Category: Food

In our final view of Truvia and PureVia, we take a look at the political history of stevia – the base of rebiana, opinions of some of the major players in this debate and offer our final views on the subject.

NOTE: This article is the 3rd part of a series about Truvia and PureVia. You may want to read the first two parts to better understand this article:

Part 1: Truvia and PureVia – A Window to the Past or the Future?
Part 2: Truvia and PureVia – The Science

A History Spent in the Shadows

The plant stevia provides the rebiana sweetener found in both Truvia and PureVia.  Originally, stevia was used, in its whole leaf form, as a prized sweetener of the indigenous Guarani people throughout Paraguay in South America.  It did not find fame in the modern, western food supply until Japan began cultivating and using it in diet soft drinks (including Diet Coke) during the 1970s, a process that continues today.  Building on that success, stevia began to be sold throughout the world, including the United States, during the 1980s.  Its path from here has since become mired in controversy.

Stevia was officially banned from sale in the US as a sweetener in 1991, driven from the market after an anonymous safety petition led the FDA to conclude that it was an unsafe food additive.  The FDA has declined to release the petitioner’s affiliation, although it is suspected to be someone with links to aspartame – a popular artificial sweetener that had just come to market in the 1990s.

Because of the 1991 decision, an ‘Import Alert‘ was then issued by the FDA maintaining that information regarding stevia leaves – the same source of Truvia and PureVia – was [emphasis mine]:

“…inadequate to demonstrate its safety as a food additive or to affirm its status as GRAS” (GRAS = Generally Recognized as Safe, FDA speak for labeling that recognizes a product’s safety).

This position is at odds with just about every other natural food in existence.  Because the FDA has no mandate to test real foods, it makes little sense why this decision was made.  Any food ‘in common use’ before 1958 was automatically grandfathered into being deemed GRAS, and so – with stevia’s history of being safely used as a sweetener in South America for centuries – it clearly qualified.

We contacted the FDA but they declined to comment on this position.

A Change in Position

Stevia was completely banned from the United States until 1994, when the the Congress passed legislation that allowed stevia to be used solely as, ‘an herbal supplement’.   Interestingly though, the sweetener was still banned from being sold as a sweetener.  This contradictory stance established in 1994 – where stevia remained banned from sale as a sweetener but remained for sale as a supplement – continues clear into today.

The closest we can get to a followup opinion from the FDA on the matter doesn’t come for another 8 years.  From the FDA’s now discontinued magazine named, appropriately enough, “FDA Consumer Magazine“, this was the only other mention of stevia on the FDA’s website for almost 15 years [emphasis mine]:

Another product, stevia, is derived from a South American shrub. Though it can impart a sweet taste to foods, it cannot be sold as a sweetener because FDA considers it an unapproved food additive. “The safety of stevia has been questioned by published studies,” says Martha Peiperl, a consumer safety officer in FDA’s Office of Premarket Approval. “And no one has ever provided FDA with adequate evidence that the substance [stevia] is safe.” Under provisions of 1994 legislation, however, stevia can be sold as a “dietary supplement,” though it cannot be promoted as a sweetener.

Ms. Peiperl of the FDA is referring to the idea that one of the two sweeteners in stevia called steviocide, might cause mutations in the DNA of people who eat it regularly.  As we reported in our scientific review of rebiana, the studies that suggested stevia was mutagenic were widely dismissed because the amount of stevia required to cause the defect was so far in excess of what anyone could ever possibly consume.

Stranger still, after a large review of scientific literature, the World Health Organization declared in 2006 that stevia is completely safe and even potentially beneficial for people with hypertension (WHO).  That opinion was further codified at the 69th annual JEFCA (Joint FAO/WHO Expert Committee on Food Additives) conference (.pdf link), where stevia was recognized as being non-mutagenic.

Clearly, quite a few scientists could have “provided FDA with adequate evidence that the substance [stevia] is safe” in Ms. Peiperl’s words.  The only problem was that the FDA never asked to reevaluate stevia, for what are likely political reasons from what we have seen so far.

Another Policy Switch

In December 2008. the FDA opened yet another chapter in this debate and declared that rebaudioside A (rebiana) – the other sweetener found in stevia – was GRAS.  Somehow, ABC News broke this story:

From the official GRAS approval letter:

The subject of the notice is rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni. The notice informs FDA of the view of Cargill, Incorporated (Cargill) that rebaudioside A is GRAS, through scientific procedures, for use as a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by current good manufacturing practices (cGMP).

Obviously aware of yet another policy contradiction, the FDA puts out a one-line statement in the GRAS notice about stevia, the plant that remains banned as a sweetener [emphasis mine]:

The rebaudioside A that is the subject of GRAS Notice No. GRN 000253 is a highly purified component of the stevia plant. As such, FDA notes that the GRAS notice for the use of a specific purified component of stevia, such as rebaudioside A, and FDA’s response do not necessarily apply to the uses of other stevia products.

The wording of this final statement here is especially interesting because the FDA is leaving the door open for yet further interpretation.  If this decision ‘does not necessarily apply’ to other uses of Stevia, companies that want to use stevia in their products may be able to petition the FDA for yet another policy change. Regardless, despite rebiana being approved as GRAS, stevia can still only be sold as a dietary supplement, not as a sweetener.

From the Peanut Gallery…

Nutrition Wonderland repeatedly tried to get in touch with different offices inside of the FDA to clarify their contradictory positions regarding stevia and rebiana but our calls were never returned.  Without a direct comment from the FDA, we can only speculate as to what was happening with regard to their policy – but that position really isn’t that hard to ascertain from the evidence.

Based on the financiers of the rebiana studies (Cargill and Coca-Cola), the speed with which this decision was made and the history of stevia, we are left to conclude that rebiana- and consequently Truvia and PureVia – were simply approved because of who petitioned the FDA.

Now, the FDA’s ruling does not mean that rebiana is not safe – but then again we don’t know that it is completely safe.  It’s hard what to know here.  We do know one thing though – with giants like Coca-Cola, Cargill, PepsiCo and Merisant banging at the FDA’s door, it becomes pretty obvious that there was little chance rebiana would be kept out of the market, regardless of what the science said.  The FDA’s position on stevia has never (well, post 1991 at least) sided with science.  This decision brings into question many of the other food additives that the FDA has approved, namely aspartame – whose makers may have been active in getting stevia banned.

Nutrition Wonderland also contacted the Center for Science in the Public Interest (CSPI), a reputable food watchdog, who was cautiously optimistic about Truvia back in June 2008 in a WebMD article.  They have since dramatically reversed their position based largely upon new information from a report put out by UCLA showing why rebiana and stevia in general is unsafe.  You can view it below:

We read over its arguments as to why rebiana is unsafe in this report but they are not as convincing as CSPI would have you believe.  While rebiana is not fully tested, this report finds fault with nearly every study published to date on the subject of stevia.  Its hard to buy into the idea that this much bad science was performed.  Nutrition Wonderland has extreme doubts about the Truvia-sponsored science we thoroughly discussed in our earlier review but the safety of stevioside seems well proven, based on its use in Japan for over 30 years.  Additionally, this report may have been performed at the behest of CSPI itself, making us leery of its findings as much as we are leery of Cargill’s.

We contacted the CSPI repeatedly to make sense of their changing positions but they have not made a public statement to us regarding this situation.

Final Words about Stevia > Rebiana > Truvia/PureVia

In general with food, we see a destructive pattern with each refined product brought onto the market place.  Whole grains reduce the risk of heart disease while refined grains increase it.  The fructose in honey helps the body, while the fructose in HFCS has been linked to obesity, diabetes and insulin resistance.  Cold pressed natural oils dramatically reduce inflammation, while heavily refined hydrogenated oils promote inflammation – and chronic disease.  Why refined rebiana would be better for us than the whole leaf stevia has not been explained.

There is some reason to think extracts of stevia, specifically stevioside, could prove extremely beneficial in a refined form but Truvia and PureVia do not contain any of that material.  Both sweeteners are proprietary formulas containing the largely untested rebiana and large amounts of erythritol, another non-caloric sweetening agent.  In fact, by volume, Truvia and PureVia have more erythritol than they do rebiana.  There is still no science testing Truvia and PureVia themselves, which would show how these two sweeteners (rebiana and erythritol) metabolize together.

More than anything, Nutrition Wonderland strongly believes these sweeteners were developed so that the companies involved, especially Cargill and Merisant, could own the intellectual property behind stevia – in effect owning the food.  Cargill released some justification for all this trouble, if you don’t mind very corporate video:

It would have been far easier to just use stevia for commercial food production – but, since you cannot patent a natural food, this opportunity was overlooked in our opinion.  This pattern of using the intellectual property of food for profit is well established across the 21st century agribusiness industry, modeled after highly successful power plays by chemical giants in the sale of GMO seeds.

We have doubts about the sponsored science involved, doubts about the motive of this product in general and deep suspicions as to why stevia remains banned from the marketplace.  Truvia and PureVia may in fact be perfectly safe – and preliminary science shows that to be the case – but far more research on these new sweeteners is required.  Even still, we will probably never know the truth.  It is now the American public’s turn to be the guinea pigs for another agribusiness experiment.  You can easily opt out of this debate – as we are – by enjoying any of these safe sweetening options:

• regular stevia sweetener ‘supplements’
• blackstrap molasses (unrefined)
• organic agave nectar
• brown “turbinado” cane sugar (avoid brown sugar from sugar beets as they are now GMO)

The FDA recently announced that they have cleared a new, zero calorie sweetener called rebaudioside A (rebiana) for sale in the US, calling it ‘safe for use in foods and beverages‘.

NOTE: This article is the 2nd part of a series about Truvia and PureVia. You may want to read the first part to better understand this article:

Part 1: Truvia and PureVia – A Window to the Past or the Future?

As a result of this decision, two products featuring the new sweetener are coming to market – Truvia and PureVia.  Truvia was jointly developed between the soft drink maker Coca-Cola and agribusiness giant Cargill while PureVia was developed by PepsiCo in partnership with artificial sweetener industry veteran Merisant (under the proxy Whole Earth Sweetener Company).

The Coca-Cola Company has already announced products, including Sprite Green and Odwalla Mojito Mambo and Pomegranate Strawberry Juices, that will be for sale in 2009 containing the additive Truvia.  Not to be outdone, PepsiCo will put PureVia in Sobe Zero Calorie Life Water and Trop50 – a new low calorie orange juice slated for March 2009 release.

The idea of a real, zero calorie sweetener has been a goal of many agribusiness giants for some time but have Truvia and PureVia been adequately tested?   Nutrition Wonderland has gone through the science surrounding these new sweeteners and spoken with some major industry players to get the scoop.  We have found some positives and some serious negatives, which we will review here.

Starting From the Beginning

Truvia and PureVia contain mostly the same chemical formula, as you can see in our chart below.  Both are mostly made of two sweeteners, erythritol and rebiana (called Reb A in PureVia).  Erythritol is a substitute low calorie sugar-alcohol sweetener developed by the French company Cerestar who was later purchased by Cargill.  Sugar-alcohols are not really sugars; they require adding hydrogen to sugar molecules so the body ignores them.  Erythritol is a favorite because it supposedly does not cause as many stomach aches as other similar sweeteners.

It was FDA approved back in 2001 based on contract science, some of which was sponsored by Cerestar itself [1,2].  The World Health Organization also reviewed erythritol and found it to be safe.  Little other science exists on the subject.

We could spend more time on erythritol but there is not much new to report about it.  It has not been extensively used (up until now), it has not been extensively studied and it was approved quite awhile ago now.  It is a bit of a sweetener dark horse, if you will.

PureVia, but not Truvia, adds in another sweetener called isomaltulose – another supposedly safe sweetener with just a little contract science behind it.  It is derived from regular sucrose to create a sweetener with a longer sustained energy release in the body.  The FDA gave this one a green light back in 2006 at the behest of German sugar giant Sudzucker AG.  Again, it has seen very little use in the American food supply and we just don’t know very much about it scientifically beyond the fact that it does not harm teeth and does not cause stomach aches.

The other major component of Truvia/PureVia, rebiana, comes from a small herb plant called stevia.  Stevia originally comes to us from South America – where it has been used medicinally for centuries by indigenous people.  Rebiana sweeteners represent the first commercial applications of stevia in the United States but not the first in the world.  Another sweetener derived from stevia – called stevioside – was developed by the Japanese in the late 1970s and now controls 40% of the sweetener market in Japan.  Consequently, what we scientifically know about stevia is mostly based on stevioside, not rebiana – a problem we will see throughout this discussion.

The Concensus on Stevioside

The science we do have about stevia has only come about recently – in the last 20 years or so.  Despite very few (if any) reports of adverse reactions in the Japanese population from stevioside, some studies found that it was mutagenic, that is it could mutate the DNA of rats.  These findings were later dismissed in scientific literature multiple times when it was shown only extremely large amounts – far larger than anyone could consume – created the mutation.

Subsequent study of stevioside’s medical effects have found it confers significant health benefits to those who use it medicinally.  Improved immune system regulation [1,2,3] and improve glucose absorption in the body [1,2],  have led some researchers to suggest stevioside:

“may have the potential of becoming a new antidiabetic drug for use in type 2 diabetes”

Even further, stevioside helps regulate cholesterol and triglycerides [1,2], which means it may treat metabolic syndrome (also known as syndrome X).

On the whole, these findings suggest stevioside has major benefits but what about rebiana?

The Rouge Rebiana

If you follow any of those study links above, they will dump you into the PubMed scientific database.  The US National Institute of Health (NIH) requires all studies they fund (which is a considerable number) to publish their studies into this database.  Logically, we first looked for Truvia and PureVia here.

A search for either sweetener nets zero search results, as of February 2009 (feel free to try it yourself, click here) – despite all the stevioside research.  However, searching for rebiana nets us 49 very recent results, presumably the ones the FDA used to clear this product (compared to 181 for stevioside).

Diving through the search results leads us to a special supplementary release in July 2008 by The Food and Chemical Toxicology Journal called “Rebaudioside A: An Assessment of Safety”.  As an aside, it should be noted this release perfectly coincided with Coca-Cola’s first PR campaign that released Truvia to the public with a lavish promotion at Rockefeller Center in New York City last summer.  Below is some footage of the event:

As for the science in this tome, we find a total of 11 research articles published about rebiana.  One of them [#12] is a review of the toxicity of stevioside , which, as we covered above, we declared safe by a decent battery of tests.  Two others [#2, #11]  deal with the development of rebiana from the stevia plant, both casually suggesting the toxicology information of stevioside should equally apply to rebiana – a dubious claim at best considering how little research has been done on the later.

However, another study in this group [#5] actually demonstrates that the two sweeteners are relatively similar.  They based this statement on how quickly they are absorbed by the body as you can see in this chart:

While it seems convincing, this report did not use a control group or use any kind of statistical analysis to determine if the slight difference in absorption between the two sweeteners was statistically significant.  Further, the study used about 20% (.8 mg/kg) more rebiana than stevioside in its test, a factor that is sure to skew results.  Their observations also omitted an important data point when observing stevioside at the critical 1 hour mark.  Not to mention, the time schedule on the main graph in the report is misleadingly constructed to show each observation as having occurred in hourly succession (when in fact no observations were made in hours 2 or 3).  This science is very poor in quality and, not surprisingly, funded by Cargill.

Another one of the studies [#4] dealt directly with the toxicity of rebiana by super-dosing rats and observing them.  Most rats ended up eating significantly less food and consequently attaining lower body weight as they aged, consistent with other megadose sweetener studies.  But, most importantly, the rats did not die from rebiana so we could count that as a good thing.  Methodology in this study was far more convincing than the previous study – controls were used and statistical significance was achieved.  Still, the result of this study – that rebiana produces appetite suppression, should be followed up with additional study, something the authors do not call for.  Again, you should note that this study was funded by Cargill which may have influenced the lack of a call for additional study, though this is a minor critique.

Rebiana: The Human Studies

Two of the remaining studies deal with people instead of mice, so they should carry the most weight in your mind.  The first, [#6] in rebiana study supplement] tested rebiana against blood pressure and found high dosed patients maintain the same blood pressure in a randomized, double-blind placebo trial, the best type to use.  We can say a few bad things about this study but nothing ridiculously major; it was only 4 weeks long, it did not test against people who already have high blood pressure (a substantial portion of the population), and, again, Cargill funded the study.  Overall, this is encouraging but it is only the first study of its kind so its hard to draw too much from it.

The other human study deals with rebiana and how it effects people with type II diabetes..  The study uses a megadose, 7X what a heavy user would probably ingest, and followed a little more than 100 patients for about 4 months.  Results of this placebo study show no severe effects on blood pressure or blood sugar.  However, there was one case of hyperglycemia – that is too much glucose in the blood stream – but in a group of diabetics, something like this seems likely to happen during a 4 month period of time.  And let’s not forget to mention that some Cargill money managed to squeeze its way into the study.

In a way, this particular finding was a bit of a disappointment.  There was hope that rebiana would treat diabetes much like it is suspected stevioside can but this is the second study to disprove that.  The first study on this topic showed that rebiana was not able to deliver any of the metabolic syndrome reducing effects of stevioside, so a consensus is forming.  A few others studies show rebiana helps regulate glucose, but there is still much more investigation necessary.

First Thoughts

The studies we have about rebiana – and consequently Truvia and PureVia – are a mixed bag.  As we showed, some demonstrate safety, some show risk.  None really deal with potential side effects, an issue with a product that will find its way deep into the food supply.  Most surprisingly though, absolutely no published studies have actually tested Truvia or PureVia themselves.  This is probably because the sweeteners themselves were not ready in advance to be tested but we must ask why the American public is being silently asked to bear that burden.

It would appear rebiana (along with erythiritol and isomaltulose) present little risk to people with high blood pressure and type II diabetes but in the world of science, your opinions are an extension of the crowd.  In a sense, you are only as good as those that have come before you.  With rebiana, there is no concensus, no crowd – so there is no way we can give any type of authoritative opinion on it yet.  The crowds surrounding erythiritol and isomaltulose are even more sparse.

That’s all a problem with a new product and one the makers of Truvia and PureVia have done very little to assuage.  While most of these studies appear to verify that rebiana et al., do not have toxic effects, they are all very short term and funded exclusively by industry.  It is beyond unlikely that any study funded by Cargill is going to show rebiana and Truvia to be anything but the safest sweetener ever to arrive on planet earth.  Having said that, some of their studies do appear to demonstrate safety of rebiana but it so hard for us to believe these results with so much of their own money on the table.

Now, lets give Truvia and PureVia a little credit here.  This is the first sweetener product(s) developed by an agribusiness interest that is not purely a chemical.  A real plant is involved here and that is the first time that has ever happened.  Not only that, the stevia plant shows some rather amazing medical benefits.  So, for a brief moment, let us congratulate Cargill and Merisant for at least starting with something very beneficial found in nature.  That is a MAJOR step in the right direction.

Still, major questions persist.  When will Truvia or PureVia actually be tested?  How can we trust science sponsored by the same people who will gain from its results? What makes this better than just using regular old stevia?

In our next and final view of Truvia and PureVia, we will talk about how all of this science relates to stevia’s controversial past, discuss some of our conversations (and lack thereof) with government/NGO players and finally present our view on the best way forward with these sweeteners.