1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400.

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


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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


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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?


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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


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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


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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


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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.


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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

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)


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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 Claims About Cancer Risk: Selenium & Cancer Antioxidant Vitamins & Cancer


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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 Claims About Cognitive Function: Phosphatidylserine & Cognitive

Dysfunction and Dementia


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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.”


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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


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Legal and Regulatory Aspects Moving Forward 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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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


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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


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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

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…


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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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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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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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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)


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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


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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


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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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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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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


1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400.

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