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“Government Perspectives and Consumer
Insights on Label Claims”
An Information Webcast from the International Food
Information Council Foundation
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• Moderators:
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International Food Information Council Foundation
– Eric Mittenthal, MS
Director, Media Relations
International Food Information Council Foundation
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and Consumer Insights on Label Claims”
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Today’s Agenda and Speakers
Food Labeling: Health Claims
Crystal Rasnake Rivers, MS
Food and Drug Administration
The Federal Trade Commission’s Approach to Health Benefits Claims
Anne V. Maher, JD
Kleinfeld, Kaplan & Becker, LLP
Claims, Consumers, Communication: A Quick Look at Food Culture
and Consumer Behavior
Nancy Childs, PhD
St. Joseph’s University
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International Food Information
Council Foundation
Mission:
To effectively communicate sciencebased information on health, nutrition,
and food safety for the public good.
Primarily supported by the broad-based
food, beverage and agricultural industries.
http://www.foodinsight.org
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Dial: 800-658-3095
Access Code: 964856914#
International Food Information Council and
Foundation Consumer Research
•
Food & Health Survey: Consumer Attitudes toward Food,
Nutrition, and Health (2006-2010)
•
Functional Foods/Foods for Health Consumer Trending
Survey (1998-2009)
•
Food Label Quantitative Web Survey and Experiment (2008)
•
Food Label Ethnographic and Focus Group Research (2006)
•
Qualified Health Claims Consumer Research Project – Focus
Groups and Web Survey and Experiment (2005)
•
Food Label & Calorie Research: Qualitative Research
Findings (2004)
•
Impact of Trans Fat Label Information on Consumer Food
Choices (2003)
www.foodinsight.org
Food Labeling:
Health Claims
Crystal Rasnake Rivers, MS
Nutrition Science Review Team, Nutrition Programs Staff
Office of Nutrition, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Nutrition Labeling & Education Act
of 1990 (NLEA)
• Amended the Federal Food And Drug
Cosmetic Act
• Basis for modern food label
• Provided for
– Mandatory Nutrition Facts panel
– Voluntary nutrition claims
• Nutrient content claims when defined by FDA
• Health claims when authorized by FDA
Nutrition Labeling & Education Act
of 1990 (NLEA)
• Rationale:
– Assist consumer in maintaining healthy
dietary practices
– Provide level playing-field for claims
– Encourage reformulation of food
products
Types of Claims
• Health Claims
– Authorized (Significant Scientific
Agreement, SSA)
– Qualified Health Claim
– Food Drug and Modernization Act
(FDAMA)
• Structure/Function Claims
• Dietary Guidance Statements
• Nutrient Content Claims
– FDAMA
Labeling Claims
Pre-Market Authorization Required?
• Health Claims (SSA and QHC) - Yes
• Nutrient Content Claims - Yes
• Structure/Function Claims - No
• Dietary Guidance- Health Messages- No
Structure/Function Claims
• Describe the role of a nutrient or dietary ingredient
intended to affect normal structure or function in
humans
– “Calcium builds strong bones”
• May characterize the means by which a nutrient or
dietary ingredient acts to maintain such structure
or function
– “Antioxidants maintain cell integrity”
– “Fiber maintains bowel regularity”
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm
Structure/Function Claims
(Contd.)
• Not pre-approved by agency
• All claims must be truthful and not
misleading
• Dietary supplements must notify FDA of
claim within 30 days after marketing
• Dietary supplements must include a
disclaimer that states FDA has not
evaluated the claim and the supplement is
not intended to "diagnose, treat, cure or
prevent any disease,“
• Foods do not need disclaimer statement
Dietary Guidance – Health
Messages
– Not a specific substance (food or food
component)
• Category of food (Fruits & Vegetables)
• General dietary guidance – Dietary Guidelines
Choose fiber-rich fruits, vegetables, and whole
grains often
Health Claim
• “Health Claim” is an expressed or implied
statement in food labeling about the relationship
of a food substance to a disease or healthrelated condition.
(21 U.S.C. 343(r)(1)(B); 21 CFR
101.14(a)(1))
• Not just “any claim about health”
• Require Pre-approval by FDA
• Can be used on conventional foods and dietary
supplements
Elements of a Health Claim
Substance
“A specific food (tomato) or component of food
(lycopene), whether in conventional food or dietary
supplement form …” (21 CFR 101.14(a)(2))
Disease or Health-Related Condition
“Damage to an organ, part, structure, or system of the
body such that it does not function properly (e.g. CHD),
or a state of health leading to such dysfunctioning (e.g.
hypertension)”
(21 CFR 101.14(a)(5))
Elements of a Health Claim
(SSA and QHC)
Causal relationship between a substance
and a disease or health-related condition
for the general U.S. population or
subpopulation (e.g., women, elderly)
– Ability to reduce the risk of disease
Not treat, prevent, cure or mitigate
 Drug
(Whitaker v. Thompson, 353 F.2d 947 (D.C. Cir. 2004))
Health Claims Characterize a Risk Reduction
Relationship Between Diet and Disease or
Health-Related Condition
Food or Food Component
Disease Risk
Reduction
Health-Related
Condition
(e.g., hypertension or
elevated LDL cholesterol)
Drug
Treat/Cure
Disease,
mitigate
Symptoms
or Signs
1990 Health Claim Standard
• NLEA permits authorization…only when it has
determined, based on the totality of publicly
available scientific evidence (including evidence
from well-designed studies conducted in a
manner which is consistent with generally
recognized scientific procedures and principles),
that there is significant scientific agreement
(SSA), among experts qualified by scientific
training and experience to evaluate such claims,
that the claim is supported by such evidence.
SSA Standard
• “…represents the agency’s best judgment as to whether
qualified experts would likely agree that the scientific
evidence supports the substance/disease relationship
that is the subject of a proposed health claim.”
• “SSA does not require a consensus or agreement based
on unanimous and incontrovertible scientific opinion.
However, on the continuum of scientific discovery that
extends from emerging evidence to consensus, it
represents an area on the continuum that lies closer to
the latter than to the former.”
Health Claims (SSA)
• Authorized claims (NLEA)
Notice and Comment Rulemaking
(540 days)
• Food and Drug Modernization Act
(FDAMA 1997)
Notification (120 days)
FDAMA
• Such claims (health or nutrient content) are
based on current, published, authoritative
statements from certain federal scientific
bodies, or the National Academy of
Sciences or any of its subdivisions
• Intended to expedite the process by which
the scientific basis for such claims is
established
Example: Potassium and reduced risk of high blood
pressure and stroke
Process for Authorizing SSA
Health Claims
•
•
•
•
Review petition for completeness
File petition (publicly available – dockets)
Conduct regulatory and science review
Draft denial, proposed or interim final rule
(Fed Reg)
• Public comment
• Draft final rule (Fed Reg) (540 days)
• If needed, request extension
Reviewing the Scientific Evidence





Define substance/disease relationship
Identify relevant studies
Classify studies
Rate studies for quality
Rate for strength of body of evidence:
quantity, consistency, relevance
Evidence Based Review of Health
Claims
Selected Authorized Health
Claims
•
•
•
•
•
•
•
•
Calcium and osteoporosis
Dietary fat and cancer
Dietary saturated fat and cholesterol and heart disease
Fiber containing grain products, fruits and vegetables
(certain foods) and cancer
Fruits, vegetables and grain products (soluble fiber) and
heart disease
Non-cariogenic sweeteners and dental caries
Soy protein and heart disease
Plant stanols /sterols ester and heart disease
For full wording of these claims and eligibility criteria please see
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingN
utrition/FoodLabelingGuide/default.htm
Model Claim Statements (SSA)
“Low fat diets rich in fiber-containing grain products,
fruits, and vegetables may reduce the risk of some
types of cancer, a disease associated with many
factors.”
Or
“Diets low in saturated fat and cholesterol that
include 25 grams of soy protein a day may reduce
the risk of heart disease.” A serving of [name of
food] supplies __ grams of soy protein
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocument
s/FoodLabelingNutrition/FoodLabelingGuide/default.htm
What About Claims Not Meeting
SSA Standard?
Qualified Health Claims are based on
scientific evidence that is credible but that
does not meet the SSA standard
• include qualifying language to prevent
consumers from being misled about the
level of support for the claim
• considered under FDA’s exercise of
enforcement discretion (not authorized by
regulation)
Why Qualified Health Claims?
Court challenges under first amendment;
unconstitutional restriction on commercial
speech
1999 Pearson v Shalala
Process for Issuing Enforcement
Discretion for QHCs
•
•
•
•
•
Review petition for completeness
File petition (publicly available - dockets)
60-day comment period
Regulatory and science review
Draft denial letter or letter of enforcement
discretion (270 days) – not a regulation
• If needed, request extension
Qualified Health Claims
• QHCs: Heart Disease
– Omega 3 fatty acids (EPA/DHA)
– Monounsaturated fatty acids from olive oil
– Unsaturated fatty acids from corn oil
– Walnuts
– Nuts
– B vitamins and vascular disease
• QHCs: Cancer
– Calcium and colon/rectal cancer
– Green tea and breast/prostate cancer
– Selenium and certain cancers
– Antioxidant vitamins and certain cancers
– Tomato and prostate cancer
For full wording of these claims and eligibility criteria please see
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/default.htm
Denied Qualified Health Claims
• Calcium and menstrual disorders
• Calcium and kidney stones
• Calcium and cancer (other than breast and
prostate)
• Gluosamine/chrondroitin sulfate and
Osteoarthritis
• Fiber and cancer
• Lycopene and cancers
• Vitamin E and heart disease
• Lutein and macular degeneration
• Green tea and heart disease
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/default.htm
Model Claim Statements (QHC)
• Monounsaturated Fatty Acids from Olive
Oil and Coronary Heart Disease (Oct.
2004)
“Limited and not conclusive scientific evidence
suggests that eating about 2 tablespoons (23
grams) of olive oil daily may reduce the risk of
coronary heart disease due to the
monounsaturated fat in olive oil. To achieve this
possible benefit, olive oil is to replace a similar
amount of saturated fat and not increase the
total number of calories you eat in a day. One
serving of this product contains [x] grams of olive
oil.”
Who Can Use Health Claims?
Once a health claim is either authorized
(SSA level) or issued through a letter of
enforcement discretion (QHC), any
manufacturer may make the claim on the
label (conventional food or dietary
supplement), if the requirements as stated
in the regulation or in the letter of
enforcement discretion are met.
Disqualifying Nutrient Levels
(All Health Claims)
Means the levels of total fat, saturated fat,
cholesterol, or sodium in a food above
which the food will be disqualified from
making any health claim.
(21 CFR 101.14(a)(4))
Specific Disqualifying Levels for
Foods
•
•
•
•
Total fat:
Saturated fat:
Cholesterol:
Sodium:
13 g
4g
60 mg
480 mg
per RACC, per label serving size, and only for
foods with RACCs of 30 g or less or 2 Tbsp or
less, per 50 g
Minimum Nutrient Contribution
Requirement (“jelly bean rule”)
Must contain prior to any nutrient
fortification, 10% or more of the DV for
vitamin A, vitamin C, iron, calcium, protein,
or dietary fiber per RACC
(21 CFR 101.14(e)(6))
Exemptions to “jelly bean rule”
• To ensure use of health claims is
consistent with “Dietary Guidelines for
Americans” and not used on foods of little
nutritional value; however…
• FDA may exempt where use of a health
claim assists consumers in achieving
healthy dietary practices
• Case-by-Case
Thank You
http://www.fda.gov/Food/LabelingNutrition/default.htm
The Federal Trade Commission’s Approach to
Health Benefits Claims
Presentation by
Anne V. Maher
Kleinfeld, Kaplan & Becker, LLP
International Food Information Council Webinar
Washington, DC
∞
November 17, 2010
TOPICS




Basics of FTC’s Advertising Law
Identifying Claims and Determining Ad
Meaning
FTC’s Ad Substantiation Policy
Current FTC Ad Enforcement Priorities
FTC Jurisdiction

Section 5 of the FTCA broadly prohibits “unfair
and deceptive acts and practices”

Sections 12 and 15 (pertaining to FDA regulated
products) prohibits “false advertising” that is
“misleading in a material respect.”
Reach of FTC Act

Act applies to representations for:


virtually all products and services
in all types of communications – e.g., print,
broadcast, websites, direct mail, telemarketing
scripts, point-of –purchase displays, banner
and pop up ads, WOM marketing, blogs and
even labels.
Who is Liable?


All parties who participate directly or
indirectly
Not just manufacturers, but ad agencies,
distributors, retailers, catalogue
companies, infomercial producers,
individuals, expert endorsers call centers
FTC/FDA Jurisdiction


Overlapping authority
Liaison agreement:



FDA: labeling
FTC: advertising
Agencies coordinate closely on food &
dietary supplement policy issues
Basic Principles of FTC
Advertising Law


Advertising must be truthful and not
misleading
Objective claims must be substantiated
before they are made
When is an Ad Deceptive
1983 Deception Policy Statement



Representation or omission likely to
mislead the consumer
Acting reasonably under the circumstances
Misrepresentation must be material
Identifying Claims and
Interpreting Ad Meaning




Consumer driven
Express and implied claims
Net impression of ad
Disclosure of material information
When To Disclose Qualifying
Information

Disclosure of material information in light
of representations made or suggested


E.g., limited applicability of advertised benefit
significant safety concerns
FTC’s 1994 Food Advertising
Enforcement Policy Statement

How FTC harmonizes its advertising policy with
NLEA/FDA labeling regulations

Nutrient Content Claims: FTC uses same
definitions (“low fat” definition same in ad as on
label)

Comparative Nutrient Content Claims – follows
FDA’s definition of “less” and “more”

allows broader range of comparisons as long as
significance of difference is not overstated
FTC’s 1994 Food Advertising
Enforcement Policy Statement (con.)

Unqualified health claims in advertising should
meet FDA's significant scientific agreement
standard

Qualified health claims may be permitted,
although not yet authorized by the FDA, if the
claims are expressly qualified to convey clearly
and fully the extent of the scientific support.
FTC’s 1994 Food Advertising
Enforcement Policy Statement (con.)
“Carefully Qualified”

Qualified claims must be “presented in a manner
that ensures that consumers understand both the
extent of the support for the claim and the
existence of any significant contrary view within
the scientific community.”
FTC Ad Substantiation Policy
1984 Policy Statement

Before disseminating an ad, advertiser
must have a “reasonable basis” for all
express and implied claims

For health-related claims, a reasonable
basis consists of “competent and reliable
scientific evidence.”
Competent and Reliable
Scientific Evidence Standard


“Tests, analyses, research studies conducted in an
objective manner by persons qualified to do so, using
procedures generally accepted in the profession to yield
accurate and reliable results”
Some recent orders have elaborated on this standard
(see below)
FTC Substantiation Guidance
(1998)



Purpose to give some
flesh to the “c&r scientific
evidence” standard
through simple
explanations and
hypothetical examples
Tailored to the dietary
supplement industry, but
applies equally to claims
for foods
Available at www.ftc.gov.
Competent and Reliable
Scientific Evidence Standard

Rigorous but flexible standard: level of
evidence depends on nature of claim

Key question: what would experts in the
field consider adequate?
Competent and Reliable
Scientific Evidence Standard





Generally, well-controlled human clinical
studies
High quality (controlled, double blinded)
Consistent w/ larger body of evidence
Match btwn claim and studies (dose, form,
route of administration, degree of effect)
Should not exaggerate certainty of science
Remedies/Penalties in Food
Advertising Actions

Prohibition against future claims



Disclosure/Informational Remedies



Claims challenged
“Fencing in” to reasonably related conduct
Disclaimers/Warnings in future advertising
Corrective Advertising
Monetary Relief

Uncommon in food - as opposed to dietary
supplement – but that may be changing
Recent changes to Substantiation
requirements in FTC consent Orders


In some orders, FTC is defining “competent
and reliable scientific evidence” more
concretely with regard to certain categories of
claims
Reason: to provide clearer guidance that will
facilitate the defendants’ compliance with the
FTC order and make the order easier to
enforce.
New Order Provisions – 1st Tier


Specified Disease Claims: Where defendant made claims
that product could treat, cure, prevent, or reduce the risk
of disease, order will require such claims to be approved
by FDA:
 through OTC drug monograph or approved new
drug application (in the case of diet supps, and
food, if company made treatment/cure claims for
food), or
 By regs under Nutrition Labeling and Education Act
(in case of foods)
Bottom Line: if claim would not be permitted in labeling,
the order won’t permit it in advertising
New Order Provisions – 2nd Tier


For weight-loss claims and claims of reduced
duration of acute diarrhea, reduced absences
from school/daycare due to illness:
orders define “competent and reliable
scientific evidence” as consisting of at least
two adequate and well-controlled human
clinical studies of the Covered Product, or of an
Essentially Equivalent Product
New Order Provisions – 3rd Tier


This provision generally covers broad categories of
products and claims beyond those specifically challenged
in the complaint
Claims about the health benefits, performance, or efficacy
of foods, drugs, or diet supps:
 Standard “competent and reliable scientific evidence”
language with two clarifications:
 Both quality and quantity of evidence must meet
accepted scientific norms
 Evaluate studies in context of entire body of relevant
evidence
Current Enforcement Priorities in Food
and Supplement Advertising Area




Treatment/cure/prevention claims –
especially if numerical
Immunity claims
Products for children’s health/performance
Weight Loss
Anne V. Maher
Kleinfeld Kaplan & Becker
1140 Nineteenth St. NW
Washington, DC 20036
202-223-5120
[email protected]
CLAIMS
CONSUMERS
COMMUNICATION:
A Quick Look at Food Culture and
Consumer Behavior
Nancy Childs
Professor of Food Marketing
Saint Joseph’s University
IFIC Forum - November 17, 2010
In the U.S. approximately…
One billion
eating occasions
a day
1,000,000,000
Agenda Highlights
WHAT WE KNOW ABOUT CONSUMERS
AND FOOD
WHAT WE KNOW ABOUT CONSUMERS
AND FOOD LABELS
LOOKING FURTHER AHEAD
WHAT WE KNOW ABOUT
CONSUMERS AND FOOD…
Consumers are not alike!
Demographic
Sociographic
Psychographic
Life Stage
Medical Status
Health Beliefs
Diets
Many dimensions in our relationship
with food
Sensory
Social
Emotional
Financial
Setting
Health -Nutrition
Beliefs & Restrictions:
Religion
Vegetarian
Cultural, Allergies, etc.
Cost
Taste
Nutrition
Convenience
We are moving targets.....
Demographics
Attitudes
Lifestage
Checked when purchasing a
product for first time…
2008 %
2009 %
Price
71
76
Nutrition Label or Ingredients
43
47
Health Claims
29
25
Brand Name
28
26
Organic Claims
15
15
2009 US Grocery Shopper Trends, FMI Research
Price dominates but nutrition information
gaining importance
Consumers and Food Culture
Taste is SUPREME
But
price and convenience govern in today’s
real world
… food access, literacy, and nutrition literacy
Lifestyle, Food Culture
& Behavior Change
• When and why?
Where we purchase food…
• 49% of the food dollar spent in restaurants
• Typical day over 130 million consumers are
food service patrons
NRA Restaurant Industry Forecast, 2010.
ADULTS EAT ALONE OR WITHOUT CHILDREN
Food Buzz
Fresh
Local
Artesian
Affordable
Fast Casual
Home Grown
Everyone is a food expert today
• Cooking is a spectator
sport
• Celebrity chefs and food
authors have cultural
authority
• Cooking now a hobby
Obesity remains overwhelming…
NCHS (Natl Ctr Health Stat.), Health US, 2009, released 2010
WHAT WE KNOW ABOUT
CONSUMERS AND FOOD LABELS…
So much competition for attention
Nutrition Facts Panel dominates
• Credible information
source
• Familiar and trusted
• Years of consumer
education
Consumers want information…
• Economics 101 – “Rational human” seeks
information
On food labels and menu labels (if asked)
…but it doesn’t guarantee use
Awareness
Understanding
Action - Behavior Change
Label information does assist…
• Directly assists consumers who are
knowledgeable and seeking information
• Increases nutrition media coverage
• Often accompanied with nutrition
differentiated advertising
• Incrementally adds to consumers’ nutrition
knowledge base
• Directly impacts manufacturer formulations
• Results in a healthier range of
product choice
Caveats on consumer understanding
• Food category preconceptions dominate
• Emotions trump science – marketing works
OR emotions can support science…
Claim length matters…
• Front panel dominates – total impression and
purchase influence
• Back panel shares specific information
• Short and long claims have similar
understanding
• More information on front of package leads to
better nutrition discrimination
• Nutrition Facts Panel retains primary
credibility over claims and front of package
More findings….
• “Magic bullets” generally not convincing
• When discussing food, consumers relate to
benefits, not disease
• Dissonance is disturbing
• More label use if:
Special diet
Higher income
Better nutrition knowledge
LOOKING FURTHER AHEAD…
What we need going forward...
• Innovative approaches to encourage label use
among those with less healthy dietary habits
• Penetrate consumer food category beliefs
• Providing and rationalizing nutrition
information in all eating situations
In Conclusion…
Claims and Front of Package contribute
directly (label information) and indirectly
(expanded product choices and external
information sources) to increased
consumption of healthier products.
Consumers and products are moving
targets
Nutrition Information
and the Rational Human
Not a panacea
BUT
Useful
A forward influence
An educational process
Nancy Childs, PhD.
THANK YOU
[email protected]
Questions and Answers
[email protected]
CPE Credit
At the conclusion of this web cast,
Registered Dietitians can download a
Certificate of Completion for 1.0 CDR
Continuing Professional Education credits
at: FoodInsight.org “Hot Topics”
THANK YOU!
For more information:
International Food Information Council Foundation
1100 Connecticut Avenue NW, Suite 430
Washington, DC 20036
Phone: (202) 296-6540
Web: http://www.foodinsight.org