Legal and Regulatory Aspects Moving Forward

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Legal and Regulatory Aspects Moving Forward

• Presented by
• Zackler Associates
• www.foodlaw.com
• [phone]

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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
• 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

• Obesity Litigation
• Pelman v. McDonalds 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
• McDonalds 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

• McDonalds 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
ForwardOverview 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 Foods Dietary 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 ClaimsStandard 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)
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Statutory Health ClaimsApproved 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 ClaimsLegal 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 ClaimsProcedure

• File petition for review by FDA
• Response within 270 days

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Qualified Health ClaimsStandard 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 ClaimsApproved Claims

• Qualified Claims About
• Cancer Risk
• Cardiovascular Disease
• Cognitive Function
• Neural Tube Birth Defects

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Qualified Health ClaimsApproved Claims

• Qualified Claims About Cancer Risk
• Selenium Cancer
• Antioxidant Vitamins Cancer

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Qualified Health ClaimsApproved 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 ClaimsApproved Claims

• Qualified Claims About Cognitive Function
• Phosphatidylserine Cognitive Dysfunction and
  Dementia

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Qualified Health ClaimsApproved 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/FunctionFood

• 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/FunctionDietary 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, welfarefoods, 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 TopicsLow 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 TopicsLow 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

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Current Regulatory TopicsLow Carb

• Why no FDA Action? (contd)
• Glacial responsiveness
• Inside the beltway politics
• Too many other things on FDAs plate (e.g.
  bioterrorism)
• PR problem with general public clamoring for Low
  Carb food

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Current Regulatory TopicsGlycemic 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 TopicsObesity

• FDA Working Group on Obesity
• Calories Count
• Calories Nutritional Labeling
• Calories Serving Size Regulations

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Current Regulatory TopicsProposed New Serving
Sizes Effect on Nutritional Claims

• Negative claimslow in
• Positive claimshigh in

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Current Regulatory TopicsUSDAs New
MyPyramidEveryones Confused
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Current Regulatory TopicsUSDAs New MyPyramid

• Based on the principles of the USDAs 2005
  Dietary Guidelines for Americans
• Customized guidelines depending on age, sex and
  physical activity

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Current Regulatory TopicsNew USDA Food Pyramid
2005
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Current Regulatory TopicsNew 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 TopicsNew USDA Food Pyramid
2005
18 Year Old Male gt60 min. of phys. act. 18 Year Old Female lt30 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
ForwardConclusions

• 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
• [phone]
• azackler_at_foodlaw.com
• sweinstein_at_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
Procedure Statutory 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 ClaimsLegal Source

• 403(r) of the FDCA authorizes the Secretary of
  Health and Welfare to approve health claims

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Statutory Health ClaimsProcedure

• 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 TopicsUSDA 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 TopicsUSDA 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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Current Regulatory TopicsUSDA Dietary
Guidelines 2005

• Key Food Groups to Encourage (contd)
• 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 TopicsUSDA 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 TopicsUSDA 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 TopicsUSDA 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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