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
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Regulatory Sources
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Methods of Regulation
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Regulatory Sources
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Federal Government/Executive Branch
Agencies
State Government
Local Government
Private Legal Actions
Industry Standards
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Federal Government /
Executive Branch Agencies
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USDA Regulates the Farm
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FDA Regulates the Processing,
Distribution and Labeling of Food and
Dietary Supplements
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FTC regulates advertising
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State Government
(“Federalism”)
On-site food preparers (cafeterias,
restaurants) and retailers
 Who will regulate restaurants?
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Tougher state regulations
 Will restaurants seek federal protection?
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Can ban food items or ingredients
(ephedrine)
 Off-label regulation
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Websites
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Local Government
(“Localism”)
Zoning—(GMO farming bans in
California counties)
 Bans, labeling requirements?
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Private Legal Actions
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Obesity Litigation
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Pelman v. McDonald’s under N.Y. Unfair
Practices Act
California Unfair Practices Act
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Hardee suit against makers of reduced sugar
cereals
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Industry Standards
Trade Associations
 Unilateral Actions by Food Processors
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McDonald’s eliminates supersizing; and
promotes exercise
 Kraft voluntarily limits advertising to
children
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Increased Regulatory Pressure
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Means of Regulation
Prohibition
 Remediation
 Warning labels
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Prohibition
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Food Ingredients
Not practical
 No public acceptance
 Backdoor prohibition by warning label
(trans fat)
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Advertising Restrictions
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Children
• Legal Restraints (COPPA)
• Voluntary Restraints (Kraft)
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Remediation
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McDonald’s approach
End supersizing
 Put “healthy” alternatives on menu
 Encourage exercise
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No voluntary change in product
formulation or promotional activities
 Not a viable alternative to warning
labels and advertising restrictions
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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
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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
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Claims That Can Be Made By
Food & Dietary Supplements
Claim Type
Foods
Dietary Supplements
YES
YES
Statutory
YES
YES
Qualified
YES
YES
Nutritive
YES
YES
Non-nutritive
NO
YES
Nutritional Content
Health
Structure/Function
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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
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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
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Source: Guidance for Industry, Qualified Health Claims
in the labeling of Conventional Foods and Dietary
Supplements, 12/28/2002)
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Statutory Health Claims—
Approved Claims
21 CFR 101.72 to 101.83.
 Total 12 and include claims such as:
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calcium and osteoporosis
 fiber and cancer
 fiber and heart disease (five of these claims
pertain to heart disease)
 folate and neural tube birth defects.
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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.
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Qualified Health Claims—
Procedure
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File petition for review by FDA
Response within 270 days
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Qualified Health Claims—
Standard of Approval
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Totality of publicly available evidence supports
the claim.
Uses a “B, C, D” grading system.
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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)
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Qualified Health Claims—
Approved Claims
Qualified Claims About:
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Cancer Risk
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Cardiovascular Disease
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Cognitive Function
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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:
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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
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Types of Claims Permitted:
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Procedure:
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Nutritive Structure/Function (“S/F”) claims
(e.g. claims based on GRAS ingredients)
No FDA approval or notice required
Labels:
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No FDA disclaimer required
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Structure/Function—
Dietary Supplements
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Types of Claims Permitted:
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Procedure:
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Nutritive S/F claims
Non-nutritive S/F claims (e.g. antioxidants)
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.”
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FDA vs. FTC Enforcement
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FDA
Public health, welfare—foods, drugs,
cosmetics, dietary supplements
 Prohibits adulteration/mislabeling
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FTC
Economic regulation
 Prohibits unfair methods of competition or
deceptive acts or practices affecting
commerce
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Legal and Regulatory Aspects
Moving Forward
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Current Regulatory Topics
Low Carb
 Glycemic Index
 USDA Food Pyramid
 Obesity
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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”
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Current Regulatory Topics—
Low Carb
Why no FDA Action?
Deregulatory mindset?
 Indecision?
 Low Carb is scientifically sound?
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• FDA Working Group On Obesity recommended
approval of low carb type nutrient content
claims
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Current Regulatory Topics—
Low Carb
Why no FDA Action? (cont’d)
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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
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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
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Current Regulatory Topics—
Obesity
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FDA Working Group on Obesity
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“Calories Count”
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Calories & Nutritional Labeling
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Calories & Serving Size Regulations
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Current Regulatory Topics—
Proposed New Serving Sizes
Effect on Nutritional Claims
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Negative claims—“low in”
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Positive claims—“high in”
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Current Regulatory Topics—
USDA’s New “MyPyramid”
Everyone’s Confused…
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Current Regulatory Topics—
USDA’s New “MyPyramid”
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Based on the principles of the USDA’s
2005 Dietary Guidelines for Americans
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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.
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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
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Zackler & Associates
www.foodlaw.com
3824 Grand Avenue
Oakland, CA 94610
(510) 834-4400
azackler@foodlaw.com
sweinstein@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))
Procedure
Petition 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)
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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
Statutory: Petition/Rule Making
Procedure
Qualified: Petition/”Enforcement Discretion”
Definition
Approved Claims
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.
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
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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
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Food Groups to Encourage
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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 2,000calorie intake
 Choose a variety of fruits and vegetables
each day (select from all five vegetable
subgroups
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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 lowfat 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
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