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1
Legal and Regulatory Aspects Moving
Forward
Presented by:
Zackler & Associates
www.foodlaw.com
(510) 834-4400
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Overview of Regulatory Sources and Methods
Regulatory Sources
Methods of Regulation
Zackler & Associates
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Regulatory Sources Federal Government/Executive
Branch Agencies State Government Local Government Private Legal Actions Industry Standards
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Federal Government / Executive Branch Agencies
USDA Regulates the Farm
FDA Regulates the Processing, Distribution and Labeling of Food and Dietary Supplements
FTC regulates advertising
Zackler & Associates
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State Government(“Federalism”)
On-site food preparers (cafeterias, restaurants) and retailers
Who will regulate restaurants? Tougher state regulations Will restaurants seek federal
protection? Can ban food items or ingredients
(ephedrine) Off-label regulation
WebsitesZackler & Associates
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Local Government(“Localism”)
Zoning—(GMO farming bans in California counties)
Bans, labeling requirements?
Zackler & Associates
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Private Legal Actions Obesity Litigation
Pelman v. McDonald’s under N.Y. Unfair Practices Act
California Unfair Practices Act Hardee suit against makers of reduced
sugar cereals
Zackler & Associates
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Industry Standards
Trade Associations Unilateral Actions by Food
Processors McDonald’s eliminates supersizing;
and promotes exercise Kraft voluntarily limits advertising to
children Increased Regulatory Pressure
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Means of Regulation Prohibition Remediation Warning labels
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Prohibition Food Ingredients
Not practical No public acceptance Backdoor prohibition by warning label
(trans fat) Advertising Restrictions
Children• Legal Restraints (COPPA)• Voluntary Restraints (Kraft)
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Remediation
McDonald’s approach End supersizing Put “healthy” alternatives on menu Encourage exercise
No voluntary change in product formulation or promotional activities
Not a viable alternative to warning labels and advertising restrictions
Zackler & Associates
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Warnings on Food Labels and Restaurant Menus
“Caution: this food contains excessive amounts of fat and may be hazardous to your health.”
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Legal and Regulatory Aspects Moving Forward—Overview of Current Federal Regulation
Claims that can be made by foods and dietary supplements
Nutrient Content Claims vs. Health Claims (Statutory and Qualified)
Statutory vs. Qualified Health Claims Structure/Function: Food vs. Dietary
Supplement FDA vs. FTC Enforcement
Zackler & Associates
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Claims That Can Be Made By Food & Dietary Supplements
Claim Type FoodsDietary
Supplements
Nutritional Content YES YES
Health
Statutory YES YES
Qualified YES YES
Structure/Function
Nutritive YES YES
Non-nutritive NO YES
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Statutory vs. Qualified Health Claims Procedure Standard of Approval Approved Claims
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Statutory Health Claims—Standard of Approval
Significant Scientific Agreement (“SSA”) “There is significant scientific agreement
among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by the totality of the publicly available scientific evidence including evidence from well-designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles.”1
1 Source: Guidance for Industry, Qualified Health Claims in the labeling of Conventional Foods and Dietary Supplements, 12/28/2002)Zackler & Associates
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Statutory Health Claims—Approved Claims
21 CFR 101.72 to 101.83. Total 12 and include claims such as:
calcium and osteoporosis fiber and cancer fiber and heart disease (five of these
claims pertain to heart disease) folate and neural tube birth defects.
Zackler & Associates
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Qualified Health Claims—Legal Source
Decision of the U.S. Court of Appeals for the District of Columbia in Pearson v. Shalala which held that it is a violation of the First Amendment to prohibit food manufacturers from making scientifically based health claims that have not been approved by the FDA.
Zackler & Associates
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Qualified Health Claims—Procedure
File petition for review by FDA Response within 270 days
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Qualified Health Claims—Standard of Approval
Totality of publicly available evidence supports the claim.
Uses a “B, C, D” grading system. B = evidence is not conclusive C = evidence is limited and not conclusive D = little scientific evidence
Source: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, (07/10/2003)
Zackler & Associates
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Qualified Health Claims—Approved Claims
Qualified Claims About: Cancer Risk Cardiovascular Disease Cognitive Function Neural Tube Birth Defects
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Qualified Health Claims—Approved Claims
Qualified Claims About Cancer Risk: Selenium & Cancer Antioxidant Vitamins & Cancer
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Qualified Health Claims—Approved Claims
Qualified Claims About Cardiovascular Disease: Nuts & Heart Disease Walnuts & Heart Disease Omega-3 Fatty Acids & Coronary Heart
Disease B Vitamins & Vascular Disease Monounsaturated Fatty Acids From
Olive Oil and Coronary Heart Disease
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Qualified Health Claims—Approved Claims
Qualified Claims About Cognitive Function: Phosphatidylserine & Cognitive
Dysfunction and Dementia
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Qualified Health Claims—Approved Claims
Qualified Claims About Neural Tube Birth Defects and 0.8 mg Folic Acid & Neural Tube Birth Defects
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Structure/Function Claims
Food vs. Dietary Supplements
Types of Claims Permitted Procedure Labels
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Structure/Function—Food
Types of Claims Permitted: Nutritive Structure/Function (“S/F”)
claims (e.g. claims based on GRAS ingredients)
Procedure: No FDA approval or notice required
Labels: No FDA disclaimer required
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Structure/Function—Dietary Supplements Types of Claims Permitted:
Nutritive S/F claims Non-nutritive S/F claims (e.g. antioxidants)
Procedure: Manufacturers must notify FDA of the claim
within 30 days after putting the supplement in retail distribution
Labels: “This statement has not been evaluated by
the Food and Drug administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Zackler & Associates
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FDA vs. FTC Enforcement FDA
Public health, welfare—foods, drugs, cosmetics, dietary supplements
Prohibits adulteration/mislabeling FTC
Economic regulation Prohibits unfair methods of competition
or deceptive acts or practices affecting commerce
Zackler & Associates
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Legal and Regulatory Aspects Moving Forward Current Regulatory Topics
Low Carb Glycemic Index USDA Food Pyramid Obesity
Zackler & Associates
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Current Regulatory Topics—Low Carb
Claim was never approved by FDA as a nutrition or health claim (statutory or qualified)
“Industry civil disobedience”
Zackler & Associates
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Current Regulatory Topics—Low Carb
Why no FDA Action? Deregulatory mindset? Indecision? Low Carb is scientifically sound?
• FDA Working Group On Obesity recommended approval of low carb type nutrient content claims
Zackler & Associates
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Current Regulatory Topics—Low Carb
Why no FDA Action? (cont’d) Glacial responsiveness Inside the beltway politics Too many other things on FDA’s plate (e.g.
bioterrorism) PR problem with general public clamoring for
Low Carb food
Zackler & Associates
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Current Regulatory Topics—Glycemic Index
Which road will be taken? Formal approval by FDA as a
nutritional claim Low Carb (non-approval) model
Zackler & Associates
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Current Regulatory Topics—Obesity
FDA Working Group on Obesity “Calories Count”
Calories & Nutritional Labeling
Calories & Serving Size Regulations
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Current Regulatory Topics—Proposed New Serving Sizes Effect on Nutritional Claims
Negative claims—“low in”
Positive claims—“high in”
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Current Regulatory Topics—USDA’s New “MyPyramid”Everyone’s Confused…
Zackler & Associates
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Current Regulatory Topics—USDA’s New “MyPyramid”
Based on the principles of the USDA’s 2005 Dietary Guidelines for Americans
Customized guidelines depending on age, sex and physical activity
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Current Regulatory Topics—New USDA Food Pyramid 2005
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Current Regulatory Topics—New USDA Food Pyramid 2005
Primary challenge in using the new pyramid is how to formulate and market products that accurately reflect all of the variations among the various types of pyramids.
Zackler & Associates
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Current Regulatory Topics—New USDA Food Pyramid 2005
18 Year Old Male>60 min. of phys. act.
18 Year Old Female <30 min. of phys. act.
Calorie Pattern 3200 1800
Grains 10 ounces 6 ounces
Vegetables 4 cups 2.5 cups
Fruits 2.5 cups 1.5 cups
Milk 3 cups 3 cups
Meats & Beans 7 ounces 5 ounces
Oils 11 teaspoons 5 teaspoons
Extras--Sugars & Extra Fats
Limit to 650 Calories Limit to 195 Calories
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Legal and Regulatory Aspects Moving Forward—Conclusions More state and local regulation of
processed food industry More regulatory flexibility at federal
level More willingness by industry to
assert nutritional claims and health claims without explicit FDA approval
Zackler & Associates
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Zackler & Associates
www.foodlaw.com3824 Grand AvenueOakland, CA 94610(510) [email protected]@foodlaw.com
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Appendix
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Nutrient Content
Legal Source§406(q) of the FDCA (21 U.S.C. 343(r)(1)(a))
ProcedurePetition process under §101.69 See Sample Petition
Definition
Characterizes the amount of nutrient or dietary substances in a food which has been scientifically proven to be either good (e.g. “high in Vitamin C”) or bad (e.g., “low fat”) for the human diet
Approved Claims
21 CFR Part 101, Subpart D (§101.54 - §101.69)
Zackler & Associates
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Health Claims
Legal Source
Statutory: §403(r) of the FDCA (21 U.S.C. 343(r)(1)(b)
Qualified: Pearson v. Shalala
ProcedureStatutory: Petition/Rule Making
Qualified: Petition/”Enforcement Discretion”
Definition
Characterizes the relationship between a food, or a food component, and a disease or health-related condition. Unlike a nutrient content claim, it is specific to a recognized medical condition.
Approved Claims
Statutory: 21 C.F.R. Part 101, Subpart E (§101.72 -§101.83)
Qualified: FDA website (not CFR published)
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Statutory Health Claims—Legal Source
§403(r) of the FDCA authorizes the Secretary of Health and Welfare to approve health claims
Zackler & Associates
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Statutory Health Claims—Procedure
Claims approved through a petition process involving public rule making under the Administrative Procedure Act (“APA”). Approved claims are published as regulations in the CFR.
See Sample Petition
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Current Regulatory Topics—USDA Dietary Guidelines 2005 Food Groups to Encourage
Fruits, vegetables, whole grain, fat-free/ low fat dairy
Nutrients Fats Carbohydrates Sodium and Potassium
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Current Regulatory Topics—USDA Dietary Guidelines 2005
Key Food Groups to Encourage Two cups of fruit and 2 1/2 cups of
vegetables per day for a reference 2,000-calorie intake
Choose a variety of fruits and vegetables each day (select from all five vegetable subgroups
Zackler & Associates
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Current Regulatory Topics—USDA Dietary Guidelines 2005
Key Food Groups to Encourage (cont’d) Consume 3 or more ounce-equivalents
of whole-grain products per day Consume 3 cups per day of fat-free or
low-fat milk or equivalent milk products
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Current Regulatory Topics—USDA Dietary Guidelines 2005
Fats Consume less than 10% of calories from
saturated fatty acids and keep trans fatty acid consumption as low as possible
Keep total fat intake between 20-35% of calories
Select lean, low-fat, or fat-free meat, poultry, dry beans, & milk or milk products
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Current Regulatory Topics—USDA Dietary Guidelines 2005
Carbohydrates Choose fiber-rich fruits, vegetables, and
whole grains often Choose and prepare foods & beverages
with little added sugars or caloric sweeteners
Reduce the incidence of dental caries by practicing good oral hygiene and consuming less sugar and starch containing foods and beverages
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Current Regulatory Topics—USDA Food Recommendations
Sodium & Potassium Consume less than 2,300 mg
(approximately 1 tsp of salt) of sodium per day
Choose and prepare foods with little salt.
Consume potassium-rich foods, such as fruits and vegetables
Zackler & Associates