September 4, 2008
WASHINGTON Laboratory tests show that the sweetener, rebiana, an extract of stevia leaves, causes mutations and DNA damage, which raises the prospect that it causes cancer, according to a new report by toxicologists at the University of California, Los Angeles. In a letter to FDA, the Center for Science in the Public Interest said FDA should require additional tests before accepting rebiana as GRAS.
"A safe, natural, high-potency sweetener would be a welcome addition to the food supply," said CSPI executive director Michael F. Jacobson. "But the FDA needs to be as sure as possible that rebiana is safe before allowing it into foods that would be consumed by tens of millions of people. It would be tragic if the sweetener turned out to cause cancer or other problems."
One key animal study has not been conducted, according to the UCLA experts and CSPI. The FDA's guidelines advise testing prospective major new food additives on two rodent species, usually rats and mice, the new sweetener has only been tested on rats. The toxicologists' report said that because several studies found mutations and DNA damage, a lifetime mouse study designed to evaluate the risk of carcinogenicity and other health problems is particularly important.
Two companiesCargill and Merisanthave told the FDA that rebiana should be considered GRAS, a category given less scrutiny by the FDA than ordinary food additives. A third company, Wisdom Natural Brands, has declared that its stevia-based sweetener is GRAS and will market it without giving evidence to, or even notifying, the FDA. That company gave CSPI only a heavily redacted report prepared by scientists it hired to declare its stevia derivative, which is of unknown purity, is safe.
Stevia is legal in foods in Japan and several other countries, but the United States, Canada, and the European Union bar stevia in foods because of older tests that suggested it might interfere with reproduction. New tests sponsored by Cargill did not find such problems.
"I am not saying that rebiana is harmful, but it should not be marketed until new studies establish that it is safe," Jacobson said.
Cargill's version of rebiana is called Truvia and would be used by Coca-Cola. Pepsis version is called PureVia and is produced by Merisants Whole Earth Sweetener division. Merisant is best known for marketing the Equal brand of aspartame.
CSPI has not questioned the safety of two artificial sweeteners, sucralose (Splenda) and neotame, but said that suggestive evidence indicates that saccharin, aspartame (Equal, NutraSweet), and acesulfame-K pose small risks of cancer.
"The whole issue of what gets GRAS status needs to be reviewed by Congress," Jacobson said. "Its crazy that companies can just hire a few consultants to bless their new ingredients and rush them to market without any opportunity for the FDA and the public to review all the safety evidence."
Source: Center For Science In The Public Interest
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