sweetener sucralose in a multitrophic battery of aquatic organisms. Environ. Toxicol. Chem. 2011, 30:673-681.
15. Marçon F., et al. Development and formulation of a 0.2% oral solution of midazolam containing gamma-cyclodextrin. Int. J. Pharm. 2009, 379(2):244-250.
16. Mechlin C., et al. Splenda® improves tolerance of oral potassium citrate supplementation for prevention of stone formation: results of a randomized double-blind trial. J. Endourol. 2011, 25:1541-1545.
17. Miller, G., 1991. "Sucralose" In: Lyn O'Brien Nabors., Robert Gelardi (Eds.), Chapter 10 in Alternative Sweeteners, second ed. Marcel Dekker, Inc.
18. Rahn A., Yaylayan V.A. Thermal degradation of sucralose and its potential in generating chloropropanols in the presence of glycerol. Food Chem. 2010, 118:56-61.
19. Roberts A., et al. Sucralose metabolism and pharmacokinetics in man. Food Chem. Toxicol. 2000, 38:S31-S41.
20. Sims J., et al. The metabolic fate of sucralose in rats. Food Chem. Toxicol. 2000, 38:S115-S121.
21. US FDA (US Food and Drug Administration), 1999. Food additives permitted for direct addition to food for human consumption: sucralose [21CFR Part 172; Docket No. 99F-0001]. Fed. Regist. US. 64, 43908-43909. Available from: http://www.fda.gov/ohrms/dockets/98fr/081299b.txt.