1. Caffeine Safety: A Three-Decade
Review…and the 2013 Landscape
James R. Coughlin, PhD CFS
President, Coughlin & Associates
Aliso Viejo, California
jrcoughlin@cox.net
www.linkedin.com/in/jamescoughlin
Institute of Food Technologists Webinar:
“The Buzz on Caffeine:
New Developments in Safety, Regulation
and Adverse Event Reporting“
“November 12, 2013

2. Outline
• My Historical Perspective on Caffeine & Health Issues
• Caffeine in 2013…
• Energy Drinks, other Foods/Beverages
• Congressional, FDA, Health Canada, EFSA, FSANZ
Activities
• Where do we go from here?
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3. A 30+ Year Perspective on Caffeine/Health
…on Rats, Mice & Humans
…on Almost Every Disease
…on “Good” & “Bad” Science and Policy
…on “Good” & “Bad” Media Coverage
…on Caffeine’s Beneficial Health Effects
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4. Much Confusion over Caffeine
“Perhaps no substance has been the subject of
more conflicting media and scientific reports in
recent years than caffeine. So, is a cup of coffee
bad for you or not?”
Los Angeles Times, September 11-13, 1994 risk series
- But no one was even asking back then -
“So, is a cup of coffee (or caffeine) good for
you or not?”
4

5. Caffeine/Health Conclusions:
1978 - 2013
… First 20 Years:
Mostly Bad News! Caffeine was linked to many animal
toxicities and human disease!
… Last 15 or so years…Very Big Turn Around:
The “Good News” is that almost all of the Bad News about
caffeine was WRONG!
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6. Caffeine’s “Maligning” Started in the Late 1970’s and
Ballooned in the 1980’s and Early 1990’s
• Coffee and heart attacks, was it the caffeine?
• Caffeine and birth defects in rats (U.S. FDA, 1978);
reproductive & developmental effects in humans
• Caffeine and urinary calcium loss, osteoporosis
• Caffeine anxiety, sleep disturbance, “addiction”
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8. Caffeine and Reproductive Effects
• Began with birth defects (missing digits) in rats gavaged
(force-fed) very high-doses (FDA, 1978)
• Then human studies followed: delayed conception;
premature birth; low birth weight babies; fetal death;
spontaneous abortion (miscarriage), congenital defects
• But now there are more than 25 published reviews
supporting caffeine’s safety:
• Peck, Leviton, Cowan (Food Chem. Toxicol. 2010)
• Brent, Christian, Diener (Birth Defects Res. 2011)
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9. Caffeine and Osteoporosis
• Excess calcium loss & bone loss in post-menopausal
women causes millions of bone fractures (mostly hip)
• Earlier acute, 24-hour human studies on non-caffeine
consuming subjects were originally misinterpreted
• Many longer-term, human clinical studies have shown
little excess calcium loss or bone loss and no
increased risk of osteoporosis.
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10. Caffeine and “Addiction”
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11. Caffeine and “Addiction”
• Dependence, tolerance and withdrawal headache were
cited in many published studies (mostly among psychiatric
patients)
• Headlines since the late 1980’s:
• “Caffeine Addiction More Than Just Java Jive --
Caffeine Junkies”
• “Study Finds Caffeine Has Qualities of Addictive Drug”
• Current view is very reassuring:
• Caffeine is not classified as an addictive drug (APA,
DSM-5 psychiatric “bible” published May 2013)
• Addiction over-warnings trivialize dangers of real drugs
of abuse.
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12. What Science Allowed the Bad Myths to Happen…
and Why have Some New Myths Popped Up?
… Acute vs. Chronic effects:
 Partial / full tolerance to caffeine develops in humans
consistently consuming caffeine and coffee daily
… Most of the Myths and Fears are based on:
 Acute effects’ testing of non-coffee consuming subjects
 Massive doses of caffeine fed to animals for a lifetime
 Smaller, poorly conducted human studies
…Failure to Know the Vast Literature
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13. 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).
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14. “Risk Reductions” with Caffeine Consumption
• Parkinson’s Disease
• Alzheimer’s Disease
• Depression & suicide
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15. So with all this more recent good
news, why are we still worrying
about Caffeine?
~
New safety concerns have been
raised for Energy Drinks and New
Products containing Caffeine.
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16. Recent Studies/Reviews on
Energy Drinks?
~
…by researchers who do not know
the 30-years of caffeine literature
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22. 22

23. U.S. FDA Concerns over Caffeine
and Energy Drinks
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24. “Experts” Letter to FDA Commissioner
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25. Added Caffeine in Gum - FDA Statement on Wrigley’s
Announcement (May 8, 2013)
Michael R. Taylor, FDA Deputy Commissioner for Foods and Veterinary
Medicine, provided this response to Wrigley's announcement regarding
withdrawal of Alert Energy Caffeine Gum:
On May 8, 2013, 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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26. Backgrounder for the Institute Of Medicine (IOM) FDA-Requested
Workshop on Potential Health Hazards of Caffeine In Food and
Dietary Supplements (6/28/2013) – 21 Questions Posed
• Exposure
• Absorption, distribution, metabolism, and excretion (ADME)
• Cardiovascular effects
• Neurological and behavioral effects
• Tolerance and withdrawal
• Population risk characteristics
• Scientific data on caffeine
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31. • Goal - To bring together and summarize relevant research
on the use and biology of Energy Drinks and to highlight the
most critical research gaps.
• Sponsored by NIH Office of Dietary Supplements and
several other NIH Institutes.
• Talks focused on patterns of use, sensitive subpopulations,
safety and health effects of Energy Drinks and their
ingredients.
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32. Taylor’s Blog on Caffeine
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33. Other Regulatory Agencies
Concerns
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35. European Food Safety Authority
• EFSA. Scientific Opinion of the Panel on Food Additives and Nutrient
Sources added to Food, on a request from the Commission on the use
of taurine and D-glucurono-γ-lactone as constituents of the so-called
“energy” drinks. EFSA Journal (2009) 935, 1-31.
• Zucconi et al., 2013. “Gathering consumption data on specific
consumer groups of energy drinks.” [190 pp.]
www.efsa.europa.eu/publications
• EFSA opinion on caffeine’s safety requested by the European
Commission (Feb 2013):
• Delays any authorization of certain health claims from art. 13.1
• Maximum levels of caffeine intake from all sources
• Risk of interaction of caffeine with alcohol and other ingredients of “Energy
drinks”
• Population groups: population in general, adults performing physical
activities of various intensities, pregnant women, lactating women, children
and adolescents
• EFSA may issue its opinion within six months.
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36. Food Standards Australia New Zealand
(FSANZ)
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38. ILSI – “Beverage Caffeine Intakes in the U.S.”
• 96% of beverage caffeine consumed is from coffee, soft drinks and
tea
• Coffee remains the largest contributor to beverage caffeine intakes
• Energy drinks, energy shots and chocolate beverages contribute
little to caffeine intakes
• Only 4.3% of all caffeinated beverage consumers were consumers
of energy drinks
• In teenagers (13–17 years) or young adults (18–24 years), 9-10% of
caffeinated beverage consumers were consuming energy drinks
• Intakes from energy drinks represent less than 2% of total daily
mean caffeine values for all caffeinated beverage consumers.
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39. What Happens
Next?
~
Thank You!