Reading Labels for Health and Profit

April 23, 2015

Dr. Julie B. Hirsch

http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf

http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM437566.pdf

Today’s Sources

The American Food Industry

• Contributes about 20% of the U.S. GNP

• Employs about 14 million individuals

• Provides an additional 4 million jobs in related industries

U.S. Food and Drug Administration (FDA)

• Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective

• Protecting the public from electronic product radiation • Assuring cosmetics and dietary supplements are safe and properly

labeled • Regulating tobacco products • Advancing the public health by helping to speed product innovations • Helping the public get the accurate science-based information they

need to use medicines, devices, and foods to improve their health

Protecting and Promoting Your Health

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htmCFSAN

Center for Food Safety and Applied Nutrition (CFSAN)

• The Center regulates: $417 Billion worth of domestic food $49 Billion imported food $60 Billion in cosmetics

377,000 registered food facilities that manufacture, process, pack, or hold food consumed by humans or animals in the US and several thousand cosmetic firms

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/WhatWeDo/default.htm

CFSAN primary responsibilities

• the safety of substances added to food• seafood and juice Hazard Analysis and Critical Control Point

(HACCP) regulations • regulatory and research programs to address health risks associated

with foodborne, chemical, and biological contaminants • regulations and activities dealing with the proper labeling of foods

(e.g., ingredients, nutrition health claims) • regulations and policy governing the safety of dietary supplements,

infant formulas, and medical foods • food industry postmarket surveillance and compliance • industry outreach and consumer education

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/WhatWeDo/default.htm

Foods and Packaging

FDA does not pre-approve labels for food products

Food Packages and Labels

Principal Display Package (PDP)Front of Package (FOP)

Nutrition Facts Panel

The FDA is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled.

FDA's regulatory authority for food and cosmetics comes from:• The Federal Food and Drugs Act of 1906 • The Federal Import Milk Act (1927) • The Federal Food, Drug, and Cosmetic Act of 1938• The Public Health Service Act (1944) • The Fair Packaging and Labeling Act (1966) • The Infant Formula Act of 1980, as amended • The Nutrition Labeling and Education Act of 1990 • The Dietary Supplement Health and Education Act of 1994 • Food Allergen Labeling and Consumer Protection Act, 2004 • Food and Drug Administration Amendments Act of 2007 • Other Related Statutes

Food Packages and Labels – Role of FDA

FDA oversees

• Ingredients• Nutrition facts• Nutrient content claims• Raw fruits, vegetables, fish• Allergy information

Nutrition Facts Panel

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm2006828.htm

Food Labeling GuideSeptember 1994; Revised April 2008; Revised October 2009. Revised January 2013

http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf

Why Read the Food Package?

1. Make informed choices

2. Determine nutritional value

3. Compare similar products

4. Increase awareness of the links between good nutrition and reduced risk of chronic diet related diseases

Why eat/buy Cheerios?

Cheerios is clinically proven to be the only leading cold cereal to help lower

cholesterol in a low fat diet

80s

Early 90s

Memory:Ate as a

KidHealthy

Good as a

Snack

Tastes Great

Babies Love Them

Nice Texture/Crunchy

Packaging/Labeling of Foods

RequiredFront• Product Name• Manufacturer• Net WeightElsewhere• Ingredients (by concentration)

• Nutrient Content Nutrition Facts Panel

Allowed/Regulated

Comparisons• Nutrient Content Claims

High, low, potency

• Dietary Guidance Relevance to Food Guide Pyramid

Health Claims• Health Claims

• Qualified Health Claims

• Structure Function Claims

Requirement

Calories

Protein

Carbohydrate

Fat

Vitamin A Vitamin C

CalciumIron

Sodium

Cholesterol

Macronutrients

Calories

Micronutrients

Others Cholesterol Sodium

2

1

4

3

How to Understand and Use the Nutrition Facts Label

The % Daily Values (%DVs) are recommendations for key nutrients for a 2,000 calorie daily diet

%DV • To be used as a frame of reference • Helps you determine if a serving of food is high or low in a nutrientNote: a few nutrients, like trans fat, do not have a %DV

http://www.fda.gov/Food/LabelingNutrition/ConsumerInformation/ucm078889.htm

More Nutrition Facts

Can add more nutrients to the Nutrition Facts

panel if you fortify

Can highlight ‘healthfulness’ by including

unsaturated fats http://nutritiondata.self.com/

Proposed Changes to the Nutrition Facts Panel: NEW GUIDELINES

• Greater Understanding of Nutrition Science

• Updated Serving Size Requirements and New Labeling Requirements for Certain Package Sizes

• Refreshed Design

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm385663.htm

MARCH 7, 2014

What’s in the foodNCC Nutrient Content Claim21 CFR 101.13(b), 21 CFR 101.13(a)

Why the food is good for you

http://www.fda.gov/Food/LabelingNutrition/LabelClaims/default.htm

Increasing Scientific Rigor

A claim that expressly or implicitly characterizes the level of a nutrient low in saturated fat no sodium high in vitamin C fat free

Look for FLAGS

Content

Comparison

                                              

                                     

Content Claims

Phrase % DRI

Excellent source 20% or more

Good source 10%

Free Depends on nutrient

In General MUST have more than 10% of nutrient

Relative Claims

Light, Lite, Reduced, Less, More, Fewer• Need reference food

• Must be same type for comparison

• Must state reference food and % difference

• Must be prominent on label

• Cannot use if reference already meets claim

Note: strict regulations as to when and how you can say what you want to say

• Calories• Sugar• Sodium • Fat• Cholesterol

Types of HEALTH Claims allowed

A. Health Claims

B. Qualified Health Claims

C. Structure/Function Claims

LEAST Scientific Evidence

MOSTScientific Evidence

Health Claims (Unqualified)

“Characterize The Relationship” Of A Food “To A Disease Or Health-Related Condition”

• MUST be FDA approved Currently 12 specific “health” claims

• All about PREVENTION – reducing RISK “may help to reduce the risk … (of a disease)”

Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims1 January 2009http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm073332.htm

Health Claims APPROVAL

1. Submit petition Show proof from publicly available scientific evidence of the

effects

2. Need Significant Scientific Agreement among experts (SSA)

There is a very high standard of scientific proof required before FDA can be expected to issue

such a regulation

1. Calcium, Vitamin D, and Osteoporosis

2. Dietary Lipids (Fat) and Cancer

3. Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease

4. Dietary Non-cariogenic Carbohydrate Sweeteners and Dental Caries

5. Fiber-containing Grain Products, Fruits and Vegetables and Cancer

6. Folic Acid and Neural Tube Defects

Approved Health Claims

7. Fruits and Vegetables and Cancer

8. Fruits, Vegetables and Grain Products that contain Fiber, particularly Soluble fiber, and Risk of Coronary Heart Disease

9. Sodium and Hypertension

10. Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease

11. Soy Protein and Risk of Coronary Heart Disease

12. Stanols/Sterols and Risk of Coronary Heart Disease

Health claims on labels

Website regulation different – FTC not FDA

Health Claims

Qualified Health Claim

If FDA concludes that it cannot approve a proposed “health claim”

because the claim is not supported by “significant scientific agreement”

the agency may instead approve a

“qualified health claim”

QHCs are still based on the totality of publicly available evidence but the scientific support does not have to be as strong as that for SSA

ALL Qualified Health Claims Allowed by FDA

ALL Qualified Health Claims Allowed by FDACancer Risk

Tomatoes and/or Tomato Sauce & Prostate, Ovarian, Gastric, and Pancreatic Cancers (F) Calcium and Colon/Rectal Cancer & Calcium and Recurrent Colon/Rectal Polyps (S) Green Tea & Cancer Selenium & Cancer (S) Antioxidant Vitamins & Cancer (S)

Cardiovascular Disease Risk Nuts & Heart Disease Walnuts & Heart Disease Omega-3 Fatty Acids & Coronary Heart Disease (F/S) B Vitamins & Vascular Disease (S) Monounsaturated Fatty Acids From Olive Oil and Coronary Heart Disease (F) Unsaturated Fatty Acids from Canola Oil & Coronary Heart Disease (F) Corn Oil & Heart Disease (F)

Cognitive Function Phosphatidylserine (soy derived) & Cognitive Dysfunction and Dementia (S)

Diabetes Chromium Picolinate & Diabetes (S)

Hypertension Calcium & Hypertension, Pregnancy-Induced Hypertension, and Preeclampsia (S)

Neural Tube Birth Defects 0.8 mg Folic Acid & Neural Tube Birth Defects (S)

KEY:(F) Food also in blue(S) Supplements ONLY

Qualified Claims Language

http://www.ift.org/pdfs/expert/ff/FinalReport.pdf

Structure Function Claims

Role of a nutrient or dietary ingredient intended to affect the structure or function in humans

• Cannot talk about disease

• General reference

• Examples: Builds strong bones Does not cause tooth decay For a healthy heart

Structure Function Claim

Structure Function ClaimsStructure

Function Claim

Structure/Function Regs

http://www.ift.org/pdfs/expert/ff/FinalReport.pdf

Structure Function Claim

Proposed Changes to the Nutrition Facts Panel: NEW GUIDELINES

• Greater Understanding of Nutrition Science

• Updated Serving Size Requirements and New Labeling Requirements for Certain Package Sizes

• Refreshed Design

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm385663.htm

MARCH 7, 2014

Dietary Guidelines

http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm

100% Organic must contain

(excluding water and salt) ONLY organically certified produced ingredients

The USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food.  Organic food differs from

conventionally produced food in the way it is grown, handled, and processed.

ORGANIC must consist of at least

95% organically produced ingredients (excluding water and salt)

Made with Organic Ingredients

Processed products that contain at least 70% organic ingredients

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004446

The USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food.  Organic food differs from

conventionally produced food in the way it is grown, handled, and processed.http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004446

Natural vs. Organic Labeling

• Natural and organic are not interchangeable.

• Only food labeled "organic" has been certified as meeting USDA organic standards

• USDA has policy for meat and poultry products. This states that products can only carry a 'natural' claim if they

contain no artificial or synthetic ingredients, and if they are minimally processed

• No FDA definition of ‘natural’ in NLEA (Nutrition Labeling & Education Act)

http://www.ers.usda.gov/topics/natural-resources-environment/organic-agriculture/organic-market-overview.aspx#.U1cyFlVdW8A

Aggressive claim makers: Winners & Losers

POM vs. Coke

• Willfully misleading consumers? 0.3% Pomegranate 0.2% Blueberry juice 0.1% Raspberry juice

FDA Wants Your Opinion on Dairy-Product Labels

Recent Lawsuit Action News: Apr 2012

• Class Action Lawsuit in California• The plaintiff alleges Muscle Milk, and

others, is in violation of multiple California consumer protection laws including false advertising and negligent misrepresentation, by leading consumers to believe that Muscle Milk products are healthy and nutritious

• Both sides claiming victory

http://www.bevnet.com/news/2012/muscle-milk-lawsuit-needs-bulking-uphttp://www.foodnavigator-usa.com/Regulation/Attorney-in-Muscle-Milk-lawsuit-You-can-t-just-whip-up-a-blend-of-saturated-fat-and-fractionated-oil-and-slap-a-healthy-label-on-it

Many problems for Muscle Milk

Jelly Bean Rule

• A regulation that protects consumers by preventing manufacturers from marketing junk food as health food

• Under the "Jelly Bean Rule," health claims are prohibited on products containing "disqualifying nutrient levels." That is, products cannot carry health claims if they contain

"excessive levels of fat, saturated fat, cholesterol, or sodium" or contain virtually no nutritive value at all

No food may bear a disease prevention claim unless it contains 10% or more of the DRV for vitamin A, vitamin C, iron, calcium, protein or fiber before supplementing

Getting around legislation…

7-Up Plus: 2004

Diet Coke Plus: Spring 2007

• ‘Sparkling Beverage’• 1st nutrient-enhanced soda

15% DV of Niacin, B6 and B12 10% DV for zinc and magnesium

Great taste has its benefits

VitaminWater

7-Up Natural

• May 2006, Cadbury Schweppes Launches Now Natural Campaign for 7-Up

• By removing calcium disodium EDTA (a flavor preservative), the new lemon-lime 7-Up is replaced with "natural flavors"

Fast Forward 2007

• Soda….

• Still on the label: filtered carbonated water,

high fructose corn syrup, natural citric acid, natural flavors and natural potassium citrate

• Sued by CSPI and others

• Removed Original Language

7UP 2013

http://www.7up.com/products/

Jelly Belly Sport Beansformulated to fuel and

replenish your body during intense activity with carbohydrates, electrolytes and vitamins C and E