Health Options Alan Titchenal  & Joannie Dobbs                    Monday, April 21, 2003

Stevia may be super sweet, but FDA has reservations

Sweetness is big business and this relates to more than just sugar. Low-calorie or calorie-free sweeteners such as aspartame, saccharin, acesulfame-K and sucralose are used in a wide variety of foods.

Makers of a number of other sweet substances have tried to obtain Food and Drug Administration approval for use of their products in foods. But the FDA requires clear and substantial evidence of safety.

Many people would like to see another sweetener approved -- stevioside, produced in the leaves of a plant called stevia that grows wild in parts of Paraguay and Brazil. The fresh leaves taste like a spoonful of sugar. The ground dried leaves are said to be 15 to 45 times as sweet as common table sugar and stevioside itself is 250 to 300 times as sweet as sugar.

Question : Why won't the FDA approve the use of stevia in foods?

Answer : Food additives must be on the list of substances "Generally Recognized as Safe," commonly called the GRAS list. For a new substance to make the GRAS list, there must be substantial evidence that it will cause no harm to consumers in the amounts it is likely to be consumed. It took 16 years of research for aspartame to reach the GRAS list.

The FDA's current position on stevia is that toxicological studies have been insufficient to make a decision on its safety. The FDA is also concerned about evidence that stevia may have an adverse effect on fertility and blood sugar levels.

Q: Is stevia an approved sweetener in other countries?

A: Yes and no. Stevia has been used in Japan as a sweetener in pickles and other foods typically consumed in small amounts. It has also been used in South America by natives. However, neither Canada nor the European Union allows stevia to be added to food products. Their concerns are similar to those raised by the FDA, and also include possible associations with cancer and birth defects.

Q: If stevia is not on the GRAS list, why can it and its extracts be sold in health food stores?

A: Many non-GRAS substances -- for example, stevia and herbs such as ephedra and echinacea -- can be sold legally as dietary supplements. But it is not legal to add them to foods. It is also illegal to market stevia as a sugar substitute or package it in ways that imply it is a sweetener.

It is an awesome responsibility to approve food additives that will be consumed by millions of people.

More time and a lot more research is necessary to determine if it is safe to add stevia to foods.