3.1 Introduction
Nutrition labeling regulations differ in countries around the world. The focus of this chapter is on nutrition labeling regulations in the USA, as specified by the Food and Drug Administration (FDA), with a brief summary of regulations for the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). A major reason for analyzing the chemical components of foods in the USA is nutrition labeling regulations. Nutrition label information is not only legally required in many countries but also is of increasing importance to consumers as they focus more on health and wellness.
The FDA was authorized under the 1906 Federal Food and Drug Act and the 1938 Federal Food, Drug, and Cosmetic (FD&C) Act to require certain types of food labeling [1, 2]. This labeling information includes the amount of food in a package, its common or usual name, and its ingredients. In 1973, the FDA promulgated regulations that permitted, and in some cases required, food to be labeled with regard to their nutritional value. The 1990 Nutrition Labeling and Education Act (NLEA) [2, 3] modified the 1938 FD&C Act to regulate nutrition labeling. Additionally, the 1997 Food and Drug Administration Modernization Act (FDAMA) [4] also amended the FD&C act and included provisions that sped up the process for approving health and nutrient content claims. The FDA amended in 2016 its nutrition labeling regulations for conventional foods and dietary supplements, with compliance dates of 2020 and 2021, depending on the sales level of the food manufacturer. These regulations, as they relate to food analysis, are the focus of this chapter.
- 1.
What nutrients must be analyzed
- 2.
How samples are to be collected
- 3.
What methods of analysis are to be used
- 4.
How data are to be reported
- 5.
How data can be used to calculate caloric content
- 6.
How data can be used for claims made on the food label
Following coverage of FDA regulations, Sect. 3.3 will give a general discussion of similarities and differences between FDA and USDA regulations.
Complete details of the current nutrition labeling regulations are available in the Federal Register and the Code of Federal Regulations (CFR) [5–8]. In developing a nutrition label for a food product, it is important to review the details of the regulations in the CFR and utilize other routinely updated resources available via the Internet. During the product development process, the effect of formulation changes on the nutritional label may be important. As an example, a small change in the amount of an ingredient may determine if a product can be labeled low fat. As a result, the ability to immediately approximate how a formulation change will impact the nutritional label can be valuable. The use of nutrient databases and computer programs designed for preparing and analyzing nutritional labels can be valuable and can simplify the process of preparing a nutritional label. The use of computer programs to prepare nutritional labels is beyond the scope of this chapter. However, an example computer program (TechWizard™, Owl Software) and a description of how this program can be used to prepare a nutrition label are found in the laboratory manual that accompanies this text.
3.2 US Food and Drug Administration Food Labeling Regulations
For each aspect of nutrition labeling regulations related to food analysis described below, only FDA labeling requirements are covered. While the focus here is on mandatory nutrition labeling, it should be noted that the FDA has guidelines for voluntary nutrition labeling of raw fruit, vegetables, and fish (21 CFR 101.45).
3.2.1 Mandatory Nutrition Labeling
3.2.1.1 Format

Mandatory information shown on an example nutrition label, Nutrition Labeling and Education Act of 1990, amended 2016 (Courtesy of the Food and Drug Administration, Washington, DC)

Mandatory and voluntary information shown on an example nutrition label, Nutrition Labeling and Education Act of 1990, amended 2016 (Courtesy of the Food and Drug Administration, Washington, DC)
3.2.1.2 Daily Values and Serving Size
Reference daily intakes (RDIs) for vitamins and minerals essential in human nutrition
Nutrient |
RDI |
---|---|
Vitamin A |
900 μg |
Vitamin C |
90 mg |
Calcium |
1,300 mg |
Iron |
18 mg |
Vitamin D |
205 μg |
Vitamin E |
15 mg |
Vitamin K |
120 μg |
Thiamin |
1.2 mg |
Riboflavin |
1.3 mg |
Niacin |
16 mg |
Vitamin B6 |
1.7 mg |
Folate |
400 μg |
Vitamin B12 |
2.4 μg |
Biotin |
30 μg |
Pantothenic acid |
5 mg |
Phosphorus |
1,250 mg |
Iodine |
150 μg |
Magnesium |
420 mg |
Zinc |
11 mg |
Selenium |
55 μg |
Copper |
0.9 mg |
Manganese |
2.3 mg |
Chromium |
35 μg |
Molybdenum |
45 μg |
Chloride |
2,300 mg |
Potassium |
4,700 mg |
Choline |
550 mg |
Daily reference values (DRVs) of food componentsa
Food component |
DRV |
---|---|
Fat |
78 g |
Saturated fatty acids |
20 g |
Cholesterol |
300 mg |
Total carbohydrate |
275 g |
Fiber |
28 g |
Sodium |
2,300 mg |
Protein |
50 g |
Added sugars |
50 g |
3.2.1.3 Rounding Rules
Rounding rules for declaring nutrients on nutrition label
Nutrient/serving |
Increment rounding a,b |
Insignificant amount |
---|---|---|
Calories, calories from saturated fat |
<5 Cal – express as zero |
<5 Cal |
≤50 Cal – express to nearest 5 Cal increment |
||
>50 Cal – express to nearest 10 Cal increment |
||
Total fat, trans fat, polyunsaturated fat, monounsaturated, saturated fat |
<0.5 g – express as zero |
<0.5 g |
<5 g – express to nearest 0.5 g increment |
||
≥5 g – express to nearest 1 g increment |
||
Cholesterol |
<2 mg – express as zero |
<2 mg |
2–5 mg – express as “less than 5 mg” |
||
>5 mg – express to nearest 5 mg increment |
||
Sodium, potassium |
<5 mg – express as zero |
<5 mg |
5–140 mg – express to nearest 5 mg increment |
||
>140 mg – express to nearest 10 mg increment |
||
Total carbohydrate, total sugars, added sugars, sugar alcohols, dietary fiber, soluble fiber, insoluble fiber, protein |
<0.5 g – express as zero |
<1 g |
<1 g – express as “Contains less than 1 g” or “less than 1 g” |
||
≥1 g – express to nearest 1 g increment |
||
Vitamins and minerals |
<2 % of RDI – may be expressed as: |
<2 % RDI |
1. Zero |
||
2. An asterisk that refers to statement “Contains less than 2 % of the Daily Value of this (these) nutrient (nutrients)” (or use symbol < in place of “less than”) |
||
3. For vitamin D, calcium, iron, potassium: statement “Not a significant source of _____ (listing the vitamins or minerals omitted)” |
||
≤10 % of RDI – express to nearest 2 % increment |
||
>10–≤50 % of RDI – express to nearest 5 % increment |
||
>50 % of RDI – express to nearest 10 % increment |
||
Fluoride |
<0.1 mg – express as zero |
|
≤0.8 mg – express to nearest 0.1 mg |
||
>0.8 mg – express to nearest 0.2 mg |
3.2.1.4 Caloric Content
- 1.
Specific Atwater factors for Calories per gram of protein, total carbohydrate, and total fat
- 2.
The general factors of 4, 4, and 9 Cal/g of protein, total carbohydrate, and total fat, respectively
- 3.
The general factors of 4, 4, and 9 Cal/g of protein, total carbohydrate (less the amount of nondigestible carbohydrates and sugar alcohols), and total fat, respectively [Note: Regulations specify a general factor of 2 Cal/g for soluble nondigestible carbohydrates shall be used, and general factors for caloric value of sugar alcohols is provided in 21 CRF 101.9 (c)(1)(i)(F), i.e., 0–3.0, depending on the specific sugar alcohol.]
- 4.
Data for specific food factors for particular foods or ingredients approved by the FDA
- 5.
Bomb calorimetry data subtracting 1.25 Cal/g protein to correct for incomplete digestibility
3.2.1.5 Protein Quality
Reporting the amount of protein as a percent of its Daily Value on FDA-regulated foods is optional, except if a protein claim is made for the product, or if the product is represented or purported to be used by infants or children under 4 years of age, in which case the statement is required [21 CFR 101.9 (c) (7)]. For infant foods, the corrected amount of protein per serving is calculated by multiplying the actual amount of protein (g) per serving by the relative protein quality value. This relative quality value is the protein efficiency ratio (PER) value of the subject food product divided by the PER value for casein. For foods represented or purported for adults and children 1 year or older, the corrected amount of protein per serving is equal to the actual amount of protein (g) per serving multiplied by the protein digestibility-corrected amino acid score (PDCAAS). Both the PER and PDCAAS methods to assess protein quality are described in Chap. 24. The FDA allows use of the general factor 6.25 to calculate the protein content from the measured nitrogen content, except when official AOAC procedures require use of a different conversion factor (described in Chap. 18).
3.2.2 Compliance
3.2.2.1 Sample Collection
Random sampling techniques are used by the FDA to collect samples to be analyzed for compliance with nutrition labeling regulations. A “lot” is the basis for sample collection by the FDA, defined as “a collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible, and designated by a common container code or marking, or in the absence of any common container code or marking, a day’s production.” The sample used by the FDA for nutrient analysis consists of a “composite of 12 subsamples (consumer units), taken 1 from each of 12 different randomly chosen shipping cases, to be representative of a lot” [21 CFR 101.9 (g)].
3.2.2.2 Methods of Analysis
The FDA states that unless a particular method of analysis is specified in 21 CFR 101.9(c), appropriate methods of AOAC International published in the Official Methods of Analysis [9] are to be used. Other reliable and appropriate methods can be used if no AOAC method is available or appropriate. If scientific knowledge or reliable databases have established that a nutrient is not present in a specific product (e.g., dietary fiber in seafood, cholesterol in vegetables), the FDA does not require analyses for the nutrients.
Nutritional label components: commonly used AOAC International official methods and food analysis textbook coverage
Nutrient |
Name of method |
AOAC official method number |
AOAC official method locator number |
Food analysis book chapter |
---|---|---|---|---|
Calories |
One of multiple methods allowed by FDA: Calories = (g of carbohydrate × 4 Cal/g) + (g of protein × 4 Cal/g) + (g of fat × 9 Cal/g) |
|||
Total carbohydrate |
Calculation for proximate composition (100 % = total fat + protein + total carbohydrate + moisture + ash) |
Proximate analysis |
||
Dietary fiber |
Enzymic-gravimetric method for total, soluble, and insoluble dietary fiber |
991.43 |
32.1.43 |
19 |
Total sugars |
HPLC |
977.20 |
44.4.13 |
19 |
Added sugar |
No analytical method; Must be calculated based on formulation |
– |
– |
|
Protein |
Dumas |
968.06 |
4.2.04 |
18 |
Total fat |
Gas chromatography |
996.06 |
41.1.28A |
17 |
Saturated fat |
Gas chromatography |
996.06 |
41.1.28A |
17, 23 |
Trans fat |
Gas chromatography |
996.06 |
41.1.28A |
17, 23 |
Cholesterol |
Capillary gas chromatography |
976.26 |
45.4.06 |
23 |
Moisture (to calculate total carbohydrate) |
Forced draft oven at 105 ± 1 °C for 4 h (note: other methods would be official/more appropriate for certain foods) |
925.10 |
32.1.03 |
15 |
Ash (to calculate total carbohydrate) |
Dry ashing using muffle furnace at 550 °C |
923.03 |
32.1.05 |
16 |
Sodium |
Inductively coupled plasma – optical emission spectroscopy |
985.01 |
3.2.06 |
9 |
Vitamin D |
Liquid chromatography – mass spectrometry |
2002.05 |
45.1.22A |
20 |
Calcium |
Inductively coupled plasma – optical emission spectroscopy |
985.01 |
3.2.06 |
9 |
Iron |
Inductively coupled plasma – optical emission spectroscopy |
985.01 |
3.2.06 |
9 |
Potassium |
Inductively coupled plasma – optical emission spectroscopy |
985.01 |
3.2.06 |
9 |
3.2.2.3 Levels for Compliance
Basis for compliance of nutrition labeling regulation by Food and Drug Administration and Food Safety and Inspection Service of the US Department of Agriculture
Class of nutrients |
Purposes of compliance |
Nutrients regulated |
% requireda |
---|---|---|---|
I |
Added nutrients in fortified or fabricated foods |
Vitamin, mineral, protein, dietary fiber |
≥100 % |
II |
Naturally occurring (indigenous) nutrients |
Vitamin, mineral, protein, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, polyunsaturated or monounsaturated fat |
≥80 % |
*b |
Calories, total sugars, added sugar (when only source in food is added sugars), total fat, saturated fat, trans fat, cholesterol, sodium |
≤120 % |
3.2.3 Nutrient Content Claims
The FDA has defined nutrient content claims that characterize the level of a nutrient, according to specific definition (21 CFR 101.13, 101.54–101.67). The terms include the following: “free,” “low,” “lean,” “light,” “reduced,” “less,” “fewer,” “added,” “extra,” “plus,” “fortified,” “enriched,” “good source,” “contains,” “provides,” “more,” “high,” “rich in,” “excellent source of,” and “high potency.” Of these terms, “less” (or “fewer”), “more,” “reduced,” “added” (or “extra,” “plus,” “fortified,” and “enriched”), and “light” are relative terms and require label information about the food product that is the basis of the comparison. The percentage difference between the original food (reference food) and the food product being labeled must be listed on the label for comparison.
The use of nutrient content claims on food labels is typically based on the content of specific nutrients per reference amount or per serving. For example, the terms “free” or “low” for total fat, saturated fat, cholesterol, and sodium relate to specific amounts of those nutrients. Also, terms such as “high,” “excellent source,” and “enriched” require that the nutrient identified contain a specific percentage of the DV per reference amount. The term “healthy” or its derivatives may be used on the label or in labeling of foods under conditions defined by the FDA, replying on very specific levels of various nutrients. Note that the FDA requirements on nutrient content claims do not apply to infant formulas and medical foods.
3.2.4 Health Claims
Nutrition Labeling Education Act (NLEA)-authorized health claims
Claim |
CFRa reference |
---|---|
Calcium and osteoporosis |
21 CFR 101.72 |
Dietary fat and cancer |
21 CFR 101.73 |
Sodium and hypertension |
21 CFR 101.74 |
Dietary saturated fat and cholesterol and risk of coronary heart disease |
21 CFR 101.75 |
Fiber-containing grain products, fruits, and vegetables and cancer |
21 CFR 101.76 |
Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease |
21 CFR 101.77 |
Fruits and vegetables and cancer |
21 CFR 101.78 |
Folate and neural tube defects |
21 CFR 101.79 |
Dietary noncariogenic carbohydrate sweeteners and dental caries |
21 CFR 101.80 |
Soluble fiber from certain foods and risk of coronary heart disease |
21 CFR 101.81 |
Soy protein and risk of coronary heart disease |
21 CFR 101.82 |
Plant sterol/stanol esters and risk of coronary heart disease |
21 CFR 101.83 |
3.3 US Department of Agriculture Food Labeling Regulations
The FDA and FSIS of the USDA have coordinated their regulations for nutrition labeling. The USDA regulations require nutrition labeling of most meat or meat products (9 CFR 317.300–317.400) and poultry products (9 CFR 381.400–381.500). The differences that exist in the regulations are due principally to the inherent differences in the food products regulated by the FDA and USDA (USDA regulates only meat, poultry, and egg products). The two agencies maintain close harmony regarding interpretation of the regulations and changes made in regulations. Some general areas in which differences exist between FDA and USDA nutrition labeling requirements are the following: (1) nutrients allowed on label by voluntary declaration, (2) serving size regulations, (3) compliance procedures, and (4) nutrient content claims. One specific difference is that FSIS does not require trans fats as a mandatory nutrient, but permits it to be declared voluntairly. Two other specific areas different for USDA from FDA regulations are summarized below.
Regarding compliance, FSIS specifies for nutritional analysis the methods of the USDA Chemistry Laboratory Guidebook [14]. If no USDA method is available and appropriate for the nutrient, methods in the Official Methods of Analysis of AOAC International [9] are to be used. If no USDA, AOAC International, or specified method is available and appropriate, FSIS specifies the use of other reliable and appropriate analytical procedures as determined by the Agency. FSIS provides information on how it collects samples for compliance analysis is [9 CFR 317.309 (h), 381.409 (h)].
- 1.
“Enriched” and “Fortified” are not defined in the FSIS regulations.
- 2.
“Lean” and Extra lean” are defined and approved for all USDA-regulated products but only for the FDA-regulated products of seafood, game meat, and meal products.
- 3.
The term “___% Lean” is approved only for USDA-regulated products.
This section has only briefly summarized the USDA nutrition labeling regulations and compared them to the FDA regulations. The reader is referred to the CFR regulations listed above for all details of USDA nutrition labeling regulations.
3.4 Summary
A major reason for analyzing the chemical components of food in the USA (and many other countries) is nutrition labeling regulation. The FDA and FSIS of the USDA have coordinated their regulations on nutrition labeling. Regulations that implement the NLEA of 1990 require nutrition labeling for most foods regulated by the FDA, and FSIS requires the same label on most meat and poultry products. The regulations were amended in 2016 regarding nutrition information on the label in an attempt to help consumers maintain healthy dietary practices. Nutrition labeling regulations define the format for the nutrition information and give the rules and methods to report specific information. Specifications include sample collection procedures, the method of analysis to be used, and the nutrient levels required to ensure compliance with nutrition labeling regulations. Specific nutrient content claims and health claims are allowed on the nutrition label. The nutrition labeling regulations covered in this chapter are only those closely linked to food analysis. Readers are referred to appropriate sections of the CFR for all details of FDA and USDA regulations.
3.5 Study Questions
- 1.
Utilize the data in the table below that you obtained on the nutrient content of your cereal product (actual amount per serving) to help develop a nutrition label that meets FDA requirements under the NLEA, amended in 2016. Use appropriate rounding rules to complete the blank columns. If you wanted to report the protein content as a percent of the Daily Value, what would you need to do?
Actual amount per servinga
Amount per serving reported on label
% daily value reported on label
Calories
192
–
Total fat
1.1 g
Saturated fat
0 g
Trans fat
0 g
Cholesterol
0 mg
Sodium
267 mg
Total carbohydrate
44.3 g
Dietary fiber
3.8 g
Total sugars
20.2 g
–
Incl. added sugars
6.6 g
Protein
3.7 g
–
Vitamin D
2 μg
Calcium
210 mg
Iron
4.3 mg
Potassium
217 mg
- 2.
The FDA and FSIS of the USDA have very similar regulations for nutrition labeling.
- (a)
Identify the differences in regulations between the FDA and FSIS regarding the first choice of methods for nutritional analysis.
- (b)
Identify one difference between the agencies in nutrient content claims that is consistent with the statement that the differences in regulations between the agencies are primarily due to the inherent differences in the food products they regulate.
- (a)
Acknowledgements
The authors thank Drs. Ann Roland and Lance Phillips of Owl Software (Columbia, MO) for their review of this chapter and helpful comments to ensure consistency with the new nutrition labeling regulations.

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