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Stevita Co. ( Oscar Rodes) Vs. the FDA
In 1988, Oscar Rodes, the President and founder of Stevita Co. Inc., introduced to the US market the pure stevia extract (steviosides) and teas sweetened with ground stevia leaves, harvested and extracted in Brazi.
The steviosides ( stevia extract) would be a new form of stevia in the market because until that time only leaves , whole or ground or in the form of syrup, were available to the US consumer. Oscar Rodes contacted FDA officials to find out if there was any objection for the sale of the pure extract .
Even though stevia logically should be classified as a GRAS substance ( a natural product in use prior to 1958 by a large population without any report of adverse health effect) and automatically safe as a food ingredient, FDA did not agree with this logical classification and denied Oscar Rodes the permit to sell the pure extract in the local market unless he subjected his extract to a battery of pharmacological studies that would cost multi-million dollars, taking several years to complete and with no guarantee of approval because of political reasons. As a result , he cancelled the introduction of the pure extract and continued selling the teas which used only ground leaves as ingredients.
On June 20th, 1991 FDA agents accompanied by US Marshals showed up at his Arlington, TX, warehouse and announced that all stevia teas in the warehouse , by court order, had been subjected to seizure and condemnation in the form of burning because the teas contained stevia, which was an adulterated food item. On the following month FDA issued an import alert and banned all food products containing stevia in the USA.
After Congress passed the Dietary Supplement and Education Act of 1994 (DSHEA)which allowed stevia products to be sold as dietary supplements, Oscar Rodes attempted to reintroduce the pure stevia extract in the US market in 1996, properly labeled as a dietary supplement. with the trade name "SteviaSweet". However, on the very first shipment , FDA customs inspectors detained the entire shipment because the word "sweet" in the trade name. According to the inspectors , the word "sweet" rendered the product "adulterated" thus unfit for human consumption. Later on, Oscar reintroduced the same product in the US market, properly relabeled as dietary supplement, with the "Stevita" trade name.
In late 1997 FDA agents inspected Stevita's warehouse in Arlington and subsequently issued "warning letters". The main issue was that Stevita Co.was selling third parties books about stevia. Some of the books mentioned the history, chemistry, and uses of stevia around the world, and that the primary use of stevia in some countries was as a sweetener. According to FDA 's interpretation, these books rendered all the stevia products in Stevita Co's warehouse as adulterated because stevia was not approved as a sweetener. Stevita Co's attorneys contested this interpretation with FDA officials , but during this time of dispute FDA"s agents were confiscating all Stevita's stevia shipments.
Finally, on May 1998, with his stevia inventory almost depleted, Oscar decided to make a deal with FDA by promising to stop selling the books in exchange for the release of his inventory by the FDA, so that Stevita could continue in business. On May 19th, Oscar received a fax from FDA with the following order: " The agency appreciates Stevita Co. express intention to comply with the Law. However, a current inventory must be taken by an investigator of this office, who will also be available to witness destruction of the cookbooks, literature and other publications.." Also, Oscar was ordered to recall all the books he had sold and destroy them. He refused to destroy the books - he had agreed to stop selling but not destroy them - and the dispute continued with Stevita Co practically shutting down because of the lack of inventory. Finally, thanks to intervention by the press and assistance from some members of Congress, on June 29, FDA advised Stevita Co's ' attorney that he could continue selling the books with the exception of a cookbook which named Stevita stevia as one ingredient in some of the recipes.
The books that were ordered to be destroyed:
The Stevia Story by Linda and Bill Bonvie and Donna Gates,
Cooking with Stevia by James and Tanya Kirkland,
Nature's Sweet Secret by David Richards
As of today, FDA has still not approved, or at least its position is not clear, on the use of stevia extract with all its sweet components as a food in this country. FDA has assigned GRAS status to only stevia recrystalized extracts with high concentration of Rebaudioside A (Reb A), only one of the several sweet components of the stevia leaf.
For more info go to:
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www.stevia.net/bookburning.htm
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