FDA
Orders
Books
Destroyed
7/2/98
Stevia is an herb, native to South America, which has been approved for use in the United States as a dietary supplement. In South America, however, Stevia has been used for centuries as a natural sweetener. But the FDA has not approved Stevia as a food additive and, apparently, feels that its jurisdiction extends to controlling information or destroying books which talk about Stevia's sweetening properties. Oscar Rodes owns Stevita Co., an importer and distributor of Stevia since early 1996. In mid-1996, Rodes attempted to import Stevia, both in ground and extract forms under the trade name "Stevia Sweet". The FDA, however, held his first shipment at customs and ordered him to change the labels so as not to suggest that the herb would, in fact sweeten foods or beverages to which it was added. Rodes complied. Then, in October of 1997, the FDA came to Rodes' warehouse to inspect his operation. "They took samples of the product and copied everything off of our web site," Rodes told The Week Online. In addition to the Stevia, the FDA also noticed three books that Rodes had in stock. The books, James Kirkland's "Cooking with Stevia: The Naturally Sweet and Calorie-Free Herb," David Richard's "Stevia Rebaudiana: Nature's Sweet Secret" and Linda Bonvie et al.'s "The Stevia Story: A Tale of Incredible Sweetness and Intrigue," told of Stevia's properties as a natural, calorie-free sweetener. "They took copies of each book as well" said Rodes. In February of 1998, a shipment of Stevia, bound for Rodes' warehouse, was detained by the Dallas, TX office of the FDA at customs. The Dallas office notified him that the shipment was being held up for "investigation", "even though this product, and the labels on the product, had already been approved by Washington," said Rodes. The Dallas office later told Rodes that if they released the product, it would be "contaminated" by the presence of the literature already in circulation. Then on March 6, Rodes received a warning letter from the FDA stating that the presence of the books, and the contents of his web site "rendered the product adulterated." The letter told him that he had five days to reply or to take corrective action. Rodes called his attorney, James Turner, in Washington, DC. Turner sent a letter requesting a fifteen day extension. On March 26, Turner answered the FDA letter, saying that Rodes had agreed to all of their requests, except for the books, which he wanted to continue to offer for sale. On April 27, FDA agents came back to Rodes' place of business and took inventory. They inspected the product labels and looked at his records. On May 12, with over 14,000 units of product being held up, Rodes, through his attorney, sent a letter to the FDA agreeing not to sell the books. "I felt I had no choice" he said. "We had over 250 unfilled back orders. We had already been forced to let employees go, and it was down to just my wife and I. This is my business. We have to eat." On May 19, Rodes received a fax from the FDA which said, in part, "...a current inventory must be taken by an investigator of this office, who will also be available to witness the destruction of the cookbooks, literature and other publications for the purpose of verifying compliance." Upon receipt of the above-mentioned fax, alerting him that FDA agents would be in later in the day, Rodes attempted to contact his attorney, but he was unavailable. When the agents arrived, they did yet another inspection. Rodes alerted the agents that he himself would not destroy the literature, but if they insisted upon doing so, he would videotape their actions for his records. At that point, the agents called their office and, instead of destroying the books, took a marker and signed and dated the title page of each one in stock. The agents returned to Rodes' place of business on both May 12 and May 13. Shortly after this incident, Rodes was contacted by a Dr. Julian Whitaker, who asked if he could purchase the three books. Rodes explained his situation and refused to sell them. Thereafter, Dr. Whitaker contacted Jonathan W. Emord, a Washington, DC first amendment attorney, who then contacted the FDA stating an intention to commence legal action if the books were not released for sale. On June 5, Emord received a faxed letter from Annamarie Kempic of the FDA's enforcement bureau stating that Mr. Rodes was free to sell the books to his client and that "we have contacted Rodes and advised him not to destroy the books at this time." On June 8, Mr. Emord received another fax from Ms. Kempic stating that "The FDA Dallas District informs me that it was Mr. Rodes who chose the option of destroying the books." "That's absurd," Rodes told The Week Online. "I don't want to destroy my own books! How would I ever recover the cost?" At this time, the FDA is withholding two separate shipments of Stevia from Rodes. These shipments contain legal product with labeling approved by the FDA. The only answer that Rodes has gotten is that the presence of the literature in the marketplace somehow "adulterates" the product. "They had told me that I should recall the 4,000 books that I had already sold," Rodes said. "That is impossible." At this time, the FDA is withholding two separate shipments of Stevia from Mr. Rodes. These shipments contain legal product with labeling approved by the FDA. The only answer that Mr. Rodes has gotten is that the presence of the literature in the marketplace somehow "adulterates" the product. "They had told me that I should recall the 4,000 books that I had already sold." Mr. Rodes said. "That is impossible." In the end, the FDA's Stevia crackdown may provide more protection to the artificial sweetener industry than the public. Stevia is highly regarded both in South America and in industrialized nations like Japan as a natural, calorie-free sweetener. It is legally available in the US, intended for human consumption; the only thing that the FDA doesn’t want people to know is that it is sweet. The FDA did not return phone calls seeking comment on this story.
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