Special Thank You to. Speakers. Participation Information. Presenter Disclosure. No, Low and Reduced Calorie Sweeteners: Hot Topics from A - Z

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1 Diabetes Care and Education Practice Group presents: No, Low and Reduced Calorie Sweeteners: Hot Topics From A to Z Robyn Flipse, MS, RD Alan Rulis, PhD Thank you for joining us. Our program will begin shortly. You can download the handouts by logging in at the Member Features tab My Media DCE Leaders Special Thank You to Andrea Dunn, RD, LD, CDE DCE Chair Lisa Brown, RD, LD, CDE Chair Elect Workgroup Members Suzanne Pecoraro, RD, MPH, CDE Paula Ackerman, MS, RD, CDE Kim Hadley, RD, CDE Andrea Hebert, RD, CDE Amy Hess Fischl,MS, RD,LDN, Niharika Jaiswal, RD, CDE BC-ADM,CDE Michelle Nabatian Routhenstein, MS RD CDN Industry Relations Chair Mary Lou Perry, RD, CDE Susan Rizzo, RD, LD, CDE Donna Plyler, RD, CDE Professional Development Adam Reppert, RD, CDE Sarah Williams, RD, LD, CDE Contact us: DCEwebinars@gmail.com Participation Information Handouts: ; log in, go to Member Features tab My Media Attendee control panel upper right Polling questions vote using keyboard Question and Answer session Submit at any time using Questions Pane Speaker will answer at end of program Speakers Robyn Flipse, MS, RD Registered Dietitian specializing in food, nutrition and health communications. She has been on the professional staffs at The Estee Corporation, Raritan Bay Health Services Corporation, the College of Medicine and Dentistry and Jersey Shore University Medical Center Hospital. rlflipse@aol.com Alan Rulis, PhD Retired from the federal government in 2006 after 30 years at the U.S. Food and Drug Administration, including nine as Director of the FDA s Office of Food Additive Safety ( ). He was Senior Advisor for Special Projects in the FDA s Center for Food Safety and Applied Nutrition from 2004 until his retirement. arulis@exponent.com Presenter Disclosure Robyn Flipse, MS, RD Discloses that she is a consultant for The Coca- Cola Company and for McNeil Nutritionals, LLC, makers of Splenda. FDA Regulatory Approval Process for Food Ingredients Safety Decisions on Low- and Reduced- Calorie Sweeteners Academy of Nutrition & Dietetics D C E Practice Group -- Webinar -- February 12, 2013 Alan Rulis, Ph.D. Exponent, Inc. 1

2 Resource Paper FDA s Food Ingredient Approval Process Safety assurance based on scientific assessment A.M. Rulis & J.A. Levitt, Regulatory Toxicology & Pharmacology 53 (2009) Some questions about additives: (including non-nutritive sweeteners) How does FDA reach decisions on the safety of food ingredients? What constitutes adequate safety data? Who performs the studies for premarket safety review of new food additives? Who reviews the safety data? How does FDA reach decisions in the face of uncertainty in the scientific data and information? How is precaution built into the FDA process? Should safety decisions, once made, ever be reviewed? How, and by whom? What is the standard for overturning a previous decision? How does FDA adapt to and consider new scientific knowledge? How does the GRAS process work? What are the criteria for GRAS status? To Cover: 1. Brief Historical Context 150 years of Saccharin: Some things never change 2. FDA s Modern Context: Law, science and policy: Regulatory decision making 3. A Few Examples Aspartame, Acesulfame-K, Sucralose, and GRAS uses of stevia and SGFE To Cover: 1. Brief Historical Context 150 years of Saccharin: Some things never change 2. FDA s Modern Context: Law, science and policy: Regulatory decision making 3. A Few Examples Aspartame, Acesulfame-K, Sucralose, and GRAS uses of stevia and SGFE Chemical Structure of Discoverers of Saccharin, 1879 Ira Remsen Constantine Fahlberg Two photos of Professor Ira Remsen ( ) Second President of Johns Hopkins University Fahlberg, an Ira Remsen research fellow 2

3 Smithsonian Museum of American History Reconstruction of Remsen s Lab at Johns Hopkins University At the turn of the 20 th Century: Saccharin begins its controversial regulatory history Harvey Wiley (FDA s founding father ) thought saccharin was unsafe President Theodore Roosevelt was in favor of it (he used it himself on the advice of his physician) Disagreements ensued at a remarkable 1908 White House meeting between Dr. Wiley and President Roosevelt Harvey Wiley s 1929 Memoir From Dr. Wiley s 1929 Memoir Roosevelt: You tell me that saccharin is injurious to health? Wiley: Yes, Mr. President, I do tell you that. Roosevelt: Dr. Rixey gives it to me every day. Wiley: Mr. President, he probably thinks you may be threatened with diabetes. Roosevelt: Anybody who says saccharin is injurious to health is an idiot. Saccharin not without controversy Saccharin not without controversy Court cases from 1908 to 1925: While FDA eventually gave up the struggle, the agency still believed it to be harmful to health 1958 saccharin appears on the first GRAS* lists 1977 FDA proposed to ban it again (bladder cancer in rats) 1977 Congress overrode the ban, asked NAS to study; warning label placed on products containing it Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals Congress places a moratorium on FDA s proposed ban. 2000: New studies show the mechanism of action for cancer in rodent studies not to be relevant to human exposure. The National Toxicology Program, in the 9 th edition of its Report on Carcinogens, removes saccharin from the list of substances reasonably anticipated to be a human carcinogen. 2000: President Clinton signs into law a bill to remove the warning label from saccharin containing products. * More about GRAS later 3

4 Today an assortment of alternative sweeteners and growing Today an assortment of alternative sweeteners and growing Alitame Saccharin Monk fruit (Siraitia grosvenorii) or SG fruit extract (SGFE) Stevia (Reb-A) Neotame Alitame Sugar Alcohols Alitame Saccharin Monk fruit (Siraitia grosvenorii) or SG fruit extract (SGFE) Stevia (Reb-A) Neotame Alitame Sugar Alcohols Tagatose NHDC Thaumatin Aspartame Sucralose Acesulfame-K Cyclamate Trehalose Tagatose NHDC Thaumatin Aspartame Sucralose Acesulfame-K Cyclamate Trehalose To Cover: Polling Question # 1 1. Brief Historical Context 150 years of Saccharin: Some things never change 2. FDA s Modern Context: Law, science and policy: Regulatory decision making 3. A Few Examples Aspartame, Acesulfame-K, Sucralose, and GRAS uses of stevia and SGFE 1. Do you feel you have a good understanding of the FDA s food additive approval process and Generally Recognized as Safe (GRAS) process? a) Yes b) No The Modern FDA Context, 2013 The Harvey W. Wiley Building College Park, MD Answers come at the Intersection of Science, Law and Regulatory Policy The Federal Food, Drug, & Cosmetic Act Chemistry, Toxicology (Paracelsus), Risk Assessment, Safety Assessment Risk Management, Risk Communication; Threshold of Regulation, Priority Setting, The Principle of Commensurate Effort, Labeling, Precaution, etc. 4

5 The FD&C Act Defines food additive (w/ GRAS exemption ) Requires premarket approval of new uses of food additives, if not GRAS Establishes the standard of data review Establishes the standard of safety Establishes formal rulemaking procedures for petition review since FDAMA of 1997: Defines food contact substance (FCS) Establishes a premarket notification program for food contact substances For both food additives and GRAS * ingredients. The standard of safety - reasonable certainty of no harm The standard of review - Fair evaluation of the data... * GRAS to be defined and discussed more later in this presentation. REASONABLE CERTAINTY OF NO HARM Legislative History of the FD&C Act The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive. It does not -- and cannot -- require proof beyond any possible doubt that no harm will result under any conceivable circumstance. H.R. Report No. 2284, 85th Congress 1958 The Standard of Safety: Reasonable Certainty of No Harm It is not intended to ensure, nor is it possible to ensure, safety with absolute certainty:. i.e., Reasonable Certainty of No Harm is not : Certainty of no conceivable (theoretical) possibility of harm. No Harm to Health The Reasonable Certainty of No Harm standard is, in fact, a no harm standard, where harm is harm to health. Traditional Safety Evaluation Estimation of probable consumer exposure to the additive Review of toxicological studies in animals Safety decision using formal rulemaking (i.e., publication in the Federal Register with rights of review) 5

6 Toxicological Testing the FDA/CFSAN Redbook Minimum Toxicity Tests Concern Levels ordinarily required I II III Short-term tests for genetic toxicity Metabolism & pharmacokinetic studies Short-term tox tests with rodents Subchronic tox tests with rodents Subchronic tox tests with nonrodents Reproduction study w/ teratology phase One-Yr tox tests with non-rodents Carcinogenicity study with rodents Chronic tox/ carcinogenicity study with rodents FDA Safety Evaluation (the Cliff s Notes Version) Conservative estimation of probable consumer exposure to the additive (EDI based on lifetime average eaters only estimates using serving sizes, freq. of eating, and concentration in the food) FDA review of toxicological studies in animals (HNEL from chronic studies and thresholds for toxic effects) Application of appropriate Safety Factors or uncertainty factors (10 [species extrapolation], 10 [human variation] to get the ADI) Safety decision by comparing ADI to EDI (no anticipated adverse effects at human consumption levels) EDI: Estimated daily intake mg/kg bw/d in humans; HNEL: Highest no-effect level mg/kg bw/d in animals; ADI: Acceptable daily intake mg/kg bw/d in humans The fundamental Safety Criterion The EDI must not exceed the ADI. EDI and ADI are decision benchmarks Both are very conservative estimates. In reality, people s actual exposures are often far below the EDI. To Cover: 1. Brief Historical Context 150 years of Saccharin: Some things never change 2. FDA s Modern Context: Law, science and policy: Regulatory decision making 3. A Few Examples Aspartame, Acesulfame-K, Sucralose, and GRAS uses of Stevia and SGFE Examples The food additives : Aspartame Acesulfame-K Sucralose GRAS Ingredients: Stevia; SGFE 6

7 Examples The food additives : Aspartame Acesulfame-K Sucralose GRAS Ingredients: Stevia; SGFE Aspartame Controversy from Day 1 Discovered in 1965 by G. D. Searle s chemist James Schlatter Initial FDA approval in 1974 for dry food use OK d for soft drink use in 1983 ADI in the U.S.: 50 mg/kg bw/day Objections filed upon first FDA approval in 1974 FDA convenes a Public Board of Inquiry Aspartame OK d by FDA for soft drink use 1985 Consumer complaints; CDC analyzes 1987 GAO report: FDA followed proper procedures in approving aspartame and in monitoring aspartame safety. Recent Challenges to Aspartame Safety Studies by Dr. Morando Soffritti of the Cesare Maltoni Cancer Research Center, of the European Ramazzini Foundation of Oncology and Environmental Sciences in Bologna, Italy Published in 2005, 2006, and 2010 Not all the data were made available, including, at times, some histopathology slides Nevertheless, after reviewing the new data: Both FDA and the European Food Safety Authority concluded that there is no reason to revise the previously established ADI for Aspartame. In response to updated Ramazzini data of 2009, EFSA stated that there is no indication of carcinogenic or genotoxic potential, and no reason to change the ADI. After 2010 studies of Saffritti and Halldorsson, EFSA again reaches the same conclusion. 7

8 Recent review paper: Berna Magnuson et al, Critical Reviews of Toxicology, (8) pp : Aspartame: a safety evaluation based on current use levels, regulations, and toxicology and epidemiology studies. FDA s 2006 statement on Aspartame To date.the agency has not been presented with scientific information that would support a change in our conclusions about the safety of aspartame. Those conclusions are based on a detailed review of a large body of information, including more than 100 toxicological and clinical studies regarding the sweetener's safety. Examples 1988 The food additives : Aspartame Acesulfame-K Sucralose GRAS Ingredients: Stevia; SGFE Acesulfame-Potassium, Acesulfame-K (or simply, ACK ) ACK discovered accidentally in 1967 by Karl Clauss of Hoechst. ACK first permitted for use as a nonnutritive sweetener in food in July 1988 for dry food uses. (53 FR 28379, and 28381) Hoechst Celanese Corp. (currently Nutrinova, Inc.) petitioned FDA for use of ACK in nonalcoholic beverages in 1990 Expansion of ACK use to nonalcoholic beverages raised new issues A particular breakdown product of ACK in acidic beverages, i.e., acetoacetamide, presented potential toxicological safety concerns to FDA Even though this chemical is NOT the primary additive. The FD&C Act Sec. 409(c)(5)(a) addresses any substance formed in or on food because of the use of the additive 8

9 FDA s conclusions: Examples These concerns were ultimately resolved, however, by FDA conducting an in depth risk assessment on the compound FDA approved ACK for use in non-alcoholic beverages in Final Rule published July 6, 1998, (83 FR ) The food additives : Aspartame Acesulfame-K Sucralose GRAS Ingredients: Stevia; SGFE 1998 Sucralose timeline Original petition filed by McNeil Specialty Products Co. in May Final rule permitting use published by FDA in April Almost 11 years under FDA review. Principal Factors in the Sucralose Safety Review Identity Intake estimates Toxicology testing The ADI -- EDI comparison Special Studies (diabetics) Final Safety Judgment During the Safety Review FDA required additional studies Six new studies to resolve an issue with the growth rate and body weight gain of the test animals; and Five new studies to resolve an issue concerning blood glucose homeostasis as a potential issue for glucose control in diabetics. 9

10 Sucralose Final Rules Examples Regulation permitting sucralose to be used as a sweetener in a wide variety of foods, including beverages, was published in Fed. Reg. of April 3, Subsequently this was expanded to include general use in food, limited only by cgmp, in 64 FR 43909, Aug. 12, The food additives : Aspartame Acesulfame-K Sucralose GRAS Ingredients: Stevia; SGFE G R A S generally recognized as safe What is the GRAS concept? How is it similar to, and how does it differ from, FDA s traditional pre-market safety evaluation process for food and color additives? GRAS and Fed. Food, Drug, and Cosmetic Act definition of food additive 201(s): any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food if such substance is not generally recognized, among experts qualified by scientific training and experience to be safe under the conditions of its intended use What is different about the GRAS process? While the safety standard is the same as for food additives (RCNH). Information must be widely publicly disseminated, and there also must be a basis to conclude that there is a consensus among qualified experts that the proposed use is safe. As noted, this approach is permitted by the FD&C Act, and represents an exemption to the FDA premarket review and approval procedures. FDA s GRAS Notice * Procedures Submitter sends a GRAS Notice to FDA asserting GRAS status for a use of a food ingredient Notice Includes all relevant safety data Notice shows that these data are in the public domain and are not only known by, but also accepted by, a consensus among qualified scientists Notice may contain a report by an Expert Panel that has vetted and supports the submitter s conclusions * GRAS notices are submitted to FDA under its proposed rule of April 17, 1997, published in the Federal Register at 62 FR Comment Period re-opened on December 28, 2010; comments were due by March 28,

11 Safety Evaluation (applicable to many GRAS situations) Conservative estimation of probable consumer exposure to the additive (EDI based on lifetime average high eaters only estimates using serving sizes, freq. of eating, and concentration in the food) FDA review of toxicological studies in animals (HNEL from chronic studies and thresholds for toxic effects) Application of appropriate Safety Factors or uncertainty factors (10 [species extrapolation], 10 [human variation] to get the ADI) Safety decision by comparing ADI to EDI (no anticipated adverse effects at human consumption levels) EDI: Estimated daily intake mg/kg bw/d in humans; HNEL: Highest no-effect level mg/kg bw/d in animals; ADI: Acceptable daily intake mg/kg bw/d in humans FDA s response to a GRAS Notice and Expert Panel Opinion No final rule in the Federal Register or regulation in the Code of Federal Regulations FDA does not necessarily make its own agency decision about the safety of the use of the ingredient Rather, by letter FDA acknowledges the conclusion of the independent Panel and community of experts, and may indicate that it has no further questions at this time. Ingredient is safe and lawful in use based on submitter s assertion of GRAS Stevia was the subject of a 2008 G R A S Notice to FDA Chemical Structure of Rebaudioside-A a steviol glycoside from leaves of the Stevia rebaudiana, plant Initial submitters of GRAS exemption claims for stevia made use of FDA s voluntary GRAS Notice Process The first GRAS exemption claims for stevia were submitted to FDA in May 2008 Principal Factors in the submitters stevia safety dossiers Identity, manufacture, and purity specifications Intake estimates Toxicology testing ADME**; Animal feeding studies Human clinical data including BP and blood glucose homeostasis data ADI -- EDI comparison Final Safety Judgment by GRAS notice submitters including Expert Panel opinions ** Absorption, Distribution, Metabolism, Excretion Stevia has been the subject of numerous G R A S Notices to FDA GRAS Notice No. GRN 252; Whole Earth Sweetener, Co. Date of FDA Response Letter December 17, 2008 GRN 253; Cargill, Inc. December 17, 2008 GRNs 278, 282, 303, 318, 329, 348, 354, 365, 369, 380, 388, 393, and 418 Between July 2009 and June 2012 Typical FDA response letters conclude that, the agency has no questions at this time. The time frame from submission to FDA response is months, not years. 11

12 Chemical Structure of Siraitia grosvenorii principal sweetening component Mogroside V (a.k.a. Monk Fruit extracts) SGFE Principal Elements in the submitters SGFE safety dossier Identity, manufacture, and purity specifications Intake estimates Toxicology testing ADI -- EDI comparison Final Safety Judgment by GRAS notice submitters including Expert Panel opinions SGFE has been the subject of two G R A S Notices to FDA GRAS Notice No. GRN 301; J Heimbach, LLC (Bio Vittoria, Ltd.) GRN 359; Cantox Health Sciences, Intl., (Guilin Layn Natural Ingreds. Corp.) Date of FDA Response Letter January 15, 2010 April 11, 2011 THANK YOU!.looking forward to your QUESTIONS No, Low and Reduced Calorie Sweeteners: Hot Topics From A - Z SUGAR Tuesday, February 12, 2013 Presented by Robyn Flipse, MS, MA, RD Sponsored by The Calorie Control Council OR SUBSTITUTES? 12

13 Objectives for Clinical Application Identify distinct features of approved no, low, reduced calorie sweeteners available today and those in development Review intake trends for caloric sweeteners and no, low, and reduced calorie sweeteners, and the current dietary guidelines for them Recognize populations with any restrictions in their use of no, low and reduced calorie sweeteners Objective #1: Identify distinct features of approved no, low and reduced calorie sweeteners available today and those in development Explore benefits of no, low and reduced calorie sweeteners based on available evidence Other Terms for Sweeteners Natural sweetener Sugar alcohol Synthesized sweetener Polyglycitol Alternative sweetener Polyol Sugar replacer High-intensity sweetener Sugar substitute Intense sweetener Artificial sweetener No calorie sweetener Low calorie sweetener Non-nutritive sweetener Reduced calorie sweetener Noncaloric sweetener Approved Terms for Added Sugars on Ingredient Lists Anhydrous dextrose Brown sugar Confectioner s powdered sugar Corn syrup Corn syrup solids Dextrose Fructose High fructose corn syrup Honey Invert sugar Lactose Malt syrup Maltose Maple syrup Molasses Nectars Pancake syrup Raw sugar Sucrose White granulated sugar Other Terms for Added Sugars Not Recognized by FDA as Ingredients Agave nectar Fruit nectar Beet sugar Glucose Cane juice Liquid fructose Cane sugar Rice sugar or syrup Crystal dextrose Sugar cane juice Evaporated corn sweetener Sorghum syrup Fruit juice concentrate Table sugar J Acad Nutr Diet. 2012;112(5): J Acad Nutr Diet. 2012;112(11): Features of Intense Sweeteners in Use Intense Sweetener FDA Approved GRAS Sweetness Sugar ADI 1 mg/kg BW EDI 2 mg/kg BW Acesulfame Potassium Aspartame Monk Fruit Extract (luo han guo) Neotame , Not Established Saccharin Stevia (steviol glycosides) Sucralose Acceptable Daily Intake is a value 100 times greater than the amount found to be the highest amount with no effect and consistent with the FDA standard reasonable certainty of no harm. 2 Estimated Daily Intake is derived from the amount of the additive to be added to foods, assuming 100% replacement of sugars and other nonnutritive sweeteners, and the typical consumption of those foods by people of different ages and health status. 3 As established by the JECFA 13

14 How Much Sweetener Can You Use? Sweetener ADI mg/kg BW Tabletop mg/packet Beverages mg/ounce 150 lb (68 kg) person/day Total mg packets ounces Acesulfame K Aspartame Neotame 18 Not available Not available 1224 Not Not available available Saccharin Stevia (steviol glycosides) GRAS or Sucralose Color-coded Table-top Sweeteners Pink = Saccharin Green = Stevia Blue = Aspartame Monk Fruit Extract GRAS Not available Not available Not Not Not available available available 1 Determined by Joint Expert Committee on Food Additives of the Food and Agriculture Organization and World Health Organization Yellow = Sucralose Orange = Monk Fruit Extract Features of Polyols in Use Polyols FDA Approved GRAS Sweetness x Sugar 1 Erythritol Isomalt Estimated Thresholds 2 Isomaltulose.50 Not available Hydrogenated Starch Hydrolysates (HSH) Lactitol Maltitol g 40 g Varied depending on mix of polyols Mannitol g Sorbitol g 40 g 30 g ylitol 1 30 g 1 J Acad Nutr Diet. 2012;112(5): Am J Clin Nutr. 1995;62(suppl):1161S-1168S New & Novel Sweeteners in Development Name Generic/Brand Composition Sweetness sugar Status Alitame/Aclame L-aspartic acid + D-alanine 2000 FDA petition declined in 1986; not currently under review in US Brazzein/Cweet Protein from fruit of W. African Oubli plant Patent to genetically engineer it into maize, then extract it Curculin Protein from fruit of Malaysian plant Not legal in US; approved in Japan D-Tagatose Naturally occurring monosaccharide found in dairy products GRAS; ADI 15g/50 kg/d; EDI 7.5g/d Glycyrrhizin Glycoside found in licorice root GRAS as a flavoring agent in US, not as sweetener Mabinlin Miraculin Proteins extracted from seed of Chinese plant Glycoprotein from berryof W. African plant 10 Not approved in US Not sweet, but a taste-modifier Denied GRAS status in US, no FDA application Monellin Protein from fruit of W. African shrub Not legal in US;approved in Japan Neohesperidin dihydrochalcone Pentadin Thaumatin Trehalose/Ascend Glycoside derived from citrus 340 Not approved in US; approved by EFSA Protein from fruit of W. African Oubli plant Mixture of proteins from W. African katemfe fruit Alpha-linked disaccharide naturally found in rye fungus 500 Not approved in US 2000 GRAS as flavor enhancer in US; approved by EFSA, Israel, Japan.45 GRAS in US; inexpensively made from starch in Japan Objective #2: Review intake trends for caloric sweeteners and no, low, and reduced calorie sweeteners, and the current dietary guidelines for them Use of Caloric and Noncaloric Sweeteners in US Consumer Packaged Foods, ,451 unique processed and packaged food and beverage products were identified that were not raw, single ingredients, or duplicate products in different sizes. Most commonly used Caloric Sweeteners: o Corn syrup o Sorghum o Cane o High fructose Corn Syrup o Fruit Juice Concentrate 17 distinct food and beverage categories contained some type of sweeteners. 77% of the calories purchased contained caloric sweetener, 3% noncaloric sweetener, 23% had no sweeteners. 73% of the volume of foods purchased contained caloric sweetener, 15% contained noncaloric. Most common Noncaloric Sweeteners in Diet Beverages: o Acesulfame potassium o Aspartame o Sucralose o Saccharin J Acad Nutr Diet. 2012;112(11):

15 Figure 3 Trends in the proportion of total calories and total volume of consumer packaged goods purchased during that contain any caloric sweetener and any noncaloric sweetener Closing the Sugar Gap with No, Low and Reduced Calorie Sweeteners Containing Any Caloric Sweeteners (CS) % Total calories purchased containing any CS % Total volume purchased containing any CS Containing Any Noncaloric Sweeteners (NCS) ^ % Total calories purchased containing any NCS % Total volume purchased containing any NCS NHANES Dietary Guidelines AHA/ADA 2009 % total energy from added sugars/day grams of added sugar/day teaspoons of added sugar/day J Acad Nutr Diet. 2012;112(11): Copyright 2012 Academy of Nutrition and Dietetics Terms andconditio Small Changes Can Lead to Big Results A habitual energy imbalance of about kcal per day may be sufficient to cause the gradual weight gain seen in most persons. This means unintended weight gain occurs easily but also that modest, sustained changes in lifestyle could mitigate or reverse such energy imbalance. N Eng J Med 2011; Calories Saved with No, Low and Reduced Calorie Sweeteners Product Calories In Place of Calories saved Table-top sweetener (one packet) 0 Sugar (2 tsp) 32 Fat-free, light yogurt (6 oz container) 80 Fat-free yogurt 95 Sugar-free syrup (1/4 cup) 20 Syrup 180 Sugar-free preserves (1 tbsp) 10 Preserves 40 Sugar-free pudding (1/2 cup) 60 Pudding 70 Sugar-free gelatin (1/2 cup) 10 Gelatin 70 Diet soda (12 oz) 0 Regular soda 140 Light cranberry juice cocktail (8 oz) 0 Cranberry juice cocktail 90 Objective #3: Recognize populations with any restrictions in their use of no, low and reduced calorie sweeteners Children and Pregnant Women FDA approval covers the entire population Toxicology testing is done on males, females and the developing fetus. Appropriate animals models are used Saccharin crosses the placental barrier, but there is no evidence that saccharin effects reproduction or the fetus in animal studies 1 Diabetes in pregnancy requires nutrient density without high carbohydrate intake or excess calories Using ADI, children could have higher intakes due to their relatively smaller size and high food and fluid intake Polyols are naturally found in foods and in common medicines 1 Samuel M. Cohen, Ph.D., Professor and Chair, Pathology and Microbiology, Havlik-Wall Professor of Oncology, University of Nebraska School of Medicine 15

16 Phenylketonuria Aspartame (Equal, Nutra-sweet) is composed of the amino acids phenylalanine and aspartic acid Phenylalanine is widely found in protein-rich foods and all dietary sources must be controlled for PKU 6000 consumer products worldwide contain aspartame Products in US and UK must have label statement, Phenylketonurics: Contains Phenylalanine PKU in US is 1 in 15,000 births Diabetes, Impaired Glucose Tolerance and Hypoglycemia All are managed, in part, by control of the type and amount of carbohydrate in the diet No and low calorie sweeteners have no impact on glucose and insulin levels, though bulking agents may Polyols are absorbed more slowly than glucose or sucrose so have a lower postprandial glucose response Polyols have a low glycemic index Polyols provide an average of 2 calories per gram Half the polyols (and fiber) are counted as Net Carbs J Am Diet Asso.2008;108(4):S34-S39 Nutr Res Rev. 2003;16: Adaptation to Polyols Best if consumed in a solid form with a meal Introduce slowly, like adding more fiber to the diet Easier to tolerate if eaten in small amounts throughout the day Allow for differences in gastrointestinal motility, transit time, enzymatic activity, gut microflora Consider pre-existing GI conditions (celiac disease, irritable bowel syndrome, lactose intolerance) Objective #4: Explore benefits of no, low and reduced calorie sweeteners based on available evidence Hunger, Appetite, and Weight Control: Available evidence indicates nonnutritive sweeteners do not affect appetite in adults, while there are insufficient studies in children to draw a conclusion Nonnutritive sweeteners do not increase food intake in adults or children and can create a modest energy savings if used in place of sugar-sweetened products When used in place of more energy dense foods, nonnutritive sweeteners can improve diet quality and weight management J Acad Nutr Diet 2012;112(5): Diabetes Management and Glycemic Response Nonnutritive sweeteners were not found to raise plasma glucose, insulin, HbA 1c or C-peptide in subjects with diabetes mellitus or non-diabetic subjects Most low and no calorie tabletop sweetener packets contain bulking agents that are a source of carbohydrates so they may raise plasma glucose levels if consumed in large enough quantities The substitution of nonnutritive sweeteners for nutritive sweeteners in foods, beverages or recipes that contain other glycemic ingredients does not modify the effect of those ingredients Diab Care. 2012;35(8): Position of the Academy of Nutrition and Dietetics: Use of Nutritive and Nonnutritive Sweeteners J Acad Nutr Diet 2012;112(5):

17 Diet Quality and Dental Health Regular users of diet soda had several markers of healthier diets, including higher intakes of fruits, vegetables, whole grains, low fat dairy products and less saturated fat and sodium 1 The biggest consumers of diet beverages were white males and females between years of age with higher education and higher income, who were more physically active and either trying to lose weight or not gain weight 2 A meta-analysis conducted by the American Dental Association found xylitol effective in preventing and reducing the occurrence of dental caries 3 A health claim that sweeteners do not promote dental caries has been approved for sugar alcohols, erythritol, D-tagatose, sucralose, and isomaltulose 4 1 Diab Care. 2009;32: Drewnowski & Rehm 2012, unpublished 3 J Food Sci. 2005;70(1), S42-S46. 4 J Am Diet Asso. 2006;106(12): Conclusion Human beings have an innate preference for sweet tasting foods and beverages Excess calories from all sources contribute to weight gain and obesity Added sugars are widely available, making it easier to consume more of them Alternative sweeteners are available that can give foods and beverages a sweet taste with fewer calories No, low and reduced calorie sweeteners can be used to replace some caloric sweeteners in order to reduce total caloric intake Thank you Robyn Flipse, MS, MA, RD Nutrition Communication Services Flipse.com Question & Answer We will begin the Q & A with the questions submitted during the program You can continue to submit using the Questions Pane We will post the answers to unanswered questions on the DCE website () Post-Webinar Survey & CPEU You will be receiving an within the next 24 hours that contains a link to the post-webinar survey Upon completion of the survey, you will be re-directed to another link to obtain your Certificate of Completion Deadline to complete the survey : February 19, 2013 One week after the webinar! Our next Diabetes and Depression: Using an integrated care approach to help improve diabetes outcomes Date/Time Tuesday, March 19 th 12 noon Central Time Presenters Chris Beamish, MSW, LICSW Laura Nielsen, Psy.D., LP Watch for details in DCE Updates & 17