FDA Status for the Sweetener Stevia

Stevia is a herb, any one of a number of species found throughout Central and South America. Specifically, it refers to Stevia rebaudiana, the leaves of which have been used as a sweetener for hundreds of years. Stevia is particularly popular in Japan, where it has been commercially available since the early 1970s. However, its path to market in the United States has been a much more difficult one.


Thirty years ago, Stevia was available in the United States, although somewhat difficult to find. This changed after a controversial 1985 study stated that a substance produced when Stevia was digested caused mutations in the livers of rats. Afterward, citing a lack of studies on Stevia’s safety, the FDA banned imports into the United States in 1991, calling the plant a “unsafe food additive.” Many in the natural foods industry hold that this action was taken at the behest of the manufacturer of Nutrasweet, fueling a suspicion still prevalent in those circles that actual science takes a backseat to the concerns of big business at the FDA. After the passage of the Dietary Supplement Health and Education Act in 1994, the FDA allowed restricted sales of Stevia as long as it was labeled as a dietary supplement rather than a “food additive.”

Technical Approval

Stevia and products made from Stevia remained in this legal limbo until December of 2008, when the FDA allowed the use of two sweeteners derived from Stevia: Coke’s Truvia and Pepsi’ Purevia. Many natural foods websites hailed this as FDA “approval” of Stevia. Technically, this is not true. What the FDA actually did was “decline to object” to the sale of various drinks containing those companies’ Stevia-derived sweeteners. The agency “concluded there is no basis to object to the use of certain refined Stevia preparations in food.”

Legal Limbo

What this means is that, according to the FDA, Stevia itself still cannot be marketed as a sweetener, only as a dietary supplement, unless it’s in the form of Truvia or Purevia, in which case the FDA will neither approve nor object. As you might expect, this has again led to charges that the FDA conducts its business for the benefit of large companies rather than American society as a whole.


The goal of those who want to sell Stevia as a sweetener, or who simply wish to be able to purchase it without trouble, is the FDA’s GRAS, for “Generally Regarded As Safe” status. It is also argued that Stevia should not even be subject to FDA authority, as it was not only used prior to the 1958 law giving the FDA that authority, but that the law itself was targeted at manufactured rather than natural additives–so while the sweetener Truvia would fall under the FDA’s authority, Stevia itself would not.

Despite the FDA’s lack of objection to Truvia and Purevia, neither those products nor Stevia itself have found a place on that list.  It doesn’t mean that they aren’t safe, just that the FDA declines to say so one way or the other.


About Author

Posts By content
  • yoda

    SweetLeaf Sweetener was actually the first stevia product to be receive the GRAS (genrally recognized as safe) designation in March 2008, about 9 months before Truvia and PureVia, and therefore can be marketed as a sweetener as well. In fact, SweetLeaf Stevia is the only food and beverage ingredient in the US to receive the “No Questions” letter from the FDA and two GRAS certifications for the same product.

  • yoda

    I think there are at least a couple other stevia brands that have now acheived GRAS status, but I can’t remember specifically which ones…

    Anyway, Truvia and PureVia are not alone…

  • oscar rodes

    In 1988 I met with FDA officials to discuss a stevia extract GRAS petition I was planning to file. At that time they told me that stevia could not be considered a GRAS substance and named a list of pharmacological studies that would have to be performed, costing millions of dollars and several years to be completed and with no guarantee of approval .
    Actually I am glad for the consumer sake, that Cargill, with their lobbying power and deep pockets have received at least this no objection from the FDA. I t was a benefit to the consumer, but unfair to the smaller stevia companies, because this FDA approval gives monopolistic power to just one , or a few companies with money and influence on FDA decisions.