June 2009

Background

Low-calorie sweeteners (sometimes referred to as non-nutritive sweeteners, artificial sweeteners or sugar substitutes) are ingredients added to food to provide sweetness without adding a significant amount of calories. In fact, they can also play an important role in a weight management program that includes both good nutrition choices and physical activity.

Low-calorie sweeteners have a long history of safe use in a variety of foods ranging from soft drinks, to puddings and candies, as well as the table-top packet version. They are some of the most studied and reviewed food ingredients in the world today and have passed rigorous safety assessments. In the U.S., the most common and popular low-calorie sweeteners allowed for use today are:

• acesulfame potassium (Ace-K)
• aspartame
• neotame
• stevia sweeteners
• saccharin
• sucralose

When added to food, these low-calorie sweeteners provide a taste that is similar to that of table sugar (sucrose), and are generally several hundred to several thousand times sweeter than sugar. They are often referred to as intense sweeteners. Because of their intense sweetening power, these sweeteners are used in very small amounts and thus add only a negligible amount of calories to foods and beverages. As a result, they practically eliminate or substantially reduce the calories in products such as diet beverages, light yogurt and sugar-free pudding.  Additionally, low-calorie sweeteners do to not promote dental caries and they are safe for all segments of the population, including people with diabetes.

Knowing the facts about the safety, benefits, and uses of low-calorie sweeteners allows us to enjoy a broader variety of palatable foods.

Facts about Safety

Low-calorie sweeteners are thoroughly tested and carefully regulated by federal authorities and international regulatory and scientific organizations to ensure the safety of foods, beverages and other products that contain them. Also, food manufacturers are required to list low-calorie sweeteners on the product label.

The acceptable daily intake (ADI) must be considered prior to approval for any food ingredient, including low-calorie sweeteners. The ADI is defined as the estimated amount (expressed in milligrams per kilogram of body weight per day) that a person can safely consume on average every day over a lifetime without risk. Worldwide evaluation concludes that (consumer) intake of low-calorie sweeteners is in fact well below the ADIs set for these ingredients. Moreover, regulators around the world typically set ADIs at levels 100 times less than levels found to be safe in key animal model studies. These studies include daily exposure for up to a lifetime. In the United States, the ADI is set by the U.S. Food and Drug Administration (FDA). Internationally, ADIs are set by the Joint Expert Committee on Food Additives (JECFA) of the United Nations’ World Health Organization (WHO) and the Food and Agriculture Organization (FAO) and the European Union’s European Food Safety Authority (EFSA).

Real Facts About Low-Calorie Sweeteners

• FACT: Low-calorie sweeteners do not increase the risk of cancer. Studies show that low-calorie sweeteners do not cause cancer. A recent epidemiological study by the National Cancer Institute (NCI) showed that aspartame use is not associated with any increased risk of cancer, even among individuals who have high aspartame intakes.

While two recent studies by a group of Italian researchers reported a link between aspartame and cancer in rats, the FDA found “significant shortcomings” in the design and interpretation of both studies, and has stated several times (as recently as April 2007) that it does not plan to change its position on the safety of aspartame. The safety of aspartame was again confirmed in September 2007, when a panel of experts published a safety report on aspartame in Critical Reviews in Toxicology, which found “no credible evidence that aspartame is carcinogenic.”

Studies on other low-calorie sweeteners have also shown them not to be cancer-causing.

• FACT: Low-calorie sweeteners do not increase the risk of other diseases. For example, the aspartame safety report mentioned above also concluded that aspartame does not cause seizures and has no adverse effects on behavior, cognitive function, or neural function.

• FACT: All FDA-approved low-calorie sweeteners are safe for consumption by pregnant women and children. However, the advice of a physician and/or dietitian is recommended to ensure that dietary plans including low-calorie sweeteners meet the desired calorie and nutrient goals.

More Facts about Low-Calorie Sweeteners Approved for Use in the U.S.

Acesulfame-K (Ace-K)—FDA concluded that the safety of Ace-K is consistent with research findings from other countries. EFSA's reexamination of the sweetener in 2000 reaffirmed its safety. No human health problems associated with the consumption of Ace-K have been reported in the literature, despite more than 15 years of extensive use in many countries.

Ace-K is not broken down by the body and is eliminated unchanged by the kidneys. It has no effect on serum glucose, cholesterol or triglycerides and people with diabetes may safely include products containing Ace-K in their diet.

Aspartame—Discovered in 1965, FDA approved its use in dry foods in 1981 and its use in beverages in 1983. In 1996, FDA approved aspartame as a general purpose sweetener, concluding that it could be used in all categories of foods and beverages. Due to anecdotal reports and unscientific allegations, the safety of aspartame was reevaluated and confirmed again in 2002 by both the French Food Safety Agency and EFSA.

Additionally, in 2006, the AFC Panel of EFSA evaluated a long-term study on the carcinogenicity of aspartame and concluded that, based on the current data available, there is no reason to further review the safety of aspartame.

Aspartame has been proven safe for the general population, except for individuals with a rare hereditary disease known as phenylketonuria (PKU), who must restrict their intake of phenylalanine from all sources including aspartame. Foods containing aspartame as an ingredient must include a statement on the label advising phenylketonurics.

Neotame—Neotame was approved by FDA in July 2002 as a general purpose sweetener. This intense sweetener is approximately 7,000 times sweeter than sugar. Neotame has also received favorable evaluation by JECFA and is approved for use in other countries, including most parts of Eastern Europe, Australia, Russia, Mexico and several South American countries.

Prior to its approval for use as a general purpose sweetener, neotame was subjected to well over 100 extensive scientific studies. These studies included toxicity, developmental and reproductive and carcinogenicity research. Human studies were also conducted and “no significant effects of neotame were observed.”

Stevia Sweeteners—Stevia sweeteners are natural, contain zero calories, and are 200-300 times sweeter than sugar. Stevia sweeteners are highly purified steviol glycosides, which make up the sweetest part of the stevia plant. The stevia plant is native to South America, but it can be found growing in many countries, including China, Brazil, Argentina, Paraguay, India and South Korea. Stevia sweeteners are approved for food and beverage use in several countries and can be found in the U.S. in many products, including some juice and tea beverages, and as a tabletop sweetener.

In December 2008, the FDA stated it had no questions regarding the conclusion of an expert panel that steviol glycosides are generally recognized as safe (GRAS) for use as general purpose sweeteners. Prior to this, stevia (in its unpurified form) was only permitted for use as a dietary supplement in the U.S.

The safety of stevia sweeteners for human consumption has been established through rigorous peer-reviewed research, including metabolism and pharmacokinetic studies, general and multi-generational safety studies, intake studies and human studies. This research is consistent with JECFA’s review of steviol glycosides completed in 2008, which concluded that steviol glycosides are safe for human consumption.

Saccharin—Originally discovered in 1878, saccharin is the oldest low-calorie sweetener approved for use in the marketplace today. Over thirty years ago, a study found a link between saccharin and stomach cancer in rats. This caused FDA to propose that saccharin be banned and to mandate a warning label on products containing saccharin. However, subsequent research has shown no link to stomach cancer from saccharin consumption in humans and, based on federal legislation in 2001, products containing saccharin no longer have to carry a warning label. In addition, the National Toxicology Program of the National Institutes of Health (NIH) recommended in its “Report on Carcinogens, 9th Edition” that saccharin be removed from the list of potential carcinogens, and the California Environmental Protection Agency (EPA) also removed saccharin from its Proposition 65 list of carcinogens.

Today saccharin is still safely and widely used, often in combination with other sweeteners.

Sucralose—In 1999, the FDA approved sucralose as a general purpose sweetener for use in all categories of foods and beverages. The research on sucralose's safety has also been reviewed by JECFA and EFSA, which both concluded it is safe for human consumption. More than 100 scientific studies have been conducted on sucralose to determine its safety and use prior to government approval.

The FDA and EFSA both reviewed studies in diabetics using sucralose and found that sucralose has no adverse health on blood glucose control. Additionally, FDA and other experts have found no adverse health effects with regard to sucralose use.

Facts about Low-Calorie Sweeteners and Weight Management

As Americans face the increasing problem of obesity, foods sweetened with low-calorie sweeteners can offer help with weight management. Research indicates that people who incorporate foods sweetened with low-calorie sweeteners in their diet actually consume fewer calories than those who do not. Additionally, low-calorie sweeteners may help individuals to be more satisfied with their eating plans, helping them to lose weight and keep it off. While a few studies have suggested that low-calorie sweeteners may cause weight gain, they have not changed general scientific consensus that low-calorie sweeteners can aid in weight management.

In January 2008, researchers at Purdue University found that consumption of saccharin led to increased appetite and weight gain in rats. Due to sample size and flaws in the study design, many experts agree that the results cannot be applied to humans. In addition, clinical studies in humans conducted over the past 20 years have shown that using low calorie sweeteners can help with weight loss/maintenance. A 2006 review of aspartame’s role in weight management demonstrated a weight loss of 0.2kg/week (or 0.4 lb) when aspartame-sweetened products were substituted for those sweetened with sugar. Similar findings were seen in a 1997 study published in the American Journal of Clinical Nutrition, which found that aspartame helps with weight loss and long-term weight maintenance.

Experts agree that successful weight management requires more than just calorie reduction—moderation along with sensible eating habits and physical activity are integral in reaching an optimal weight.

Summary

Low-calorie sweeteners are safe and play an important role in providing a broader variety of foods, beverages and other products to satisfy the palates of people across the world. They provide flexibility when making food choices and can aid individuals with reducing calorie and carbohydrate intake. They are safe for the general public, including people with diabetes, children and pregnant women. Based on the body of scientific studies and safety evaluations, both consumers and healthcare professionals can safely utilize low-calorie sweeteners in their daily eating and weight management plans.

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