Editorial: Regulation Schmegulation
Stop me if you’ve heard this one before: a natural sweetener with a great taste and zero calories.
That is the promise of Truvia, the latest product to hit the guilt-free-sweetener market. Truvia is made from the leaves of the Stevia rebaudiana plant, a native of Paraguay, that has been used for years as a sugar substitute in South America, Japan, China and Korea. It has not been allowed in the EU or the US, however, on the basis of ‘insufficient’ safety data.
In early animal studies, stevia extracts were linked to liver cancer in animals. They also had the pharmaceutical-like effect of lowering blood pressure and altering glucose sensitivity. The stevia plant is also a source of phytosterols (plant-based hormones) and there were concerns about reproductive abnormalities. But what really kept stevia off the market was a familiar handicap of most herbs – truly natural products don’t come with money-spinning patents.
Enter agri-giant Cargill, which has secured the patent for a sweetener derived from a highly purified extract of the plant. The sweetener has been developed in partnership with Coca-Cola, which has exclusive global rights to use it in beverages, and Cargill expects to have Truvia-sweetened products on the market by the end of the year.
The term ‘stevia’ usually refers to a crude powder or liquid preparation made from the leaves of the stevia plant. Such preparations contain a mixture of components, not just those that give the leaf a sweet taste. The sweetness of stevia comes from glycosides, and while there are a variety of glycosides in the leaf, the two most abundant are stevioside and rebaudioside A – from which rebiana, marketed as Truvia, is made.
How has a product that only a few years ago was subject to US Food and Drug Administration (FDA) import restrictions, and is still restricted in the EU, come so quickly to the marketplace? Frighteningly, under a newer and expedited FDA process, companies are able to pursue a route called ‘self-determination of GRAS [generally recognised as safe] status’. This allows for the safety of products to be determined by the views of experts assembled by the manufacturer. As long as the manufacturer can show there are significant published, peer-reviewed studies available in the public domain the product can be given a tentative go-ahead.
Never mind that the dozen studies giving rebiana the all clear were funded by Cargill, and are authored, according to reports, by scientists with some potential conflicts of interest. Some of them are in the employ of Cargill and Coca-Cola, other are members of Cantox, a scientific and regulatory consulting firm that helps get products on the market. Some sit on the International Editorial Board of Food and Chemical Toxicology, the journal that published some of the studies. One is a managing editor of that publication.
Cargill defends the research, arguing that rebaudioside A – a different substance from that on which previous stevia studies are based – is safer. Maybe this is so. Maybe it isn’t. It seems baffling, however, that approval for a substance that could potentially be used in thousands of products and consumed by billions of people daily could be made on the basis of a dozen studies financed by the manufacturer and reviewed by a team also financed by the manufacturer.
When manufacturers are allowed to sign themselves off on to the marketplace with no real checks and balances, the regulatory process is clearly in chaos. A product that will be consumed by billions should be subject to rigorous scientific scrutiny not only for its safety when taken in isolation, but also for its safety when mixed with other food additives and chemicals; when taken by pregnant women, developing children and the elderly; and when mixed with the types of medications that people who regularly consume sweeteners are also likely to be taking. It is not at all clear that this has been the case with stevia – or rebiana.
You have been warned.
- This editorial first appeared in the July/August 2008 edition of the Ecologist.
