Transcript Document

Unit 2 Seminar
NS440-01
March 9, 2011
Amy Bridges, MS, RD, LDN
The Nutrition Labeling and Education Act
(NLEA)
• Requires most foods have nutrition labeling
• Requires food labels that state health claims to comply with
certain guidelines
• FDA is responsible for regulating food labels
• Regulations are frequently updated and it is the food
industries responsibility to remain current with legal
requirements
• All updated requirements are published in the Federal
Register prior to effective date and summaries are posted on
FDA’s website
Federal Laws
The laws governing food products under FDA’s
jurisdiction are:
• FDCA (Food, Drug, and Cosmetic Act)
• FPLA (Fair Packaging and Labeling Act)
What is required on the label?
• Name of food
• Net content
• Name and address of manufacturer or
distributor
“The purpose of food-labeling laws and
regulations is to ensure that consumers
are able to make informed decisions
about a product based on its label and
labeling.”
Do you feel believe manufacturers
have the consumer’s best interest in
mind?
The Food label
• Principal Display Panel (PDP): Area most likely to be
on display for retail
▫ Example: Front of cereal box
• Common or the usual name is required
▫ Form of the food is required if optional forms exist
▫ % from fruit juice required (flavored beverages are
exempt)
• Imitation
▫ Resembles another product but is nutritionally inferior
• Statement of identity: tells the consumer what they
are buying
▫ FDA established name
▫ Use common name
▫ Descriptive terms may be used if no established/common
name exists
The Food Label
• Net Quantity
▫ Must appear on PDP
▫ Liquid, solid, or dry measurements
• Information Panel
▫ Address of manufacturer, ingredient list, nutrition label
▫ Part of the label, to the right of PDP
• Ingredients
▫ All are required (for all foods composed of 2 or more
ingredients)
▫ Listed in descending order
▫ Identifies allergens (FALCPA)
The Food Label
• Ingredients Present in Amounts of 2% or Less by Weight
• Use of Collective or Generic Ingredient Names
• Foods with Standard of Identity
• Allergens
• Name and Address of Manufacturer, Packer or Distributer
• Country of Origin
▫ If foreign in origin
• Artwork
▫ May not be misleading
The Food Label
Nutritional Labeling
• Nutrition Labeling & Education Act (NLEA 1990)
• Failure to comply resulted in
mislabeled/misbranded foods
• Intended to be universal in the marketplace
• Show how foods fit into a balanced diet
• To allow credible health claims to be made
• Must be contained in Nutrition Facts box
• Must be located on PDP or information panel
Nutritional Labeling
Must declare:
▫ Serving size
▫ Calorie information
 Calories and calories from fat (if >0.5g fat/serving)
 Trans fat (not listed if <0.5g trans fat/serving)
▫ Nutrient Declarations
 Weight in grams/%DV
▫ Percent Daily Value
 Declared for each nutrient
 Based on 2000 calorie diet
▫ Format Modifications
 Package size, Omissions,
Nutrition Claims• Free
▫ Calorie: less than 5
calories/serving
▫ Sugar: less than 0.5 g/serving
▫ Sodium: less than 5
mg/serving
▫ Fat: less than 0.5 g/serving
▫ Saturated fat: less than 0.5 g
per referenced amount
▫ Cholesterol: less than 2
mg/serving
What do they really mean?
• Low
▫ Calorie: less than 40
calories/serving
▫ Sodium: less than 140
mg/serving
▫ Very low sodium: 35mg or
less
▫ Fat: less than 3 g/serving
▫ Saturated fat: less than 1
g/serving
▫ Cholesterol: less than 20
mg/serving and 2 g or less
saturated fat
Nutrition Claims• Lean & Extra Lean
▫ Lean: less than 10 g fat, 4.5 g
saturated fat, and 95 mg
cholesterol per serving/per
100 g
▫ Extra lean: less than 5 g fat, 2
g saturated fat, and 95 mg
cholesterol per serving/per
100 g
What do they really mean?
• High
▫ Must contain >20% DV for
that nutrient
▫ “Rich in”
▫ “High”
▫ “Excellent source of”
Nutrition Claims• Reduced
▫ Must contain at least 25% less
of the nutrient or calories
than that of the referenced
product
What do they really mean?
• More
▫ Must contain a nutrient that
is at least 10% of the DV or
more than the referenced
product
▫ “Fortified, enriched, and
added” nutrients
Nutrition Claims• Light
▫ Must be nutritionally altered
▫ 40 calories or less, 3 grams of
fat, and 50% less sodium than
the original product
• % Fat Free
▫ Must be a low-fat or fat-free
product
▫ The claim must reflect the
amount of fat in 100 grams of
the food
▫ i.e. if a food has 2.5 grams of
fat in 50 grams the claim is
95% fat free
What do they really mean?
• Healthy or Fresh
▫ Has a specific meaning
related to special foods.
Can you name any foods you recently
consumed making any these
nutrition claims?
Health Claims
• A food is misbranded if a claim is made in
relation to a nutrient and disease if not approved
by FDA.
• Including:
▫
▫
▫
▫
Third party references
Written statements
Symbols
Vignettes
Approved Health Claims
• Calcium/Osteoporosis
• Sodium/HTN
• Fat/Cancer
• Fruits & Vegetables/Cancer
• Saturated fat/cholesterol/CHD
• Folic acid/Neural tube defects
• Fiber/Cancer
• Sugar alcohols/Dental caries
• Fiber/Risk for CHD
• Fiber from whole oats/CHD
USDA Regulated Products
• Regulated by FSIS
• Packaging requires:
▫
▫
▫
▫
▫
▫
Name of product
List of ingredients in descending order
Name/place of business or the manufacturer
Net quantity of contents
Nutrition label including Nutrition Facts box
Safe handling statements
DSHEA
• Dietary Supplement Health Education Act (1994)
• Allowed manufacturers of dietary supplements to
make health claims which describe the role of a
nutrient or dietary ingredient intended to affect
normal structure or function in humans
• Examples: “Calcium builds strong bones”
DSHEA
• Characterize the means by which a nutrient or
dietary ingredient acts to maintain such
structure or function
• Example: “fiber maintains normal bowel
function” or “antioxidants maintain cell integrity
DSHEA
• Describe general well-being from consumption
of a nutrient
• Claim could also describe a benefit related to a
nutrient deficiency
▫ Example: vitamin C and scurvy
DSHEA: What it really means…
• Expanded the legal definition of a dietary
supplement to include herbal, botanical, and
diet products
• Manufacturers no longer had to demonstrate the
safety of the product before selling
• The FDA had to prove product was unsafe before
it was taken off the market
Requirements for Claims
• #1: You can make the claims if you have
substantiated that the claims are truthful and
not misleading (not specified)
• #2: Must notify the FDA w/in 30 days of using
the claim
• #3: Must have disclaimer
Health Claim vs. Disease Claim
• Disease claim
▫ Requires the product to be regulated by the FDA
as a drug
▫ Clinical trials to prove safety and efficacy
• Health Claim:
▫ CANNOT mention and specific disease or
identifiable signs/sx of a specific disease
▫ CANNOT use word such as treat, diagnose,
prevent, cure, or mitigate
Disease Claim Criteria
1.
2.
3.
4.
5.
Claims an effect on a disease or
class of diseases
Claims an effect on
characteristic signs or
symptoms of disease using
scientific or lay terminology
Claims an effect on a condition
associated with a natural state
or process
It is an implied disease claim
because of the product name,
formulation, use of pictures, or
other factors
Claims that a product belongs to
a class of products that is
intended to diagnose, mitigate,
treat, cure or prevent a disease
6.
Claims to be a substitute for a
product that is a therapy for a
disease
7. Claims to augment a therapy or
drug intended to diagnose,
mitigate, treat, cure or prevent a
disease
8. Has a role in the body’s
response to a disease or to a
vector of disease
9. Claims to treat, prevent or
mitigate adverse events
associated with a therapy for a
disease
10. Otherwise suggests an effect on
a disease or diseases
Consequences of Deregulation
• May or may not work
▫ Manufacturer doesn’t prove efficacy
• May contain harmful ingredients or may not
contain active ingredient
• Examples
▫ Vitamin A
▫ Vitamin E
▫ Ephedra
Question
• Does it make sense to regulate supplements in
this way?
• What should we tell consumers?