The document provides an overview of general FDA requirements for food labeling and regulations. It discusses key points such as: - The top two federal regulatory agencies for food are the USDA and FDA. Most FDA regulations can be found in Title 21 of the Code of Federal Regulations and most USDA regulations are in Title 7 and 9. - Key labeling requirements include the principal display panel, information panel, ingredient listing, nutrition facts panel, allergen labeling, and name and address of the manufacturer. Specific guidelines address type size, prominence, and placement of this labeling. - Additional requirements cover topics such as preservatives, country of origin, net quantity, inspection legends, and safe handling instructions. Product standards are

1. General FDA Requirements
for the Food Industry
Y. Martin Lo, Ph.D.
University of Maryland

2. Fifteen U.S. agencies regulate
food safety
Top two federal regulatory units:
U.S.D.A.
F.D.A.

3. Where to find Laws and Regulations?
U.S. Code (Public & Private Laws)
http://www.gpoaccess.gov/plaws/index.html
Code of Federal Regulations (CFR)
http://www.gpoaccess.gov/cfr/index.html
Most FDA Regulations: Title 21
Most USDA Regulations: Title 7 & 9

4. Regulatory References
Definition of Food Standards
Regulatory Information - CFR, Policy
Memos, Directives, Inspection Acts
FDA vs. USDA Label Approval
Requirements

5. Panel Requirements
Principle Display Panel (PDP) - the
panel the consumer sees first
Information Panel - first usable panel to
the right of the PDP

7. What is information
panel labeling?
The “information panel labeling” refers to
label statements that are generally required
to be placed together, without any intervening
material, on the information panel, if such
labeling does not appear on the PDP.
These label statements include the name and
address of the manufacturer, packer or
distributor, the ingredient list, nutrition
labeling and any required allergy labeling.

8. What is the prohibition
against intervening material?
Information that is not
required by FDA is
considered intervening
material and is not
permitted to be placed
between the required
labeling on the
information panel (e.g.,
the UPC bar code is not
FDA required labeling).

9. What type size, prominence
and conspicuousness is
required?
For information panel labeling, use a print or
type size that is prominent, conspicuous and
easy to read.
Use letters that are at least one-sixteenth
(1/16) inch in height based on the lower case
letter "o".
The letters must not be more than three times
as high as they are wide, and the lettering
must contrast sufficiently with the background
so as to be easy to read.

10. What type size, prominence
and conspicuousness is
required? (cont.)
Do not crowd required labeling with
artwork or non-required labeling.
Smaller type sizes may be used for
information panel labeling on very small
food packages as discussed in 21 CFR
101.2(c) & (f)
Different type sizes are specified for the
Nutrition Facts Label.

11. The name of the food
statement
The statement of identity is the
name of the food. It must appear
on the front label, or PDP /
alternate PDP.
Generally, this is considered to
be at least 1/2 the size of the
largest print on the label.
Place the statement of identity on
the PDP in lines generally parallel
to the base of the package.

12. Modified Statement of
Identity
Labels must describe
the form of the food in
the package if the food
is sold in different
optional forms such as
sliced and unsliced,
whole or halves, etc.

13. Imitation Product
Generally a new food that resembles a
traditional food and is a substitute for the
traditional food must be labeled as an
imitation if the new food contains less protein
or a lesser amount of any essential vitamin or
mineral.
Use the same type size and prominence for
the word "imitation" as is used for the name of
the product imitated.

14. More Required Features
Signature Line - use only name of
company, city, state and zip code
Net Weight - Location, Wording, Size &
Spacing, Retail vs. Foodservice
Inspection Legend - Meat vs. Poultry

15. Net Quantity of Content
The net quantity
statement (net quantity
of contents) is placed
as a distinct item in the
bottom 30 percent of
the principal display
panel, in lines generally
parallel with the base of
the container.

16. What name and address must
be listed on the label?
Name and address of the manufacturer,
packer or distributor. Unless the name
given is the actual manufacturer, it must
be accompanied by a qualifying phrase
which states the firm's relation to the
product (e.g., "manufactured for "or
"distributed by").

17. What name and address must
be listed on the label? (cont.)
Street address if the firm name and
address are not listed in a current city
directory or telephone book;
City or town;
State (or country, if outside the United
States); and
ZIP code (or mailing code used in
countries other than the United States).

18. Where should the country of origin be
declared on an imported food?
The law does not specifically require that the country
of origin statement be placed on the PDP, but
requires that it be conspicuous.
If a domestic firm's name and address is declared as
the firm responsible for distributing the product, then
the country of origin statement must appear in close
proximity to the name and address and be at least
comparable in size of lettering.
If a foreign language is used anywhere on the label,
all required label statements must appear both in
English and in the foreign language.

20. Ingredient Statements

21. Ingredient Statements
Listing ingredients in descending order of
predominance by weight means that the
ingredient that weighs the most is listed first,
and the ingredient that weighs the least is
listed last.
Use a type size that is at least 1/16 inch in
height (based on the lower case “o”) and that
is prominent, conspicuous, and easy to read.

22. Preservatives
When an approved chemical preservative is
added to a food, the ingredient list must include
both the common or usual name of the
preservative and the function of the preservative
by including terms, such as “preservative,”
“to retard spoilage,” “a mold inhibitor,” “to help
protect flavor,” or “to promote color retention.”
Example: “INGREDIENTS: Dried Bananas,
Sugar, Salt, and Ascorbic Acid to Promote Color
Retention”

23. Food Allergens
Food Allergen milk
Labeling and egg
Consumer fish
Protection Act of
2004 (FALCPA) Crustacean shellfish
tree nuts (see table)
wheat
peanuts
soybeans

25. Does FALCPA provide any specific
direction for declaring the presence of
ingredients from the three food groups
that are designated as "major food
allergens (i.e., tree nuts, fish, and
Crustacean shellfish?")
Yes. FALCPA requires that in the case of tree
nuts, the specific type of nut must be declared
(e.g., almonds, pecans, or walnuts). The
species must be declared for fish (e.g., bass,
flounder, or cod) and Crustacean shellfish
(crab, lobster, or shrimp).

26. “Contains…”
If a "Contains" statement is used on a food label, the
statement must include the names of the food
sources of all major food allergens used as
ingredients in the packaged food.
For example, if "sodium caseinate," "whey," "egg
yolks," and "natural peanut flavor" are declared in a
product's ingredients list, any "Contains" statement
appearing on the label immediately after or adjacent
to that statement is required to identify all three
sources of the major food allergens present (e.g.,
"Contains milk, egg, peanuts") in the same type (i.e.,
print or font) size as that used for the ingredient list.

28. If You Failed to Label Allergens…
A company and its management may be subject to
civil sanctions, criminal penalties, or both under the
Federal Food, Drug, and Cosmetic Act if one of its
packaged food products does not comply with the
FALCPA labeling requirements.
FDA may also request seizure of food products
where the label of the product does not conform to
FALCPA's requirements.
In addition, FDA is likely to request that a food
product containing an undeclared allergen be
recalled by the manufacturer or distributor.

29. More Required Features
Handling Statement
Safe Handling Instructions
Nutrition Facts Panel

30. Inspection Legends & Safe
Handling Instructions
Meat Poultry
Legend Legend

31. Other Terms
Serving Suggestion - must be next to all
pictures of the product
Geographic Terms - if no standard in
the regulation, then use brand - made in
...

32. Product Standards
USDA has product standards in the 9
CFR & the Food Standards & Labeling
Policy Book which can be found on line
(www.gpo.gov,
www.fsis.usda.gov/About_FSIS/labeling
_&_consumer_protection/index.asp )

33. Product Standards
USDA has finished product standards
(i.e. lasagna & meatballs) & FDA has
standards for ingredients (i.e. cheddar
cheese & enriched flour)

34. Product Standard
Examples
Lasagna with meat & sauce: 12% meat
Lasagna with meat sauce: 6% meat
Meat lasagna: 12% meat
Meatballs: must contain 65% meat, no
more than 12% binders or extenders
Poultry salad: at least 25% cooked
poultry

36. Nutrition Panels
Nutrition panels are required on all retail
products unless you fall under one of
the exemptions
Specific guidelines for the format
Specific guidelines for the serving size

37. Nutrition
Facts
Panel

38. What are the minimum type sizes and other format
requirements for the Nutrition Facts label?

39. Daily Value (DV)
The following
table lists the
DVs based on a
caloric intake of
2,000
calories, for
adults and
children four or
more years of
age.

40. In order to calculate the % DV,
determine the ratio between the
amount of the nutrient in a serving
of food and the DV for the nutrient.
That is, divide either the actual
(unrounded) quantitative amount or
the declared (rounded) amount (see
next section) by the appropriate DV.

41. The nutrients listed
below may be omitted
from the list of nutrients
and included in a single
sentence when present
at “zero” levels in a
food. This is done by
putting the label
statement (“Not a
significant source of
_________”) immediately
below the listing of
vitamins A and C,
calcium, and iron.

43. Bilingual Nutrition Panel

44. Variety Packs e.g. Cereals

45. As Packaged/
As Prepared Dual Recipes

46. Serving Size
Serving size determined from RACC
Tables (Reference Amount Customarily
Consumed)
Can be discreet, non-discreet, meal or
other
Serving size needs to be as close to the
RACC amount as possible

47. Serving Size: How to Start?
Locate the appropriate food category and
Reference Amount Customarily Consumed
(RACC) for your product in the two tables in
Section 101.12(b) of the food labeling regulations.
 Table 1 is for infant and toddler foods.
 Table 2 is foods for the general population.
FDA established RACCs for 139 food product
categories, and these values represent the
amount of food customarily consumed at one
eating occasion.

48. Serving Size: How to Start?
(cont.)
Determine the serving size for your multi-
serving product using the RACC for the product
(21 CFR 101.9(b)(2),(3), and (4)).
 The serving size is expressed as a common
household measure followed by the equivalent metric
quantity in parenthesis (e.g., “1/2 cup (112 g)”).
 Acceptable household measures are listed in order of
appropriate use in 21 CFR 101.9(b)(5).
 Rounding rules for metric quantities and a few
additional format options are included in 21 CFR
101.9(b)(7).

49. Suggested RACCs

50. Single Serving Container

51. Trans Fatty Acids
Trans fatty acids should be listed as
“Trans fat” or “Trans” on a separate
line under the listing of saturated fat
in the Nutrition Facts label (see
figure). The word “trans” may be
italicized to indicate its Latin origin.
Trans fat content must be expressed as
grams per serving to the nearest 0.5-
gram increment below 5 grams and to
the nearest gram above 5 grams. If a
serving contains less than 0.5
gram, the content, when
declared, must be expressed as “0 g.”

52. Labels for Infants and
Small Children
Nutrition Facts labels for foods specifically for
children less than 4 years do not provide % Daily
Values for the macronutrients or footnotes.
Foods specifically for children less than 2 years of
age must not present information on calories from fat
and calories from saturated fat and quantitative
amounts for saturated fat, polyunsaturated fat,
monounsaturated fat and cholesterol.
In both cases, % Daily Value is declared only for
protein, vitamins, and minerals.

54. Permitted Abbreviations
Food packages with a surface area of 40 sq. in. or less
available for labeling may use the following abbreviations
in the Nutrition Facts label:

55. Small Business
If a company produces $51,000 worth of
food, but had a total gross sales for all
products, food and non-food, of $490,000,
do they have to nutrition label?

56. Is a manufacturer that produces
institutional and restaurant foods
required to provide nutrition
information?
Foods which are served or sold for use only
in restaurants and other establishments in
which food is served for immediate
consumption are exempt from nutrition
labeling.
However, if there is a reasonable possibility
that the product will be purchased directly by
consumers (e.g., club stores), nutrition
information is required.

57. Are spices, coffee, and tea
required to be nutrition labeled?
The regulations provide for an exemption for
foods that contain insignificant amounts, as
defined in 21 CFR 101.9(j)(4), of all of the
nutrients and food components required to be
included in the nutrition label.
Exempted foods include coffee beans (whole or
ground), tea leaves, plain instant unsweetened
instant coffee and tea, condiment-type
dehydrated vegetables, flavor extracts, and food
colors.

58. Nutrient Claims
Cannot make a claim unless it is defined in
the 9 CFR or 21 CFR & must have NFP on
label
Supplements are not foods and fall under
another regulation
There are 2 types of claims-absolute &
relative

59. Absolute Claims
These claims are defined in the 9 CFR
for meat & poultry products and 21 CFR
for FDA products
The product must meet the
requirements for the claim or you
cannot use the claim on your label

60. Absolute Claims
Examples of absolute claims would be
lean, low fat, a good source of Vitamin
A
Claims are based on the RACC’s

61. Relative Claims
These claims are compared to another
product & the % or fraction difference is
on the label
The comparison product depends on
which claim you use

62. Relative Claims
These claims are also based on the
RACC amounts
Examples of relative claims would be
lite, reduced, less, and lower in

63. Antioxidant Claims
The antioxidant nutrient must meet the requirements
for nutrient content claims in 21 CFR 101.54(b), (c),
or (e) for “High” claims, “Good source” claims, and
“More” claims, respectively.
For example, to use a “high” claim, the food would
have to contain 20% or more of the Daily Reference
Value (DRV) or RDI per serving.
For a “good source” claim, the food would have to
contain between 10-19% of the DRV or RDI per
serving (21 CFR 101.54(g)(3)).

64. Example: Beta Carotene
Beta-carotene may be the subject of an
antioxidant claim when the level of vitamin A
present as beta-carotene in the food using
the claim is sufficient to qualify for the claim.
For example, if the claim is “good source of
antioxidant beta-carotene,” then at least 10%
of the RDI for vitamin A must be present as
beta-carotene per serving (21 CFR
101.54(g)(3)).

65. Health Claims
Health claims on food labels are claims by
manufacturers of food products that their food
will reduce the risk of developing a disease or
condition.
For example, it is claimed by the
manufacturers of oat cereals that oat bran
can reduce cholesterol, which will lower the
chances of developing serious heart
conditions.

66. Qualified Health Claims
Atopic Dermatitis Risk
 100% Whey-Protein Partially Hydrolyzed Infant
Formula and Reduced Risk of Atopic Dermatitis
Cancer Risk
 Tomatoes and/or Tomato Sauce & Prostate,
Ovarian, Gastric, and Pancreatic Cancers
 Calcium and Colon/Rectal Cancer & Calcium and
Recurrent Colon/Rectal Polyps
 Green Tea & Cancer
 Selenium & Cancer
 Antioxidant Vitamins & Cancer

67. Qualified Health Claims
(cont.)
Cardiovascular Disease Risk
 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
 Unsaturated Fatty Acids from Canola Oil &
Coronary Heart Disease
 Corn Oil & Heart Disease

68. Qualified Health Claims
(cont.)
Cognitive Function
 Phosphatidylserine & Cognitive Dysfunction and
Dementia
Diabetes
 Chromium Picolinate & Diabetes
Hypertension
 Calcium & Hypertension, Pregnancy-Induced
Hypertension, and Preeclampsia
Neural Tube Birth Defects
 0.8 mg Folic Acid & Neural Tube Birth Defects

69. Example: Calcium
Calcium and osteoporosis health claim:
 “Adequate calcium throughout life, as part
of a well-balanced diet, may reduce the
risk of osteoporosis" or
 "Adequate calcium as part of a healthful
diet, along with physical activity, may
reduce the risk of osteoporosis in later life."
(21 CFR 101.72(e))

70. Ex: Calcium + Vitamin D
Calcium, vitamin D, and osteoporosis:
 "Adequate calcium and vitamin D
throughout life, as part of a well-balanced
diet, may reduce the risk of osteoporosis"
or
 "Adequate calcium and vitamin D
throughout life, along with physical activity,
may reduce the risk of osteoporosis in later
life." (21 CFR 101.72(f))

71. HACCP
Hazard Analysis and Critical Control Point
Preventive, not reactive
A management tool used to protect the food
supply against biological, chemical and physical
hazards
Applicable to all phases of food production,
including basic agriculture, food preparation and
handling, food processing, food service,
distribution, and consumer handling and use

74. Commercially Sterile
Packaged Foods

75. Clostridium botulinum

76. Thermal (Heat)
Distribution/Penetration

77. IS REGISTRATION AND PROCESS
FILING THE SAME FOR U.S. FIRMS
AND FIRMS LOCATED IN OTHER
COUNTRIES?
Yes, registration and process filing is the
same for all commercial acidified and low-
acid canned food processors located in the
United States and processors in other
countries. However, processors in other
countries need to register and file processes
only for those foods that are to be imported
into the United States.

79. 2002 – Public Health Security and
Bioterrorism Preparedness and
Response Act (The Bioterrorism Act)
Requires all food manufacturers, domestic and
foreign, that produce food for consumption in
the U.S. to register with FDA.
Requires notification to FDA before any food is
imported into the U.S.
Allows FDA to detain adulterated foods.
Prohibits “port shopping”

80. 2011 – Food Safety Modernization Act
Amends Food Drug and Cosmetic Act of 1938
Regulatory paradigm shift from “reaction to
outbreaks” to “prevention of outbreaks”.
Three Major Food Laws for FDA-regulated foods:
1. 1906 Pure Food and Drug Act*
2. 1938 Food, Drug and Cosmetic Act
3. 2011 Food Safety Modernization Act
* Replaced by 1938 FDCA

81. 2011 – Food Safety Modernization Act
Four Main Themes of the Legislation
Prevention
Inspections,
Enhanced
Compliance,
Partnerships
and Response
Import Safety

82. Thank You!
Y. Martin Lo, Ph.D.; ymlo@umd.edu
Process Authority for Acidified and Low
Acid Canned Foods
Maryland HACCP Coordinator
Editor-in-Chief, Journal of Food
Processing and Preservation
Editor-in-Chief, Food Science and
Nutrition