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Natural sweetener not yet ready for FDA approval

A compound that is much sweeter than table sugar -- without the calories -- is derived from the leaves from the stevia shrub and has been used for years by South Americans to sweeten their yerba mate, a beverage similar to tea.

However, stevia, which is sold as a dietary supplement, has not yet been approved as a sugar substitute by the US Food and Drug Administration (FDA), according to a report published in the April issue of the Nutrition Action Healthletter.

Japanese manufacturers have used stevia for over 30 years, but "the FDA has turned down three industry requests to use stevia in foods in the US," writes author David Schardt, an associate nutritionist for the Center for Science in the Public Interest (CSPI), which publishes the Healthletter.

Dr. George Pauli, from the FDA's Office of Pre-Market Approvals, which regulates food additives, explained to Reuters Health that stevia "hasn't been tested the way food ingredients are generally tested to give assurance of safety." He admits that some tests have been done, but they are not "strong enough to stand behind the safety of the product."

Dan Richard, a representative of Now Foods, one of the largest sellers of stevia in the country, argues that stevia "has no known side effects" whereas aspartame -- an FDA-approved sugar substitute -- "has a list of side effects." Stevia is a "great product (which has) been around for millennia," he said in an interview with Reuters Health.

Schardt admits that the side effects of stevia are unknown, but there are concerns about using the product as a sweetener. "Although there is no evidence of harm to people, laboratory studies of stevia have found potential cancer and reproductive-health problems," he stated.

The US is not alone in its refusal to approve stevia, writes Schardt. Neither Canada nor the European Union allow food companies to add the sweetener to their products. A scientific panel from the European Union, concerned about the potential toxicity of stevioside -- stevia's main ingredient -- has declared it is "not acceptable."

Studies done by European scientists show potential infertility problems -- including decreased sperm production and increased testicle cell growth -- in male rats fed high doses of stevioside. Female hamsters that were fed large amounts of steviol, a derivative of stevioside, had "fewer and smaller offspring."

The FDA has also received reports of depression, anxiety, and hyperactivity resulting from the use of stevia.

The bottom line, according to Schardt, is "if you use stevia sparingly... it isn't a great threat to you."

The FDA "can't say it's safe or unsafe," Pauli acknowledged, but Schardt suggests that it might become a public health problem if it were approved as a sugar substitute.

"If stevia were marketed widely and used in diet sodas, it would be consumed by millions of people," he writes. "That's why the government needs to require companies to do more -- and better -- testing," Schardt concludes.


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