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Webinar presentation magnuson

This document discusses the safety of aspartame and other low-calorie sweeteners. It summarizes an expert review conducted by an international panel of toxicology experts to evaluate the scientific studies and assess the current safety of aspartame consumption. The review confirms that aspartame is safe for consumption within acceptable daily intake levels and breaks down the process used to determine these levels, which include extensive pre-market safety testing and establishing a no-observed effect level for animals that is then adjusted with safety factors. Questions about aspartame safety are addressed through this independent expert evaluation of the totality of research.

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Straight Facts About Low-Calorie Sweeteners Straight Facts About Aspartame & Other Low-Calorie Sweeteners Dr. George L. Blackburn, MD, PhD Dr Blackburn is the S. Daniel Abraham Associate Professor of Nutrition and Associate Director of the Division of Obesity Expert George L. Blackburn, MD, PhD* Nutrition at Harvard Medical School. He also serves as Chief of the Nutrition/Metabolism Laboratory and Toxicologist Bernadene Magnuson, PhD* Director of the Center for the Study of Nutrition Medicine, affiliated with the Beth Israel Deaconess Medical Center in Boston. He is an honorary member of the American Dietetic Association and an American Society for Nutrition Fellow. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company Dr. Bernadene Magnuson, PhD Dr. Magnuson is Assistant Professor of Nutrition and Food Science at the University of Maryland, where she conducts research on food toxicology, diet and cancer prevention and teaches food science and food toxicology. She was the lead author of a recent expert review of the safety of aspartame *The opinions expressed by the The Beverage Institute forown and do of The Cola-Cola Sponsored by speakers are their Health & Wellness published in the September 2007 issue of Company Reviews of Toxicology. Critical not necessarily reflect the positions or opinions of The Coca-Cola Company. December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Review of The Safety of Aspartame Bernadene Magnuson, PhD Dr. Magnuson is Assistant Professor of Nutrition and Food Science at the University of Maryland, where she conducts research on food toxicology, diet and cancer prevention and teaches food science and food toxicology. She was the lead author of a recent expert review of the safety of aspartame published in the September 2007 issue of Critical Reviews of Toxicology. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Review of the Safety of Aspartame Bernadene Magnuson, Ph.D. Expert Panel William J. Waddell, M.D., Chair John Doull, M.D., Ph.D. Robert Kroes, Ph.D., DVM Gary M. Marsh, Ph.D., F.A.C.E. Michael W. Pariza, Ph.D. Peter S. Spencer, Ph.D., FRCPath Ron Walker, Ph.D. Gary M. Williams, M.D. Critical Reviews in Toxicology, 2007; 37:629–727. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Low-Calorie Sweeteners • Questions regarding the safety of aspartame have continued to surface in the press and internet • Recent lifetime exposure studies also brought aspartame safety into question • Goal = convene an independent international panel of toxicology experts to review all scientific studies and assess the safety of current consumption of aspartame Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Background Aspartame http://www.3dchem.com/ Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Aspartame Stability • Can breakdown – with long term storage – conditions high temperature and high pH • Breakdown products – Aspartylphenylalanine (dipeptide) – Diketopiperazine (DKP) (cyclic dipeptide) Not Sweet – Methanol – Aspartate and phenylalanine • Breakdown product safety also evaluated Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Aspartame: Background Premarket Safety Evaluation • To support aspartame safety, comprehensive battery of studies were conducted – Acute, Sub-chronic, Long-term toxicity – Carcinogenicity – Genetic toxicity – Reproductive toxicity – Teratogenicity – Also human studies – blood chemistry, diabetics, children • Data reviewed by every major international food authority (FDA, Health Canada, EU, JECFA, etc.) • Approved in over 130 countries Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Aspartame: Background Aspartame ADI Values • Acceptable Daily Intake (ADI) = amount considered safe to consume every day for a life time without adverse effects – DOES NOT mean that consumption greater than ADI will have any effect because of conservative nature • ADI is set by – determining the amount animals can consume every day without effect = No-Observed Effect Level (NOEL) – Then apply “safety factors” to account for • differences between individuals (10 X) • differences between humans and animals (10 X) • NOEL/safety factors = ADI • FDA has set the ADI at 50 mg/kg body wt Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Aspartame: Background Number of Servings/day to reach ADI (50 mg/kg body weight) Food/Beverage Adult Child (150 lb.) (50 lb.) Carbonated soft drink (12 oz.) 20 6 Powdered soft drink (8 oz.) 33 11 Gelatin (4 oz.) 42 14 Tabletop sweetener (packet) 97 32 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Aspartame: Background Applications/Use of Aspartame • Carbonated soft drinks • Frozen desserts • Juices • Dairy products • Puddings, fillings, jellies • Jams, marmalades • Desserts and toppings • Breakfast cereals • Table-top sweeteners • Confectionery (tablets and powders) • Hot chocolate drinks • Chewing gum • Multivitamins • Fruit preserves • Micro breath mints • Bread spreads • Personal care products, pharmaceuticals Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Process The Process-Literature • Scientific literature databases • FDA Federal Register • Unpublished regulatory submission reports • National Toxicology Program studies • Selection of studies – Over 500 articles cited in this report – Elimination criteria • Research on sensory and/or product applications • Investigating potential health benefit Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Process The Process - Consumption • Analysis of current consumption of aspartame – Proprietary method of analysis (Burdock Group) – Food intakes from National Health and Nutrition Examination Survey (NHANES) 2001-2002, USDA. – Levels of aspartame content in foods • Typical use levels from industry • Levels reported in literature • Assumptions included all artificial sweetener were aspartame, highest level reported used as default Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings NHANES-Based Estimate of Aspartame Consumption Values for users only mg/kg bw/day 50th Percentile (Mean) 4.8 90th Percentile 10.4 95th Percentile 13.3 Acceptable Daily Intake = 50 mg/kg bw/d ADI level = considered safe to consume every day for life Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings Consumption of Aspartame • The intake of aspartame has increased in recent years; the change is not dramatic • Remains well below the ADI even for high intake subpopulations • NHANES over-estimation; assumptions • Worst-case scenario predictions suggest chronic intakes will not reach the ADI Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings Aspartame Absorption in the Gut Intestinal Lumen Mucosa Cell Portal Blood Aspartame Aspartame Esterases Esterases Methanol (10%) Methanol Methanol Aspartame + Asp/Phe Asp/Phe Peptidases Peptidases Aspartate Aspartate (40%) + (50%) Phenylalanine Aspartate + Phenylalanine Phenylalanine Dipeptide Transport System Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings Phenylalanine, Aspartic Acid & Methanol Content of Foods Phenylalanine* Aspartic Methanol Acid* 12 oz diet beverage 90 72 18 with aspartame 12 oz milk 606 888 - Medium banana 58 146 21 12 oz orange juice 36 276 23 12 oz tomato juice 58 346 107 *amino acids Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings Methanol Metabolism Purine synthesis Methanol Ch3OH CO2 + H20 Formaldehyde Formic acid HCHO- HCOO- Amino Acids Excreted Nucleic Acids in Urine Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings Methanol Metabolism Methanol CO2 + H20 Alcohol dehydrogenase in liver Formaldehyde Formic acid T = 1.5 min T = 3-6 hr Conversion very rapid: Accumulation of formic acid No accumulation = toxicity of methanol Normal range in blood = 7- 63 mg/L Lowest blood level associated with toxicity = 126 mg/dL Safe dose = 2 gm for adult Kostic and Dart, 2003 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings Formaldehyde Metabolism • Constituent of many foods • Produced during the endogenous demethylation of foods and drugs, such as caffeine – One cup of coffee produces 30 mg of formaldehyde • Essential in one-carbon pool metabolism. – Formic acid is a substrate for nucleotide synthesis • Calculated >50,000 mg formaldehyde is produced and metabolized daily in an adult human body • Adult human liver will metabolize 22 mg formaldehyde per minute to formic acid and CO2 and water Clary and Sullivan, 1999 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: The Findings Effect of Aspartame on Blood Methanol & Formic Acid Subjects Dose (mg/kg): N Methanol and formic acid (mg/dL) Health adults 34 mg/kg; n=12 methanol < LOD* 100 mg/kg; n=6 methanol peak 1.27, <LOD at 8 hr 150 mg/kg; n=6 methanol peak 2.14, <LOD at 24 hr 200 mg/kg; n=6 methanol peak 2.58, <LOD at 24 hr No change in blood formic acid Healthy Infants 34 mg/kg; n=10 methanol < LOD 50 mg/kg; n=6 methanol < LOD 100 mg/kg; n=8 methanol peak = 1.02 at 90 min, then ~0.45 at 2.5 hr Healthy adults 600 mg per hr for No change in blood methanol or formic 8 hr acid levels Lowest blood level ~ toxicity = 126.0 mg/dL Sponsored by The Beverage Institute for Health & Wellness of TheStegink et al., 1981, 1983, 1989 Cola-Cola Company *LOD= limit of detection, 0.35 mg/dL December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Panel Findings: Toxicity Studies Safety Evaluations of Aspartame • Acute toxicity • Cytotoxicity • Subacute toxicity • Bacterial studies • Chronic bioassays • Human clinical studies • Neurotoxicity – Blood chemistry, body wt • Teratogenesis – Methanol, formaldehyde • Reproductive toxicity – Headaches • Genotoxicity – Behavior and cognitive • Immunotoxicity function – Induction of seizures • Epidemiological studies Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Panel Findings: Toxicity Studies Long Term Animal Studies-Cancer • 5 with rats, doses up to 5000 mg/kg/d • 3 with mice, doses up to 4000 mg/kg/d • 3 with transgenic high cancer risk mice at doses up to 7500 mg/kg/d • 1 with hamsters, doses up to 12,000 mg/kg • 1 with dogs, doses up to 4000 mg/kg/d • 2 with rats to assess promotion of existing cancers Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Panel Findings: Toxicity Studies Long Term Animal Studies-Cancer • 14/15 animal studies had negative findings indicating no evidence of carcinogenic effect or cancer promoting effect of aspartame • One study concluded that aspartame has carcinogenic potential (Ramazzini Foundation) – This panel agreed with findings of numerous food authorities that Ramazzini study: • Numerous methodological and interpretation errors • Provided “no credible evidence that aspartame is carcinogenic” • “Is no need to further review the safety of aspartame” • “No need to revise previously established ADI” Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Findings: Toxicity Studies Studies during Pregnancy and Development • Effect of aspartame studied during reproduction, pregnancy, lactation and development in rats, mice, hamsters, rabbits and humans • No effect at doses up to 4000 mg/kg/day in rodents and 1600 mg/kg/day in rabbits • No change in breast milk composition in humans at doses up to 50 mg/kg • Conclusion – no evidence of adverse effects Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Findings: Toxicity Studies Studies on Headaches • Have been several, conflicting results with most showing no effect; however some small studies suggesting may be a susceptible subset • There is no known mechanism • Is difficult to study - no objective measure, power of suggestion and inconsistent results Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Findings: Toxicity Studies Neurotoxicity-Learning Behavior • Animal studies – Up to 4% of diet (4000 mg/kg/d), no effect on neuronal function, learning or behavior despite changes in blood and brain amino acids levels • Human studies – Normal children, hyperactive children, children with PKU, aggressive school boys, sugar- sensitive children, airline pilots – Healthy adults, adults with Parkinson’s disease, depression – No effect of aspartame on learning or behavior in all but 1 study Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Findings: Toxicity Studies Neurotoxicity-Seizures • Animals - No effect - doses up to 1000 mg/kg/d – Evaluated in a variety of animal models to induce convulsions and seizures (Pinto and Maher, 1988; Guiso et al., 1988; Cane et al.,1989; Tilson et al., 1989; Helai et al., 1996) – Genetically epilepsy-prone rats (Daily et al., 1991) • Human studies - No significant effect on seizures observed with doses of 34-50 mg/kg – Children diagnosed with petite mal seizures, individuals with epilepsy, self-reported aspartame- sensitive adults (Camfield et al., 1992; Shaywitz et al., 1994, Rowan et al., 1995) Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Findings: Toxicity Studies Epidemiological Studies Author Type of study (N) Consumption of Conclusions Asp Olney US SEER brain tumor data Not measured Incidence increased after (1996) from 9 locations aspartame on market Gurney 56 brain tumor cases 94 Dietary recall - Personal No association (1997) controls interview Hardell 30 brain tumor cases 45 Recall of low calorie soft No association (2001) controls drinks. Bunin 315 children - brain Food frequency No association between (2005) tumor, 315 controls completed by mothers of consumption during children pregnancy and risk Lim Prospective study Food frequency No associations between (2006) 473,984 subjects, 5 yr questionnaires hematopeoitic or brain from NCI Hematopoietic cancers cancers and aspartame (n=2,106); consumption Brain cancers (n=376) Gallus Case control study- various Food frequency No association between cancer (2007 ) cancer types (n = 8976 cases, questionnaires and sweetener consumption 7028 controls) Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Findings: Summary Aspartame - Summary • Metabolism is well understood and follows that of other common foods. • Consumption, even at levels much higher than that expected under typical circumstances, has virtually no impact on levels of blood constituents such as amino acids, methanol or glucose. • A well-studied sweetener whose safety is clearly documented and well established through extensive laboratory testing, animal experiments, epidemiological studies and human clinical trials. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Findings: Summary Aspartame • No credible link between consumption of aspartame at levels found in the human diet and conditions related to the nervous system and behavior, nor any other symptom or illness. • Non-genotoxic and there is no credible evidence that aspartame is carcinogenic. • Does not increase hunger in those who use it; to the contrary, studies indicate it might be an effective tool as part of an overall weight management program. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Expert Panel: Conclusions Panel Conclusions • Aspartame is a well-characterized, thoroughly studied, high-intensity sweetener that has a long history of safe use in the food supply and can help reduce the caloric content of a wide variety of foods. Critical Reviews in Toxicology, 37:629–727, 2007 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
Straight Facts About Low-Calorie Sweeteners Straight Facts About Aspartame & Other Low-Calorie Sweeteners Dr. George L. Blackburn, MD, PhD Dr Blackburn is the S. Daniel Abraham Associate Professor of Nutrition and Associate Director of the Division of Obesity Expert George L. Blackburn, MD, PhD* Nutrition at Harvard Medical School. He also serves as Chief of the Nutrition/Metabolism Laboratory and Toxicologist Bernadene Magnuson, PhD* Director of the Center for the Study of Nutrition Medicine, affiliated with the Beth Israel Deaconess Medical Center in Boston. He is an honorary member of the American Dietetic Association and an THANK YOU! American Society for Nutrition Fellow. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company Dr. Bernadene Magnuson, PhD Dr. Magnuson is Assistant Professor of Nutrition and Food Science at the University of Maryland, where she conducts research on food toxicology, diet and cancer prevention and teaches food science and food toxicology. She was the lead author of a recent expert review of the safety of aspartame *The opinions expressed by the The Beverage Institute forown and do of The Cola-Cola Sponsored by speakers are their Health & Wellness published in the September 2007 issue of Company Reviews of Toxicology. Critical not necessarily reflect the positions or opinions of The Coca-Cola Company. December 4, 2007 www.thebeverageinstitute.org

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Webinar presentation magnuson

  • 1.
    Straight Facts AboutLow-Calorie Sweeteners Straight Facts About Aspartame & Other Low-Calorie Sweeteners Dr. George L. Blackburn, MD, PhD Dr Blackburn is the S. Daniel Abraham Associate Professor of Nutrition and Associate Director of the Division of Obesity Expert George L. Blackburn, MD, PhD* Nutrition at Harvard Medical School. He also serves as Chief of the Nutrition/Metabolism Laboratory and Toxicologist Bernadene Magnuson, PhD* Director of the Center for the Study of Nutrition Medicine, affiliated with the Beth Israel Deaconess Medical Center in Boston. He is an honorary member of the American Dietetic Association and an American Society for Nutrition Fellow. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company Dr. Bernadene Magnuson, PhD Dr. Magnuson is Assistant Professor of Nutrition and Food Science at the University of Maryland, where she conducts research on food toxicology, diet and cancer prevention and teaches food science and food toxicology. She was the lead author of a recent expert review of the safety of aspartame *The opinions expressed by the The Beverage Institute forown and do of The Cola-Cola Sponsored by speakers are their Health & Wellness published in the September 2007 issue of Company Reviews of Toxicology. Critical not necessarily reflect the positions or opinions of The Coca-Cola Company. December 4, 2007 www.thebeverageinstitute.org
  • 2.
    Straight Facts AboutLow-Calorie Sweeteners Expert Review of The Safety of Aspartame Bernadene Magnuson, PhD Dr. Magnuson is Assistant Professor of Nutrition and Food Science at the University of Maryland, where she conducts research on food toxicology, diet and cancer prevention and teaches food science and food toxicology. She was the lead author of a recent expert review of the safety of aspartame published in the September 2007 issue of Critical Reviews of Toxicology. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 3.
    Straight Facts AboutLow-Calorie Sweeteners Expert Review of the Safety of Aspartame Bernadene Magnuson, Ph.D. Expert Panel William J. Waddell, M.D., Chair John Doull, M.D., Ph.D. Robert Kroes, Ph.D., DVM Gary M. Marsh, Ph.D., F.A.C.E. Michael W. Pariza, Ph.D. Peter S. Spencer, Ph.D., FRCPath Ron Walker, Ph.D. Gary M. Williams, M.D. Critical Reviews in Toxicology, 2007; 37:629–727. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 4.
    Straight Facts AboutLow-Calorie Sweeteners Low-Calorie Sweeteners • Questions regarding the safety of aspartame have continued to surface in the press and internet • Recent lifetime exposure studies also brought aspartame safety into question • Goal = convene an independent international panel of toxicology experts to review all scientific studies and assess the safety of current consumption of aspartame Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 5.
    Straight Facts AboutLow-Calorie Sweeteners Background Aspartame http://www.3dchem.com/ Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 6.
    Straight Facts AboutLow-Calorie Sweeteners Aspartame Stability • Can breakdown – with long term storage – conditions high temperature and high pH • Breakdown products – Aspartylphenylalanine (dipeptide) – Diketopiperazine (DKP) (cyclic dipeptide) Not Sweet – Methanol – Aspartate and phenylalanine • Breakdown product safety also evaluated Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 7.
    Straight Facts AboutLow-Calorie Sweeteners Aspartame: Background Premarket Safety Evaluation • To support aspartame safety, comprehensive battery of studies were conducted – Acute, Sub-chronic, Long-term toxicity – Carcinogenicity – Genetic toxicity – Reproductive toxicity – Teratogenicity – Also human studies – blood chemistry, diabetics, children • Data reviewed by every major international food authority (FDA, Health Canada, EU, JECFA, etc.) • Approved in over 130 countries Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 8.
    Straight Facts AboutLow-Calorie Sweeteners Aspartame: Background Aspartame ADI Values • Acceptable Daily Intake (ADI) = amount considered safe to consume every day for a life time without adverse effects – DOES NOT mean that consumption greater than ADI will have any effect because of conservative nature • ADI is set by – determining the amount animals can consume every day without effect = No-Observed Effect Level (NOEL) – Then apply “safety factors” to account for • differences between individuals (10 X) • differences between humans and animals (10 X) • NOEL/safety factors = ADI • FDA has set the ADI at 50 mg/kg body wt Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 9.
    Straight Facts AboutLow-Calorie Sweeteners Aspartame: Background Number of Servings/day to reach ADI (50 mg/kg body weight) Food/Beverage Adult Child (150 lb.) (50 lb.) Carbonated soft drink (12 oz.) 20 6 Powdered soft drink (8 oz.) 33 11 Gelatin (4 oz.) 42 14 Tabletop sweetener (packet) 97 32 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 10.
    Straight Facts AboutLow-Calorie Sweeteners Aspartame: Background Applications/Use of Aspartame • Carbonated soft drinks • Frozen desserts • Juices • Dairy products • Puddings, fillings, jellies • Jams, marmalades • Desserts and toppings • Breakfast cereals • Table-top sweeteners • Confectionery (tablets and powders) • Hot chocolate drinks • Chewing gum • Multivitamins • Fruit preserves • Micro breath mints • Bread spreads • Personal care products, pharmaceuticals Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 11.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Process The Process-Literature • Scientific literature databases • FDA Federal Register • Unpublished regulatory submission reports • National Toxicology Program studies • Selection of studies – Over 500 articles cited in this report – Elimination criteria • Research on sensory and/or product applications • Investigating potential health benefit Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 12.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Process The Process - Consumption • Analysis of current consumption of aspartame – Proprietary method of analysis (Burdock Group) – Food intakes from National Health and Nutrition Examination Survey (NHANES) 2001-2002, USDA. – Levels of aspartame content in foods • Typical use levels from industry • Levels reported in literature • Assumptions included all artificial sweetener were aspartame, highest level reported used as default Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 13.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings NHANES-Based Estimate of Aspartame Consumption Values for users only mg/kg bw/day 50th Percentile (Mean) 4.8 90th Percentile 10.4 95th Percentile 13.3 Acceptable Daily Intake = 50 mg/kg bw/d ADI level = considered safe to consume every day for life Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 14.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings Consumption of Aspartame • The intake of aspartame has increased in recent years; the change is not dramatic • Remains well below the ADI even for high intake subpopulations • NHANES over-estimation; assumptions • Worst-case scenario predictions suggest chronic intakes will not reach the ADI Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 15.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings Aspartame Absorption in the Gut Intestinal Lumen Mucosa Cell Portal Blood Aspartame Aspartame Esterases Esterases Methanol (10%) Methanol Methanol Aspartame + Asp/Phe Asp/Phe Peptidases Peptidases Aspartate Aspartate (40%) + (50%) Phenylalanine Aspartate + Phenylalanine Phenylalanine Dipeptide Transport System Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 16.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings Phenylalanine, Aspartic Acid & Methanol Content of Foods Phenylalanine* Aspartic Methanol Acid* 12 oz diet beverage 90 72 18 with aspartame 12 oz milk 606 888 - Medium banana 58 146 21 12 oz orange juice 36 276 23 12 oz tomato juice 58 346 107 *amino acids Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 17.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings Methanol Metabolism Purine synthesis Methanol Ch3OH CO2 + H20 Formaldehyde Formic acid HCHO- HCOO- Amino Acids Excreted Nucleic Acids in Urine Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 18.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings Methanol Metabolism Methanol CO2 + H20 Alcohol dehydrogenase in liver Formaldehyde Formic acid T = 1.5 min T = 3-6 hr Conversion very rapid: Accumulation of formic acid No accumulation = toxicity of methanol Normal range in blood = 7- 63 mg/L Lowest blood level associated with toxicity = 126 mg/dL Safe dose = 2 gm for adult Kostic and Dart, 2003 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 19.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings Formaldehyde Metabolism • Constituent of many foods • Produced during the endogenous demethylation of foods and drugs, such as caffeine – One cup of coffee produces 30 mg of formaldehyde • Essential in one-carbon pool metabolism. – Formic acid is a substrate for nucleotide synthesis • Calculated >50,000 mg formaldehyde is produced and metabolized daily in an adult human body • Adult human liver will metabolize 22 mg formaldehyde per minute to formic acid and CO2 and water Clary and Sullivan, 1999 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 20.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: The Findings Effect of Aspartame on Blood Methanol & Formic Acid Subjects Dose (mg/kg): N Methanol and formic acid (mg/dL) Health adults 34 mg/kg; n=12 methanol < LOD* 100 mg/kg; n=6 methanol peak 1.27, <LOD at 8 hr 150 mg/kg; n=6 methanol peak 2.14, <LOD at 24 hr 200 mg/kg; n=6 methanol peak 2.58, <LOD at 24 hr No change in blood formic acid Healthy Infants 34 mg/kg; n=10 methanol < LOD 50 mg/kg; n=6 methanol < LOD 100 mg/kg; n=8 methanol peak = 1.02 at 90 min, then ~0.45 at 2.5 hr Healthy adults 600 mg per hr for No change in blood methanol or formic 8 hr acid levels Lowest blood level ~ toxicity = 126.0 mg/dL Sponsored by The Beverage Institute for Health & Wellness of TheStegink et al., 1981, 1983, 1989 Cola-Cola Company *LOD= limit of detection, 0.35 mg/dL December 4, 2007 www.thebeverageinstitute.org
  • 21.
    Straight Facts AboutLow-Calorie Sweeteners Panel Findings: Toxicity Studies Safety Evaluations of Aspartame • Acute toxicity • Cytotoxicity • Subacute toxicity • Bacterial studies • Chronic bioassays • Human clinical studies • Neurotoxicity – Blood chemistry, body wt • Teratogenesis – Methanol, formaldehyde • Reproductive toxicity – Headaches • Genotoxicity – Behavior and cognitive • Immunotoxicity function – Induction of seizures • Epidemiological studies Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 22.
    Straight Facts AboutLow-Calorie Sweeteners Panel Findings: Toxicity Studies Long Term Animal Studies-Cancer • 5 with rats, doses up to 5000 mg/kg/d • 3 with mice, doses up to 4000 mg/kg/d • 3 with transgenic high cancer risk mice at doses up to 7500 mg/kg/d • 1 with hamsters, doses up to 12,000 mg/kg • 1 with dogs, doses up to 4000 mg/kg/d • 2 with rats to assess promotion of existing cancers Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 23.
    Straight Facts AboutLow-Calorie Sweeteners Panel Findings: Toxicity Studies Long Term Animal Studies-Cancer • 14/15 animal studies had negative findings indicating no evidence of carcinogenic effect or cancer promoting effect of aspartame • One study concluded that aspartame has carcinogenic potential (Ramazzini Foundation) – This panel agreed with findings of numerous food authorities that Ramazzini study: • Numerous methodological and interpretation errors • Provided “no credible evidence that aspartame is carcinogenic” • “Is no need to further review the safety of aspartame” • “No need to revise previously established ADI” Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 24.
    Straight Facts AboutLow-Calorie Sweeteners Expert Findings: Toxicity Studies Studies during Pregnancy and Development • Effect of aspartame studied during reproduction, pregnancy, lactation and development in rats, mice, hamsters, rabbits and humans • No effect at doses up to 4000 mg/kg/day in rodents and 1600 mg/kg/day in rabbits • No change in breast milk composition in humans at doses up to 50 mg/kg • Conclusion – no evidence of adverse effects Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 25.
    Straight Facts AboutLow-Calorie Sweeteners Expert Findings: Toxicity Studies Studies on Headaches • Have been several, conflicting results with most showing no effect; however some small studies suggesting may be a susceptible subset • There is no known mechanism • Is difficult to study - no objective measure, power of suggestion and inconsistent results Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 26.
    Straight Facts AboutLow-Calorie Sweeteners Expert Findings: Toxicity Studies Neurotoxicity-Learning Behavior • Animal studies – Up to 4% of diet (4000 mg/kg/d), no effect on neuronal function, learning or behavior despite changes in blood and brain amino acids levels • Human studies – Normal children, hyperactive children, children with PKU, aggressive school boys, sugar- sensitive children, airline pilots – Healthy adults, adults with Parkinson’s disease, depression – No effect of aspartame on learning or behavior in all but 1 study Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 27.
    Straight Facts AboutLow-Calorie Sweeteners Expert Findings: Toxicity Studies Neurotoxicity-Seizures • Animals - No effect - doses up to 1000 mg/kg/d – Evaluated in a variety of animal models to induce convulsions and seizures (Pinto and Maher, 1988; Guiso et al., 1988; Cane et al.,1989; Tilson et al., 1989; Helai et al., 1996) – Genetically epilepsy-prone rats (Daily et al., 1991) • Human studies - No significant effect on seizures observed with doses of 34-50 mg/kg – Children diagnosed with petite mal seizures, individuals with epilepsy, self-reported aspartame- sensitive adults (Camfield et al., 1992; Shaywitz et al., 1994, Rowan et al., 1995) Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 28.
    Straight Facts AboutLow-Calorie Sweeteners Expert Findings: Toxicity Studies Epidemiological Studies Author Type of study (N) Consumption of Conclusions Asp Olney US SEER brain tumor data Not measured Incidence increased after (1996) from 9 locations aspartame on market Gurney 56 brain tumor cases 94 Dietary recall - Personal No association (1997) controls interview Hardell 30 brain tumor cases 45 Recall of low calorie soft No association (2001) controls drinks. Bunin 315 children - brain Food frequency No association between (2005) tumor, 315 controls completed by mothers of consumption during children pregnancy and risk Lim Prospective study Food frequency No associations between (2006) 473,984 subjects, 5 yr questionnaires hematopeoitic or brain from NCI Hematopoietic cancers cancers and aspartame (n=2,106); consumption Brain cancers (n=376) Gallus Case control study- various Food frequency No association between cancer (2007 ) cancer types (n = 8976 cases, questionnaires and sweetener consumption 7028 controls) Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 29.
    Straight Facts AboutLow-Calorie Sweeteners Expert Findings: Summary Aspartame - Summary • Metabolism is well understood and follows that of other common foods. • Consumption, even at levels much higher than that expected under typical circumstances, has virtually no impact on levels of blood constituents such as amino acids, methanol or glucose. • A well-studied sweetener whose safety is clearly documented and well established through extensive laboratory testing, animal experiments, epidemiological studies and human clinical trials. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 30.
    Straight Facts AboutLow-Calorie Sweeteners Expert Findings: Summary Aspartame • No credible link between consumption of aspartame at levels found in the human diet and conditions related to the nervous system and behavior, nor any other symptom or illness. • Non-genotoxic and there is no credible evidence that aspartame is carcinogenic. • Does not increase hunger in those who use it; to the contrary, studies indicate it might be an effective tool as part of an overall weight management program. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 31.
    Straight Facts AboutLow-Calorie Sweeteners Expert Panel: Conclusions Panel Conclusions • Aspartame is a well-characterized, thoroughly studied, high-intensity sweetener that has a long history of safe use in the food supply and can help reduce the caloric content of a wide variety of foods. Critical Reviews in Toxicology, 37:629–727, 2007 Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company December 4, 2007 www.thebeverageinstitute.org
  • 32.
    Straight Facts AboutLow-Calorie Sweeteners Straight Facts About Aspartame & Other Low-Calorie Sweeteners Dr. George L. Blackburn, MD, PhD Dr Blackburn is the S. Daniel Abraham Associate Professor of Nutrition and Associate Director of the Division of Obesity Expert George L. Blackburn, MD, PhD* Nutrition at Harvard Medical School. He also serves as Chief of the Nutrition/Metabolism Laboratory and Toxicologist Bernadene Magnuson, PhD* Director of the Center for the Study of Nutrition Medicine, affiliated with the Beth Israel Deaconess Medical Center in Boston. He is an honorary member of the American Dietetic Association and an THANK YOU! American Society for Nutrition Fellow. Sponsored by The Beverage Institute for Health & Wellness of The Cola-Cola Company Dr. Bernadene Magnuson, PhD Dr. Magnuson is Assistant Professor of Nutrition and Food Science at the University of Maryland, where she conducts research on food toxicology, diet and cancer prevention and teaches food science and food toxicology. She was the lead author of a recent expert review of the safety of aspartame *The opinions expressed by the The Beverage Institute forown and do of The Cola-Cola Sponsored by speakers are their Health & Wellness published in the September 2007 issue of Company Reviews of Toxicology. Critical not necessarily reflect the positions or opinions of The Coca-Cola Company. December 4, 2007 www.thebeverageinstitute.org