Johnson and Johnson Splenda Diabetes Rebuttal Letter

Sent on May 19th, 2013

Dear Sayer, 

We would like to provide some perspective on the study you are referencing.  This study did not involve people with diabetes.  Importantly, the study was a small study that is not backed by the collective scientific data.   Clinical studies in people with Type 1 and Type 2 diabetes  and non-diabetic people have shown that SPLENDA® Brand Sweetener (sucralose) does not affect blood glucose levels, insulin, or HbA1c.  

A randomized, double-blind, placebo-controlled, crossover study designed to assess the effect of a single oral high dose of sucralose on short-term glycemic control in patients with insulin-dependent diabetes mellitus (T1DM) or non-insulin-dependent diabetes mellitus (T2DM) concluded that sucralose consumption does not adversely affect short-term blood glucose control in patients with diabetes.[1]  In addition, a longer term study in patients with type 2 diabetes demonstrated that sucralose consumption for 3 months at doses of 7.5 mg/kg/day, which is approximately three times the estimated maximum intake, had no effect on glucose homeostasis and was as well-tolerated by the study subjects.[2]

Similarly, studies in non-diabetic subjects have found no effect of sucralose on blood glucose control.  FDA and other important safety and regulatory agencies from around the world have concluded that sucralose does not adversely affect glucose control[3], and specifically in people with diabetes.[4],[5]

The study you reference presents no information on the statistical power of the study to assess the likelihood of a true relationship to the treatment, as opposed to potential confounding factors.  This is critical information in light of the conditions of the study.  In addition to the small number of subjects, the study included no review or control of diet or exercise in the days preceding the single tests of sweetened or unsweetened water and it used subjects that were excessively overweight (avg BMI = 41).  Both of these conditions can affect the endpoints measured in this study.  There was also no positive control used in the study to control for effects on taste.  Effects on insulin are possible with taste alone (cephalic phase effects) and such effects do not correlate with an adverse effect on glucose control.    

Experts from around the world have found that SPLENDA® Brand Sweetener is suitable for everyone, including those with diabetes.  Up to 4 packets of SPLENDA® No Calorie Sweetener or up to 8 teaspoons of SPLENDA® No Calorie Sweetener, Granulated, are considered a "free food" in a meal plan for people with diabetes. The Academy of Nutrition and Dietetics and the American Diabetes Association consider a free food for people with diabetes to be any food or beverage that contains less than 20 calories and 5 grams or less of carbohydrate per serving.  In fact, SPLENDA® Brand Sweetener can play a useful role in diabetes management. 

[1]Grotz VL, Henry RR, McGill JB, et al. Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes. J Am Diet Assoc. 2003;103(12):1607-1612.

[2] Mezitis NHE, Maggio CA, Koch P, Quddoos A, Allison DB, Pi-Sunyer FX. Glycemic effect of a single high oral dose of the novel sweetener sucralose in patients with diabetes. Diabetes Care. 1996;19(9):1004-1005.

[3] Baird IM, Shephard, NW, Merritt RJ, Hildick-Smith G. Repeated dose study of sucralose tolerance in human subjects. Food Chem Toxicol. 2000; 38 Suppl 2:S123-9.]  

[4] Federal Register; Vol. 63, No. 64, 1998;  

[5] Grotz VL, Munro IC. Overview of the safety of sucralose. Reg Toxicol Pharmacol. 2009. 55: 1-5

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