How sweet it is!

0 Comments | Insight on the News, August 17, 1998 | by James P. Lucier

The FDA says the natural sweetener stevia is approved as a dietary supplement but unsafe as a food. It's all right to sell as long as consumers don't learn the secret.

Right away Oscar Rodes knew he was in trouble that morning of May 19, 1998, when the fax machine clicked on and a sheet of paper began emerging with the letterhead of the Dallas district office of the Food and Drug Administration, or FDA. As president of the Stevita Co. in Arlington, Texas, Rodes was the major U.S. distributor of a herbal dietary supplement called stevia, produced in his modern plant in Brazil. He already had been through a Job's trial of warnings, actions, impoundings, recalls and re-labelings in an attempt to appease what he must have regarded as the Kafkaesque gods of the FDA.

Now, once more, the words began unrolling from the machine. "This agency appreciates Stevita Co.'s expressed intention to comply with the Law. However, a current inventory must be taken by an investigator of this office, who will also be available to witness destruction of the cookbooks, literature, and other publications for the purpose of verifying compliance. Additionally, your stevia products currently in distributor and retail channels with the offending cookbooks, literature, and other publications continue to be in violation of the Federal Food, Drug and Cosmetic Act (the Act). These products are unapproved food additives in violation of Section 409 and adulterated within the meaning of Section 402(a)(2)(C) of the Act." The letter was signed by James R. Lahar, Compliance Officer, who in calling down the majesty of the Law and the Act against miscreants, could not bear to do so without capital letters.

Two hours later, the FDA enforcers burst onto the scene and announced that they would observe the destruction of the offending cookbooks and literature. Rodes had not yet been able to contact his lawyer. "I told them that I did not have a permit for burning from the city of Arlington" Rodes tells Insight, "so I asked them whether it would be okay just to put them in the dumpster."

Meanwhile, Rodes handed a video camera to one of his associates, and told her to tape the proposed destruction of the books. With the camera on, the agents hesitated, and suddenly one said that he had been told to mark the printed materials so they couldn't be used. After six copies had been marked, the agents decided that they should contact their superiors. For two hours they attempted vainly to reach the correct official party and left without further incident.

The "offending literature" consisted of three books produced by third-party publishers. One of them, The Stevia Cookbook, identified Stevita Co. as a reliable source of uniform stevia products (the quantities required for cooking are so minute, because of stevia's intensity, that variations in concentration of the product might give unpredictable results). The second one, Nature's Sweet Secret, by David Richard, boldly revealed the secret of stevia in its title. The third book, The Stevia Story, by Linda and Bill Bonvie, not only told the stevia story but consisted in large part of a political diatribe against the FDA, listing names of officials, dates and actions that simply defied rational explanation.

The impact of the First Amendment may be unclear to the FDA enforcers. For a long time the U.S. Supreme Court allowed significant curtailment of so-called "commercial speech" But in 1995 in Rubin vs. Coors Brewing Co., the court changed its mind with regard to labeling.

The stevia problem started in March, when the FDA sent Stevita Co. a communication headed "WARNING LETTER" from Joseph R. Baca, Dallas district director of FDA. Baca had examined Stevita's 96 percent stevia products and made a disturbing discovery. "FDA has confirmed the presence of stevia in your products by laboratory analysis," he wrote. But it was not so much the presence of stevia in Stevita's stevia products but that they were "actively promoted, through labeling in the form of promotional literature, as conventional foods."

Baca claimed that these products were "promoted in colored promotional literature" in settings which intimated that stevia was not merely a dietary supplement. For example, "this literature pictures a drink appearing to be coffee or tea surrounded by jars and packets of Stevita stevia" Other offending statements included the following: "Stevia extract is 200 to 300 times sweeter than sugar -- but it is not sugar!" Still worse was the statement, "Just use it right out of the jar." Darkest of all was the inscription "Tabletop ready." Then, of course, there were the third-party cookbooks -- which actually suggested one could cook with it.

The problem is not with stevia, which the FDA permits to be sold as a dietary supplement; the problem is when the distributor tells consumers how to use it. If the same product is taken alone, it is a dietary supplement; but the same product taken with food makes it a food additive subject to a Godzilla's breath of federal regulations.