Food Companies, Stevia and FDA Regulations. What is Going On

By: Tanya Taylor, PhD | Nov 21, 2008

I hesitated to post this, but after Red-Icculus asked the exact same thing I was thinking on our Stevia Goes Even More Mainstream with Stevia in the Raw article, I decided to go ahead and say it: What the heck is going on with the credibility and effectiveness of the FDA when companies can openly launch products in direct violation of their regulations?!

Have I have missed an update on the ban by the FDA on the use of Stevia in foods as a sweetener? There is an FDA Import Alert updated 11-15-2008, in which they clearly state:

With regard to its use in foods, Stevia is not an approved food additive nor affirmed as GRAS in the United States. Available toxicological information on stevia is inadequate to demonstrate its safety as a food additive or to affirm its status as GRAS. However, with regard to its use in dietary supplements, dietary ingredients, including stevia, are not subject to food additive regulations.

Stevia Sweeteners

There have been very public launches and press releases of Stevia products that are clearly labeled as "calorie-free sweeteners." Truvia, the product of a joint venture between CocaCola and Cargill had a very public tasting event in July at the Rockerfeller Center (NY), and it's clearly labeled as "Nature's Calorie-Free Sweetener." And the label of newcomers, Stevia in the Raw Extract clearly says "100% Natural Zero Calorie Sweetener."

So, what gives?!
* Update// We love our commenters! Looks like some of these companies have gone through the "GRAS (Generally Recognized as Safe) self determination process." But it still seems odd to me that the FDA bans it as a sweetener, but companies say it's safe and it's still allowed to launch. Shouldn't GRAS self determination apply to foods that the FDA hasn't already ruled on. Or they should have to comment and respond before the product hits the market.

Comments

Sat: November 22, 2008
Cereal said:

I could be wrong,but I thought that sweetleaf had already attained GRAS status, and that the other companies were going to obtain GRAS status before they officialy released their products.

If I'm right and sweetleaf already obtained GRAS status you would think that other stevia products wouldn't have a hard time doing the same thing.

Sat: November 22, 2008
Cereal said:

I did some more research after I read this ,and found out that these companies are using the GRAS self-affirmation process. With this route all they have to do is present their product to a qualified group of scientists for review;if it passes their tests then the company will be given GRAS status.

Even if the FDA wanted the product to stay banned they would have too take the company to court, and show scientific proof that it is dangerous for human consumption.

I hope this clears everything up for you.

Fri: November 28, 2008
Cereal said:

I think the GRAS self-affirmation process is used to free up the FDA's resources; both money and time.

Also, you have to realize that the companies still have to show scientific evidence from credible sources(I believe the sources are chosen by the FDA) too obtain GRAS status. So it's not like the FDA is just taking some companies word,and giving them a free pass.