Critically evaluate the range of new evidence provided by petitioners in or after 2008 to support safety claims for the non-nutritive sweetener stevia.

Report structure (1200 words +10%)

In your answer, consider the following points

1) History of use (10%)
a) Review from 2008 US FDA document (article 2)
2) Technical data and product specifications (10%)
a) Expecting normal data from Article 2, but you should also reference other sources here
3) Biological data related to ADME (20%)
a) On page 20 section 3.1 of Article 1 (EFSA) and pg.15-18 of Article 2
b) => any critical comparisons here?
c) Consider: Absorption, Digestion, Metabolism, Excretion – can include a table
d) Compare stevia glycosides to free steviol; can bioavailability be established?
e) Evidence from animal or human trials? Any species differences??
4) Toxicological data related setting ADI (20%)
a) How has this been determined & at what level… any critical comparisons??
b) How do results compare with previous assessments (e.g. JEFCA)
c) Give detail on toxicity levels, dose, NOAEL’s set – how do you get to human ADI
5) Pre 2008 objections to safety petitions (20%)
a) Give an overview of concerns; consider availability of data / risks from studies

Assignments instructions
There are several safety dossiers for stevia. For instance, the FDA approved 18 GRAS dossiers from petitioners between 2008-2014 addressing the safety of steviol, stevioside and related natural sweeteners. The first of these dossiers (Grn252) as well the 2010 EU opinion paper certifying stevia to be safe will be used in this assignment.
You can download the documents from the links below.
Article 1
European Food Safety Authority. (2010). “Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive” Retrieved Feb, 2014, from http://www.efsa.europa.eu/en/efsajournal/pub/1537.htm.
The following sections will require close reading;
Article summary (pg. 2-4)
Absorption, distribution, metabolism and excretion (pg. 20)
Discussion (pg. 42)
Conclusion (pg. 47).
Read other sections as needed for supplementary detail

Article 2
U.S. Food and Drug Administration. (2008). “GRN No. 252: Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni ” Retrieved Feb, 2014, from http://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=252.

[On the summary page click on “252” to open the pdf.]. Alternatively the pdf link is: Here

The dossier contains 351 pages including a GRAS notification (36 pages) and an extensive group of >70 appendices and other material. The following sections will likely require close reading;
Executive summary (pg.1-10)
Review of the toxicological data (pg. 15-19)
Acute & Chronic toxicity testing (pg. 19-21)

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