Three petitions seeking approval of stevia or stevioside as a food additive have been submitted to FDA since 1989 from (1) a stevia importer in Texas; (2) the American Herbal Products Association (AHPA), a trade association; and (3) the Thomas J. Lipton Company. All three petitions were, in effect, rejected because of inadequate data on the safety of stevia and stevioside.
Cargill and Coca-Cola have developed a purified extract of stevia called Truvia. In May 2008, Cargill submitted for publication in the scientific journal Food and Chemical Toxicology a series of studies and reviews which the companies believe establishes the safety of Truvia. CSPI is reviewing this literature now, as is the Food and Drug Administration.
The FDA has not posted on their Web site any of the documentation from the three petitions. However, the full text of the petition by the AHPA, dated October 21, 1991, is available at an alternative medicine website.
http://www.holisticmed.com/sweet/stv-petition.txt
Also available is a document submitted to FDA by the Herb Research Foundation on behalf of the AHPA. http://www.holisticmed.com/sweet/stv-supp.txt
European Community
The Scientific Committee on Food for the European Commission concluded that “there are no satisfactory data to support the safe use of these products [stevia plants and leaves],” in a five-page opinion dated June 17, 1999. http://www.europa.eu.int/comm/dg24/health/sc/scf/out36_en.pdf (requires Adobe Reader plug-in)
The Committee also reiterated “its earlier opinion that the substance [stevioside] is not acceptable as a sweetener on the presently available data,” in a seven-page opinion dated June 17, 1999. http://www.europa.eu.int/comm/dg24/health/sc/scf/out34_en.pdf (requires Adobe Reader plug-in)
United Kingdom
The Advisory Committee on Novel Foods and Processes for the Ministry of Agriculture, Fisheries and Food rejected an application for use of stevia as a sweetener in herbal teas because “the applicant had not provided all of the information necessary to enable an assessment to be made,” in a three-paragraph statement dated September 24, 1998. The Committee also agreed with concerns raised about the inadequacy of the data on the safety of stevia.
http://www.maff.gov.uk/food/novel/980924.htm
World Health Organization
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) reviewed stevioside in 1998, but could not quantify an Acceptable Daily Intake (ADI) because of inadequate data on the composition and safety of stevioside. The Committee recommended that further studies be done on the metabolism of stevioside in humans and on the potential genetic effects of steviol (a metabolite of stevioside).
The text of their review, published in JECFA Monograph Series 42, is not available on the Internet. A summary table showing no ADI allocated for stevioside is dated June 1998.
http://www.who.int/pcs/jecfa/summary_51.htm
Scientific research on stevia and stevioside
The two studies referenced in the article Stevia: A Bittersweet Tale are:
- A. Yamada et al.: Chronic toxicity study of dietary stevia extracts in F344 rats. J. Food Hyg Soc Japan 26:169-183, 1985. (Not indexed in Medline and not available on the Internet)
- C. Wasuntarawat et al.: Developmental toxicity of steviol, a metabolite of stevioside, in the hamster. Drug Chem Toxicol 1998 May; 21(2):207-22. (Abstract available in Medline) http://www.ncbi.nlm.nih.gov:80/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9598301&
dopt=Abstract
Examples of pro-stevia articles
Stevia Leaf — Too Good to be Legal? By Rob McCaleb, president of the Herb Research Foundation. http://www.holisticmed.com/sweet/stv-faq.txt
Questions and Answers about Stevia, by David Richard, author of the book Stevia Rebaudiana: Nature’s Sweet Secret. http://www.healthy.net/hwlibrarybooks/stevia/questions.htm
A copy of the correspondence to FDA from Stacey Elin Rossi, quoted at the beginning of Stevia: A Bittersweet Tale. http://www.fda.gov/ohrms/dockets/dailys/100699/ec00001.pdf
(Requires Adobe Reader plug-in)
For more information
For more on stevia, please see our page on food additives: http://www.cspinet.org/reports/chemcuisine.htm
If you have relevant information about stevia, please e-mail us at stevia@cspinet.org
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