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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