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AMERICAN BEVERAGE ASSOCIATION

AMERICAN BEVERAGE ASSOCIATION. Functional Energy Drinks & United States Air Force. Gregory Addes Koyama PharmD . Candidate, 2014 University of Pacific Thomas J. Long School of Pharmacy. Major Problem Plaguing the USAF. 1 Wheeler, 2002 2 Miller, 2007. FATIGUE

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AMERICAN BEVERAGE ASSOCIATION

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  1. AMERICAN BEVERAGEASSOCIATION Functional Energy Drinks & United States Air Force Gregory Addes Koyama PharmD. Candidate, 2014 University of Pacific Thomas J. Long School of Pharmacy

  2. Major Problem Plaguing the USAF 1Wheeler, 2002 2Miller, 2007 FATIGUE Fatigue was a causal or contributing factor in 12.7% of Class A aircraft mishaps No single factor ranked more detrimentalto performance and safety than FATIGUE1 USAF Fatigue Counter-Measures2: Non-Pharmacological agents Pharmacological agents

  3. Which is moreDangerous?

  4. Dextroamphetamine & the USAF The Pros Dextroamphetamine is the most widely studied and extensively utilized pharmacologic fatigue countermeasure. Its use by military forces dates back to World War II3 The US Air Force formally authorized dextroamphetamine more than 40 ago3 Not a single event of pilot disqualification occurred due to inappropriate use or abuse3 The Cons • Drug Class: C-II • Black Box Warning: “High Abuse Potential” • Adverse Drug Reactions: • MI/Stroke • HTN • Seizures • 3Cornum, 1997

  5. Caffeine & the USAF • 4Gillingham, 2004 • 5Tikiuisus, 2004 • 6Tharion, 2003 • 7McLellan, 2005 • 8Van Dongen, 2001 USAF Caffeine Studies: • Sustain Vigilance & Reaction Time • Caffeine improved both in fatigued subjects under military conditions4,5 • Improve MARKSMANSHIP • Sleep debt and Circadian Variationhas shown to reduce accuracy6,7 • Reduce SLEEP INERTIA8

  6. Caffeine & the USAF 1Wheeler, 2002 Current Use of Caffeine: • Coffee & Soft Drinks1 • Jolt Cola • Mountain Dew • Caffeinated Gum1 • Included in Meals Ready to Eat (MREs)

  7. Everything you ever wanted to know about Energy Drinks in 3 minutes

  8. What’s in a “Energy Drink”? Caffeine L-Carnitine Guarana Extract Taurine

  9. CAFFEINE • Is it Safe? • The FDA thinks so: • Caffeine is considered safe for use in stimulant drug products for over-the-counter human use to restore mental alertness or wakefulness during fatigue or drowsiness9 • How Much is Safe? • The FDA recognizes that for healthy adults, caffeine intake up to 400 mg/day is safe10

  10. CAFFEINE

  11. L-Carnitine • What is L-Carnitine? • Quaternary Ammonium compound • Biological Role: Transport of fatty acids to mitochondria for generation of metabolic energy11 • Where is it Commonly Found? • Ground Beef (100g) • 94mg of L-Carnitine • Whole Milk (100mL) • 3.3mg

  12. L-Carnitine • Is it Safe? • The European Food Safety Authority (EFSA) found no adverse effects attributable to the consumption of L-carnitine at doses less than or equal to12: 2 grams/day

  13. Guarana Extract • What is Guarana? • “Vine plant” native to the Amazon Basin • Historically played an important role in the Tupi & Guarani Paraguayan culture13 • Use to make Tisane—or “Guarana Bread”

  14. Guarana Extract • Is Guarana Safe? • FDA-approved food additive (21 CFR 172.510) • Generally Recognized As Safe(GRAS) for use as a flavoring agent14 • Does GuaranaContribute to Caffeine Content? • Guarana in an 8ozserving of Rockstar= <1mg of caffeine14

  15. TAURINE • What is Taurine? • Occurs naturally in the diet • Considered a “ConditionallyESSENTIAL”Amino Acid14 • Found in Breast Milk & Infant Formula15,16

  16. TAURINE • Is it Safe? • Taurine does NOT have any stimulatory effects17 • The European Food Safety Authority (EFSA) found no association between Taurine & any adverse health effects17 • 3 g to 6 g of Taurine per day for up to 1 year did NOT produce adverse health effects17

  17. Are Functional Energy Drinks DANGEROUS? YES GI disturbances Cardiovascular Risks Combination with Alcohol The WORLD is a Dangerous Place… But so is the life of USAF Personnel

  18. USAF Dominance 19Meadows, 2005 A tremendous advantage held by the US military is the capacity to conduct operations on an around-the-clock basis19

  19. Threat to Mission Success The Threat In carrying out these operations, our own military forces become sleep deprived, and the problem presented by fatigue may become immense1 The Need Effective maintenance of the Human Weapon System is critical to mission success1

  20. Furthering the Mission of the USAF The Solution ENERGY DRINKS • Limited Role of Dextroamphetamine • Can only be prescribed by the flight surgeon to Aviators in the USAF2 • Energy drinks are available Over-The-Counterand have shown to be both SAFE & EFFECTIVE

  21. PERSPECTIVE • Guns & Energy Drinks • Aurora Shooting • History of mental illness & suicide attempts • “14 year old Dies from Energy Drink Consumption” • TWO 24-oz Monster Energy Drinks • History of Cardiovascular Abnormalities • Risk vs. Benefit

  22. References Wheeler, Dan, ed. Warfighter Endurance Management During Continuous Flight and Ground Operations. Brooks Air Force Base, TX: United States Air Force School of Aerospace Medicine, 2002. Miller, N.L, P. Matsangas, and L.G. Shattuck. "Fatigue and its Effect on Performance in Military Environments." Trans. Array Performance Under Stress. 2007. 231-249. Print. <http://faculty.nps.edu/nlmiller/docs/ch12.pdf>. Cornum, Rhonda, Caldwell, John, and Cornum, Kory. Stimulant Use in Extended Flight Operations. Airpower Journal 11, no. 1 (Spring 1997): 53-58. Gillingham, Robin L., Keefe, Allan A., and Tikuisis, Peter. Acute Caffeine Intake Before and After Fatiguing Exercise Improves Target Shooting Engagement Time. Aviation, Space, and Environmental Medicine 75, no. 10 (October 2004): 865-871. Tikuisus, Peter, Keefe, Allan A., McLellan, Tom M., and Kamimori, Gary. Caffeine Restores Engagement Speed But Not Shooting Precision Following 22 Hours of Active Wakefulness. Aviation, Space, and Environmental Medicine 75, no. 9 (September 2004):771-776. Tharion, W.J., Shukitt-Hale, B. and Liberman, H.R. (2003) “Caffeine Effects on Marksmanship during High-Stress Military Training with 72 hour Sleep Deprivation”, Aviation, Space, and Environmental Medicine, 74(4), 309-314. McLellan, T.M., Kamimori, G.H., Bell, D.G., Smith, I.F., Johnson, D. and Belenky, G. (2005) “Caffeine Maintains Vigilance and Marksmanship in Simulated Urban Operations with Sleep Deprivation”, Aviation, Space, and Environmental Medicine, 76(1), 39-45. Van Dongen, H.P.A., Price, N.J., Mullington, J.M., Szuba, M.P., Kapoor, S.C. and Dinges, D.F. (2001) “Caffeine Eliminates Psychomotor Vigilance Deficits from Sleep Inertia”, Sleep, 24(7), 813-819. U.S. FDA (2012). U.S. Code of Federal Regulations (CFR). Title 21—Food and Drugs (Food and Drug Administration). Washington (DC): U.S. Government Printing Office (GPO). Available at: http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR U.S. FDA (2012). Letter from Jeanne Ireland, Assistant Commissioner for Legislation to the Honorable Richard J. Durbin, Senator dated August 10, 2012 [Re: Letter of April 3, 2012 Expressing Concern About Potential Safety Issues Associated With the Consumption of so-called “Energy Drinks”]. Silver Spring (MD): U.S. Food and Drug Administration (U.S. FDA). Available at: http://www.shb.com/newsletters/FBLU/Etc/RichardDurbin-Letter-Aug2012.pdf.

  23. References Steiber A, Kerner J, Hoppel C (2004). "Carnitine: a nutritional, biosynthetic, and functional perspective". Mol. Aspects Med.25 (5–6): 455–73. EFSA (2003). Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to L-Carnitine-L-tartrate for use in foods for particular nutritional uses. The EFSA Journal (2003))19, 1-13. Weinberg BA, Bealer BK (2001). The World of Caffeine: The Science and Culture of the World's Most Popular Drug. New York: Routledge. pp. 259–60. IntertekCantox, . Scientific White Paper: Summary of Data Supporting the Safety of ROCKSTAR Energy Drinks. Mississauga, Ontario, Canada: 2013. 1-33. Print. <http://www.scribd.com/doc/129588246/Scientific-White-Paper-for-Rockstar-Energy-030813-pdf>. Laidlaw, S.A., Grosvenor, M., Kopple, J.D. (1990) The taurine content of common foodstuffs [published correction appears in JPEN J Parenter Enteral Nutr 14(4): 380]. JPEN J Parenter Enteral Nutr 14(2):183-188. Hayes, K.C., Trautwein, E.A. (1994). Taurine (chapter 31). In: Shils, M., Olsen, J., Shike, M., editors. Modern Nutrition in Health and Disease, 8th edition. Philadelphia (PA): Lea & Febiger, vol. 1, pp. 477-485. EFSA (2009). Scientific Opinion of the Panel on Food Additives and Nutrient Sources added to Food on a request form the Commission on the use of taurine and D-glucorono-gamma-lactone as constituents of the socalled “energy” drinks. (Question no EFSA-Q-2007-113, adopted on 15 January 2009 by European Food Safety Authority). EFSA J 395:1-31. Available at: http://www.efsa.europa.eu/en/efsajournal/pub/935.htm. U.S. Air Force, . "U.S Air Force: About The Air Force." Our Mission. United States Air Force, n.d. Web. 22 Sep 2013. Meadows, Maj, USAF, BSC, Andrew. Fatigue in Continuous and Sustained Airpower Operations: Review of Pharmacologic Countermeasures and Policy Recommendations. 2005. 1-35. Print. <https://flyawake.org/documents/PharmaCountermeasuresPaper.pdf>.

  24. Energy Drinks: Safety and Efficacy Issues Daniel Da Costa PharmD Candidate 2014 University of the Pacific Thomas J. Long School of Pharmacy and Health Sciences

  25. Why Discuss Energy Drinks? • From 2008-2012 the US Energy Drink Market grew by 60% • Sales of more than $12.5 billion in 2012 • Energy Drink related ER visits doubled over a 4 year span • Deaths due to Energy Drink consumption (without use with other substances) • In 2010 products containing Energy Drinks mixed with alcohol were pulled of the market due to deaths related to use • United States Senate Hearing: Energy Drinks: Exploring Concerns about Marketing to Youth

  26. What are Energy Drinks? • Refers to a class of products that contain high levels of caffeine frequently combined with other stimulants and ingredients in liquid form for consumption. • Fall into one of two categories: • Beverage • Dietary Supplements • FDA Draft Guidance for Industry: 2009 • Increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods • Concern with dietary supplements that look like, are displayed adjacent to, and are marketed, as beverages.

  27. Efficacy of Energy Drinks DAWN Report: Marketing suggests benefits such as increased energy and stamina, weight loss, and enhanced physical and mental performance http://www.orangeinks.com/wp-content/uploads/2013/03/Monster-Hulk.jpg • Increased Energy and Stamina: • Improved cycling time-trial performance after ingestion of a caffeine energy drink. • Ivy, JL. 2009 • Weight Loss: • Thermogenic effect of Meltdown RTD energy drink in young healthy women: a double blind, cross-over design study. • Rashti, SL. 2009 • Enhanced Physical and Mental Performance: • Positive effects of Red Bull® Energy Drink on driving performance during prolonged driving- • Mets, MA. 2011

  28. Military Relevance http://a1.g.akamai.net/f/1/15157/1h/dodairforce.download.akamai.com/15157/airforce/careers/career_details/i/detail/Air_Traffic_Control_694x306.jpg http://upload.wikimedia.org/wikipedia/commons/d/d0/Usaf.e3sentry.750pix.jpg http://media.dma.mil/2012/Jun/06/2000144989/670/394/0/120530-F-HF135-049.JPG http://soldiersystems.net/tag/battlefield-airman/

  29. What Makes Energy Drinks Effective? Caffeine is the most common ingredient in Energy Drinks Caffeine has shown to have stimulatory effects, increasing performance, vigilance, alertness, memory and mood • Caffeine is the most widely consumed psychoactive substance in the world • 80% of American adults consume caffeine every day • 300mgis the average daily intake of caffeine of Americans http://learning.hccs.edu/faculty/steven.dessens/steven.dessens/website_pictures/caffeine

  30. Typical Energy Drink Content • Wide range of Caffeine Content: • 6mg- Decaf 5 Hour Energy • 375mg- Rage Inferno • Photo from AngryTrainerFitness.com

  31. Safety of Energy Drinks • GRAS- Generally Regarded as Safe • Chemical or substance added to food considered safe by experts • Caffeine is regarded by the FDA as GRAS at “cola-type” levels of 71mg/12 ounces • Select Committee on GRAS Substances (SCOGS) Review Database • U.S. Food and Drug Administration Conclusion • “It is inappropriate to include caffeine among the substances generally recognized as safe (GRAS). At current levels of consumption of cola-type beverages, the dose of caffeine can approximate that known to induce such pharmacological effects as central nervous system stimulation.”

  32. Other Ingredients- GRAS? • Guarana • Taurine • L-Carnitine • B Vitamins • ED companies self determine many of these ingredients to be safe. • Independent consulting firms have reported these additives as GRAS, but this is not the opinion of the FDA

  33. Safe Dose of Caffeine? • FDA- 400mg daily is not associated with significant adverse effects in healthy adults • Some side effects: • GI upset • Jitteriness • Difficulty sleeping • Cardiovascular

  34. Caffeine Dosing Evaluation of electrocardiographic and hemodynamic effects of caffeine with acute dosing in healthy volunteers Methods: 400mg caffeine vs placebo Conclusions: Moderate caffeine consumption by healthy young adults does not acutely effect PR, QRS, QT, QTc and RR intervals However, caffeine did increase SBP in placebo vs caffeine : 119 + 7 mmHg 128+ 8mmHg -Ammar, 2001

  35. Energy Drink Safety • Impact of Energy Drinks on Electrocardiographic and Blood Pressure Parameters: A meta-analysis of Clinical Studies • Methods: Meta-analysis of three studies evaluating the impact of an energy drink on the QT/QTc interval, SBP, DBP and HR. • 132 subjects in BP analysis • 93 subjects in QT/QTc analysis • Conclusions: Energy drinks raised blood pressure significantly prolonged the QT/QTc interval. • SBP Increase: 3.5mmHg • Torcetrapib stopped in clinical trials in part due to an SBP increase of 6.6 mmHg • QTc Prolongation: 10msec • FDA Guidance Document calls for further analysis of QTc prolonging medications if the interval prolongs for more than 10msec, warranting further investigation • -Dargush, 2012

  36. Safety • Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) • 5 Deaths- Monster Energy Drink • 13 Deaths- 5 Hour Energy • Adverse Events • Seizures • Dysrhythmias

  37. Safety • DAWN Report: The number of emergency department visits involving energy drinks doubled from 10,068visits in 2007 to 20,783visits in 2011 • Over 52% of ER visits made by people aged 18-25 involved combinations of energy drinks with alcohol or other drugs. • National Academy of Sciences Report (2012): nearly half (47%) of military members surveyed reported binge drinking (consuming 5 or more drinks at one time)

  38. Safety Increasing ER Visits Mixture with Alcohol High Dose Caffeine Combination of Ingredients

  39. Energy Drinks • Increase in consumption of Energy Drinks • Increase in Emergency Room visits and deaths • Benefits of Energy Drinks • Caffeine is an effective substance within certain doses • Energy Drinks have adverse effects • Lack of data regarding combination of other ingredients in Energy Drinks

  40. References Substance Abuse and Mental Health Services Administration, Center for Behavior Health Statistics and Quality. (January 10, 2013). The DAWN Report: Update on Emergency Department Visits Involving Energy Drinks: A continuing Public Health Concern. Rockville, MD "A Survey of Popular Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and Targeted Marketing to Adolescents." Senate.gov. A Report Written by the Staff of Congressman Edward J. Markey (D-MA) in Coordination with the Staff of Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT), 10 Apr. 2013. Web. 22 Sept. 2013. "Energy Drinks and Shots: U.S. Market Trends." Packaged Facts. N.p., 29 Jan. 2013. Web. 23 Sept. 2013. CNN Wire Staff. "FDA Calls 7 Caffeine-alcohol Drinks Unsafe." CNN Health. CNN, 10 Nov. 2010. Web. 24 Sept. 2013. Ivy, JL, L. Kammer, Z. Ding, B. Wang, JR Bernard, YH Liao, and J. Hwang. "Improved Cycling Time-trial Performance after Ingestion of a Caffeine Energy Drink."International Journal of Sports Nutrition and Exercise Metabolism 19.1 (2009): 61-78. PubMed. Web. 23 Sept. 2013. Mets, MA, S. Ketzer, and Et Al. "Positive Effects of Red Bull® Energy Drink on Driving Performance during Prolonged Driving." Psychopharmacology 214.3 (2011): 737-45. Pubmed. Web. 23 Sept. 2013. Rashti, SL, NA Ratamess, J. Kang, AD Faigenbaum, A. Chilakos, and JR Hoffman. "Thermogenic Effect of Meltdown RTD Energy Drink in Young Healthy Women: A Double Blind, Cross-over Design Study." Lipids in Health and Disease 17 (2009): n. pag. PubMed. Web. 23 Sept. 2013. Nehlig A, Daval J-L, Debry G (1992). Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Brain Res Brain Res Rev 17 (2): 139-170. Cited in: Lara, 2010 Medicines in Your Home: Caffeine and Your Body." FDA.gov. Food and Drug Administration, 2007. Web. 22 Sept. 2013. <http://www.fda.gov/downloads/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/ucm205286.pdf>. Somogyi, L. "Caffeine Intake by the U.S. Population." Report Preprared for the US Food and Drug Administration (2009): n. pag. FDA. Web. 24 Sept. 2013. <http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/UCM333191.pdf> "Caffeine." U.S. Food and Drug Administration. Select Committee on GRAS Substances, 31 Oct. 2006. Web. 17 Sept. 2013. <http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing>. U.S. FDA. Letter from FDA micheleMital Active Associate Commissioner for Legislation to the Honorable Richard J. Durbin, Senatordated November 21, 2012 [Re: Letters of September 11 and October 26, 2012 Indicating that not all Concerns RE “Energy Drinks” were addressed in the Response from the Food and Drug Administration dated August 10, 2012]. Spring (MD): US Food and Drug Administration (U.S. FDA)

  41. "FDA to Investigate Added Caffeine." FDA.gov. Food and Drug Administration, 03 May 2013. Web. 22 Sept. 2013. <http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350570.htm>. Ammar, R., JC Song, Kluger J, and CM White. "Evaluation of Electrocardiographic and Hemodynamic Effects of Caffeine with Acute Dosing in Healthy Volunteers." National Center for Biotechnology Information. U.S. National Library of Medicine, Apr. 2001. Web. 17 Sept. 2013. <http://www.ncbi.nlm.nih.gov/pubmed/11310517>. Ammar, R., JC Song, Kluger J, and CM White. "Evaluation of Electrocardiographic and Hemodynamic Effects of Caffeine with Acute Dosing in Healthy Volunteers." National Center for Biotechnology Information. U.S. National Library of Medicine, Apr. 2001. Web. 17 Sept. 2013. <http://www.ncbi.nlm.nih.gov/pubmed/11310517>. Michiel L., Bots, and et Al. "Torcetrapib and Carotid Intima-media Thickness in Mixed Dyslipidaemia (RADIANCE 2 Study): A Randomised, Double-blind Trial." The Lancet 370.9582 (2007): 153-60. Elsevier. Web. 24 Sept. 2013. U.S. FDA (2012) Federal Food, Drug and Cosmetic Act (FD&C Act): Chapter II: Definitions: Sec 201 [21 USC 321]” Definition; generally [Inc. amendments to Feb. 1, 2010]: In: U.S. Code- Title 21- Food and Drug, Chapter 9. Rockville (MD) US FDA Seifert SM, Seifert SA, Schaechter JL, et al. An analysis of energy-drink toxicity in the National Poison Data System. ClinToxicol (Phila). 2013; 51(7):566-574. Substance Abuse and Mental Health Services Administration, Center for Behavior Health Statistics and Quality. (January 10, 2013). The DAWN Report: Update on Emergency Department Visits Involving Energy Drinks: A continuing Public Health Concern. Rockville, MD National Academy of Sciences. Institute of Medicine. Further Steps Needed to Reduce Stigma and Expand Access to Drug Abuse Screening and Care in Armed Forces.News from the National Academies. National Academy of Sciences, 17 Sept. 2012. Web. 22 Sept. 2013.

  42. Energy Drinks:Implications for the DoD Shawlien Lie PharmD Candidate, 2014 University of the Pacific Thomas J. Long School of Pharmacy & Health Sciences

  43. Summary of Energy Drinks (ED) What are the BENEFITS? • Energy boost • Alertness • Convenience • EDs consist of: • Caffeine and other additives • Considered dietary supplements • Not regulated by the FDA • EDs are effective, but what about safety? • Increased cardiovascular risk • Increase blood pressure • Prolonged QTc Interval

  44. Are Ingredients in Energy Drinks Considered GRAS?

  45. Association between Coffee Consumption and Mortality New England Journal of Medicine,Association of Coffee Drinking with Total & Cause-Specific Mortality, 2012

  46. Energy Consumption Survey Milazzo, unpublished • 18-question survey • ED consumption • Side effects caused by ED • Reasons for drinking ED • 11 U.S. Air Force Bases around the globe participated in 2012 • 9,335 surveys were completed • Included both Active Duty and Civilian personnel • All participants were ≥18 years old

  47. Energy Consumption Statistics Milazzo, unpublished • 77% have consumed Energy Drinks (ED) at least once • Of those deployed, 48% stated their ED consumption increased • When asked the question “why do you consume ED,” the 2 top answers were: • To increase mental alertness • Increase energy and stamina • 29% have consumed a premixed beverage consisting of caffeine, alcohol, and other stimulants.

  48. Energy Drinks • Side Effects • 28%: nervousness/ jitters • 25%: feeling drained 4-5 hours after consuming • 24%: rapid/ abnormal heart beat • Benefits: • 69%: being more awake/ alert • 55%: energetic Milazzo, unpublished

  49. Emergency Visits Milazzo, unpublished 68 out of 7,062 people have seen a physician or gone to the emergency room due to side effects of energy drinks.

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