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According to a 1994 article by Rob McCaleb of the Herb Stevia.net contends that Celestial Seasonings was permitted Research Foundation, the FDA began visiting businesses sell- to use stevia because the herb has had a long history of com- ing stevia around 1987, saying it was an unapproved food mon use without adverse health effects. Furthermore, the additive. One FDA inspector reportedly told a company presi- 1991 Import Alert acknowledges stevia's use throughout histo- dent that the manufacturer of NutraSweet® had made com- __ ry and is therefore an admission of its qualification as having plaints to the FDA to try to stop the use of stevia. GRAS status. After the 1991 Import Alert banning the importation of ste- The American Herbal Products Association maintains that via into the USA, the Herb Research Foundation produced a stevia is a food, as it has had a long history of food use, hence review by Doug Kinghorn, PhD, on behalf of the American _ it should fall into the safe category. Herbal Products Association (AHPA). The peer-reviewed Sunrider Corporation also tried this tack in 1995, stating that work concluded that stevia was safe, based on scientific evi- stevia was a "grandfathered" or "old" dietary ingredient, as it dence and historical use. The AHPA then filed a petition with had been contained in their products before the DSHEA of the FDA to have stevia leaf exempted from food additive regu- 1994. However, this approach became problematic because lations. However, the FDA concluded that there was insuffi- the company had signed a consent decree in 1984 not to sell cient evidence to prove stevia's safety. McCaleb asserts that stevia, as "Sunrider decided it was not financially prudent to evidence required to establish stevia as a food is far more com- _judicially contest this matter". prehensive than that required for artificial sweeteners such as aspartame. The Stevita Book-burning Saga Julian Whitaker, MD, believes that the In 1998, the Stevita Company and the FDA "has been after stevia since 1986, US FDA received considerable media coincidental with the growing popularity attention after it was reported that the of aspartame". FDA had ordered the burning of books GD Searle and Company developed sold by Stevita. These contained informa- aspartame (now commonly marketed as tion on the herb along with stevia recipes. NutraSweet®) by accident when creating In 1998 the Stevita The refuseandresist.org website reported 3 an ulcer drug. Many health complaints in July 1998 that Stevita had endeavoured have been reported about the negative Company and the US to import stevia in 1987 as "Stevia Sweet", health effects of asparte fi H but the FDA ordered the labels changed s headaches to tumours. “pase FDA received . as not to imply the substance would be According to James S. Turner, lawyer considerable media used as a sweetener. Later on that year, and co-founder of the Aspartame attention after it FDA agents visited the company's ware- Consumer Safety Network, Searle funded 100% of the safety studies undertak- en from 1985 to 1995 which found aspartame to be safe. Apparently all studies not funded by industry raised questions. Information linking tumours to aspartame was dismissed by the then FDA _ Deputy Commissioner, who went on to become Vice President of Clinical Research for Searle. According to another report by health author Gail Davis, a similar situation occurred in 1983 when aspartame was approved for use in "We had already been forced to let soft drinks. The FDA Commissioner employees go...we have to eat," he left soon afterwards to become a consultant for Searle's public said in the report. The FDA then arranged to come and take relations firm. inventory, and stated in a fax that an investigator would "be GD Searle was bought by Monsanto in 1985 and then available to witness the destruction of the cookbooks, litera- acquired in 2000 by J.W. Childs Equity Partners II LP. The ture and other publications". Rodes then notified the FDA company asserts that more than 200 objective studies have agents on arrival that he would not destroy the books, but found NutraSweet to be safe and that these papers were would videotape any actions by the FDA to do so. house and took copies of three books sold on stevia. FDA Dallas then detained a ship- ment of stevia at customs in February 1998, the reason later given that the shipment was contaminated because of the previously released literature. A March 6 letter regarding this mat- ter reportedly stated that the literature "rendered the product adulterated". The FDA took inventory at Stevita in April and May 1998, and Oscar Rodes agreed not to sell the books, as the hold-up was affecting business. was reported that the FDA had ordered the burning of books sold by Stevita. reviewed by relevant regulatory authorities such as the FDA, Dr Julian Whitaker became involved when he had his attor- etc. Neotame is the new sweetener to be marketed by the com- ney prepare a lawsuit to prevent destruction of the books. In pany. It is 40 times sweeter than NutraSweet and 8,000 times his article on the subject, Whitaker makes a point about the sweeter than sugar. [For more on aspartame, see feature arti- power of the FDA by quoting from Tulane University profes- cles in NEXUS 2/28, 3/01, 7/04 and 7/05.] sor James P. Carter's 1992 book, Racketeering in Medicine: The Suppression of Alternatives. Carter states: "The FDA Stevia's Safe Historical Use serves as the pharmaceutical industry's watchdog, which can Many foods have not had to go through the process of being be called upon to attack and destroy a potential competitor approved for GRAS status. Through historical use, it is under the guise of protecting the public." assumed they are safe for human consumption. Supporters of The Aspartame Consumer Safety Network reported that in stevia have put this argument forward to the FDA, but without June 1998, James Kirkland—author of one of the banned success. books—attended a congressman's public meeting at which he Stevia.net contends that Celestial Seasonings was permitted to use stevia because the herb has had a long history of com- mon use without adverse health effects. Furthermore, the 1991 Import Alert acknowledges stevia's use throughout histo- ry and is therefore an admission of its qualification as having GRAS status. The American Herbal Products Association maintains that stevia is a food, as it has had a long history of food use, hence it should fall into the safe category. Sunrider Corporation also tried this tack in 1995, stating that stevia was a "grandfathered" or "old" dietary ingredient, as it had been contained in their products before the DSHEA of 1994. However, this approach became problematic because the company had signed a consent decree in 1984 not to sell stevia, as "Sunrider decided it was not financially prudent to judicially contest this matter". Company and the US FDA received © was reported that the FDA had ordered the burning of books sold by Stevita. Stevia's Safe Historical Use Many foods have not had to go through the process of being approved for GRAS status. Through historical use, it is assumed they are safe for human consumption. Supporters of stevia have put this argument forward to the FDA, but without success. 24 = NEXUS In 1998, the Stevita considerable media attention after it www.nexusmagazine.com FEBRUARY — MARCH 2003