The herb stevia is natural, sweeter than sugar — and has no calories. People enjoy it around the world. Why won’t the FDA let you?
New Age Journal, Jan/Feb 1996
by Linda and Bill Bonvie
While classified as a civil action, “the United States of America vs. forty cardboard boxes” had all the trappings of a big-time drug bust. It took place on a summer day in 1991, when a bevy of armed federal marshals raided the Arlington, Texas, warehouse of businessman Oscar Rodes, served him with a warrant, and proceeded to seize his most recent shipment.
“They didn’t give me any advance notice or anything,” Rodes recalls. “They came in my office in the warehouse, and that’s when they showed me the papers” and “took everything away.” Rodes himself was not taken into custody. The arrest warrant was for the boxes he had just imported from South America, which contained some dried leaves and a white powder extracted from them.
“They just asked me to open the warehouse door, and they backed up the truck and loaded it up,” he recalls. “They said they were going to burn it. I was surprised-all the marshals, ready to go and take away my teas.”
All this fuss over tea? Well, not just any tea. What Rodes had imported was stevia (Stevia rebaudiana Bertoni), an herb as remarkable as it is unknown in the United States. A perennial shrub of the aster family, stevia contains natural compounds-specifically, stevioside and rebaudioside A-that are estimated to be 150 to 400 times sweeter than sugar. Advocates claim that the herb also offers a host of health benefits, and is even a tonic for the skin. But here’s the clincher: Stevia sweetens without calories. While it tastes sweeter than honey, it’s about as fattening as water.
Used for centuries in parts of South America, stevia has been discovered in recent years by much of the calorie-conscious modern world. It is now widely-and legally-consumed by millions of people, from the plant’s native Paraguay and Brazil to South Korea, Israel, and the People’s Republic of China. But no country has done more to demonstrate stevia’s dietary and economic potential than Japan, where the herb and its extracts have been used since the 1970s.
The Japanese, having subjected stevia extract to extensive safety testing and found it without health risk, now incorporate it in numerous food products, including candies, ice cream, pickles, and soft drinks (including some reportedly manufactured by Coca-Cola)-products that might otherwise have been sweetened with refined sugar or chemical substitutes. In 1988, in fact, refined stevia extract commanded a 41 percent share of Japan’s multimillion-dollar market for high-intensity sweeteners-outselling even the ubiquitous American-made chemical compound NutraSweet.
It might have been like that in the United States as well. Indeed, by the mid ’80s, a number of major food companies had recognized stevia’s potential value. Among those marketing or developing products containing stevia were tea makers Thomas J. Lipton Company, Celestial Seasonings, and Traditional Medicinals, as well as a host of smaller firms. (The herb was often listed on ingredient lists simply as “natural flavoring.”) Estimates place the amount of stevia entering the country at that time in the hundreds of tons. But just as the industry was poised to take off, the Food and Drug Administration (FDA) launched a particularly aggressive search-and- seizure campaign that was followed in 1991 by a virtual blockade of stevia through the issuance of an “import alert.”
In the fall of 1994, the agency was forced to modify the alert after Congress passed the Dietary Supplement Health and Education Act, which allows the herb to be sold if it is formulated and labeled strictly for use as a “dietary supplement.” The agency still restricts stevia’s use in teas and other food products, however, and notes that any mention of the herb’s sweetening ability could bring its regulatory wrath.
Just why the FDA would mount such a campaign remains a matter of much debate and speculation. Citing a few small studies and its mandate to protect the public, the agency claims that stevia is an “unsafe food additive” and a potential health threat. Stevia proponents, however, maintain that the FDA’s case against stevia is without merit and note that a large body of research and the herb’s track record attest to its safety. The only health threat, they contend, is to the fiscal well-being of certain players in the $700 million US artificial-sweetener industry. As Rob McCaleb, president and founder of the Herb Research Foundation, puts it: “Sweetness is big money. Nobody wants to see something cheap and easy to grow on the market competing with the things they worked so hard to get approved.”
Indeed, a number of shadowy events involving stevia suggest just how far some companies are willing to go to keep the herb off the market. According to FDA records, for example, in the late ’80s representatives of an “anonymous firm” lodged a “trade complaint” with the agency, charging that the Colorado-based tea company Celestial Seasonings was using stevia extracts in four of its products. The FDA will not identity the firm, nor say how the firm knew that Celestial Seasonings’ teas contained stevia. As a result of the complaint, however, the agency began a full-scale investigation, after which Celestial Seasonings ceased using the herb-and then, according to documents obtained from the FDA, told the agency about other tea makers that were also using it.
This apparently was not the first time a trade complaint triggered FDA action on stevia. The search-and-seizure campaign that was initiated in the mid-’80s had a similar origin, according to McCaleb, who says he has seen the complaint, and that it originated from a “sophisticated” company “with a strong interest in not having sweet natural products on the market.” Asked for a copy of the document, the FDA said it could not locate one. (That “doesn’t mean there is not one,” said Robert Martin of the FDA’s Office of Premarket Approval, just that “we cannot find one in this office.”)
More significant, perhaps, is that one stevia marketer says an FDA agent specifically mentioned the NutraSweet Company as the source of the complaint against his product. The NutraSweet Company, then owned by G. D. Searle and now a Monsanto subsidiary, says it has not put any pressure on the FDA regarding stevia.
This much is clear: The history of stevia is so riddled with questions and incongruities that the appearance of favoritism remains. As Arizona congressman Jon Kyl noted in a 1993 letter to FDA Commissioner David Kessler, MD., there is a belief among those wishing to market stevia that the agency’s import alert is really just “a restraint of trade to benefit the artificial-sweetener industry.” All of which, it should be noted, has done little to diminish the allure of this natural noncaloric sweetener. One indication of its appeal: Consumers, having heard about the herb’s properties by word of mouth, have been buying stevia-based “dietary supplements” and skin-care formulas and using them as sweeteners.
It was Moises S. Bertoni, an Italian botanist, who first described stevia in 1899-and in somewhat greater detail in 1905-having initially been told some years before about a “very strange plant” known by indigenous Indians and guides in the forests of Paraguay as kaa-he-e. Among his observations was this one published in December of 1905: “The fact is that the sweetening power of kaa-he-e is so superior to sugar that there is no need to wait for the results of analyses and cultures to affirm its economic advantage.”
Clearly, today’s FDA does not share Bertoni’s opinion-and to understand why stevia remains in bureaucratic limbo, one must understand something of the agency’s labyrinthine logic. The specific “problem” cited by the FDA in issuing its import alert for stevia is the fact that it considers the herb an “unsafe food additive.” Under laws passed nearly forty years ago amid concern over the use of chemicals in food, any substance deemed a food additive must undergo extensive and costly scientific study. Since 1970, the agency has approved only five major new additives, two of which are artificial sweeteners: aspartame (NutraSweet) and acesulfame K (Sunette).
“I had one guy from the FDA tell me ‘if we wanted to make carrots [be] against the law, we could do it.'”
As it turns out, any food that is added to another food (or even to water, which the FDA can opt to view as a food) can be classified as an additive and subject to this strict review process. But there is an exemption-if an additive is “generally recognized as safe,” or gras. gras substances get that status by either having a long history of “safe” use in food prior to 1958 or being shown to be safe through scientific procedures. But there is also an opening in the law that allows “self- determination” of gras status, whereby the person selling the substance decides that it is generally recognized as safe, based on available information.
This, in effect, is what Oscar Rodes and other stevia marketers did prior to the crackdown. The risk, as Rodes learned, is that the FDA can challenge that determination, which could put the ultimate decision in the hands of the courts. Other marketers have tried to obtain gras status for stevia through more formal channels.
One of these is Lynda Sadler, president of Traditional Medicinals, an herbal-tea company based in Sebastopol, California. When her company’s supply of stevia was embargoed in 1990, Sadler opted to formally petition the FDA. Working with the American Herbal Products Association (AHPA), whose Stevia Committee she heads, Sadler enlisted Washington, D.C., attorney William R. Pendergast to persuade the agency that the marketing of stevia should be permitted, based on its having been used safely and widely in food prior to 1958.
In 1992, Pendergast submitted a petition to the FDA listing more than 900 articles documenting that the herb has been used safely for “hundreds of years” by “millions of people.” The FDA’s response was to ask for still more information. Yet even that additional information-provided in the form of an extensively researched supplement, prepared by the Herbal Research Foundation to address the FDA’s questions failed to cut any ice at the agency. The petition has since been dropped by the AHPA, says Sadler, who explains that it was no longer worth the “effort and money.”
A two-inch-thick gras petition submitted by Lipton in January 1994 hit a similar bureaucratic wall, despite the tea company’s establishment credentials. Subsequent follow-up efforts have been met with more requests from the agency and long delays in correspondence. In both cases, the agency has refused to officially “file” the petitions, a move that would open the documents to review by the general public. McCaleb, for one, can’t think of another case where a conventional food company has submitted a petition, “then been continually told, Your petition’s not complete enough, wait, there’s just one more thing. Obviously, they [the FDA] don’t want to file this petition; they’re under some kind of pressure not to.”
Once such a petition is filed, the evidence that has been submitted would become open to public debate, McCaleb and other proponents note, leaving the agency in the position of having to defend its actions. According to Alan M. Rulis of the FDA’s Office of Premarket Approval, the reason the agency has not filed the petitions is because they still lack “the depth of information that would allow us to eventually conclude gras status.”
But the supposed incompleteness of the petitions does not explain why the agency won’t file them. As Rulis himself noted in a 1992 letter to Lipton’s attorney, the agency’s usual procedure is to “perform no in-depth prefiling review of the actual data” in a gras petition. As for the reams of data documenting stevia’s long tradition of consumption, Rulis characterizes these as “anecdotal information” based on historical records that are “pretty sketchy.” Adds Rulis’s colleague George Pauli, “What we get presented to us from time to time is that, somewhere in the remote areas of Paraguay, Indians have brewed a tea that they used in ceremonies centuries ago. . . . There are lots of things that were consumed in ceremonies. That does not necessarily make them safe for general use in the food supply.”
That kind of dismissive comment baffles Pendergast and raises the question of what the FDA is doing with all the information he has submitted. “I don’t even know that it was used in religious ceremonies,” the attorney says. “But, boy, that tells me that he hasn’t read the petition.” The FDA’s own import alert, in fact, would indicate a far greater level of awareness at the agency.
“Stevia leaves . . . have been used throughout history,” the alert notes, “and the extract, stevioside, has reportedly been approved for use in foods in Brazil and Japan. The product is used in these countries as a table-top sweetener in virtually all food commodities. . . .” The run-around given to would-be stevia marketers might be excused as simply government-agency inertia. But other events suggest that the agency is judging stevia by a capricious standard.
In one meeting with agency officials, for instance, AHPA representatives were told that filing their petition would largely depend on their providing “good” data showing that, prior to 1958, stevia was used “by a significant number of people for a substantial period of time.” According to notes of that meeting, when the group inquired just how many people over what period of time the agency would consider “significant,” the FDA’s Direct Additives Branch chief, Eugene Coleman, replied: “This may sound flippant, but we would know that number when we see it.”
“Stevia has a political problem,” observes the Herb Research Foundation’s McCaleb. “The FDA took action against stevia not based on any proclamation by FDA toxicologists or consumer complaints, or any factor other than a trade complaint-that is, a complaint from a company that did not want stevia on the market and told the FDA to get it off the market.” And while the FDA may be less than forthcoming about the identity of that company, others who were stopped from marketing stevia say they believe they know who it might be.
In 1985, Kerry Nielson was director of operations at Sunrider International, a nutritional-products firm then based in Utah, when, as he tells it, “our first problem came” in the form of a trademark infringement complaint filed by NutraSweet against a Sunrider item called Trusweet, which contained stevia-leaf concentrate.
“They were serious about it,” he recalls. “We were selling it as a natural sweetener, just like you would sell sugar. We didn’t think we were really infringing, but this was a cease-and- desist deal. We thought, We’re just a little company; how in the devil are we going to fight this thing?” Rather than do so, the company agreed to change the product’s name to Sunectar, “and we thought, Well, neat, that’s the end of that.”
But it wasn’t the end of Sunrider’s legal problems with stevia. Not long afterward, Nielson says, the US Department of Agriculture was knocking on the company’s doors. “I thought it was strange,” he said, “because they asked specifically to see the stevia,” whereas previously “they would just go through and have a look at everything. . . . When we took them over to the area where we had the stevia, the inspector dug out a bunch of red tags and started slapping them on everything.” The stevia was embargoed and the company was instructed to cease and desist from any further production.
When asked what the problem with the shipment was, the inspectors replied “suspicion of adulteration,” but declined to elaborate. Since that usually means contamination by mouse droppings or insect parts, says Nielson, “I thought it was curious that they didn’t take any samples with them. We then commenced to get lawyers to try and figure out what the real problem was.” It was an attorney based in Washington, D.C., according to Nielson, who eventually provided the company with some insight into the situation.
“Apparently, he had worked in the FDA” and “had nosed about and asked some questions . . . as if he was going to invest in a company that was going to sell a stevia product. The word he got back was ‘don’t invest, there is a lot of pressure on stevia.’ He called us back and said, Î think you’ve got a problem here.’ ” Such pressure, Nielson believes, could only have emanated from two sources-the sugar industry or G. D. Searle, the makers of NutraSweet. And, he notes, “we had already made the rounds with Searle.” But not wanting to take on either, Nielson says that Sunrider decided it would reformulate its stevia sweetener into a skin-care product, in which case “they [the FDA] should have no beef with us.”
The FDA, he notes, agreed to go along with that use, showing that the problem really “had nothing to do with adulteration.” Around the same period, Jim May’s Arizona-based herbal products firm, Wisdom of the Ancients, was also getting a lesson in the politics of stevia.
As May tells it, he had actually presented samples of a product containing stevia leaf to FDA officials to make sure he had a green light to import it. “They said, Sure, no problem- as long as it was in the form of the pure leaf or liquid concentrate, and not the refined extract, stevioside. “Then, in 1984, they called me into their office in a very friendly manner, and the guy basically said, Jim, I really hate to do this, and we have put it off as long as we can because none of us here wants to do it. But the Washington office has demanded that we stop you from importing your stevia concentrate. . . . We’re not telling you there’s anything wrong with it [or] that anybody’s had a problem. There’s no complaint other than the NutraSweet Company; they are the ones who complained that you are selling a natural sweetener that hadn’t had to go through all the testing and so forth.’
He told me it was NutraSweet that had filed the complaint with the FDA. Whether it was written I don’t know, but they went in and demanded it be removed. He said, ‘Jim, if you’d be willing to stop importing it, there will be no written paperwork, it will be just verbal between us, nothing in your record that you’ve done anything improper.'” “At the time I was only selling maybe $100 or $200 [worth] a month . . . it wasn’t worth any kind of a hassle with them,” says May, who now offers a variety of stevia supplements and cosmetics.
When asked if the FDA has been in any way pressured by NutraSweet in any of its actions against stevia, Rulis says he has “no knowledge whatsoever of any influence, so to speak, from aspartame producers in this regard.” And Richard Nelson, a spokesman for NutraSweet, says he is unaware “of any pressure we have put on the FDA regarding stevia.” “Show me some evidence,” he adds.
Today, says Nielson, “I wouldn’t trust NutraSweet as far as I can throw a barrel of it.” And while the selling of stevia tea might be akin to “spitting in the ocean” when compared to the marketing of aspartame, it’s his feeling that the idea is to “kill it while it’s little, before it has a life.” The entire episode, in fact, is one that has caused Nielson to lose his faith “in whatever I thought the FDA did for us. I felt it had nothing to do with the safety of people and everything to do with economics . . . I had one guy from the FDA tell me-and I guess what really soured me was that there was a certain arrogance-that if we wanted to make carrots [be] against the law, we could do it.'”
When pushed to the wall about stevia, the FDA tends to fall back on a handful of studies that it says raise legitimate concerns about stevia’s safety. The first of these-which has never been successfully repeated- was performed on rats in 1968 by Joseph Kuc, a Purdue University biochemist, working with a researcher in Uruguay.
Kuc, in a recent telephone interview, said that while he still “stands by the results we had”-that is, a finding of toxicity and a marked reduction in the number of young born and “restrictions in circulation to the extremities”-those results should not be interpreted as applying to humans consuming either stevia tea or its extract, stevioside.
For one thing, Kuc noted, the study involved “a very high concentration” given to the rats instead of drinking water, and consisted of the whole plant, dried as a powder, and not just the leaves. Asked if his study should be a basis for keeping stevia off the market in this country, Kuc replied: “That in itself, no.”
The second study, dealing with the effect of stevia on the fertility of mice, was published in a Brazilian pharmacological journal in 1988. One expert who reviewed this experiment was surprised by “the lack of information about the quantities that were administered and the preparation of the infusions. . . .” In addition, the reviewer observed, the study involved a small number of animals and “was highly susceptible to indelible external influences.”
In short, although the FDA refers to this study as casting doubts on stevia’s safety, it is precisely the kind of research the FDA would question if it were submitted by a petitioner. Or as Mark Blumenthal, editor of HerbalGram, a publication of the American Botanical Council and the Herb Research Foundation puts it: “The FDA would laugh them out of the room.” But the agency has at least seen this study. Other research, supposedly raising “the theoretical possibility” that the herb might cause blood sugar to drop in some people with hypoglycemia, has also been cited by the FDA even though no one at the agency has actually read the reports in question.
“We have attempted to get the studies, and thus far have not been successful,” concedes David Hattan of the FDA’s Division of Health Effects Evaluation, speaking of the research published in “small regional journals in South America.” Nonetheless, the agency felt confident enough to mention the herb’s possible hypoglycemic effect in a cautionary letter to a company planning to market stevia as a dietary supplement.
Rulis is willing to concede that the studies in question wouldn’t stand up if a petitioner were to bring them to the FDA. But then, he says, “That’s the case with all the data” on stevia. The FDA’s Pauli agrees. “Now, [these studies] are not the greatest science in the world, I will admit, but the fact is there just isn’t a lot of good science on stevia,” he says, apparently disregarding the vast body of research including chronic toxicity studies conducted by the Japanese and submitted to his agency. “Certainly, we don’t have any kind of data comparable to what we have for sweeteners used in food.”
Pauli’s comment is typical of the FDA’s tendency to introduce the subject of sweeteners-a loaded term implying a product’s need for extensive FDA review-into any discussion of stevia, which proponents seek to market as a tea. In a similar manner, Rulis refers to the agency’s “data package” on stevia as being “not nearly as robust as one which we would require for any other sweetener.”
A recent information sheet prepared by the agency’s Center for Food Safety and Applied Nutrition even inaccurately states that the “FDA has a number of active petitions for sweeteners, including stevia.” Just how important this distinction is becomes clear when Pauli talks about “the statutory requirements that, for example, sweeteners must be shown to be safe.” With that in mind, he continues, “you can’t have a double standard where somebody has gone to several millions of dollars of testing and say [to someone else] well, that’s OK,’ where you know nothing. . . . You try to keep things uniform that way.”
Perhaps the most notorious “somebody” to spend several millions on testing to get a sweetener on the market is G. D. Searle, whose NutraSweet won FDA approval in the early ’80s amid a storm of controversy that has not abated. The original review process was marred by charges of doctored records and flawed experiments, a call at one point by the FDA’s chief counsel for a grand jury probe, and the recommendation by a panel of scientific advisers that the substance’s approval be delayed until concerns about brain-tumor tests could be resolved.
Of all the complaints received by the FDA since 1980 under its Adverse Reactions Monitoring System, some 72 percent concern NutraSweet, with reports of headaches, dizziness, and vomiting common. Its manufacturer, however, continues to insist that, with the exception of people suffering from a rare condition known as pku, aspartame is harmless to the public-a position backed up by the FDA, which apparently views the consumer complaints with a skeptical eye.
It’s not surprising that stevia proponents cite aspartame’s approval when discussing what they see as the double standard applied to stevia. But the FDA’s Rulis cautions against making such comparisons. The FDA’s confidence in aspartame’s safety, he says, is one based on a “portfolio of toxicological studies of very high quality” and on the agency’s having “applied the standard of reasonable certainty of no harm based on the toxicological data that are available to us. . . . And it’s a massive amount of information.” “In any large data package, there will be adverse effects that are observed,” he adds. “The question is, Are those adverse effects mitigated by or contravened by other data of equal or better quality? I think in the case of aspartame, when all the data is taken together the inescapable conclusion is you have a material here that is safe.”
Stevia, however, appears to be another matter entirely. “It’s my understanding that there are questions raised by [the animal studies on contraceptive effects] that have not been resolved. . . . When we see a study-even if it’s a poor study-that implies the existence of an adverse effect that isn’t resolved, we have to be concerned whether that effect really could happen.” But what about the studies cited in the stevia petitions that would tend to “mitigate or contravene” the ones that so concern the FDA?
One study, for example, conducted in Japan, involved nearly 500 test animals that were administered stevia extracts over a two-year period. According to A. Douglas Kinghorn, a University of Illinois pharmacognosy professor, the highest dose levels represented 100 times the estimated daily intake of this substance in the human diet. The results were supportive of the safety of stevia extracts “when consumed as sucrose substitutes by human populations.” This “protracted and extensive investigation” found “no significant dose-related changes” in all areas examined. Two other studies of subacute toxicity, Kinghorn noted, also failed to predict any potential harm to humans from ingesting these extracts. Why haven’t these been given any credence?
“If that’s the question,” responds Rulis, ” then we probably need to investigate that and have a discussion about that. And I think on that point we probably would want to go into some detail about what the studies are, what they show, what the total data package looks like, and why our scientists have a concern that has not been erased.”
Many observers had hoped that the passage of the Dietary Supplement Health and Education Act of 1994, which exempts certain ingredients in vitamins and supplements from strict FDA review, would be stevia’s savior, allowing the herb and its many benefits to be introduced to the general public. But even though several companies are now marketing stevia and its extract as a dietary supplement (see box, page 62), the FDA has not let the matter drop.
In September, it revised its import alert with language that holds any potential stevia marketer to a strict and narrow standard, allowing the herb to be sold only if labeled as a dietary supplement and outlawing any mention of the herb’s most marketable effect: “If stevia is to be used in a dietary supplement for a technical effect, such as use as a sweetener or flavoring agent, and is labeled as such, it is considered an unsafe food additive.” All of which leaves the FDA in the perplexing position of allowing stevia packaged one way to be widely sold and consumed, while arguing that the exact same substance packaged another way is “unsafe.”
In the meantime, proponents continue to promote the herb through a stevia underground. Donna Gates, for example, author of The Body Ecology Diet and a passionate believer in the plant’s curative powers, says she’s willing to go to jail, if necessary, to champion her cause. “There are so many plants on the planet that are given to us to use to be healthy, and I believe stevia is one of those plants,” says Gates, who despite the FDA’s actions has been openly selling stevia extract as a sweetener.
Gates, in fact, sees a grassroots movement among natural-food advocates starting to take shape on this issue-a kind of tea-rescue mission infused with the same spirit of resistance that the American colonists displayed in dumping tea into Boston Harbor. “A lot of teas are using it,” she alleges, “but they just say natural flavors.” And now that the Dietary Supplement Act has “brought the industry together and made it very strong, everybody would organize” against a continued FDA attempt to keep stevia off the market.
While such talk may be overly optimistic, there are developments that suggest that stevia will indeed become far bigger than it is today-though not here in the United States. In Canada, where stevia can be sold as a tea (but not as a sweetener), a Vancouver company, Royal-Sweet International, is in the process of developing a stevia-based sweetener for which it acquired a global patent several years ago. The company isn’t waiting for Canadian or US approval of its product; it intends to direct its efforts at the fast-growing Asian market for stevia extracts.
Perhaps most significantly, the project has been undertaken as a joint research venture with Agriculture Canada, a government agency, which sees the herb as a potential high profit replacement for Canadian tobacco. A similar idea was recently suggested by the ambassador from Paraguay as a means of curtailing his country’s cultivation of marijuana. In a letter to various members of Congress and others asking for their help in loosening the import restrictions, the ambassador noted that growing stevia is an idea strongly supported by the US Drug Enforcement Agency. The ambassador apparently failed to see the irony of the fact that another agency of the US government has proclaimed stevia to be an equally forbidden substance.
Copyright 1999 by Linda Bonvie.