Historical technical challenges:
Stevia has been used as a sweetener for many centuries, without ever becoming mainstream. This is because the extract contains a mixture of different molecules that vary depending upon climate and growing conditions and it was historically impossible to produce consistent specifications necessary for a mainstream ingredient or for clinical trials to achieve FDA approval.
Technical challenges recently overcome:
This issue was only overcome in recent years by identifying the steviol glycoside molecules with the best taste profiles and by developing innovative and unique process technologies to separate and purify Stevia extract to pharmaceutical levels of purity on a reliable and consistent basis: and, importantly, to do so in commercially viable volumes.
Recent regulatory approval for major market:
Once these hurdles were overcome, Cargill and Merisant each submitted applications to the FDA in 1998 for GRAS approval. On Dec 17, 2008 the Stevia extract, Rebaudioside A (Reb‐A), received GRAS approval and since then there have been several hundred product launches by food and beverage companies globally demonstrating the widespread demand and acceptance.
Regulatory Approval Time Line
JFSA – 1971
Japanese Food Safety Commission approved Stevia as a safer alternative than Aspartame and Cyclamates.
WHO/UN FAO ‐JUNE 2006/08
Joint Expert Committee of Food Additives
(JECFA) WHO/UN FAO
Doubled the Acceptable Daily Intake (ADI) level for Stevia.
FSANZ ‐SEPTEMBER 2008
Australian/NZ food authority (FSANZ) approved Stevia as a food ingredient.
FDA ‐DECEMBER 2008
US FDA issued GRAS letter of no objection for high purity Reb‐A
EU ‐APRIL 2010
The European Food Safety Authority passes a favorable opinion of Stevia to the European Commission for authorization in the EU. Full EU approval is expected in 2011.