Where Are Stevia-Derived Sweeteners Headed?

FDAs favorable review of the safety documentation for food uses of rebaudioside A has broadened and intensified interest in the use of stevia-derived sweeteners worldwide. The expanding market opportunities trigger technological innovation while prompting various questions.

Are stevia and all stevia-derived sweeteners now GRAS? The issuance of no objection letters by FDA to Merisant and Cargill applies only to the substances identified in the GRAS notifications for the food uses submitted for FDA review. FDA concurred that the composite safety information submitted for high-purity rebaudioside A met the safety standard of reasonable certainty of no harm under the intended conditions of use.

Other producers of stevia-based ingredients wishing to offer their ingredients for formulated foods must obtain GRAS status by demonstrating that the requisite safety standard has been met for their products.

With the increased incorporation of stevia-derived sweeteners in foods, will the increased consumption result in food uses that exceed GRAS levels? Dietary intake estimates have been addressed in detail by the Joint Expert Committee on Food Additives (JECFA), Food Standards Australia and New Zealand, Merisant, and Cargill. The estimated daily intake for reb A was found to be 120 to 324 mg per person per day for a 60 kg person. This estimate was based on conservative assumptions to ensure consumer safety, and it is highly unlikely that expanded use of the stevia sweeteners will exceed the levels now considered GRAS.

What other developments with steviol glycosides are emerging? The following initiatives may impact production and improved sweetener qualities:

Expanded production of stevia and processing facilities in China and elsewhere;

Development of new seed varieties of stevia to increase rebaudioside A content;

Involvement of flavor houses to enhance the flavor profiles of steviol glycosides by creating sweetening blends or by blocking bitter taste receptors;

Utilization of enzyme technology to yield stevia-derived sweeteners with improved qualities.

What safety or regulatory concerns remain with rebaudioside A and the steviol glycosides? While the recent safety questions posed by CSPI have been unsuccessful in preventing the addition of stevia-based sweeteners to foods, they are calling for a rethink that may foreshadow future challenges.

A Citizens Petition was filed with FDA in late 2008 to prevent the addition of steviol glycosides to foods because of the drug status alleged for the sweeteners. FDA is also attempting to implement recent legislation that more broadly prohibits the addition of drugs to foods. FDAs resolutions of these two matters could impact the future food uses of steviol glycosides.

Robert McQuate, Ph.D., started his regulatory career within FDAs GRAS Review Branch. He subsequently served in technical management positions with The Dial Company and the National Soft Drink Association where he addressed high visibility food ingredient safety issues such as non-nutritive sweeteners. He has been an independent consultant since1988.

Richard Kraska, Ph.D., DABT, began his regulatory career at FDA by addressing the safety of food additives and GRAS ingredients, dealing with sensitive topics including aspartame and salt. Prior to becoming a consulting toxicologist, he served for 22 years with major chemical companies where he resolved numerous technical regulatory challenges with his toxicology expertise.

Robert McQuate will be presenting Whats Next for Stevia-Based Sweeteners at SupplySide East , Secaucus, NJ, April 28 at 10 a.m.