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The memorandum below, from the FDA to its Denver District office, is part of a number of shadowy events involving stevia. This document, however, which has been purged of several key words (including the identity of the sender), by the agency, is especially mysterious. According to FDA records, during the late '80s -- a time when stevia's benefits were just beginning to be recognized in the United States -- representatives of an "anonymous firm" lodged a "trade complaint" with the FDA. It charged that the Colorado-based tea company Celestial Seasonings was using stevia extracts in four of its products and that they were therefore "adulterated." This complaint, it is worth noting, was not based on any public concerns about the safety of stevia or reports of any adverse effects resulting from its use. It rather reflected the apparent lengths to which a company would go to keep U.S. consumers from gaining access to stevia, an unpatented natural substance. |
(Were companies allowed to use stevia in their products? Yes, under a provision in federal law that allows for self-determination of Generally Recognized as Safe (GRAS) status. This "self determination" is based on stevia's long history of "common use in food" prior to 1958, the year the FDA law took effect, and widespread use without any apparent adverse health effects.)
In a "final decision of the Department," dated April 22, 1998, Victor F. Zonana, deputy assistant secretary for public affairs, writes: "I have determined to continue to withhold the information deleted from the memorandum under the provisions of exemptions (b)(6) and (b)(7)(C) and (D) of the FOIA. Individuals who provide information to the government have an expectation of privacy. Release of their identities would discourage the voluntary submission of reports of possibly adulterated products on the market and, in turn, would severely hinder FDA's law enforcement activities. Further, disclosure would be a clearly unwarranted invasion of personal privacy."Prior to this "final decision," Bonvie had been told by an official at the office of public affairs that the individual who sent in this "complaint" was an attorney, and that his name and law office were mentioned on the above document.
As a result of the complaint, the agency began a full-scale investigation, during which Celestial Seasonings offered the FDA substantial evidence of stevia's long-term safe use. (That information is also heavily censored by the FDA in its subsequent FOI release, even to the point of blanking out the name of a country -- apparently Japan -- where stevia has long been a standard sweetener). Celestial Seasonings also applied for "official" GRAS status for the herb, which the FDA declined to process. Eventually, FDA pressure resulted in Celestial Seasonings ceasing to use the herb -- and then, according to documents obtained from the FDA, giving the agency the names of other tea makers that were also using it. (When this inconsistency in the release of 'informant' information was pointed out to the FDA, it replied that it had made a "mistake" in revealing the role of Celestial Seasonings).
Also apparently sent by the same anonymous complainant is a one-page document titled: STEVIOSIDE IN CELESTIAL SEASONINGS HERBAL TEA. It reads in part: "The alternative sweeteners known as stevioside and rebaudioside A have been found in four Celestial Seasonings Herbal Teas.....In order to obtain results as soon as possible, the analyses were performed on the residue which sifts out the the tea bags... Work will continue on this project...If it becomes important to know the level of sweetener in the entire contents of the tea bags, further work will be done..."
In a letter from Bonvie on July 20, 1996 requesting the entire document, she wrote: "The document in question does not really appear to be a legitimate 'trade complaint' calling attention to an illicit practice by a segment of industry, but rather an attempt to restrain trade and competition."
This apparently was not the first time a trade complaint triggered FDA action on stevia. The search-and-seizure campaign that was initiated in the mid-'80s had a similar origin, according to Rob McCaleb of the Herb Research Foundation, who says he has seen the complaint and that it originated from a "sophisticated" company "with a strong interest in not having sweet natural products on the market." Asked for a copy of the document, the FDA said it could not locate one. (That "doesn't mean there is not one," said Robert Martin of the FDA's Office of Premarket Approval, just that "we cannot find one in this office.")
In 1991 the FDA issued an "Import Alert" (No: 45-06, date: 5/17/91) for stevia leaves, stevioside and foods containing stevia, calling them "unsafe food additives." This prevented all stevia from entering the U.S., and again, was not based on any consumer complaints or reported ill effects. Interestingly, the 1991 Import Alert states that stevia has "been used throughout history," an admission that stevia does qualify as a GRAS product. The Import Alert was revised in September of '95, due to the Dietary Supplement Health and Education Act. Under that law, dietary supplements cannot be called "food additives," and stevia dietary supplements can now be imported into the U.S. -- provided they are not called "sweeteners" or used as "flavoring agents."