Government Perspectives and Consumer Insights on Label Claims An - - PowerPoint PPT Presentation

“Government Perspectives and Consumer Insights on Label Claims”

An Information Webcast from the International Food Information Council Foundation

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Welcome!

• Moderators:

– Elizabeth Rahavi, RD Associate Director, Health and Wellness International Food Information Council Foundation – Eric Mittenthal, MS Director, Media Relations International Food Information Council Foundation

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Questions and Answers

At any time during the webcast you can send questions to: foodandhealth@ific.org We will answer questions at the end of the web cast. Please follow us @foodinsight, @ificmedia A PDF copy of these slides will be available after the web cast at FoodInsight.org, search “Hot Topics” and “Government Perspectives and Consumer Insights on Label Claims” CPE Certificates will also be available on the same page

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 science- based 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

To Join the Audio Portion 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

• f 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

• f 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

• r 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

• f a food substance to a disease or health-

related 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),

• r 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-Related Condition (e.g., hypertension or elevated LDL cholesterol) Treat/Cure Disease, mitigate Symptoms

• r Signs

Food or Food Component Drug Disease Risk Reduction

Health Claims Characterize a Risk Reduction Relationship Between Diet and Disease or Health-Related Condition

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
• n 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

• 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

Qualified Health Claims

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

• il.”

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: 13 g
• Saturated fat: 4 g
• Cholesterol: 60 mg
• Sodium: 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,

• r 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

• f 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

• bjective 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

 Claims challenged  “Fencing in” to reasonably related conduct

 Disclosure/Informational Remedies

 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

• f 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

• f 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 amaher@kkblaw.com

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 Health -Nutrition Beliefs & Restrictions:

Religion Vegetarian Cultural, Allergies, etc.

Taste

Cost Convenience Nutrition Setting

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

Price dominates but nutrition information gaining importance

2009 US Grocery Shopper Trends, FMI Research

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

THANK YOU

Nancy Childs, PhD. nchilds@sju.edu

Questions and Answers foodandhealth@ific.org

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