Positioning Nutritional Food Products

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Positioning Nutritional Food Products

• Sarah E. Taylor, Esq.
• Covington Burling
• Washington, D.C.

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Positioning Objectives

• Avoid drug regulation
• Optimize health and nutritional claims
• Optimize nutritional formulation

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Position Product to Avoid Drug Regulation

• Drug is any article intended for use in the
  diagnosis, cure, mitigation, treatment, or
  prevention of disease in man or other animals.

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Flow Chart
? 1998 Covington Burling
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Drug Definition Intended Use

• Vendor's intent
• Determined from any relevant source
• labeling
• advertising
• promotions
• circumstances surrounding product distribution

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Drug Definition Disease

• May include

any deviation from, impairment of, or
interruption of the normal structure or function
of any part, organ, or system (or combination
thereof) of the body that is manifested by a
characteristic set of one or more signs or
symptoms, including laboratory or clinical
measurements that are characteristic of a
disease.
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Categories of Prohibited Disease Claims

• Claims suggesting the product has an effect on a
  specific disease or class of disease
• Examples
• Protective against the development of cancer
• Reduces the pain and stiffness associated with
  arthritis
• Decreases the effects of alcohol intoxication
• Alleviates constipation

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Claims suggesting that the product has an
effect, using scientific or lay terminology, on
. . . signs or symptoms that are recognizable
to health care professionals or consumers as
being characteristic of specific disease(s).

• Examples
• Improves urine flow in men over 50 years old
  (characteristic symptom of, e.g., benign
  prostatic hypertrophy).
• Lowers cholesterol (characteristic sign of,
  e.g., hypercholesterolemia).
• Reduces joint pain (characteristic symptom of
  arthritis).
• Relieves headaches (characteristic symptom
  of, e.g., migraine or tension headache).

? 1998 Covington Burling
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Claims suggesting that a product has an effect on
disease through a statement about the
formulation of the product, including a claim
that the product contains an ingredient that has
been regulated by FDA as a drug and is well known
to consumers for its use in preventing or
treating disease.

• Examples
• Aspirin
• Digoxin
• Laetrile

? 1998 Covington Burling
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Claims suggesting that a product belongs to a
class of products that is intended to diagnose,
mitigate, treat, cure, or prevent a disease.

• Examples
• antibiotic
• laxative
• analgesic
• antiviral
• vaccine

• diuretic
• antimicrobial
• antiseptic
• antidepressant

• revitalizer
• adaptogen

• Permissible S/F Claims
• energizer
• rejuvenative

? 1998 Covington Burling
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Claims suggesting that a product has an effect on
disease through the use of picture, vignettes,
symbols, or other means.

• Examples
• Electrocardiogram tracings
• Pictures of organs that suggest prevention or
  treatment of a disease state
• The prescription symbol (RX)
• Any reference to prescription use of the product
• Permissible S/F Claims
• A picture of the human body

? 1998 Covington Burling
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Claims suggesting that a product has an effect
on a consequence of a natural state that presents
a characteristic set of signs or symptoms
recognizable to health care professionals or
consumers as constituting an abnormality of the
body.

• Examples
• Treats toxemia in pregnancy.
• For decreased sexual function.
• For hot flashes.
• Alzheimers disease.
• Permitted S/F Claims
• For men over 50 years old.
• To meet nutritional needs during pregnancy.

? 1998 Covington Burling
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Prohibits claims suggesting that a product has an
effect on disease through the name of the
product.

• Examples
• Carpaltum (Carpal Tunnel Syndrome).
• Raynaudin (Raynauds Phenomenon).
• Hepatacure (Liver Problems).
• Permitted S/F Claims
• Cardiohealth
• Heart Tabs

? 1998 Covington Burling
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Position Product to Optimize Health and
Nutritional Claims

• Position product in optimal nutritional food
  category.
• Options
• Conventional Food
• Food for Special Dietary Use
• Dietary Supplement
• Medical Food

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Conventional Food Definition

• Used for Food or Drink and Components
• Chewing Gum and Components
• Food Consumed for Taste, Aroma, Nutritive
  Value.

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Food for Special Dietary Use Definition

• Meets Conventional Food Definition
• Intended to meet special nutritional needs
  associated with age, physiological conditions, or
  disease.

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Food for Special Dietary Use Definition

• Distinction from Medical Food
• Useful in supplying special dietary needs for
  patient prevented from eating normally, BUT
• NOT specifically tailored for use as the
  nutritional component of the patients
  treatment.

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Food For Special Dietary Use Definition

• Distinction from Medical Food (cont.)
• No required medical supervision
• FDA has attempted to narrow medical food
  category, redefining as foods for special dietary
  use.

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Dietary Supplement Definition

• Labeled as Dietary Supplement

Vitamin C Supplement
Energy Bar Dietary Supplement
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Dietary Supplement Definition

• Intended to supplement the diet and contains a
• vitamin/mineral
• herb/botanical
• amino acid
• dietary substance for use by man to supplement
  the diet by increasing the total dietary intake,
  or
• concentrate, metabolite, constituent, extract, or
  combination of the above

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Dietary Supplement Definition

• Intended for ingestion in tablet, capsule powder,
  softgel, or liquid form, OR
• Intended for ingestion in another form AND is not
  represented as a conventional food or the sole
  item of a meal or the diet

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Dietary Supplement Definition

• may not include a food which is represented for
  use as a conventional food,
• it may include a food that simulates a
  conventional food.

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Dietary Supplement Definition -- Simulate"

• FDA Statement

. . . there may be dietary supplements for which
the presence of the term dietary supplement
constitutes the primary, if not the only, means
by which consumers will be able to determine that
the food is a dietary supplement.
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Flow Chart
? 1998 Covington Burling
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Conventional Food Claims

• Approved Nutrient Content Claims
• Amount/Percentage Claims
• Approved Health Claims
• Traditional Structure or Function Claims
• Dietary Guidance Claims

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Dietary Supplement Claims

• Approved Nutrient Content Health Claims
• Amount/Percentage Claims (40 percent allicin, 10
  mg per capsule)
• Dietary Guidance
• Traditional Structure or Function Claims (i.e.,
  for DV nutrients only)

Calcium helps build and maintain strong bones.
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Dietary Supplement Claims

• Statements of Nutritional Support for non-DV
  dietary ingredients (e.g., herbs)
• Disclaimer
• 30 Day Postmarket Notice

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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Third Party Literature -- Dietary Supplements

• Publication
• article
• book chapter
• official abstract/peer reviewed/appears in
  article
• Reprinted in its Entirety
• Not False/Misleading
• Promotes No Specific Supplement Manufacturer or
  Brand
• Displayed/Presented With Other Such Items on
  Same Subject Matter to present balanced view
  on supplement
• If displayed in an Establishment is Physically
  Separate from the Dietary Supplements
• Has no Information Appended/Attached to it.

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Scope of Nutrient Content Claims

• Definition

A claim that expressly or implicitly
characterizes the level of a nutrient of the type
required to be in nutrition labeling for a food
or dietary supplement.
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Nutrient Content Claims Must Be Specifically
Authorized
A nutrient content claim may not be made
expressly or impliedly on the label or in
labeling unless specifically authorized by FDA
regulation (or in limited circumstances by
premarket notification).
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Scope of Health Claims

• Definition

Any claim made . . . in the labeling of food
that expressly or impliedly characterizes the
relationship of any substance to a disease or
a health-related condition.

• Implied health claims may include
• third-party references
• brand names
• symbols
• vignettes.

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Health Claims Must be Specifically Authorized

• A health claim may not be made in labeling
  unless
• specifically defined by FDA regulation, or
• authorized under the premarket notification
  procedure.
• An unapproved health claim unlawful drug
  claim.

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FDA Modernization Act (FDAMA) Claims

• FDAMA Authorizes Health and Nutrient Content
  Claims Based on the Authoritative Statement of a
  Federal Scientific Body Under a Premarket
  Notification Procedure.
• Premarket Notification Must Be Filed 120 Days
  Before Claim Introduced to the Market.
• FDA Guidance and Interim Final Rules Issued June
  1998.

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FDAMA Health Claims

• FDAMA provides that a health claim shall be
  authorized if

a scientific body of the United States
Government with official responsibility for
public health protection or research directly
relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease
Control and Prevention) or the National Academy
of Sciences or any of its subdivisions has

• published an authoritative statement which is
  currently in effect,
• which is about the relationship between a
  nutrient and a disease or health-related
  condition to which the health claim refers.

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FDAMA Health Claims

• Premarket Notification
• File 120 Days Before First Introduction of
  Labeled Food.
• Exact Words of Claims.
• Concise Description of Basis of Claim.
• Copy of Authoritative Statement.
• Balanced Representation of Scientific Literature.

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Dietary Guidance Claims

• Key No reference is made to any specific
  disease/condition.

The USDA Food Guide Pyramid recommends at least
5 servings of fruits and vegetables daily to
reduce the risk of certain chronic diseases.
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Structure Function Claims

• Conventional foods and DV-nutrients
• Claims indicating that the food affects the
  structure or any function of the body.
• E.g., Role of food or nutrient in sustaining
  normal growth and metabolism.

Calcium helps build and maintain strong bones.
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Statements of Nutritional Support (S/F Claims)

• Non-DV Dietary Ingredients
• Describes role in affecting the structure or
  function,
• Characterizes the mechanism of action, or
• Describes benefit to general well-being.

Gingko biloba supports cerebral circulation and
alertness.
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Permitted S/F Claims

• Examples
• Helps promote urinary tract health
• Helps maintain cardiovascular function and a
  healthy circulatory system
• Helps maintain intestinal flora
• Promotes relaxation

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Permitted S/F Claims

• Examples
• Reduces stress and frustration.
• Inhibits platelet aggregation.
• Improves absentmindedness.
• Helps maintain a healthy cholesterol level.
• Helps maintain regularity.

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Position Product to Optimize Nutritional
Formulation

• Considerations
• Dietary Supplements
• More Flexible Safety Standards for Dietary
  Ingredients
• May Fortify to Support Claims
• Conventional Foods
• Food Additive/GRAS Regulation
• Standards for Identity
• Fortification Policy
• Cannot Fortify to Meet Criteria for Certain Claims

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Formulation Conventional Foods

• Fortification Policy
• Guideline to Promote Rational Addition of
  Nutrients to Food
• Mandatory for More, Healthy, High Potency

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Formulation Conventional Foods

• Fortification Policy
• No fortification of fresh produce, meat, poultry,
  fish, sugars, snack foods
• May correct a scientifically recognized dietary
  insufficiency
• May fortify with prescribed nutrient package to
  balancenutrient composition of food

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Formulation Conventional Foods

• Fortification Policy
• May use nutrients for nonnutritional purpose
• Must conform with food additive regulations
  (e.g., folic acid)
• Must conform with nutritional criteria for claims
• Examine Precedents case-by-case

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Formulation Dietary Supplements

• Fortification Policy NA.
• Dietary Ingredients Exempt from Food
  Additive/GRAS Requirements
• More Flexible Safety Standards Apply.
• Ordinary Food Additive/GRAS Requirements Apply to
  Excipients, Binders, etc.
• FDA has Burden of Proof to Establish Dietary
  Supplement is Unsafe.

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Formulation Dietary Supplements

• A Dietary Ingredient is Prohibited if it

Presents Significant/Unreasonable Risk of
Illness/Injury Under Ordinary Conditions of Use
OR
Causes Dietary Supplement to be Unsafe Under
Recommended/Ordinary Conditions of Use
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Formulation Dietary Supplements

• A New Dietary Ingredient is Prohibited if

Information Inadequate to Provide Reasonable
Assurance that there is no Significant/Unreasonab
le Risk of Illness/Injury Under Ordinary
Conditions of Use

• New Dietary Ingredient

First Marketed in the United States On/After
October 15, 1994
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Formulation Dietary Supplements

• Ingredient in Food Supply
• As Article of Food
• Not Chemically Altered
• OR
• History of Use/Evidence of Safety Establishing
• reasonably expected to be safe under
  recommended conditions of use
• AND
• 75 Day Premarket Notice Filed

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FTC Policy Governing Health and Nutritional Claims

• The FTC Food Advertising Enforcement Policy
  Statement interprets and harmonizes FTC's general
  antideception policies with FDA regulations and
  policies governing health and nutrition related
  claims for foods.

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FTC Policy Nutrient Content Claims

• Applies FDA's definitions for nutrient content
  claims (e.g., "low," "high," and "lean").
• Requires synonyms ("packed with" or "lots of") to
  be used consistently with FDA-defined terms
  ("high").
• Generally uses FDA's reference amounts as basis
  for claim.
• Consults with FDA and other authorities in
  evaluating unapproved claims.
• Requires the presence of a risk-increasing level
  of a nutrient to be disclosed.

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FTC Policy Health Claims

• Applies FDA's "significant scientific agreement"
  standard as its principal guide in evaluating the
  support for unqualified health claims.
• Requires unapproved health claims to be presented
  so that consumers understand the extent of
  scientific support and any significant contrary
  scientific evidence.
• Prohibits qualified claims based on studies that
  are inconsistent with the larger body of
  scientific evidence.
• Requires health claims to be qualified to account
  for nondietary risk factors.
• Generally applies FDA's nutritional criteria for
  health claims except where claim qualified to
  avoid deception.
• Requires health claims to disclose
  risk-increasing levels of nutrients.