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Transcript of Truvia webinar final
Truvia™ rebiana Zero-calorie sweetness from the stevia leafBackground briefing: history and safety assessment
Contents
Stevia – unique plant, unique story
From Green to White
Truvia™ rebiana
Overview of research results
Expert reviews and approvals
Summary of conclusions
Implications for consumers
Stevia rebaudiana Bertoni
Stevia: unique plant, unique story
Shrub in the Asteraceae family native to northeastern Paraguay
First discovered by indigenous people who used plant’s leaves to sweeten drinks
By 1800s, stevia consumption established throughout South America, including Brazil and Argentina
Food researchers worldwide have been working with stevia for decades
– In 1931, French food chemists isolated compounds (steviol glycosides) that give stevia its sweet taste
– Japan has been using stevia commercially for over three decades
– Stevia-sweetened food and beverages are now available to consumers on every continent
US market opened in 2008 and France in 2009
Steviol glycosides – the sweet constituents
10+ glycosides in the leaf
2 most predominant stevioside rebaudioside A
CH2CH3
H
H
O
O
OO
H3CHO
OH
OH
HO
O
O
OR
HO
OH
O
OH
OH
HO
HO
O
HO
OH
OH
HO
Stevioside: R=H
Rebaudioside A: R=
From Green to White
Steviol Glycosides
Stevioside
Rebaudioside A
Others
Rebiana
The first fully characterised, high purity form of rebaudioside A
The first fully characterised, high purity form of rebaudioside A
Other components
Stevia rebaudiana Bertoni or
“stevia”
Stevia – the vocabulary
Stevia General term used to refer to the plant and commercially to food uses of Stevia rebaudiana (botanical name)
Stevia extract refers to compounds isolated (extracted) from stevia without regard to purity or identity of the compounds
Steviol glycosides Sweet tasting components in leaves of the stevia plant Leaf contains at least 10 unique steviol glycosides including rebaudioside A, stevioside, rebaudioside C
Rebaudioside A Best tasting steviol glycoside
Also called “reb A” for short
Purified from the leaf, it provides a clean, sweet taste
Rebiana* Ingredient containing high-purity rebaudioside A
Purity assures clean, sweet taste
Rebiana is not less than 97% rebaudioside A* Appears on ingredient labels in the US
Truvia ™ Brand name of leading sweetener derived from Stevia
Attributes of rebiana
Plant derived, high potency, zero calorie, good tasting sweetener
The best tasting part of the stevia leaf – not less than 97% rebaudioside A
200 300 times sweeter than sucrose
Non caloric, non glycemic
Good solubility
Heat and pH stable in food and beverage systems
Introduction to Truvia™ rebiana
Truvia™ rebiana is comprised entirely of purified steviol glycosides, containing not less than 97% rebaudioside A
Truvia™ rebiana (ingredient) and Truvia™ tabletop sweetener launched in the USA in 2008:
– Brand has established leadership position in new category of zero-calorie, plant-derived, high intensity sweeteners
Cargill, maker of Truvia™ rebiana, has applied for European regulatory approval
European Food Safety Authority recently completed a safety assessment; their Scientific Opinion published on 14 April 2010
EFSA Scientific Opinion
EFSA confirmed that steviol glycosides are safe for use in foods and beverages
“Steviol glycosides complying with JECFA specifications are not carcinogenic, genotoxic or associated with any reproductive / developmental toxicity”
EFSA established an Acceptable Daily Intake (ADI) for their safe consumption
−Expert panel established same ADI as previously established by JECFA
EFSA Scientific Opinion is critical milestone in EU approval process; final EU regulatory approval likely to be in 2011
Rebiana safety programme objective
Demonstrate the safety of rebiana for consumption by all consumers, in all foods, for all eating occasions
in all countries
Demonstrate the safety of rebiana for consumption by all consumers, in all foods, for all eating occasions
in all countries
Research on stevia and steviol glycosides
Stevia and its components have been evaluated in a range of studies over the past five decades
Studies varied widely in purpose, design and quality:– Many small studies used a crude extract of stevia, making it
impossible to attribute the observed effects to any part of the leaf
– Others injected steviol glycosides into animals or fed animals very large amounts of steviol (the breakdown product of the steviol glycosides)
Minority of these studies raised questions about potential effects on reproductive health and kidney function
Some human studies suggested beneficial effects on blood pressure and blood sugar
Rebiana safety programme
Cargill and The Coca Cola Company collaborated to develop the ingredient rebiana – high purity rebaudioside A
With guidance from global food safety experts and leading external scientists, Cargill’s research programme set out to:
– Systematically evaluate a fully characterised, high purity form of rebaudioside A
– Ensure stevioside safety data are relevant to rebaudioside A
– Resolve questions raised by regulatory authorities, with further clinical studies where appropriate
Research results overview
Programme Area Findings / Implications
Metabolism studies
Metabolism of rebaudioside A is similar to that of stevioside Extensive toxicology data on stevioside can be applied to rebiana
General toxicology
No signs of toxicity associated with daily consumption of the equivalent of 2,000 250ml servings of a rebiana-sweetened beverage (for a 68kg person)
No treatment-related effects on any organ, including kidneys and male reproductive organs
Multigenerational/reproductive toxicology
No treatment effects on reproductive health or developmental outcomes
Clinical programme
Address JECFA request for additional data pertaining to potential pharmacological effects of steviol glycosides in humans
– Blood pressure lowering effects
– Effects on blood glucose in people with diabetes
Provide definitive data to further support the safety of rebiana
– Hemodynamic effects of rebaudioside A in healthy adults with normal and low-normal blood pressure (Blood pressure study)
– Chronic consumption of rebaudioside A in men and women with type 2 diabetes mellitus (Diabetes study)
– Comparative pharmacokinetics of rebaudioside A and stevioside in humans
Blood pressure study: Changes from baseline to treatment for resting, seated blood pressure
Resting,
Seated Measurements
Rebaudioside A
(n=50)
Placebo
(n=50)p-value*
Mean ±SEM
Baseline SBP (mm Hg) 110.0 ± 1.2 110.7 ± 1.3 0.683
SBP Δ -1.3 ± 0.7 -0.4 ± 0.8 0.237
Baseline DBP (mm Hg) 70.3 ± 0.9 71.2 ± 0.9 0.529
DBP Δ -1.3 ± 0.5 -0.7 ± 0.5 0.154
Baseline MAP (mm Hg) 83.6 ± 0.9 84.3 ± 1.0 0.554
MAP Δ -1.3 ± 0.6 -0.6 ± 0.6 0.192
*ANCOVA; initial model included terms for baseline value, treatment, site, and treatment by site interaction. Values for pre- to post-treatment change in DBP were ranked prior to analysis.•SBP – systolic blood pressure; DBP – diastolic blood pressure; MAP – mean arterial pressureMaki et al. (2008) Food and Chem Toxicol 46:S40-S46
Diabetes study: Glycosylated hemoglobin at baseline to weeks 4, 8, 12, 16
Glycosylated hemoglobin
Rebaudioside A
(n=60)
Placebo
(n=62)p-value*
Mean ±SEM
Baseline (%) 6.71 ± 0.11 6.70 ± 0.10 0.964
Week 4 Δ (%) 0.02 ± 0.03 0.02 ± 0.903 0.982
Week 8 Δ 0.11 ± 0.05 0.04 ± 0.04 0.574
Week 12 Δ 0.11 ± 0.05 0.07 ± 0.05 0.248
Week 16 Δ 0.11 ± 0.06 0.09 ± 0.05 0.355
*P-values for the change from baseline are for the analysis of covariance with baseline value as the covariate. All values were ranked prior to analysis.
Maki et al. (2008) Food and Chem Toxicol. 46:S47-S63
Diabetes study: Results of secondary outcomes
Rebaudioside A
(n=60)
Placebo
(n=62)
p-value
Mean ± SEM
Baseline SBP (mm Hg) 121.6 ± 1.4 126.0 ± 1.6 0.051
Δ (mm Hg) -0.2 ± 1.0 -0.9 ± 1.1 0.775
Baseline DBP 72.5 ± 1.0 71.3 ± 1.1 0.429
Δ 0.2 ± 0.8 -1.1 ± 0.7 0.132
No effect of rebaudioside A on the following outcomes:
Fasting glucose, insulin, C-peptide Body weight Total-C, LDL-C, HDL-C, Non-HDL-C, triglycerides
Maki et al. (2008) Food and Chem Toxicol. 46:S47-S63
Publication of the science supporting safety
12 papers evaluating the safety of rebiana have been published
electronically in the peer-reviewed journal
Food and Chemical Toxicology.
The published studies clearly establish the safety of rebiana for
use as a sweetener in food and beverages.
12 papers evaluating the safety of rebiana have been published
electronically in the peer-reviewed journal
Food and Chemical Toxicology.
The published studies clearly establish the safety of rebiana for
use as a sweetener in food and beverages.
Ref: Food and Chemical Toxicology, Vol 46:7 S1-S92 (2008)
EFSA Scientific Opinion (14 April 2010)
“Steviol glycosides complying with JECFA specifications are not carcinogenic, genotoxic or associated with any reproductive / developmental toxicity”
“The Panel considers that there is no need to further test the potential of carcinogenicity of steviol glycosides in other species (e.g. mouse)”
Expert reviews - 2008
Food and Chemical Toxicology Published safety studies
Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Comprehensively examined the safety data and set a permanent ADI
GRAS (Generally Recognised As Safe) Independent Expert Panel
Critically reviewed Truvia ™ rebiana database of studies
Determined its safety for general purpose use as a sweetener
Food and Drug Administration (FDA) Issued no-objection letterRebiana affirmed as Generally Recognised as Safe (GRAS)
Toxicology Forum Panel multi-stakeholder symposium
Reviewed safety of rebaudioside A
Expert reviews - 2009/10
French Food Safety Agency AFSSA Assessed safety of rebaudioside A
Temporary legal approval of ≥97% rebaudioside A for up to a maximum of 2 years, for use in certain food and beverages in France, published on 6 September 2009
First market in EU to approve
European Food Safety Authority (EFSA) Reviewed safety of steviol glycosides, including rebaudioside A
Expert panel’s Scientific Opinion officially published on 14 April 2010
Acceptable Daily Intake (ADI)
Definition of ADI – Estimate of the amount of a food additive that can be consumed daily
over an entire lifetime without appreciable health risk
ADI for steviol glycosides is 4 mg/kg bw/day on a steviol basis – Established by JECFA and EFSA
Translated for rebiana is 12 mg/kg bw/day– Approximately equivalent to 23 teaspoons of Truvia™ tabletop
sweetener every day over the course of a lifetime
EFSA said ADI could be exceeded at max. proposed usage level– Projected uses were based on provisional industry estimates and may
need to be adjusted before final EU regulation
Summary of conclusions
Truvia™ rebiana is safe for use in food and beverages
High purity rebaudioside A (rebiana) is fully differentiated from crude stevia
Truvia™ rebiana is reproducibly purified to specifications that exceed regulatory requirements
Clinical studies indicate lack of pharmacological action of steviol glycosides– No effect on blood pressure in individuals with normal and
low-normal blood pressure
– No effect on glucose homeostasis
Successive independent expert assessments have validated the weight of safety evidence
EFSA is the latest and most relevant to European regulatory approval
Implications for consumers
Truvia™ sweetener provides a zero-calorie sweetening choice for consumers
Truvia™ sweetener is already in use in France following French regulatory approval of rebaudioside A
Once approved for EU-wide use, it will be available as a tabletop sweetener and as an ingredient in foods and beverages
As research and safety assessments show, it can safely be used by all consumers, whether watching weight or managing diabetes
Key references
Food and Chemical Toxicology 46 (2008) S1-S92Peer-reviewed published papers; available on request from Cargill
EFSA Journal 2010;8(4):1537
http//www.efsa.europa.eu/en/scdocs/scdoc/1537
Joint FAO/WHO Expert Committee on Food Additives. 69th Meeting, 2008. JECFA/69/SC, 4 July 2008. Steviol glycosides ADI
Food and Drug Administration (FDA), 2008. http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154989.htm
Journal officiel de la République Française, 6 September 2009, éd. no. 206 http://textes.droit.org/JORF/2009/09/06/0206 - item 6
For further information or to request Food and Chemical Toxicology reprints contact:
Amy Boileau, Ph.D, R.D.Manager, Regulatory & Scientific AffairsFood Ingredients & Systems, [email protected]
Truvia™ sweetenerZero-calorie sweetness from the stevia leaf