FDA Publishes Consumer Article On Sweetener Safety

The new generation of FDA employees needs to do their history homework! Over time, the truth about aspartame approval (NutraSweet/Equal®) has been forgotten and buried deeper and deeper in the FDA files. To bring you up-to-date, I have posted the FDA's list of over 92 various health reactions to aspartame . These health reactions were submitted to the FDA from 1982 through 1991 by medical doctors and aspartame victims. After 1991, the FDA stopped filing them as specific "aspartame" reactions, and began listing them under symptom categories with generic and/or unknown sources.

Dr. Janet Starr Hull

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Artificial Sweeteners: No Calories ... Sweet!

Artificial sweeteners can help consumers cut down on calories and control weight, help to manage chronic conditions such as diabetes, and potentially prevent cavities, according to the American Dietetic Association (ADA).

To date, five artificial sweeteners are approved by the Food and Drug Administration: aspartame, saccharin, acesulfame-K, neotame, and sucralose. The agency regulates artificial sweeteners as food additives, which must be approved as safe before they can be marketed.

"The FDA evaluates a sweetener's composition and properties, how much of the substance is likely to be consumed, and various types of safety studies," says Laura Tarantino, Ph.D., director of the Office of Food Additive Safety in the FDA's Center for Food Safety and Applied Nutrition.

For each of the approved sweeteners, the typical amount used by U.S. consumers is well within designated "acceptable daily intake levels (ADI)," or levels that can be consumed safely every day over a lifetime. Here's a detailed look at each of the sweeteners.

Aspartame

Aspartame is 200 times sweeter than sugar. It has a caloric value similar to sugar (4 kcal/g), but the amounts used are small enough to consider aspartame essentially free of calories. Brand names include NutraSweet and Equal. Aspartame was first approved by the FDA in 1981 as a tabletop sweetener, and for use in gum, breakfast cereal, and other dry products. The use of aspartame was expanded to sodas in 1983, and then to use as a general-purpose sweetener in all foods and drinks in 1996.

Before approval, the FDA reviewed numerous studies showing that aspartame did not cause cancer or other adverse effects in laboratory animals. "This included three studies in which rats were fed aspartame in proportions more than 100 times higher than humans would likely consume," Tarantino says.

In the mid-1990s, a researcher raised concerns that a rise in brain cancer incidence in the United States was linked to aspartame use. According to FDA experts, there is no scientific evidence supporting a link between aspartame and any type of cancer. The National Toxicology Program, part of the U.S. Department of Health and Human Services, also conducted aspartame studies in mice and found no cancer link.

In 2005, the European Ramazzini Foundation (ERF) published new findings of a long-term feeding study on aspartame in rats. ERF scientists concluded that aspartame causes leukemia and lymphoma and that current uses of aspartame should be reevaluated. After reviewing the study data, however, the European Food Safety Authority (EFSA) released a statement in May 2006 that said the ERF's conclusion was not supported by the data. After learning of the ERF study results, the FDA requested the study data and received a portion of the data in February 2006. The FDA will announce its conclusions after completing its review.

"At this time, our position that aspartame is safe is based on the large body of information previously reviewed," Tarantino says. "Our conclusions are based on a detailed review of more than 100 toxicological and clinical studies on safety."

When ingested, aspartame is converted in the body to methanol and two amino acids--aspartic acid and phenylalanine. Tarantino says, "These substances are produced in much greater amounts in other common foods."

Because of the phenylalanine component, aspartame does carry a risk for people with the rare genetic disorder phenylketonuria. People who have this disorder should avoid or restrict aspartame use because of their body's difficulty in metabolizing phenylalanine. Its use can cause phenylalanine to build up in the blood at higher levels than normal. The aspartame regulation requires that a statement be placed on the label of all products containing aspartame specifically to alert phenylketonurics of the presence of phenylalanine.

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Posted on July 23, 2006 in FDA | Link

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