James R. Coughlin, PhD CFS

27th Annual SCAA Exposition & Symposium

Caffeine Scrutiny: A Closer Look at the Heightened Attention on Caffeine

Is the Increased Scrutiny about Caffeine’s Safety Justified?

I Don’t Believe It Is!

…Let’s Explore…

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Agenda

• Caffeine & Health Issues - My Historical Perspective • Beverage Caffeine Intakes • Caffeine - Key Safety Issues (Historical and Current)

• Reproductive Effects • Cardiovascular Effects - the Key Topic of Debate

• Caffeine and “Addiction” • Energy Drinks & Caffeine in Newer Foods / Beverages • U.S. Congress & FDA, Health Canada, EFSA, DGAC • Conclusions and Future Directions • Q & A’s

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“Caffeinated” - Journalist Murray Carpenter (2014)

“Making stops at the coffee farms of central Guatemala, a synthetic caffeine

factory in China, and an energy shot bottler in New Jersey, among numerous

other locales around the globe, Caffeinated exposes the high-stakes but murky

world of caffeine, drawing on cutting-edge science and larger-than-life characters

to offer an unprecedented understanding of America’s favorite drug.”

“This addictive, largely unregulated substance is everywhere—in places you’d

expect (like coffee and chocolate) and places you wouldn’t (like chewing gum and

fruit juice), and Carpenter reveals its impact on soldiers, athletes, and even

children. It can make you stronger, faster, and more alert, but it’s not perfect, and

its role in health concerns like obesity and anxiety will surprise you.”

My 34-Year Perspective on Caffeine / Health

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

…on “Well Conducted” & “Poorly Conducted” Science …on “Good” & “Bad” Policy Decisions & Extensive

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 force-fed massive doses (U.S. FDA, 1978); and hundreds of subsequent studies on reproductive & developmental effects in humans

• Caffeine and urinary calcium loss; osteoporosis risk? • Central Nervous System[CNS]: stimulant effects, anxiety,

sleep disturbance, “addiction”?

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Political Cartoon in 1986, when a coffee study claimed a link to heart attack

What “Science” Allowed the Myths to Build and Why Do a Few Still Persist?

… Studies of Short-term vs. Long-term 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

epidemiology studies with confounding and biases Many unwarranted assumptions, erroneous analyses

and factual misrepresentations in the literature.

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But since 2000 or so…

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

Medical and scientific 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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Caffeine Contents of

Various Beverages and

Daily Intakes

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Another source of scrutiny….

International Life Sciences Institute (ILSI) Caffeine Working Group Sponsorship

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“Beverage Caffeine Intakes in the U.S.”*

• 96% of beverage caffeine is 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 Institute

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Caffeine and Potential 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) – this started the huge furor over caffeine and birth defects

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

• 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 reproductive safety.

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Another source of scrutiny….

ILSI Caffeine Working Group Sponsorship

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ILSI Caffeine Working Group Sponsorship

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ILSI North America Scientific Session: "Caffeine - Friend or Foe?” Jan. 20, 2015, Phoenix

Caffeine: An Overview Harris Lieberman, PhD US Army Research Inst. of Environmental Medicine Behavioral Effects of Caffeine: An Update Andrew Smith, PhD University of Cardiff Reproductive Health Effects of Caffeine: An Overview of Epidemiologic Evidence Jennifer Peck, PhD University of Oklahoma Cardiovascular Effects of Caffeine: Role of Individual Genetic Variation Ahmed El-Sohemy, PhD University of Toronto Concluding Panel Discussion on Benefits and Risks James Coughlin, PhD, CFS Coughlin & Associates

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Cardiovascular Disease Issues

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The scrutiny is confusing and unwarranted… since recent data are positive

Caffeine and Increased Blood Pressure

• Previous small studies showed that short-term caffeine given to caffeine-naïve subjects increased BP, heart rate, plasma epinephrine & norepinephrine, plasma renin activity and urinary catecholamines

• In 1981, Robertson did a double-blind study of the effects of long-term caffeine 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.

Robertson, 1981. “Tolerance to the Humoral and Hemodynamic Effects of Caffeine in Man.”

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* All Cardiovascular 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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Encouraging findings continue …..

“Addiction”

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Yet another area for scrutiny to continue…..

Caffeine and “Addiction” has been an issue since the late 1980’s

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Caffeine and “Addiction”

• Dependence, tolerance and withdrawal headache were cited in many studies going back to the late 1980’s (but most early studies of psychiatric patients consuming up to 20 cups/day)

• These studies were begun by researchers who proved that nicotine was addictive; then turned to caffeine

• Headlines since the late 1980’s, such as:

• “Caffeine Addiction More Than Just Java Jive -- Caffeine Junkies”

• “Caffeine is a Drug of Abuse” • “Study Finds Caffeine Has Qualities of Addictive Drugs”

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Caffeine and “Addiction” (cont’d)

Current view from a recent major evaluation 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 in May 2013 after many years of study), but advised more research

• However, DSM-5 did recognize caffeine intoxication (massive

doses) and withdrawal disorder (headache)

• We believe that addiction over-warnings trivialize dangers of real drugs of abuse.

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Why the “Bad” Health Effects don’t deserve such scrutiny

• 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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• Alzheimers • Parkinson’s • Cancer research

– Liver – Breast – Endometrial – Oral – Pharyngeal – Esophageal – Colorectal

• Type II Diabetes

There is exciting news to share

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 and endurance sports performance

• 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 good news, 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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Why does the Scrutiny continue?

U.S. Congress and FDA Concerns

over Caffeine and Energy Drinks

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U.S. Senate Report Released April 2013

• Report by Offices of (then) Rep. Markey (D-MA), Sen. Durbin (D-IL) and Sen. Blumenthal (D-CT), April 10, 2013: – Inconsistent

representation and claims

– Inadequate labeling – Unsubstantiated claims

of benefits – Targeting children – Effects of other

constituents unknown

U.S. Senate Report Released January 2015

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Very Recent Studies / Scientific 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.”

Statement on Wrigley’s “Alert Energy” Caffeine Gum Withdrawal (May 2013) by 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 from 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 caffeine consumption 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 FDA Blog on Caffeine (August 2013)

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“Dietary Guidelines for Americans 2015” (8th Edition)

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DGAC’s Conclusions for Coffee and Caffeine (comment period extended to May 8)

• Coffee review was very reassuring: “Currently, strong evidence shows that consumption of coffee within the moderate range (3 to 5 cups per day or up to 400 mg/d caffeine) is not associated with increased long-term health risks among healthy individuals. In fact, consistent evidence indicates that coffee consumption is associated with reduced risk of type 2 diabetes and cardiovascular disease in adults. Moreover, moderate evidence shows a protective association between caffeine intake and risk of Parkinson’s disease. Therefore, moderate coffee consumption can be incorporated into a healthy dietary pattern, along with other healthful behaviors.” • Caffeine review was mostly focused on Energy Drinks: Children, adolescents and women who are pregnant or considering pregnancy should not consume very high levels of caffeine from beverages or supplements (e.g., energy shots, fortified foods).

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Caffeine Interest by Non-U.S.

Regulatory Agencies

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Food Standards Australia New Zealand (FSANZ)

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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 European Commission (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)

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EFSA’s Draft Conclusions (January 2015)

• EFSA received comments and feedback on the Draft through public consultations with stakeholders in March; Key provisional findings:

– Single doses of caffeine up to 200 mg and daily intakes of up to 400 mg do not raise safety concerns for adults (18-65 years).

– It is unlikely that caffeine interacts adversely with other constituents of “energy drinks” or with alcohol.

– For pregnant women, caffeine intakes of up to 200 mg per day do not raise safety concerns for the fetus.

– For children (3-10 years) and adolescents (10-18 years), daily intakes of 3 mg per kg of body weight are considered safe.

– Single doses of 100 mg may increase sleep latency and shorten sleeping time in some adults.

• EFSA basically endorsed these intake levels without doing their own risk assessment; higher intakes are still considered safe.

http://www.efsa.europa.eu/en/press/news/150115.htm

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Summary and Conclusions

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

Medical and scientific evidence has been building strongly that moderate coffee and caffeine intake is SAFE! Many well-done human studies even support the safety of higher intakes of coffee and caffeine In the last decade or so, hundreds of human studies have shown that coffee and caffeine may actually be GOOD for us!!!

~

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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Take Home Messages…

Thank You for Your

Attention!

James R. Coughlin, PhD CFS President, Coughlin & Associates

Aliso Viejo, California

jrcoughlin@cox.net www.linkedin.com/in/jamescoughlin

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