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Food Labeling and Food Safety
Kind®, Naked® and Legal Issues ....
Do you Know who Really regulates
Your Pizza and Where Your Beef is
From?
What is “Smart” About FOP
Labelling?
Roseann B. Termini, Esq.
www.fortipublications.com
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Roseann B. Termini, Food and
DrugLaw: Federal Regulation of Drugs,
Biologics, Medical Devices, Foods,
Dietary Supplements, Personal Care,
Veterinary and Tobacco Products
Regulations
www.fortipublications.com
c. 2016 Roseann B. Termini, Esq., All rights reserved. Unauthorized use strictly
prohibited by law. www.fortipublications.com
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Key Objective
Make it COOL
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“Real” Objectives
Increase Awareness
Discuss Current Issues
“Predict” the Future
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Overview
Historical Perspective
Regulations and Definitions
Product Label Exercise
Future Trends
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Historical Perspective
1906 Federal Food and Drugs Act
1913 The Gould Amendment
1924 In U.S. v. 95 Barrels Alleged Apple Cider Vinegar
1938 The Federal Food, Drug, and Cosmetic Act
1957 The Poultry Products Inspection Act authorizes USDA
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1966 The Fair Packaging and Labeling Act
1960’s White House Conference: Food and Nutrition
1967 Federal Meat Inspection Act
1977 Saccharin Study & Labeling Act
1988 Surgeon General C. Everett Koop formal recognition of
the role of diet in certain chronic diseases
1988 Official FDA agency with Presidential appointment of
the FDA Commission
Historical Perspective -
Continued
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1990 Nutrition Labeling and Education Act
1992 “Policy Statement” Applicable to Foods Developed from
New Plant Varieties
1993 FDA issues the final regulations implementing NLEA
1993 Seven Health Claims approved
1994 Nutrition labeling of meat and poultry
Food Allergen Labeling and Consumer Protection Act of 2004
(FALCPA)
Historical Perspective
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MILESTONE LEGISLATION
1997 Food and Drug Administration Modernization Act
2007 FDA Amendments Act
2010 Mandatory Restaurant Labelling
2011 Food Safety Modernization Act
2014 FDA Safety and Innovation Act
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Who REALLY has Jurisdiction
over your Pizza ?
What type of pizza?
Who has primary jurisdiction?
What issues are involved with “Jurisdictional Overlap”?
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Overview
FDA responsible for assuring safety, wholesomeness, and
labeling of foods sold in the US (includes imports)
Labeling terminology defined by FDA
Most foods must bear nutrition labeling
Specific compliance is required for nutrient and health claims
Food industry responsibility to keep current
Federal Register, Title 21CFR101 annual updates, FDA
www.fda.gov
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Regulations and Definitions
Function of Labels
Compliance with regulations (21CFR101)
Provide information about the product
Differentiate product from competitors
Inform consumers on how to use or prepare product
Warn consumers about potential problems or improper use
Provide manufacturer contact information
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Regulations and Definitions
Nutritional Label
Original Proposed
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Regulations and Definitions
Nutrient Claims
Free
Low
Lean
Extra Lean
High
Good Source
Government defines “core” terms
Reduced
Less
Fewer
Light
More
Healthy
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New and improved
Fresh
Imitation
Juice/Drink/Beverage
Regulations and Definitions
Nutrient Claims
Other Terminology
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Any claim on the package label or on other
labeling of a food that characterizes the
relationship of any nutrient or other
substance in the food to a disease or health-
related condition
Regulations and Definitions
Health Claims
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Approved Health Claims
Significant Scientific
Agreement
Calcium and Osteoporosis - amended to include Vitamin D
Dietary Saturated Fat and Coronary Heart Disease Risk
Dietary non-carcinogenic Carbohydrate Sweeteners and
Dental Caries
Fiber Containing Grain Products, Fruits and Vegetables-
Reduced Risk of Cancer
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Approved Health Claims
Significant Scientific
Agreement
Folic acid and Decreased Neural Tube Defects
Fruits, Vegetables and Cancer
Soluble Fiber and Reduced Coronary Heart Disease Risk
Sodium and Hypertension
Soy Protein and Reduced Risk of Coronary Heart Disease
Stanols/Sterols and Reduced Risk of Coronary Heart
Disease
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Health Claims
FDAMA Health Claims
Authoritative Statement
Authoritative Statement
Scientific Authority
Examples:
Choline
Potassium and High Blood Pressure Stroke Risk
Whole Grain Foods and Cancer and Heart Disease Risk
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Health Claims Qualified
FDA Categories: GRADES
B Evidence not conclusive
C Evidence is limited
D Evidence is little
Where is Category “A”?
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Health Claims
Qualified Claim Example
Nuts and Heart Disease
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Structure Function Claims
Role of nutrient or dietary ingredient intended to affect
normal structure in humans
Example:
Calcium builds strong bones
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Nutrient Content Claims
Characterizes LEVEL of a nutrient in a food
Key is consistency
Example “lite”
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Regulations and Definitions
Labeling Exemptions
Some food served for immediate consumption
Read-to-eat foods not for immediate consumption but
prepared on site
Food shipped in bulk if not for sale in that form
Medical foods
Plain coffee and tea, some spices and flavor extracts, and
other foods with no significant nutrient content
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Preemption
And now—we interrupt your regular TV show to bring you a
special program on….
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Preemption
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The Restaurant Disclosure
Dilemma
Settled by the 2010 Health Care Legislation
Patient Protection and Affordable Care Act of
2010, §4205
Chain restaurants
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Impetus for Legislation-
New York City Board of Health disclosure regulation
Other local governments and states followed NY City Board
of Health.
Disclosure
20 or more locations
Disclosure- nutrient content information
Vending Machines and Restaurants
Regulations effective date of Dec. 2016
extended until Final Guidance issued.
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Product Statement on
Labeling and Packaging
Labels can comply with existing regulations; however,
confusing- misleading to consumers.
Ex. “Real Fruit”
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The "Fruit Juice" Statement
and the Displayed Images
Williams v. Gerber Products Company
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WILLIAMS V. GERBER
Think about this: Do you agree with the court’s decision
that the pictures of real fruit and other labeling constituted
misbranding?
Kind®
What do you think?
Kind® Warning Letter
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c. 2016 Roseann B. Termini, Esq., All rights reserved.
Unauthorized use strictly prohibited by law .
Naked®
Name Implications
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c. 2016 Roseann B. Termini, Esq., All rights reserved.
Unauthorized use strictly prohibited by law .
Smart Choices Program
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Smart Choices Program
The “17” Warning Letters 2010
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Smart Choices Program
Request for Comments for Front of Package Labelling
www.regulations.com
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c
Smart Choices Program 2016
Smart is Back
Think About It.....
Could the FOP Smart Choice Program work in Tandem with the FDA Proposed Label?
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c
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C O O L
Background
Country of Origin Labelling (COOL)
Farm Security and Rural Investment Act (2002 Farm Bill)
Amended the Agricultural Marketing Act
Suppliers provide information to Retailers
Retailer notification for Shellfish and Fish: April 2005
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Exemption: If Covered Commodity is an Ingredient in
Processed Food Item
C O O L
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2008 Farm Bill expanded food commodities
Requires the retailers to notify consumers of the country of
origin of beef, lamb, pork, chicken, goat meat, peanuts,
pecans, macadamia nuts, fruits and vegetables, ginseng
Applies to domestically produced commodities
C O O L
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How to notify
label, sticker, twist tie
“Product of the United States”
“ Grown in Mexico”
COOL Notification
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C O O L
Who must keep COOL records?
Suppliers
Retailers
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COOL Enforcement
Industry outreach
Fines imposed only after finding that retailer and or supplier
failed to make good faith effort to comply
Willful violation
COOL and WTO
Beef and Pork: COOL Rescinded H.R.2029
- Consolidated Appropriations Act, 2016
https://www.congress.gov/bill/114th-
congress/house-bill/2029/text
Why COOL Rescinded- WTO barriers
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Gluten-Free Labeling of Foods
Voluntary Labelling
Must Meet Specified Parameters
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PHOs
Partially Hydrogenated Oil
FDA 2015 Determination
Not GRAS (not generally recognized as safe)
How Issued-Order specific to Ban
3 year phase out
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Hot Topic ISSUES
FSMA
GE/GMO/Biotechnology still controversial ex. Vermont
Functional Foods/Pharmafoods/Nutraceuticals
Cloned meat safety issues and consumer perception
“Natural” definition
Food Safety Modernization Act Final Rules
Administrative Detention (2013)
Preventive Controls –Risk Based and CGMPs (2015)
Produce Safety (2015)
Foreign Supplier Verification for Importers-Animal and Human Food(2015)
Accreditation-3rd Party (2015)
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FSMA Proposed Rule
Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
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GMO
Controversy: Industry vs. Right to Know
State vs. Federal
Vermont as an Example
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Natural
How to Define
Historical Background
FDA did not define
Why not?
Why address now?
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OPEN FORUM DISCUSSION
Communication
Cooperation
Coordination
Proactive
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Clarity
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Roseann B. Termini, Food and
DrugLaw: Federal Regulation of Drugs,
Biologics, Medical Devices, Foods,
Dietary Supplements, Personal Care,
Veterinary and Tobacco Products
Regulations (2015)
www.fortipublications.com
c. 2016 Roseann B. Termini, Esq., All rights reserved. Unauthorized use strictly
prohibited by law. www.fortipublications.com
Contact Information
www.fortipublications.com
Publications SSRN Author page
http://ssrn.com/author=944614
All Topics Food and Drug Law Blog
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