© 1999 by Vanessa McGrady
On May 15, 1998, Oscar Rodes found himself in the eye of a First-Amendment hurricane. His successful company was nearly crippled by the Food and Drug Administration, and the America he called home resembled the dictatorship of his native Brazil.
Rodes and his family have owned and operated the Stevita Corporation in Arlington, Texas, since 1996. His business involves importing extract of the stevia plant, an herb 300 to 500 times sweeter than sugar, with no calories, fat, or known adverse effects. Stevia is used all over the world as a sweetener for soda, candy and other foods. All over, that is, except in the United States.
Still, Rodes and others can sell stevia just as long as they don't refer to its sweetening properties in any literature or labels. Because the herb has not undergone the rigorous and expensive research to gain approval as a sweetener, under FDA regulations it can only be sold as a "nutritional supplement."
And that's where Rodes' trouble began. Along with stevia products, Stevita offered three books about stevia, all extolling the plant's sweet properties and one, a cookbook, calling for Stevita's brand of stevia. The FDA saw this as a labeling infringement. So from February until May 1998, the agency impounded all Stevita's shipments from Brazil. Rodes said it was his understanding that he would not be able to get his supplies until some 2,000 books were destroyed. He agreed to stop selling the books.
To further cement this understanding, Arlington's FDA Compliance Officer, James Lahar, sent a fax that day to Rodes. It read, in part:
Two hours later, agents showed up at Stevita headquarters.
"I was startled. I was, at the same time, furious. I had no chance to donate the books to the library or sell them back to the publisher," Rodes said.
A phone call from his lawyer confirmed that Rodes was not legally bound to obey the order. No books were destroyed that day, and the agents left.
"But it didn't stop there," said Rodes. "They wanted us to recall the books we had already sold."
Even though Rodes refused to recall the books, customers, including health food stores, began sending the books back because they were worried about the FDA's wrath. The result of the slowdown cost Rodes at least $10,000 in books and lost business.
"This was a malicious, improper use of the FDA's authority," said Rodes' lawyer, James Turner, who works out of Washington, D.C., and specializes in food and drug law. "What should have been two separate cases were lumped into one. The labeling question should never have affected the shipments," he said.
By the end of June, the FDA granted Rodes permission to sell two of the books, but still prohibited the sale of the cookbook and had not rescinded the order to recall them.
This issue is apparently a hot potato for the agency. James Lahar, the compliance officer who gave the original order, offered no comment, and instead, referred to a Washington, D.C., spokesperson, who also would not speak. Three other public affairs officers also declined comment. It seems "spokesperson" is a gross misnomer in this case.
A little attention goes a long way
A small item about Stevita's troubles in the local newspaper got the attention of national media and of State Rep. Dan Burton, who ordered an investigation. Once big-name reporters started calling, the FDA "clarified" the issue in a September 11, 1998 letter to Burton.
"First, it must be stated that the FDA has never ordered the destruction of Stevita Company cookbooks or any other books or publications related to stevia, as has been alleged," wrote Melinda K. Plaisier, the FDA's deputy associate commissioner for legislative affairs. She called the order a "misunderstanding." In that letter, she also enclosed a copy of a memo that specifically reminds agents that the FDA doesn't condone or seek destruction of any books.
Was all this a figment of Rodes' imagination then? No. Rodes was a victim of an unctuous bureaucracy.
"You're in the world of George Orwell," said Turner, Rodes' lawyer.
While no one put a gun to Rodes' head and ordered the books destroyed, it was clear that unless Rodes complied with the order to stop selling and destroy the books, his shipments of stevia would remain at the airport. The destruction, then, would technically be voluntary.
Rodes agreed to comply, he said, because he wanted to stay in business.
"We make a profit selling books, but we're really selling stevia," he said.
The whole episode is an ugly reminder for Rodes. One of the reasons he came to the United Sates in the late '60s was so he could escape a government of censors.
"This looks like a dictatorship. In the '60s, we had a dictatorship in Brazil. Friends just disappeared. We never thought we'd see this here," Rodes said. "If [the FDA] has the opportunity to overstep their bounds to show how fierce they are, how powerful they are, and how intimidating they are, they'll do it."
What's all the fuss about a little plant?
Why does the FDA wreak such vengeance on stevia and other natural products? If you ask James Kirkland, author of the offending cookbook, Cooking With Stevia: The Naturally Sweet and Calorie-Free Herb, it's because the aspartame industry is worried about competition.
"Everything that I have read and researched shows that stevia is probably safer than sugar, the leading cause of diabetes. Aspartame could cause cancer in rats. It's pure poison… Aspartame breaks down at 85 degrees. One component is formaldehyde, the other two are known carcinogens," Kirkland said.
The problem isn't that the FDA has found anything bad about stevia. There's just not enough good research done to declare it safe as a food sweetener. The agency blocked its import in 1991, and then relented in 1995 after Congress passed the Health Freedom Act. They granted lukewarm approval as a "nutritional supplement," meaning it's "unsafe" for stevia to be added to food or beverages as a sweetener or labeled as such, but it's fine to just take it plain, or add it to your diet as, well, a "supplement."
"It's a stupidly convoluted and ignorant position held by the FDA," says Turner.
According to the FDA's adverse-effects database, stevia products have been reported on three separate occasions by consumers to provoke anxiety and depression. In comparison, Slim Fast diet drinks showed up thirty-one times out of 2,450 adverse events, with consumers citing symptoms of dizziness, vomiting, accelerated heart rate, rectal bleeding, nervousness and disorientation. Aspartame came up twelve times.
In 1970, Japan outlawed any unnatural forms of sweetener, including saccharin. Now stevia is that country's leading alternative sweetener — they wolfed down 700 metric tons in 1985 alone. It's common to find stevia in Asia, Latin America, the Pacific Rim and Mexico, where it's used in candy, soda, and other products. There have been no reported problems in the nearly twenty years of its use.
Kirkland, a former employee of Stevita in the financial department, quit his job once he learned that his association with the company could be interpreted as a labeling problem, advocating the use of the plant as a sweetener. The next edition of Cooking with Stevia, however, will not call for the Stevita brand name.
"The FDA has no right to tell me what I can and can't write," he maintains.
The book still is not being sold through Stevita, but can be purchased at health food stores, Nutrabooks out of Denver, and on the Internet.
Kirkland uses the extract in a variety of ways, from cookies and ice cream to curried chicken and cornbread. Because the stevia extract is so much more powerful than sugar, it can't be used as a direct substitute and recipes have to be modified. Too much and the brew turns bitter.
Still, Kirkland thinks stevia will catch on eventually in America.
"America's long been ready. Big business is trying to prevent Americans from knowing the truth," he said. "What's going to need to happen is more awareness of what stevia is," he said.
So what is it?
Stevia Rebaudiana Bertoni, a cousin to chrysanthemum, grows wild as a shrub in Brazil and Paraguay and is cultivated in those countries. Mexico, Canada, Japan, and China also grow stevia. According to David Richard's Stevia Rebaudiana: Nature's Sweet Secret, one of the books targeted by the FDA and then later pardoned, Stevia's extracts are made in Brazil by taking the sweet glycosides from the leaves. Those extracts are refined and then put into powder or liquid forms and imported.
There is underwhelming evidence of adverse effects. Stevia has not been found to promote tooth decay or raise blood sugar levels. Neither are there fat or calories in the extract. One group of studies in the 1980s suggested a possible link between stevia and salmonella. Another study in the 1960s linked the plant to heart disease. Richard and Turner say those studies have been completely refuted. And can a million Japanese be wrong?
Putting a dent in the First Amendment
In M.C. Escher-like logic that can only be understood by government workers, Rodes still cannot sell the cookbook to the general public, but may distribute copies to a Dr. Julian Whitaker for research purposes only. (Whitaker had filed a formal complaint with the FDA.) He has had no problem selling the other two books since late June 1998.
Who won? "From a business standpoint, we won," said Turner.
Then why are the cookbooks still piled in Stevita's warehouse? Rodes says it's because the FDA still has not rescinded the original order to recall the books, and he fears being stung for acting out of compliance.
Sure, he could return them to the publisher or donate them to libraries. But Rodes is so frustrated at this point, he says, "When I get enough, I'll burn them. Make a big bonfire in the back."
Who lost? The First Amendment.
Turner says the FDA orders books burned all the time, and US Marshals routinely carry out those orders. In 1967, the agency ordered the Church of Scientology, for example, to destroy literature touting "E-Meters" — sort of crude lie detectors. He adds that cases similar to this one, involving other products, are in litigation all over the country.
"The FDA," Turner says, "is a dangerous agency that has lost its focus."
As for Rodes, at the time of this writing, he and Turner were considering taking legal action against the FDA for infringing on Rodes' First Amendment rights. The case would be time-consuming and expensive, but a win could help others in Rodes' situation.
Rodes says: "If they become nasty, if they push me to the wall to do this stupid recall, I'll shut down the business and go to court."l
For more about stevia, visit these Web sites:
The Stevita Home Page ¾
Cooking with Stevia: The Naturally Sweet & Calorie-Free Herb ¾
World Health Online ¾
The Stevia Story: A Tale of Incredible Sweetness and Intrigue ¾
To order Stevia Rebaudiana: Nature's Sweet Secret ¾
A petition to change the status of stevia ¾
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