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Your Questions Answered

General

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What is SPLENDA® Brand Sweetener (sucralose)?

SPLENDA® Brand Sweetener, also known as sucralose, is a no-calorie sweetener that can be used as part of a healthy diet to reduce consumption of calories and carbohydrates from sugar.

It is made through a patented process that starts with sugar and converts it to a no calorie, non-carbohydrate sweetener. The result is a very stable sweetener that tastes like sugar, but without its calories. After you eat SPLENDA® Brand Sweetener, it passes through the body without being broken down for energy so the body does not recognize it as a carbohydrate.

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Can children use SPLENDA® Brand Sweetener (sucralose)?

Yes. SPLENDA® Brand Sweetener (sucralose) can be used by everyone, including children. SPLENDA® Sweetener Products are a great way to reduce the amount of added sugars your child eats daily, and may even help your child to eat healthier foods. Try using SPLENDA® No Calorie Sweetener on fruit for a sweetness to match your child's tastes. It can be a great way to replace higher-calorie treats that might also be lower in important vitamins and minerals. SPLENDA® Sweetener Products can also be used in beverages, on hot and cold cereals, and with whole grains. You can even bake some of your child's favorite special-occasion treats like cookies and cake, but with less added sugar. If you have questions about your child's diet/nutritional needs or weight, please check with your child's doctor and/or a registered dietitian.

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Can pregnant and lactating women use SPLENDA® Brand Sweetener (sucralose)?

Yes. All FDA-required studies to support the safety of sucralose during pregnancy and nursing have been performed. As a result, the FDA and other important health authorities have concluded that sucralose is suitable for use by everyone, including pregnant and nursing women. SPLENDA® Brand Sweetener may be used as part of a healthy prenatal and postnatal diet to help reduce excess calories from added sugars. Of course, women who are pregnant or breastfeeding should always talk with their doctor about their nutritional and caloric needs to support their health as well as their baby's health.

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Is there anyone who can't use SPLENDA® Brand Sweetener (sucralose)?

SPLENDA® Brand Sweetener, or sucralose, is suitable for everyone, and the sweet taste can be enjoyed by the whole family, including people with diabetes, children, and women who are pregnant or nursing.

Like other no-calorie sweetener products formulated for consumer use, SPLENDA® Sweetener Products contain additional ingredients to provide volume and texture. If you have a medical condition that requires you to avoid certain ingredients, the ingredients in SPLENDA® Sweetener Products are listed on the packaging for handy reference. The SPLENDA® information line can also help you verify whether certain ingredients are contained in our products. Call 1-800-7-SPLENDA (1-800-777-5363) or visit our Web site at www.splenda.com.

If you have questions about whether a specific ingredient is allowed in your dietary plan, we suggest that you check with your doctor and/or a registered dietitian.

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Is there a daily limit to how much SPLENDA® Brand Sweetener (sucralose) I can use? /What is the Acceptable Daily Intake (ADI) for SPLENDA® Brand Sweetener (sucralose)?

Because there are no health risks expected with sucralose use, you may consume a variety of products containing SPLENDA® Brand Sweetener (sucralose) to reduce your calorie and carbohydrate intake from sugar every day without concern that you are exceeding a safe intake level.

The term Acceptable Daily Intake (ADI) is not a threshold for safety. Regulators derive this intake level, however, as a way to help describe safety. It represents a daily intake that, if maintained over a lifetime, is 100 times lower than amounts found to be safe in studies designed to detect potential safety risks. FDA defined an ADI for sucralose, of 5 mg/kg body weight. Other important health and regulatory bodies, such as the Joint Expert Committee on Food Additives of the World Health Organization, the European Union's Scientific Committee on Food and Food Standards, Australia/New Zealand, have set the ADI for sucralose at 15 mg/kg/day.

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What happens to SPLENDA® Brand Sweetener (sucralose) after it is ingested?

After it is ingested, most (about 85%) is not absorbed and passes through the body unchanged in the stool. Of the small amount that is absorbed, most leaves the body unchanged in the urine within 24 hours.

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How do I know SPLENDA® Brand Sweetener (sucralose) is safe?

SPLENDA® Brand Sweetener has no known side effects. Sucralose (or SPLENDA® Brand Sweetener) has been the subject of extensive safety testing, with more than 20 years of research and over 110 scientific studies. Its safety is well documented and the U.S. Food and Drug Administration, along with regulatory, health, and food safety authorities from around the world, have concluded that it is safe. It has been used throughout the world by millions of people since 1991 and there are no warning labels on the products to exclude anyone from enjoying SPLENDA® Brand Sweetener. Sucralose is approved for use in over 80 countries and is currently used in more than 4,000 products worldwide.

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When was SPLENDA® Brand Sweetener (sucralose) approved by the Food and Drug Administration (FDA)?

The FDA approved sucralose in 1998 for use in 15 food and beverage categories following a rigorous review process. Sixteen months later, the FDA extended its approval of sucralose to use as a general-purpose sweetener, which means that sucralose is permitted for use in all foods, beverages and dietary supplements, and medical foods. It can also be used in drug products.

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How does SPLENDA® Brand Sweetener (sucralose) compare to other no-calorie sweeteners?

SPLENDA® Brand Sweetener is unique among no-calorie sweeteners, with clear benefits. It has a clean, sugar-like taste without the bitter aftertaste of some other no-calorie sweeteners, such as saccharin and acesulfame-K. And unlike aspartame, it holds up to heat, so it can be used in cooking and baking. The great taste and many uses of sucralose have made possible a wide range of lower-sugar and lower-calorie food and beverages for healthy meal planning.

SPLENDA® No Calorie Sweetener-the number one market leader among low-calorie sweeteners-is an excellent choice for those who want to reduce their added sugar intake, as well as their calorie and carbohydrate intake from sugar.

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A new study claiming that sucralose has negative environmental effects has been published in the journal, Chemosphere, based on research from the University of Stockholm. What is McNeil's response to this study?

The study performed at Stockholm University utilized non-standard study protocols that have not been validated for a regulatory environmental risk assessment. Both the U.S. Environmental Protection Agency (EPA) and the Organization for Economic Cooperation & Development (OECD) have validated test methods that are recommended for use in environmental risk assessment for regulatory purposes. Validated test methods were not used in this study. The absence of validated methodology combined with the absence of any other data that would otherwise support the researchers' findings makes it impossible to draw any meaningful conclusions from this study. Importantly, and in contrast, sucralose underwent extensive environmental testing as part of the approval process. The environmental studies conformed to validated test methods and good laboratory practices (GLP) that are accepted by government regulatory agencies around the world for the purposes of environmental risk assessment. All regulatory authorities who reviewed the environmental data on sucralose concluded that sucralose poses no risk to the environment.

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What kind of environmental studies have been conducted on sucralose?

A comprehensive range of scientific studies on sucralose has been conducted to investigate the potential impact on plant and aquatic life. All studies on sucralose have been conducted to internationally agreed protocols validated for regulatory purposes. Specific studies clearly demonstrate that sucralose has no adverse effect on fish, invertebrates (e.g., water flea), algae or higher plants. These studies showed no effects at concentrations of sucralose that were many times greater than would be found in the environment. Sucralose has been found to be essentially inert in biological systems. More recently, studies have been conducted with fish, freshwater and marine invertebrates and algae that further confirm that sucralose does not build up in the food chain and is environmentally safe.

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Health

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Can patients on chemotherapy use SPLENDA® Brand Sweetener (sucralose)?

Yes. Health authorities around the world have confirmed that sucralose, the sweetening ingredient in SPLENDA® Sweetener Products, can be used safely by everyone. This is based on a strong body of research, which includes studies about sucralose and how it acts in the body. Sucralose has been found to be safe for daily use over a person's lifetime in amounts hundreds of times greater than what could ever be expected to be eaten. Experts know that sucralose is a very stable substance, most of which is not absorbed after it is eaten.

If you have further questions, your doctor is a good source for information.

Separately, we do suggest that you check with your doctor and/or a registered dietitian about your nutritional needs during chemotherapy, since chemotherapy can affect your overall nutritional status and daily calorie intake.

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Will SPLENDA® Brand Sweetener (sucralose) upset my stomach/cause stomach issues?

No. SPLENDA® Brand Sweetener has no known side effects, including any stomach issues.

However, some lower-calorie foods, such as sugar-free ice cream, contain sugar alcohols in addition to SPLENDA® Brand Sweetener. Sugar alcohols (such as mannitol, sorbitol, xylitol, lactitol, and maltitol) are sometimes a cause of stomach upset or gastrointestinal problems in sensitive individuals, if too much is eaten. If you think you are sensitive to sugar alcohols, or other particular food ingredients, the product label with its ingredient listing can help you choose foods that are suited to your needs.

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Does sucralose cause headaches/migraines?

No. Research does not support that sucralose causes migraines or headaches. There are no adverse effects expected with sucralose use. Headaches and migraines are very common events in people and can be caused by many things. Sucralose is not known to produce changes in the body that are associated with headaches or migraines. For example, sucralose has no known effects on vasodilation (opening of blood vessels) or blood pressure. Studies show no effect on blood glucose or insulin levels and there are no known effects on the nervous system.

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Does sucralose affect the kidneys?

No. Sucralose does not affect the kidneys. Research shows that when consumed, most sucralose is largely unabsorbed and simply passes out of the body in the stool. The small amount that is absorbed also passes harmlessly out of the body through the urine. Sucralose has no known side effects, including any involving the kidneys. More than 20 years of research and over 110 scientific studies confirm the safety of sucralose.

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Does sucralose affect the liver?

No. Sucralose does not affect the liver. Research shows that when consumed, most sucralose is largely unabsorbed and simply passes out of the body in the stool. The small amount that is absorbed also passes harmlessly out of the body through the urine. Sucralose has no known side effects, including any involving the liver. More than 20 years of research and over 110 scientific studies confirm the safety of sucralose.

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Does SPLENDA® Brand Sweetener (sucralose) cause tooth decay?

No. SPLENDA® Brand Sweetener, or sucralose, the sweetening ingredient in SPLENDA® Sweetener Products, does not promote tooth decay.

Studies also show that SPLENDA® No Calorie Sweetener (packets and granulated) have significantly less potential to cause cavities than sugar, although they contain a small amount of carbohydrate to provide texture and volume.

SPLENDA® No Calorie Sweetener Minis and SPLENDA® MIST™ No Calorie Sweetener will not promote tooth decay because they contain very little or no carbohydrate that can be the source of energy for oral bacteria that can cause calories.

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Are there any known interactions with medications and SPLENDA® Brand Sweetener?

No. There are no known interactions with medications and SPLENDA® Brand Sweetener. Except for providing sweetness, studies show that sucralose (SPLENDA® Brand Sweetener) is essentially inert in the body. SPLENDA® Brand Sweetener Products can be enjoyed by everyone, including those on one or more medications.

There is sometimes confusion about the effects of no-calorie sweeteners, which are often the result of misinformation and/or misinterpretation of information. This includes, for example, a recent study in male rats funded by the Sugar Association that discussed the possibility of effects on drug absorption. This study, however, was subsequently found by recognized medical and public health experts to have serious design flaws and conclusions that are unreliable and unsupported by the study data. The Expert Panel that investigated this study, published their findings in the journal, Regulatory Toxicology and Pharmacology, and concluded that the results of the study in question cannot be viewed as evidence that either SPLENDA® No Calorie Sweetener or sucralose cause any adverse effects. Specifically, the Expert Panel noted that "effects on drug absorption are also not expected with sucralose," in light of the scientific evidence. For more information, go to News and Latest Research on this site.

Collective research shows that sucralose is safe for use throughout a lifetime and for all segments of the population, including children, people with diabetes, and women who are pregnant or nursing.

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Diet

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How can SPLENDA® Brand Sweetener (sucralose) help with weight management?

SPLENDA® Brand Sweetener can help decrease caloric intake by replacing sugar. For example, for every 2 teaspoons of sugar you replace with SPLENDA® No Calorie Sweetener, you save over 25 calories. Another example that can save you approximately 150 calories is replacing one 12-fl. ounce can of soda sweetened with sugar or high-fructose corn syrup with a beverage sweetened with SPLENDA® Brand Sweetener. Using SPLENDA® Brand Sweetener along with regular physical activity can be a great way to help with weight management.

In fact, a 2007 study published in Pediatrics, the official journal of the American Academy of Pediatrics, demonstrated that by making 2 simple changes daily-using SPLENDA® Brand Sweetener as part of a program to reduce calorie intake and increasing activity levels-families can help overweight children slow their rate of weight gain.

An article in The New York Times (J. Brody, February 17, 2009) also points out that when used properly, no-calorie sweeteners can aid in weight management. The article states, "Small changes in caloric intake can result in small but meaningful healthier weights."

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Does SPLENDA® Brand Sweetener (sucralose) cause weight gain?

No. SPLENDA® Brand Sweetener does not cause weight gain-rather, it can help decrease caloric intake when used in place of sugar. The use of no-calorie sweeteners to help decrease caloric intake, along with regular physical activity, may help with weight management.

While it has been suggested by some that no calorie sweeteners may cause weight gain, such conclusions are frequently based on studies that were not designed to understand actual effects on weight management. Often, they are studies of very short duration, involving only a small number of animals. This includes, for example, a recent study in male rats funded by the Sugar Association that was subsequently found by recognized experts in nutrition and public health to have serious design flaws and conclusions that are unreliable and unsupported by the study data. The Expert Panel that investigated this study, published their findings in the journal, Regulatory Toxicology and Pharmacology, and concluded that the results of the study in question cannot be viewed as evidence that either SPLENDA® No Calorie Sweetener or sucralose cause any adverse effects. For more information, go to: News and Latest Research on this site.

By contrast, studies for up to 3 years in people support that no calorie sweeteners can be useful in weight management strategies. Additionally, rigorous, large studies in rats that received sucralose at doses equal in sweetness to over 40 pounds of sugar per day over a lifetime showed that sucralose does not cause increases in body weight. There are a lot of data to support that sucralose and other no-calorie sweeteners can be useful in strategies for weight management.

In fact, a 2007 study published in Pediatrics, the official journal of the American Academy of Pediatrics, demonstrated that by making 2 simple changes daily-using SPLENDA® Brand Sweetener as part of a program to reduce calorie intake and increasing activity levels-families can help overweight children slow their rate of weight gain. Further, an article in The New York Times (J. Brody, February 17, 2009) emphasizes that when used properly, as a substitute for added sugars, no calorie sweeteners can help with weight management. The article states, "Some people use non-nutritive sweeteners as a crutch; others use them to help create a healthy diet."

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Diabetes

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If SPLENDA® Brand Sweetener (sucralose) starts from sugar, can people with diabetes use it?

Yes. Even though SPLENDA® Brand Sweetener starts with sugar, changes made through a patented process result in the no-calorie, non-carbohydrate sweetener that is sucralose. Sucralose, or SPLENDA® Brand Sweetener, tastes like sugar, without any of sugar's calories. And, like sugar, it stays sweet even when it's used in cooking and baking.

The body does not recognize SPLENDA® Brand Sweetener as a sugar. In fact, clinical studies have shown that SPLENDA® Brand Sweetener (sucralose) does not affect blood glucose levels, insulin, or HbA1c. In a meal plan for people with diabetes, up to 4 packets of SPLENDA® No Calorie Sweetener or up to 8 teaspoons of SPLENDA® No Calorie Sweetener, Granulated, are considered a "free food." The American Dietetic Association and the American Diabetes Association consider a free food to be any food or beverage that contains less than 20 calories and 5 grams or less of carbohydrate per serving.

Like other no-calorie sweeteners formulated for consumer use, the granulated and packet products contain small amounts of carbohydrate (less than 1 gram per serving) that provide needed volume and texture. These are common food ingredients, which include maltodextrin and/or dextrose. Ingredients in all SPLENDA® No Calorie Sweetener products add so few calories per serving that all SPLENDA® No Calorie Sweetener Products meet the Food and Drug Administration's criteria for no-calorie foods (<5 calories/serving).

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Can people with diabetes use the SPLENDA® Sugar Blend products?

Yes. People with diabetes can eat a variety of food products, according to the dietary program prescribed by their doctor and/or a registered dietitian. These can include foods sweetened with sugar. However, meal plans for people with diabetes usually control total carbohydrate intake, and often calorie intake. In a meal plan for people with diabetes, up to 4 packets of SPLENDA® No Calorie Sweetener or up to 8 teaspoons of SPLENDA® No Calorie Sweetener Granulated is considered a "free food." The American Dietetic Association and the American Diabetes Association consider a free food to be any food or beverage that contains less than 20 calories and 5 grams or less of carbohydrate per serving.

When used in place of sugar, SPLENDA® Sugar Blend can also help people with diabetes reduce their intake of carbohydrates and calories by providing half the calories and carbohydrates of sugar, but with all of sugar's taste. It is important to note that SPLENDA® Sugar Blend does contain sugar, so people with diabetes need to consider this when counting their carbohydrate intake. Carbohydrate and calories can also be present from other ingredients in foods and beverages sweetened with any SPLENDA® Sweetener Product. People with diabetes need to count these calories and carbohydrates when planning their meals. To help people manage intake, all of the recipes made with SPLENDA® Sweetener Products available at www.splenda.com provide complete nutrition information.

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Can patients on dialysis use SPLENDA® Brand Sweetener (sucralose)?

Yes. There are no safety concerns expected for patients on dialysis.

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Ingredients

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What is in SPLENDA® Sweetener Products?

All SPLENDA® Sweetener Products contain SPLENDA® Brand Sweetener, or sucralose, the no-calorie sweetening ingredient that gives all SPLENDA® Sweetener Products the great taste people love without all the calories.

Like other no-calorie sweeteners formulated for consumer use, SPLENDA® No Calorie Sweetener Packets and Granulated products contain small amounts of carbohydrate (less than 1 gram per serving) to provide volume and texture. These common food ingredients are dextrose (packets) and maltodextrin (packets and granulated). Ingredients in all SPLENDA® No Calorie Sweetener products provide so few calories per serving that all SPLENDA® No Calorie Sweetener Products meet the Food and Drug Administration's criteria for no-calorie foods (<5 calories/serving).

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SPLENDA® Brand Sweetener (sucralose) contains chlorine. Is that safe?

Yes. Chlorine is a natural part of salt, which is found in many foods, like lettuce, tomatoes, mushrooms, melons, and peanut butter, and chlorine is added to most public water supplies. Chlorine is also a part of more complex molecules found in such things as lentils, peas, and potatoes. It is a part of daily life. In the case of SPLENDA® Brand Sweetener, chlorine is used in a process that alters sugar to create the very stable no calorie sweetener, sucralose. A large amount of research shows that sucralose can be used safely by everyone and that there is no cause for concern about safety because of chlorine.

What's more, SPLENDA® Brand Sweetener does not build up in the body, nor is it broken down to yield any free chlorine or smaller chlorinated molecules, and sucralose is calorie-free.

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Does SPLENDA® Brand Sweetener (sucralose) contain formaldehyde?

No, SPLENDA® Brand Sweetener does not contain formaldehyde.

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Does SPLENDA® Brand Sweetener (sucralose) contain aspartame?

No, SPLENDA® Brand Sweetener does not contain aspartame. Aspartame is another no calorie sweetener unrelated to sucralose.

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Does SPLENDA® Brand Sweetener (sucralose) contain lactose?

No, SPLENDA® Brand Sweetener does not contain lactose, nor do any of the SPLENDA® Sweetener Products, except for SPLENDA® No Calorie Sweetener Minis.

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Does SPLENDA® Brand Sweetener (sucralose) contain any ingredients derived from genetically modified organisms (GMOs)?

No, SPLENDA® Brand Sweetener, or sucralose, does not come from genetically modified sources and the manufacturing process does not use any ingredients that come from genetically modified sources.

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