Caffeine Safety Review over Three Decades: Is the Increased Concern Justified? James R. Coughlin, PhD CFS President, Coughlin & Associates Aliso Viejo, California [email protected]www.linkedin.com/in/jamescoughlin 25th International Conference on Coffee Science Armenia, Colombia September 9, 2014
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Caffeine Safety Review over Three Decades: Is the Increased Concern Justified?
James R. Coughlin, PhD CFSPresident, Coughlin & Associates
• But now there are more than 25 published reviews supporting caffeine’s safety.
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Caffeine and “Addiction”
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Caffeine and “Addiction”• Dependence, tolerance and withdrawal headache were cited
in many published studies going back to the late 1980’s (but mostly among psychiatric patients consuming up to 20 cups/day)
• Current view is very reassuring:• Caffeine use was not classified as a “substance use
disorder” (the new term for addiction) in the American Psychiatric Assn’s DSM-5 “bible” (published May 2013)
• However, DSM-5 did recognize caffeine intoxication and withdrawal disorders
• Addiction over-warnings trivialize dangers of real drugs of abuse.
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Caffeine and Osteoporosis
• Excess calcium loss & bone loss in post-menopausal women causes millions of bone fractures (mostly hip)
• Acute, 24-hour human studies done in the 1980’s on non-caffeine consuming subjects were originally misinterpreted
• Many longer-term, human clinical studies have since shown little excess calcium or bone loss and noincreased risk of osteoporosis.
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Coffee/Caffeine and Cancer Risk • Coffee contains trace levels of animal carcinogens
produced by heat in the “Maillard Browning Reaction,” including acrylamide and furan
• Over 550 human epidemiology studies have been published since the 1970’s on many human organs
• Most health authorities across the globe now agree that coffee drinking (and caffeine) is NOT a cancer risk, and coffee may actually reduce the risk of numerous cancers
• I have termed this the “Coffee-Cancer Paradox”
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Summary Conclusions on the “Bad” Health Effects
• Long established history of safe global caffeinated coffee consumption (and decaffeinated as well)
• But more animal, clinical & epidemiologic studies will be published, and continued media attention is sure to come
• More recent studies and re-examinations of older disease issues have been quite reassuring
• Consumers can be assured that their health will not be adversely affected by the enjoyment of coffee and caffeine as currently consumed.
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Caffeine’s Beneficial Physiological Effects• Mild central nervous system (CNS) stimulant
• Improves cognitive performance and mental processing; increases wakefulness; improves work performance and enhances mood
• Increases capacity for physical work & exercise; improves muscular performance and endurance sports
• Relaxes smooth muscle, especially bronchial (opens airways), and increases blood flow in heart and kidneys
• Produces a slightly higher metabolic rate (some evidence of an ergogenic “fat burning” effect)
So with all this more recent goodnews, why are we still worrying about
Caffeine?
New safety concerns have been raised for Energy Drinks and new food products containing added
Caffeine
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U.S. Congress and FDA Concerns
over Caffeine and Energy Drinks
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Very Recent Studies / Reviews on Concerns over Energy Drinks…
…done by researchers who do not know the 30+ years of caffeine literature…on hypertension, arrhythmias, heart attacks, strokes, reduced mortality
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“Experts” Letter to FDA Commissioner
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Caffeine has become the
“Poster Child” for GRAS troubles
“Generally Recognized as Safe”(1958 Food Additives Amendment)
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FDA Statement on Wrigley’s “Alert Energy” Caffeine Gum Withdrawal (May 2013)Michael R. Taylor, FDA Deputy Commissioner for Foods & Vet. Medicine:
Wrigley (a subsidiary of Mars) announced its decision to pause production, sales, and marketing of Alert Energy Caffeine Gum. This announcement was made following a series of discussions with the FDA in which the agency expressed concerns about caffeine appearing in a range of new foods and beverages.
The FDA applauds Wrigley’s decision and its recognition that we need to improve understanding and, as needed, strengthen the regulatory framework governing the appropriate levels and uses of caffeine in foods and beverages. The company’s action demonstrates real leadership and commitment to the public health.
We hope others in the food industry will exercise similar restraint. We look forward to working with industry, the scientific and medical community, and all interested parties to address the issues posed by added caffeine in foods and beverages.
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My U.S. Senate Oral Testimony 1. The caffeine content in energy drinks is equivalent to that
of an equal amount of coffee, and less than that of coffeehouse coffees.
2. The health outcomes of caffeine consumption have been thoroughly studied for decades, and the best available scientific & clinical evidence does not support the idea that caffeine should be prohibited (and certainly not a single source of caffeine).
3. Coffee, tea and soda are the primary sources of caffeine in U.S. diets, including diets of children and teens. Current exposure assessments conducted by the FDA indicate that caffeine consumption by children and youth is not a safety concern.
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IOM Workshop Objectives Set by FDA• Evaluate the epidemiological, toxicological, clinical and other relevant
literature to describe important health hazards associated with caffeineconsumption from ALL foods and beverages.
• Delineate vulnerable populations who may be at risk from caffeine exposure.
• Describe the possible risk of caffeine’s cardiovascular and other health effects, including additive effects with other ingredients and effects related to preexisting conditions.
• Explore safe caffeine exposure levels for general and vulnerable populations.
• Identify data gaps on caffeine stimulant effects, including but not limited to cardiovascular, central nervous system, or other health outcomes.
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Mike Taylor’s Blog on Caffeine
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Concerns of Other
Regulatory Agencies are
Similar
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European Food Safety Authority (EFSA)
• Zucconi et al., 2013. “Gathering consumption data on specific consumer groups of energy drinks.” [190 pages] www.efsa.europa.eu/publications
• EFSA opinion on caffeine’s safety was requested by the EC (Feb 2013); established a Working Group on Caffeine…
• Maximum levels of caffeine intake from all sources • Risk of interaction of caffeine with alcohol and other
ingredients of “Energy Drinks”• Focus: general population, adults performing physical
activities of various intensities, pregnant & lactating women, children & adolescents
• Several meetings of the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA Panel)
• Draft Opinion will issue early November, public consultation for 6-8 weeks, adoption by Spring 2015.
“Food additives on the rise as FDA scrutiny wanes”Washington Post, August 17, 2014
• “The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the FDA, which is responsible for ensuring the safety of chemicals streaming into the food supply.”
• “We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s Deputy Commissioner for Food.
• “Within the past six months, top officials at the FDA and in the food industry have acknowledged that new steps must be taken to better account for the additives proliferating in the food supply.”
• “This is what happened with caffeine. In 1959, the FDA approved it as GRAS, allowing soft drink manufacturers to add it to their products. But now food manufacturers are loading caffeine into energy drinks, maple syrup, jelly beans and marshmallows.”
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Cardiovascular Issues
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“Tolerance to the Humoral and Hemodynamic Effects of Caffeine in Man” – Vanderbilt University’s David Robertson (1981)
• Previous studies showed acute caffeine given to caffeine-naïvesubjects increased BP, heart rate, plasma epinephrine & norepinephrine, plasma renin activity and urinary catecholamines
• Robertson did a double-blind study of the effects of chroniccaffeine administration on these same variables
• Demonstrated that near complete tolerance for both the humoral and hemodynamic variables developed over the first 1-4 days of caffeine intake
• Showed no long term adverse effects of caffeine on BP, heart rate, plasma renin activity, plasma catecholamines, or urinary catecholamines.
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Cardiovascular Disease (CHD), Stroke and Overall Mortality of Coffee / Caffeine Consumption
* All studies – either no increased risk or reduced risk *• Andersen 2006 – Iowa Women’s Health Study, coffee