Overview of Caffeine Safety Issues: What’s All the Fuss About?

James R. Coughlin, PhD CFSPresident, Coughlin & Associates

Aliso Viejo, Californiajrcoughlin@cox.net

www.linkedin.com/in/jamescoughlin

Panel Discussion - “Caffeine, Energy Drinks and Ingredients: Are You

Prepared for FDA Action?

Supply Side West Global Expo & Conference

Las Vegas, October 8, 2014

Is the Increased Concern about Caffeine’s Safety

Justified?

I Don’t Believe It Is!

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Agenda

• Caffeine & Health Issues - My Historical Perspective

• Caffeine Safety Issues in 2013-2014…

• Caffeine-containing Beverages’ Long History of Safe Use

• Energy Drinks & Newer Foods / Beverages

• U.S. Congress & FDA, Health Canada, EFSA

• Cardiovascular Issues – the Key Topic of Debate

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My 30+ Years Perspective on Caffeine / Health

…on Rats, Mice & Humans, and Almost Every Disease

…on “Good” & “Bad” Science

…on “Good” & “Bad” Policy Decisions & Media Coverage

…on Caffeine’s Beneficial Health Effects

… First 20 Years: Much Bad News! Caffeine was linked to many animal toxicities and human diseases!

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Caffeine’s “Maligning” Started in 1970’s and Ballooned in 1980’s/Early 1990’s

• Coffee and heart attacks…was it the caffeine?

• Caffeine and birth defects in rats (U.S. FDA, 1978); hundreds of subsequent studies on reproductive & developmental effects in humans

• Caffeine and urinary calcium loss; osteoporosis risk?

• Central Nervous System: anxiety, sleep disturbance, “addiction”?

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What “Science” Allowed the Myths to Build and Why Do a Few Still Persist?… Studies of Acute vs. Chronic Effects:

Acute effects testing of non-caffeine consuming subjects (the “caffeine-naïve” subject)

Partial / full tolerance to caffeine develops in humans consistently consuming caffeine and coffee daily

… Most of the Myths and Fears are based on:

Massive doses of caffeine fed to pregnant animals Smaller, poorly done and not-well-controlled human

studies with confounding and biases Many unwarranted assumptions, erroneous analyses

and factual misrepresentations in the literature. 9

But since 2000 or so…

The “Good News” is that almost all of the earlier bad news about coffee and caffeine was WRONG!

Medical evidence has been building strongly that coffee and caffeine may actually be GOOD for us!!!

Let’s briefly examine the evidence for some of the myths and facts.

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“Beverage Caffeine Intakes in the U.S.”

• 96% of beverage caffeine consumed from coffee, soft drinks and tea; Coffee remains the largest contributor

• Energy drinks & shots and chocolate beverages contribute little to caffeine intakes

• Teenagers (13-17 years) or young adults (18-24 years) -9-10% of their caffeine comes from energy drinks

• Intakes from energy drinks represent less than 2% of total daily mean caffeine values for all caffeinated beverage consumers.

Sponsor: International Life Sciences Institute12

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Caffeine and Reproductive Effects

• Issue first began with birth defects (missing toes) in rats force-fed by stomach tube with very high-doses of caffeine (FDA, 1978)

• But no adverse effects were seen in FDA’s follow-up “sipping” study of the same high doses

• Human studies followed: delayed conception, premature birth, low birth weight babies, fetal death, spontaneous abortion (miscarriage), congenital birth defects

• 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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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)

• Risk reductions for Parkinson’s & Alzheimer’s diseases, depression & suicide.

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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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“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.”

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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Caffeine Interest by Non-U.S.

Regulatory Agencies

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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 mid-December, public review & consultation for 6-7 weeks, adoption by Spring 2015.

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Food Standards Australia New Zealand (FSANZ)

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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

• Lopez-Garcia 2006, 2006, 2008, 2011 – Harvard cohort studies, coffee & caffeine

• Greenberg 2008 – Framingham cohort, caffeinated coffee• Zhang 2009, 2009 – Harvard Nurses & Health Professionals cohort, men & women, coffee

• Wu 2009 – Meta-analysis of 21 cohort studies, coffee

• de Koning Gans 2010 – Coffee / tea & CHD / mortality / stroke

• Larsson 2011 – Meta-analysis, coffee / stroke

• Mesas 2011 – Meta-analysis, hypertensives, coffee RCTs & cohort studies

• Freedman 2012 – NIH-AARP cohort, coffee, total & cause-specific mortality

• Floegel 2012 – EPIC / Europe cohort study, coffee / chronic diseases

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Take Home Messages…

~Attackers should understand the

Caffeine literature before they accuse it as the causative agent!

~Caffeine in coffee, energy drinks & other foods and beverages is safe for human

consumption!

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Thank You for Your Attention!

jrcoughlin@cox.net