A citizen’s petition alleging that stevia has therapeutic benefits and is therefore a drug, must be met with a strong and united response from all stevia stakeholders. These include the heavyweights Cargill, Coca-Cola, Merisant, Pepsi-Cola, as well as Wisdom Natural Brands, PureCircle and Blue California.
The petitioner, identified as Coburn & Coffman PLLC in Washington DC, contends that stevia glycosides (SGs) are drugs and therefore cannot be legally added to conventional foods.
The petition focuses on § 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA), and was made on the grounds that SGs have been studied for therapeutic uses, such as effects on blood pressure and blood sugar levels, with clinical trials supporting these therapeutic uses.
The law firm refused to say anything apart from “no comment” when contacted last week. The first question to ask is “Who is behind the petition”? Various suggestions were made, but none backed up by anything more that speculation. Watch this space for clarification.
The next question is why? Unfortunately, it is difficult to answer this without knowing who is behind the petition, but commercial interest is a possibility. The law firm, however, states that it is a matter of public health. This rings somewhat hollow given the sky-rocketing statistics for obesity and diabetes.
Is it in the public interest to block a natural, low-calorie sweetener? The answer is clearly no.
Positives can always be drawn from all situations, and in this case, whatever the petition’s outcome, there are lessons to be learned. Some industry insiders have said that this move was anticipated months ago, simply because § 301(ll) is something of a loophole. If such things can be anticipated then measures must be made to close the hole before others exploit it.
Last week I spoke to various industry insiders on this subject, and the overall impression is that the petition will fail. But the link between the sweetener and the word ‘drug’ may leave a lasting impression in the minds of consumers. If that is the case then the marketing people have some work to do.
The road to FDA GRAS determination for stevia has been relatively long. Previous unsuccessful attempts to affirm GRAS status include the American Herbal Products Association’s 1992 petition, and Lipton-Unilever’s 1994 petition. On both occasions the petitions were refused.
The global regulatory climate is changing, however. The Australian and New Zealand food standards authority approved steviol glycosides for use in foods just over a week ago, Switzerland has followed, and in June 2008 the United Nations Food and Agriculture Organisation’s Joint Expert Committee on Food Additives (JECFA) concluded that stevia extracts containing 95 percent steviol glycosides are safe for human use in the range of four milligrams per kilogram of body weight per day.
The importance of the JECFA conclusions should not be underestimated. They clearly pave the way for global approvals. The road to stevia approval is almost over, and soon stevia and the food industry could be skipping off into the sunset to live happily ever after.
Stephen Daniells is the science editor for NutraIngredients.com and FoodNavigator.com. He has a PhD in chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.
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