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displayed two books. One, written by himself, was on cooking May 27, 1998, that "literature or publications that promote with stevia, and the other book gave information on construct- Stevita stevia products for use as a conventional food and that ing home-made bombs. He held up the books and asked the are marketed with or displayed with those products cause the rhetorical question, "Which of these publications is legal?" products to be adulterated as an unapproved food additive". Whitaker contends that Patricia and Oscar Rodes of Stevita The agency also noted in correspondence on June 8, 1998, were given poor legal advice, which led to their agreeing to regarding books, that "FDA had advised Mr Rodes that he stop selling their books. He says that James Lahar from the should take care not to use them to stimulate sales of Stevita FDA mandated a book-burning when he and other agents con- brand stevia, as that could cause them to be labeling [sic] fiscated the company's stevia, pressuring Stevita not to sell the under the Federal Food, Drug and Cosmetic Act". books. Oscar Rodes called his local television station to Cooking with Stevia was the book that an FDA official dated attract public attention to his company's plight. FDA officers and initialled so it could not be sold. This action was taken on initialled and dated six books so they could not be sold. six copies of the book. Whitaker's attorneys, Emord and Whitaker reported that the FDA backed down after his Associates, noted the action in their letter of June 8, 1998, lawyer filed suit, advising that no books would need to be when they accused the FDA of acting unlawfully under the destroyed and that Whitaker may buy any of the books him- United States Constitution. After a mix-up over the amount of self. books defiled, Emord and Associates wrote that the "material The story according to the FDA is quite different. After the point is not the number of books defiled, but that the agents public's attention was gained, FDA documentation is clearly defiled any of the books". Dan Burton's letter to the FDA above the District Office level. In a memo to file on April 9, makes a similar point, stating that "FDA has no authority from 1999, FDA Acting Associate Commissioner for Regulatory Congress to issue an enforcement letter that provides for the Affairs, Gary J. Dykstra, maintained use of FDA officers to take a ‘current that FDA never ordered the books inventory' of a dietary supplement destroyed. Nevertheless, he company's books..." acknowledged that an FDA letter of . . The FDA responded to claims of May 19, 1998, states that "a current Whether or not FDA maintains its acting inappropriately regarding inventory must be taken by an inves- | [fg position and stevia remains the destruction of books by stating tigator of this office, who will also be that it had “acted within its authority available to witness destruction of illegal asa food or food under the FD&C Act and the the cookbooks, literature, and other additive, it is still available requirements of the First publications for the purpose of veri- Amendment". However, FDA fying compliance". The memo also asa food supplement. revised its Compliance Policy Guide notes that "Neither Stevita nor its "to provide further guidance regard- attorney, Ms Sarracino, had informed ing the disposition of books and FDA that the company intended to other printed materials that serve as destroy these materials". However, labeling". he goes on to state that "the District Office assumed that the This was due to the petition submitted on behalf of Julian M. company might choose to destroy them". Whitaker and also David Dean Richard, an author of one of An October 26, 1998, letter from Dan Burton, Chairman of the books called into question. Richard stated in an affidavit the Committee on Government Reform and Oversight, 105th that he lost sales of his book due to the FDA's actions of June Congress of the US House of Representatives, stated that the 1998. Under FDA guidelines, labelling can include "a book, FDA had no authority from Congress to be available to wit- reference publication, or a reprint or copy of a scientific jour- ness the destruction of books. Furthermore, it would be more nal article". appropriate under the First Amendment "to refuse to be a party Whether or not FDA maintains its position and stevia to the destruction of the books". Burton adds that FDA's May remains illegal as a food or food additive, it is still available as 19 letter was "grossly inappropriate...(regardless of whether a food supplement, therefore the end result is the same: the company agreed to allow the agency to violates [sic] its humans ingest it, anyway. First Amendment rights)". Chairman of the Committee on Government Reform and Oscar Rodes denies he chose to destroy the books. As Oversight, Dan Burton, noted this inconsistency in his letter to reported on refuseandresist.org, Rodes refuted the FDA claim the FDA: "I find the agency's treatment of stevia baffling (it is by stating: "That's absurd. I don't want to destroy my own safe as a dietary supplement but unsafe as a food additive?)..." books! How would I ever recover the cost?" FDA investigators also requested a copy of The Stevia Story: Stevia Safety Studies A Tale of Incredible Sweetness and Intrigue, by Linda Bonvie, Various concerns have been expressed over the safety of ste- Bill Bonvie and Donna Gates. This created a stir, as the book via. Many countries have claimed their reason for not consid- was published independently of Stevita, though it was avail- ering stevia for consumption is the lack of conclusive proof of able for sale through the company. Furthermore, the book its safety. questions FDA's treatment of stevia. Eventually, no action In a Joint FAO/WHO Expert Committee on Food Additives was taken regarding this item. As the FDA stated, "the book (JECFA) report on stevioside, it is noted that in rats, stevioside did not mention Stevita or its products and the agency had no "is not readily absorbed from the upper intestine but is hydrol- interest in the book". ysed to the aglycone, steviol, before absorption from the gut." Books considered problematic by the FDA included The effects of steviol on the body are not completely known, Cooking with Stevia, by James Kirkland, and The Natural but it may be a problem because animal studies are contradic- Choice, by Kay Randall (also known as Patricia Rodes). Both tory. It was found that steviol: "...exhibited greater acute tox- persons were involved in managing Stevita Company. Dallas icity than stevioside in hamsters but not in rats. Steviol was District Office informed the firm's lawyers by telephone on __ clearly genotoxic [DNA damaging] after metabolic activation, its position and stevia remains illegal as a food or food additive, it is still available as a food supplement. Stevia Safety Studies Various concerns have been expressed over the safety of ste- via. Many countries have claimed their reason for not consid- ering stevia for consumption is the lack of conclusive proof of its safety. In a Joint FAO/WHO Expert Committee on Food Additives (JECFA) report on stevioside, it is noted that in rats, stevioside "is not readily absorbed from the upper intestine but is hydrol- ysed to the aglycone, steviol, before absorption from the gut." The effects of steviol on the body are not completely known, but it may be a problem because animal studies are contradic- tory. It was found that steviol: "...exhibited greater acute tox- icity than stevioside in hamsters but not in rats. Steviol was clearly genotoxic [DNA damaging] after metabolic activation, NEXUS #25 FEBRUARY — MARCH 2003 www.nexusmagazine.com