Outline
Food Labels: Meanings and Implied
Messages
 Mandatory label info
 Nutrient claims
 Health Claims
 Process Info
Donna M. Byrne
Professor of Law
§ 343. Misbranded food
A food shall be deemed to be misbranded—
(q) Nutrition information . . . unless its label or labeling
bears nutrition information . . .
Standards of Identity, 21 CFR § 101.3
§ 101.3 Identity labeling of food in packaged form.
(a)
The principal display panel of a food in package form shall bear as one of its
principal features a statement of the identity of the commodity.
(b) Such statement of identity shall be in terms of:
(1) The name now or hereafter specified in or required by any applicable Federal law
or regulation; or, in the absence thereof,
(2) The common or usual name of the food; or, in the absence thereof,
(3) An appropriately descriptive term, or when the nature of the food is obvious, a
fanciful name commonly used by the public for such food..
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Sec. 137.305 Enriched Farina
(1) It contains in each pound not less
than 2.0 milligrams (mg) and not
more than 2.5 mg of thiamin, not
less than 1.2 mg and not more than
1.5 mg of riboflavin, not less than
16.0 mg and not more than 20.0
mg of niacin or niacinamide, not
less than 0.7 mg and not more than
0.87 mg of folic acid, and not less
than 13.0 mg of iron (Fe).
Optional Label Information
Nutrient Claims – e.g. ―fat free‖
• Nutrient Claims
(b) Fat content claims. (1) The terms ‗‗fat free,‘‘ ‗‗free of fat,‘‘ ‗‗no
fat,‘‘ ‗‗zero fat,‘‘ ‗‗without fat,‘‘ ‗‗negligible source of fat,‘‘ or
‗‗dietarily insignificant source of fat‘‘ . . . may be used on the
label or in labeling of foods, provided that:
• Health Claims
• Process Information
(i) The food contains less than 0.5 gram (g) of fat per reference
amount customarily consumed and per labeled serving
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Nutrient Claims – e.g. low fat
 (2) The terms ‗‗low fat,‘‘ ‗‗low in fat,‘‘ ‗‗contains a small
amount of fat,‘‘ ‗‗low source of fat,‘‘ or ‗‗little fat‘‘ may be used
on the label or in labeling of foods, . . . provided that:
 (i)(A) The food . . .contains 3 g or less of fat per reference
amount customarily consumed;
Cholesterol content claims
(d) Cholesterol content claims. (1) The terms ‗‗cholesterol
free,‘‘ ‗‗free of cholesterol,‘‘ ‗‗zero cholesterol,‘‘ ‗‗without
cholesterol,‘‘ ‘‘no cholesterol,‘‘ ‗‗trivial source of
cholesterol,‘‘ ‗‗negligible source of cholesterol,‘‘ or
‗‗dietarily insignificant source of cholesterol‘‘ may be used
on the label or in the labeling of foods, provided that:
Cholesterol content claims
 (i) For foods that contain 13 g or less of total fat per
reference amount customarily consumed, per labeled
serving, . . . :
 (A) The food contains less than 2 mg of cholesterol per
reference amount customarily consumed and per
labeling serving or, in the case of a meal product or main
dish product, less than 2 mg of cholesterol per labeled
serving;
Cholesterol content claim
(A) The food contains less than 2 mg of cholesterol per
reference amount customarily consumed and per
labeling serving . . .
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101.13 (h)(1) If a food bears a nutrient claim, and
Has more than:
 13.0 g fat
 4.0 g saturated fat
 60 mg cholesterol
 480 mg of sodium
per serving or reference amount,
Then the label must also say, ―See nutrition information for
__________ content.‖
Sodium content?
Nutrient and Health Claims
Health Claims
 (e) Prohibited health claims. No expressed or implied health
claim may be made on the label or in labeling for a food,
regardless of whether the food is in conventional food
form or dietary supplement form, unless:
(6) . . . the food contains10 percent or more of the Reference
Daily Intake or the Daily Reference Value for vitamin A, vitamin
C, iron, calcium, protein, or fiber per reference amount
customarily consumed prior to any nutrient addition.
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―Rich‖ in Whole Grain
Conditions for the Use of "Healthy"
Nutrient Claims
Individual Food
Seafood/Game Meat
low fat
TOTAL FAT
< 5 g fat /RACC & /100g
low fat
low sat fat
SATURATED FAT
< 2 g sat fat /RACC & /100g
low sat fat
≤ 480 mg /RACC and /l.s.; or /50 g, if
RACC is small
SODIUM
≤ 480 mg /RACC and /l.s.; or /50 g, if
RACC is small
≤ 600 mg /l.s.
"High," "Rich In," or "Excellent 20% or more of the DV per RACC.
Source Of"
"Good Source," "Contains," or 10%-19% of the DV per RACC.
"Provides"
"More," "Fortified,"
"Enriched," "Added,"
"Extra," or "Plus".
10% or more of the DV per RACC.
(May only be used for vitamins, minerals,
protein, dietary fiber, and potassium)
Meal/Main Dish
≤ disclosure level
CHOLESTEROL
< 95 mg /RA & /100 g
≤ 90 mg /l.s.
Contains at least 10% of DV /RACC for
vitamins A, C, calcium, iron, protein, or
fiber except: raw fruits and vegs.; frozen or
canned single ingredient fruits and vegs.
(may include ingredients whose addition
does not change the nutrient profile of the
fruit or veg.); enriched cereal-grain
products that conform to a standard of
identity in 21 CFR 136, 137, or 139.
BENEFICIAL NUTRIENTS
Contains at least 10% of DV /RACC for
vitamins A, C, calcium, iron, protein, or
fiber
Contains at least 10% of the DV /l.s. of two
nutrients (for a main dish product) or of
three nutrients (for a meal product) of vit.
A, vit. C, calcium, iron, protein, or fiber.
Per 21 CFR 104.20
FORTIFICATION
Per 21 CFR 104.20
Per 21 CFR 104.20
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutri
tion/FoodLabelingGuide/ucm064916.htm
―To help reduce the risk of heart disease‖
Requirements:
`"Diets rich in whole grain foods and other plant foods and low
in total fat, saturated fat, and cholesterol may reduce the risk
of heart disease and some cancers."
Contains 51 percent or more whole grain ingredients by weight per
RACC, and
- Dietary fiber content at least:




3.0 g per RACC of 55 g
2.8 g per RACC of 50 g
2.5 g per RACC of 45 g
1.7 g per RACC of 35 g
- Low fat
Docket No. 1999P-2209)Whole Grain Foods and Risk of Heart Disease and Certain Cancers
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21 CFR 101.82
Serving Size 55g
Total Fat 1g -- this
counts as low fat
Dietary Fiber 6g
Soy Protein and Risk of Coronary Heart Disease
(21 CFR 101.82)
- At least 6.25 g soy protein per RACC
- Low saturated fat,
- Low cholesterol, and
- Low fat (except that foods made from whole soybeans that
contain no fat in addition to that inherent in the whole soybean are
exempt from the "low fat" requirement)
 Required terms:




What’s not said?
 GMOs?
 Gluten?
 - "Heart disease" or "coronary heart disease"
 - "Soy protein"
 - "Saturated fat" and "cholesterol"
 Claim specifies daily dietary intake levels of soy protein associated
with reduced risk
 Claim specifies amount of soy protein in a serving of food
21 CFR 101.82
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Genetically engineered?
Not labeled
GMA: Consumers don’t need to know
Thus,“extended shelf life” or “slowripening,” as descriptions of the
characteristics of a food, are more important for consumer
understanding than the fact that the food has been processed or
treated in a particular manner.
GMA: Consumers don’t need to know
Science-based approach
It is the outcome of the process, and not a description of the process
itself, that should be disclosed to consumers.
Clones OK
Focus on food identity and
safety
―Virtually identical‖
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Label not needed
 Clone?
 Not a clone?
§ 343. Misbranded food
TITLE 21 > CHAPTER 9
CHAPTER 9—FEDERAL FOOD, DRUG, AND
COSMETIC ACT
Process Information
A food shall be deemed to be misbranded—
A food shall be deemed to be misbranded—
(a) False or misleading label If
(a) False or misleading label If
(1) its labeling is false or misleading in any particular
(1) its labeling is false or misleading in any particular
???
???
rBGH/ rBST
rBGH/rBST
recombinant Bovine Growth Hormone
recombinant Bovine Somato Tropin
 Genetically engineered
 Growth hormone
 Makes cows give more milk
 Marketed by MONSANTO* as
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rBGH milk? or non-rBGH milk?
Required
Process Labeling
 Country of Origin
 Meat and Fish
 Fish: Wild or Farm
Voluntary
 GMOs
Consumers
 rBST
 Organic
 Cloned
 Antibiotics in chicken
Information
Irrelevant (Who Cares)– no impact on sales
Positive (Good News) – helps sales
Negative (Bad News) – hurts sales
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Negative (Bad News) Information
Label function = warning
POSILAC
Consumer choices
―Leading dairy animal health product‖
―Enhances milk production‖
―Improves efficiency‖
Preferences
Knowledge
―It can play a critical role in helping farmers with limited
resources here and around the world.‖
Doesn’t care
Cares a lot
Know-it-all
Not misled
Not misled
Ignorant
Not misled
Could be misled
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Food allergens
Food allergens
 Under FALCPA, a "major food allergen" is an ingredient that is one of
All packaged foods regulated by FDA under the FD&C Act that
are labeled on or after January 1, 2006, must comply with
FALCPA's food allergen labeling requirements.
the following eight foods or food groups or an ingredient that contains
protein derived from one of them:








milk
egg
fish
Crustacean shellfish
tree nuts
wheat
peanuts
soybeans
 Although more than 160 foods have been identified to cause food
allergies in sensitive individuals, the "major food allergens" account for
90 percent of all food allergies. Allergens other than the major food
allergens are not subject to FALCPA labeling requirements.
Allergen labeling
Process: ―Made with Organic‖
National Organic Program
Organic Junk Food
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