Presentation in Risk Communication Symposium, DIFSC Dubai, November 2019

1. California Proposition 65 Risk Communication
Case Study on Coffee and Carcinogens:
The “Coffee–Cancer Paradox”
James R. Coughlin, M.S. Ph.D. CFS
President, Coughlin & Associates
Aliso Viejo, California
jrcoughlin@cox.net
www.linkedin.com/in/jamescoughlin
Symposium - Food Risk Communication:
How to Ensure a Consistent, Balanced Risk
Analysis Approach
13th Dubai International Food Safety Conference
November 11, 2019

2. Presentation Outline
1. My Perspective on Coffee/Health and Risk Communication
2. What is California Proposition 65? What about Acrylamide?
3. What has been happening in the Prop 65 Coffee/Acrylamide/Cancer
Warning lawsuits since 2010?
4. IARC’s Conclusions on Coffee, 1991 and 2018
• Does Coffee cause human cancer? NO!
• Does Coffee protect against human cancer? YES!
5. Benefit - Risk Evaluation of Coffee – The “Holistic Approach”
6. “Coffee-Cancer Paradox” explained
7. Four Decades of Risk Communication Challenges!
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3. My 38 Years’ Perspective on Coffee/Caffeine & Health
 Tens of thousands of published studies…
 …on Rats, Mice & Humans
 …on Almost Every Disease
 …on “Good” & “Bad” Science
 …on “Good” & “Bad” Health/Regulatory Policy & Media Coverage
 …on Coffee/Caffeine’s Beneficial Health Effects
 During my first 15-20 Years: Much Bad News! Coffee & Caffeine were linked to
many animal toxicities and human diseases, but many early studies were small
and done very poorly! And the global media did much bad risk reporting!
 But since 2000 or so…The “GOOD NEWS” is that almost all of the earlier bad
news about coffee/caffeine was WRONG! The media reporting has been MUCH
more favorable!
~ So both may actually be GOOD FOR US!!! ~
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6. My “Baptism by Fire” into Risk Communication…
Out of the Frying Pan and into the Fire!
 Sodium Nitrite (1979):
• After my PhD and postdoctoral research on the Maillard Browning
Reaction, nitrite and carcinogenic N-nitrosamines (UC Davis, 1974-1979)
• My first industry position was at Armour Meat Company
• Faced nitrite ban in processed meats as an animal carcinogen, based on
a study by MIT researchers, but that turned out to be a false alarm!
• But 40 years later, processed meats are now classified by IARC as a
Group 1 “human carcinogen” while nitrite is not a carcinogen.
 Coffee / Pancreatic Cancer (1981):
• I moved to General Foods Corporation HQs in NY
• Harvard human study by prominent epidemiologist Dr. Brian MacMahon,
but that also turned out to be a false alarm!
• But here I am still talking to you today about coffee and cancer.
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7. Grocery Manufacturers Association Science Forum,
Washington, DC, March 2018
“Strategic Issues Session - When Science is Not Enough:
Communication Strategies to Turn Crisis into Success”
This session highlighted the challenges and opportunities arising
from global trends in food policy and the role of strategic
communications to build political and public support for desired
policy outcomes...focus on IARC decisions on meats, glyphosate and
coffee.
Karl Brophy, CEO, Red Flag Consulting
Bill Murray, CEO, National Coffee Association of USA
Jack Bobo, Chief Communications Officer, Intrexon
Kate Loatman, Executive Director, International Council of
Beverage Associations
~ I concluded that “The Science is Never Enough!” ~
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8. California “Proposition 65” - “Safe Drinking Water
and Toxic Enforcement Act of 1986”
 A California law passed by 66% of the voters
 Two major provisions for listed chemicals -
• “Right-to-Know” warnings on consumer products and in the
environment and workplace
• Prohibition of discharge of the chemicals into sources of drinking
water in the state
 Almost 1,000 carcinogens and reproductive/developmental toxicants have
been added to the Governor’s List, and more are added each year
 Manufacturers must determine for themselves if predetermined “safe
levels” of exposure are exceeded on a daily basis
 A chemical’s exposure must be determined as micrograms / day.
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11. Ammonia
Alkyl amines
Amino acids
Proteins
Phospholipids
Aldehydes
Ketones
Sugars
Carbohydrates
Lipids
Carbonyls
Esters
Amides (Acrylamide)
Heterocyclic Compounds
Amine
Carbonyl
Amino-Carbonyl
Interaction
(Amadori Products)
HEATHEAT
Furans Oxazoles
Pyrroles Imidazoles
Thiophenes Pyridines
Thiazoles Pyrazines
Melanoidins
(pigments)
Volatile Compounds
(aroma chemicals)
General Scheme of Maillard Browning Reaction

12. ACRYLAMIDE
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14. Acrylamide Battleground under California Prop 65
 Listed as a carcinogen in 1990; “Safe Harbor” level = 0.2 μg/day; but even if
it’s just barely detectable, a 1-ounce serving of any food exceeds this level
 French Fries & Potato Chips: California Attorney General’s lawsuits settled
in 2008; cancer warnings put up on fries, but not on chips
 Cereals: 2009 “Bounty hunter” lawsuit; Appeals court agreed in 2018 that no
cancer warning labels were required
 Other Foods: hundreds of products have been targeted since 2002
 “Brewed” Coffee lawsuit: Council for Education & Research on Toxics
(CERT) filed a lawsuit in April 2010; brewed coffee averages only about 10
ppb acrylamide; industry decided to put up cancer warning signs in
California coffee shops in 2011 [and they are still up!]
 “Roasted” Coffee lawsuit: CERT filed another lawsuit in May 2011, and a
huge court battle has ensued…and the fight is still on!
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16. Los Angeles Superior Court, “Roasted” Coffee
Lawsuit Brought by Council for Education and
Research on Toxics [CERT] in 2011
March 28,2018 Decision
Judge Berle, a non-scientist, decided
singlehandedly that none of the Coffee Companies’
arguments [legal or safety] won out
This court case is still ongoing
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18. Coffee and Human Cancer
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21. The Working Group actually came to a Group 4 conclusion at first,
“probably not carcinogenic to humans,” but the Monographs
Director forced them into a compromise to Group 3, claiming that
the downgrade from Group 2B (in 1991) to Group 4 was
impossible for IARC.
 They
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22. My Conclusions on IARC’s Coffee Evaluation
[Working Group 2016, Final Monograph 2018]
 The IARC Working Group was not able to associate even one human organ to an
increased risk of cancer due to coffee consumption, but concluded that coffee is
Group 3, “not classifiable as to its carcinogenicity to humans”. Monograph No. 116
was published in June 2018.
 Their correct evaluation on breast, prostate and pancreas cancer should have been
sufficient evidence to give coffee a Group 4, “probably not carcinogenic to
humans.” [but only 1 substance out of over 900 has ever gotten this IARC ranking].
 For liver and uterine endometrium cancers, where they correctly concluded
“reduced risk” of cancer, IARC would actually need to establish a new ranking
category of Group 5, “probably reduces the carcinogenicity to humans.”
 In sum, IARC’s final classification as Group 3 “not classifiable” is unsupported by
the vast scientific evidence on coffee and cancer…they got this wrong!
 But this was actually considered a “victory” for the global coffee industry, since
coffee did spend 25 years as Group 2B “possibly carcinogenic to humans” based
on the now recognized lack of association to human bladder cancer.
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“Coffee - Cancer Paradox”
Using a “Benefit-Risk” and “Holistic”
Approach for Coffee and Cancer Risk
Assessment
[modeled on the “French Wine Paradox”]

24. The “Coffee / Cancer Paradox”
 In 2007, I coined the term “Coffee-Cancer Paradox” – which results from doing a
“Benefit-Risk” evaluation using the “Holistic Approach” – looking at the whole food or
beverage, a paradigm we should be exploring more often
 All global health and regulatory authorities, including IARC and Prop 65, now agree
that coffee drinking is NOT causing any increased risk of human cancer
 In fact, hundreds of human studies show significant risk reductions for numerous
cancers, in spite of the presence of many animal carcinogens [like acrylamide, furan,
furfuryl alcohol, 4-MEI, PAHs, Ochratoxin A, aldehydes & other carbonyls] at low “parts
per billion” concentrations in brewed coffee
 How can this be? What is protecting against cancer?
 Coffee’s naturally occurring antioxidants (the chlorogenic acids)
 Heat-formed antioxidants (coffee’s brown color, the melanoidin polymers) having
these properties: chemo-preventive, antioxidant, antimicrobial, soluble dietary
fiber, chelate toxic metals, probably improve the microbiome
 Chemicals in coffee can induce detoxification enzymes, mainly Glutathione-S-
transferase, which is well known to detoxify acrylamide itself
So, here is the Paradox – Coffee contains dozens of animal
carcinogens at trace levels, but it actually reduces some organ
cancer risks in people without causing cancers in any other
organs.
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25. California Prop 65 Regulation Finally Exempts Coffee
from Cancer Warnings [June 2019] Based on IARC
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30. Consumer Reports Magazine
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32. THE Health Beverage!!!

34. Thank You!
~
Questions ? during Panel
James R. Coughlin, MS PhD CFS
jrcoughlin@cox.net
1-949-916-6217
www.linkedin.com/in/jamescoughlin