GFS Design System — FDA Food Labeling & Nutritionals

01 Regulatory Overview FDA labeling authority and key legislation

Federal Food Labeling Framework

The U.S. Food and Drug Administration (FDA) regulates food labeling under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These regulations are codified primarily in Title 21 of the Code of Federal Regulations, Part 101 (21 CFR 101). All food products sold in interstate commerce that are under FDA jurisdiction must comply with these labeling requirements. This page serves as the authoritative GFS reference for all labeling operations.

Legislation / Rule	Public Law / CFR	Year	Key Provision
Nutrition Labeling and Education Act (NLEA)	P.L. 101-535	1990	Required Nutrition Facts on most packaged foods
FALCPA	P.L. 108-282, Title II	2004	Mandated major allergen labeling (Top 8)
FDA Gluten-Free Rule	21 CFR 101.91	2014	Defined "gluten-free" as <20 ppm
Nutrition Facts Label Update	21 CFR 101.9	2016 / eff. 2020	Added Sugars, Vitamin D, Potassium; updated DVs
FASTER Act	P.L. 117-11	2021 / eff. Jan 1, 2023	Added sesame as 9th major allergen
Bioengineered Food Disclosure	7 CFR 66	2018 / eff. Jan 1, 2022	National standard for GMO labeling
"Product of USA" Final Rule	USDA FSIS	2024	Meat/poultry: born, raised, slaughtered in US

■ FDA jurisdiction covers most food products. USDA FSIS regulates meat, poultry, and egg products. Alcohol is regulated by TTB. GFS products fall primarily under FDA authority.

02 Nutrition Facts Panel Format Current FDA format (2020 rules) -- Standard & Dual-Column

FDA-Compliant Nutrition Facts -- 21 CFR 101.9

The Nutrition Facts panel was updated by FDA final rule published May 27, 2016, with a compliance date of January 1, 2020 (January 1, 2021 for manufacturers with less than $10M in annual food sales). Key changes include: larger/bolder type for Calories and Serving Size, mandatory declaration of Added Sugars, Vitamin D, and Potassium, updated Daily Values, and the revised footnote.

Standard Format

Nutrition Facts

About 15 servings per container

Serving size 1 oz (28g)

Calories 110

% Daily Value*

Total Fat 9g12%

Saturated Fat 5g25%

Trans Fat 0g

Cholesterol 30mg10%

Sodium 180mg8%

Total Carbohydrate 0g0%

Dietary Fiber 0g0%

Total Sugars 0g

Includes 0g Added Sugars0%

Protein 7g

Vitamin D 0mcg0%

Calcium 200mg15%

Iron 0mg0%

Potassium 20mg0%

* The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Example: Natural Cheddar Cheese -- 1 oz serving

Dual-Column Format (2-3 servings per container)

Nutrition Facts

2 servings per container

Serving size 1 cup (228g)

Per serving Per container

Calories250500

% DV*% DV*

Total Fat 12g15%31%

Saturated Fat 3g15%30%

Trans Fat 0g

Cholesterol 30mg10%20%

Sodium 470mg20%41%

Total Carbohydrate 31g11%23%

Dietary Fiber 0g0%0%

Total Sugars 5g

Includes 0g Added Sugars0%0%

Protein 5g

Vitamin D 2mcg10%20%

Calcium 260mg20%40%

Iron 6mg35%70%

Potassium 235mg6%10%

* The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Dual-column required for packages containing 2-3 servings (21 CFR 101.9(b)(2)(i)(D))

2020 Label Update -- Key Changes

Typography

"Calories" and calorie count: largest, boldest type
"Serving size" and servings per container: larger, bolder
Serving sizes updated to reflect current consumption patterns

New Required Nutrients

Added Sugars -- indented under Total Sugars with % DV
Vitamin D -- now mandatory (was voluntary)
Potassium -- now mandatory (was voluntary)
Vitamins A and C now voluntary

Updated Daily Values

Sodium: 2,400mg changed to 2,300mg
Dietary Fiber: 25g changed to 28g
Calcium: 1,000mg changed to 1,300mg
Actual amounts declared for vitamins/minerals

■ Typography: FDA specifies Helvetica or Arial for the Nutrition Facts panel. Bold 8pt minimum for "Nutrition Facts" heading. All rules (lines) must be black. Panel background must be white or other neutral color for legibility.

03 Daily Value Reference Table Complete nutrient DVs per 21 CFR 101.9

Reference Daily Values (RDVs) -- Adults and Children 4+ Years

Nutrient	Daily Value	Unit	Status	Notes
Total Fat	78g	grams	Mandatory	Based on 2,000 calorie diet
Saturated Fat	20g	grams	Mandatory	Indented under Total Fat
Trans Fat	--	grams	Mandatory	No DV established; no % DV declared
Cholesterol	300mg	milligrams	Mandatory
Sodium	2,300mg	milligrams	Mandatory	Reduced from 2,400mg in 2020 update
Total Carbohydrate	275g	grams	Mandatory
Dietary Fiber	28g	grams	Mandatory	Increased from 25g in 2020 update
Total Sugars	--	grams	Mandatory	No DV; no % DV declared
Added Sugars	50g	grams	New 2020	New requirement; indented under Total Sugars
Protein	50g	grams	Mandatory	% DV not required unless protein claim made
Vitamin D	20mcg	micrograms	New 2020	Now mandatory; replaces Vitamin A
Calcium	1,300mg	milligrams	Mandatory	Increased from 1,000mg in 2020 update
Iron	18mg	milligrams	Mandatory
Potassium	4,700mg	milligrams	New 2020	Now mandatory; replaces Vitamin C

Voluntary Nutrients

Nutrient	Daily Value	Unit	When Required
Calories from Fat	--	--	No longer required (removed 2020)
Vitamin A	900mcg RAE	micrograms RAE	If added as supplement or claim made
Vitamin C	90mg	milligrams	If added as supplement or claim made
Vitamin E	15mg	mg alpha-tocopherol	If added or claim made
Vitamin K	120mcg	micrograms	If added or claim made
Thiamin (B1)	1.2mg	milligrams	If added or claim made
Riboflavin (B2)	1.3mg	milligrams	If added or claim made
Niacin	16mg NE	mg NE	If added or claim made
Vitamin B6	1.7mg	milligrams	If added or claim made
Folate / Folic Acid	400mcg DFE	mcg DFE	If added or claim made
Vitamin B12	2.4mcg	micrograms	If added or claim made
Biotin	30mcg	micrograms	If added or claim made
Pantothenic Acid	5mg	milligrams	If added or claim made
Phosphorus	1,250mg	milligrams	If added or claim made
Iodine	150mcg	micrograms	If added or claim made
Magnesium	420mg	milligrams	If added or claim made
Zinc	11mg	milligrams	If added or claim made
Selenium	55mcg	micrograms	If added or claim made
Copper	0.9mg	milligrams	If added or claim made
Manganese	2.3mg	milligrams	If added or claim made
Chromium	35mcg	micrograms	If added or claim made
Molybdenum	45mcg	micrograms	If added or claim made
Chloride	2,300mg	milligrams	If added or claim made
Choline	550mg	milligrams	If added or claim made
Monounsaturated Fat	--	grams	Voluntary; no DV established
Polyunsaturated Fat	--	grams	Voluntary; no DV established
Soluble Fiber	--	grams	Voluntary; no separate DV
Insoluble Fiber	--	grams	Voluntary; no separate DV
Sugar Alcohols	--	grams	If sugar alcohols are declared on labeling

■ Daily Values are based on a 2,000 calorie reference diet per 21 CFR 101.9(c)(9). Updated DVs reflect 2016 final rule (effective 2020). When a DV is not established, % DV is not declared on the label.

04 Serving Size Requirements RACC values, dual-column, rounding

Reference Amounts Customarily Consumed (RACC) -- 21 CFR 101.12

Serving sizes on the Nutrition Facts label are based on Reference Amounts Customarily Consumed (RACC), not recommended amounts. RACC values are established by FDA in 21 CFR 101.12 and reflect amounts of food customarily consumed per eating occasion, based on nationwide food consumption survey data. Manufacturers must use these values as the basis for declaring serving sizes.

GFS Product Category RACC Values

Product Category	RACC	Label Serving Size	Household Measure	CFR Reference
Natural Cheese (cheddar, swiss, etc.)	30g	1 oz (28g/30g)	1 cube or 1 slice	101.12(b) Table 2
Process Cheese / Cheese Product	28g	1 oz (28g)	1 slice	101.12(b) Table 2
Cream Cheese	30g	2 tbsp (30g)	2 tablespoons	101.12(b) Table 2
Cottage Cheese	110g	1/2 cup (113g)	1/2 cup	101.12(b) Table 2
Butter / Margarine	14g	1 tbsp (14g)	1 tablespoon	101.12(b) Table 1
Milk / Fluid Dairy	240mL	1 cup (240mL)	1 cup (8 fl oz)	101.12(b) Table 1
Frozen Vegetables	85g	2/3 cup (85g)	2/3 cup	101.12(b) Table 2
Pancakes / Waffles (frozen)	110g	2 pancakes (220g)	2 pancakes	101.12(b) Table 2
Frozen Entrees / Meals	--	Entire package if <2 RACC	Varies	101.12(b) Table 2
Whey Protein Concentrate	30g	1 scoop (30g)	1 scoop	101.12(b) Table 2

Serving Size Declaration Rules

Single-Serving Containers

If package contains <200% of RACC: entire package = 1 serving
If package contains 200%-300% of RACC: manufacturer may declare 1 or 2 servings
If 200%-300%: dual-column format required if declared as 2 servings
If package contains >300% of RACC: cannot be single serving

"About" Rounding Rules

2-5 servings: round to nearest whole number
6+ servings: use "About" before the number (e.g., "About 7 servings")
Serving sizes expressed in household/metric: round metric to nearest whole number if >5g
Household measures: use standard fractions (1/4, 1/3, 1/2, 2/3, 3/4)

■ RACC values are not "recommended" amounts -- they reflect customary consumption. FDA updated many RACC values in 2016 to better reflect current eating patterns (e.g., ice cream RACC changed from 1/2 cup to 2/3 cup).

05 Allergen Labeling FALCPA + FASTER Act -- The 9 Major Allergens

The 9 Major Food Allergens -- Federal Law

FALCPA (Food Allergen Labeling and Consumer Protection Act, P.L. 108-282, Title II, effective January 2006) requires that the label of a food containing a "major food allergen" declare the allergen in plain English. The FASTER Act (Food Allergy Safety, Treatment, Education, and Research Act, P.L. 117-11, effective January 1, 2023) added sesame as the 9th major allergen. These apply to all FDA-regulated packaged foods sold in the United States.

Allergen 01

Milk

Includes casein, whey, lactalbumin, lactoglobulin, and all dairy derivatives

FALCPA 2004

Allergen 02

Eggs

Includes albumin, globulin, lysozyme, ovalbumin, ovomucin, and all egg derivatives

FALCPA 2004

Allergen 03

Fish

Species must be declared (e.g., bass, flounder, cod). Includes all fin fish.

FALCPA 2004

Allergen 04

Crustacean Shellfish

Species must be declared (e.g., crab, lobster, shrimp). Does not include mollusks.

FALCPA 2004

Allergen 05

Tree Nuts

Specific type must be declared (e.g., almonds, cashews, walnuts, pecans, pistachios, macadamia, Brazil nuts, hazelnuts, chestnuts).

FALCPA 2004

Allergen 06

Peanuts

Arachis hypogaea. Legume (not a tree nut). Includes peanut flour, oil (unless highly refined), butter.

FALCPA 2004

Allergen 07

Wheat

Includes all species of wheat (durum, semolina, spelt, kamut, einkorn, emmer). Does not cover all gluten sources.

FALCPA 2004

Allergen 08

Soybeans

Includes soy protein, soy lecithin, soy flour, soy sauce, tofu, tempeh, miso, edamame.

FALCPA 2004

Allergen 09 -- NEW

Sesame

Added via FASTER Act. Includes sesame seeds, tahini, sesame oil, sesame flour. Effective January 1, 2023.

FASTER Act 2023

Allergen Declaration Methods

FALCPA provides two acceptable methods for declaring major food allergens. Either method satisfies the requirement. The "Contains" statement is the more common approach used by GFS.

Method 1: "Contains" Statement (Preferred by GFS)

A separate "Contains" statement immediately after or adjacent to the ingredient list, identifying all major food allergens present in the product.

Ingredients: Pasteurized milk, cheese cultures, salt, enzymes.
Contains: Milk.

Ingredients: Whole wheat flour, water, eggs, soybean oil, sugar, nonfat dry milk, leavening (sodium bicarbonate, sodium aluminum phosphate), salt.
Contains: Wheat, Eggs, Soy, Milk.

Method 2: Parenthetical in Ingredient List

The common name of the allergen food source is declared in parentheses after the ingredient name where it might not otherwise be recognized.

Ingredients: Enriched flour (wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), water, sugar, soybean oil, casein (milk), sodium caseinate (milk), lecithin (soy), salt.

Note: If using Method 2 alone, every instance of every allergen in the ingredient list must be identified. A "Contains" statement is still recommended by FDA as a best practice even when using parenthetical declarations.

Cross-Contact / "May Contain" Advisory Labeling

Advisory statements are voluntary. Statements such as "may contain [allergen]," "produced in a facility that also processes [allergen]," or "made on shared equipment with [allergen]" are not required by FALCPA. However, they must be truthful and not misleading (21 CFR 101.100). FDA has issued guidance recommending that manufacturers use advisory labeling when there is a reasonable possibility of cross-contact. Advisory statements must not be used in place of required allergen declarations, and should not be used as a substitute for cGMPs to prevent cross-contact.

Made in a facility that also processes tree nuts, peanuts, and sesame.

■ FALCPA: Public Law 108-282, Title II (2004). FASTER Act: Public Law 117-11 (2021, effective Jan 1, 2023). Fish, crustacean shellfish, and tree nuts require species-level declaration. Highly refined oils from allergenic sources are exempt under FALCPA.

06 Ingredient Listing Requirements 21 CFR 101.4 -- Descending order of predominance

Ingredient Declaration Rules

Rule	Requirement	CFR
Order	Ingredients listed in descending order of predominance by weight as added during manufacture	101.4(a)(1)
Common Names	Common or usual name of each ingredient required. Chemical names not acceptable for common ingredients.	101.4(a)(1)
Colors	Must be declared by name (e.g., "FD&C Red No. 40" or "Red 40"). Exempt colors: caramel color, annatto extract, etc.	101.22(k)
Flavors	"Natural flavors," "artificial flavors," or "natural and artificial flavors." Specific flavor source not required except for allergens.	101.22
Chemical Preservatives	Must declare name AND function: e.g., "sodium benzoate (preservative)" or "BHT (to preserve freshness)"	101.22(j)
Spices	May be declared collectively as "spices" except when the spice is also a coloring agent (e.g., paprika, turmeric, saffron must be named)	101.22(a)(2)
Water	Must be declared if it is an ingredient. Exempt if added during processing and subsequently evaporated (incidental additive).	101.4(a)(1)
Incidental Additives	Exempt from declaration if present at insignificant levels and have no technical/functional effect in the finished food.	101.100
Sub-Ingredients	Multi-component ingredients must declare sub-ingredients in parentheses, or each sub-ingredient listed in the overall ingredient list.	101.4(b)(2)

GFS Product Ingredient Examples

Natural Barrel Cheddar

Pasteurized milk, cheese cultures, salt, enzymes.

Process Cheese Slices

Cheddar cheese (pasteurized milk, cheese cultures, salt, enzymes), water, milkfat, sodium citrate, salt, sorbic acid (preservative), annatto and paprika extract (color).

AA Grade Butter

Pasteurized cream, salt.

Frozen Pancakes (USDA)

Whole wheat flour, water, eggs, soybean oil, sugar, nonfat dry milk, leavening (sodium bicarbonate, sodium aluminum phosphate), salt.

■ Standard of identity products (e.g., "cheddar cheese" per 21 CFR 133.113) may use standardized ingredient terms. Non-standardized foods must use common/usual names per 101.4.

07 Gluten-Free Labeling 21 CFR 101.91 -- <20 ppm threshold

FDA Gluten-Free Rule (Effective August 5, 2014)

FDA's final rule defines "gluten-free" as containing less than 20 parts per million (ppm) of gluten. This threshold is based on the lowest level that can be reliably detected using validated analytical methods, and is consistent with international standards (Codex Alimentarius). The rule applies to all FDA-regulated foods bearing gluten-free claims.

Aspect	Requirement
Threshold	<20 ppm gluten (unavoidable presence)
Covered Claims	"Gluten-free," "no gluten," "free of gluten," "without gluten"
Applies To	All FDA-regulated packaged foods
Does NOT Apply To	Meat/poultry (USDA), most alcohol (TTB), restaurant food
Enforcement	FDA compliance since August 2014
Naturally GF Foods	May be labeled "gluten-free" (e.g., cheese, butter)

Gluten-Containing Grains

Wheat (including durum, semolina, spelt, kamut, einkorn, emmer, farro)
Rye
Barley (including malt, malt extract, malt vinegar)
Triticale (wheat-rye crossbreed)

GFS Gluten-Free Products

Natural Cheddar Cheese -- inherently gluten-free
Butter AA Grade -- inherently gluten-free
IQF Broccoli -- inherently gluten-free
Whey Protein Concentrate 80 -- verify supplier COA

Caution

Brown Box Pancakes and other wheat-based USDA items are NOT gluten-free. Process cheese products may contain wheat-derived ingredients (modified food starch) -- verify supplier specifications.

■ 21 CFR 101.91. Testing method: R5 ELISA (Mendez method) or equivalent validated method. FDA can take enforcement action if a product labeled "gluten-free" contains 20 ppm or more gluten.

08 Nutrient Content Claims 21 CFR 101.13, 101.54-101.67

Authorized Nutrient Content Claims -- Complete Reference

Claim	Requirement	CFR
Calorie Free	<5 calories per RACC and per labeled serving	101.60(b)
Low Calorie	≤40 calories per RACC (and per 50g if RACC is small)	101.60(b)
Reduced Calorie / Fewer Calories	≥25% fewer calories than reference food	101.60(b)
Light / Lite (calories)	1/3 fewer calories than reference food	101.56
Light / Lite (fat)	50% less fat than reference food	101.56
Fat Free	<0.5g fat per RACC and per labeled serving	101.62(b)
Low Fat	≤3g fat per RACC (and per 50g if RACC is small)	101.62(b)
Reduced Fat / Less Fat	≥25% less fat than reference food	101.62(b)
Saturated Fat Free	<0.5g saturated fat and <0.5g trans fat per RACC	101.62(c)
Low Saturated Fat	≤1g saturated fat per RACC; ≤15% of calories from saturated fat	101.62(c)
Cholesterol Free	<2mg cholesterol per RACC and per labeled serving; ≤2g saturated fat per RACC	101.62(d)
Low Cholesterol	≤20mg cholesterol per RACC (and per 50g if RACC is small); ≤2g saturated fat per RACC	101.62(d)
Sodium Free	<5mg sodium per RACC and per labeled serving	101.61
Low Sodium	≤140mg sodium per RACC (and per 50g if RACC is small)	101.61
Very Low Sodium	≤35mg sodium per RACC (and per 50g if RACC is small)	101.61
Reduced Sodium / Less Sodium	≥25% less sodium than reference food	101.61
Sugar Free	<0.5g sugars per RACC and per labeled serving	101.60(c)
Good Source / Contains / Provides	10-19% DV per RACC	101.54(c)
High / Rich In / Excellent Source	≥20% DV per RACC	101.54(b)
More / Fortified / Enriched / Added	≥10% DV more than reference food per RACC	101.54(d)
Lean (meat/poultry/seafood)	<10g fat, <4.5g saturated fat, <95mg cholesterol per RACC and per 100g	101.62(e)
Extra Lean (meat/poultry/seafood)	<5g fat, <2g saturated fat, <95mg cholesterol per RACC and per 100g	101.62(e)
High Fiber	≥20% DV fiber (5.6g) per RACC; must also meet "low fat" definition or declare fat level	101.54(b)

GFS Application: Natural cheddar cheese is a "Good Source of Calcium" (15% DV per oz) and a "Good Source of Protein." Butter contains no qualifying nutrient content claims due to high saturated fat content.

■ Comparative claims ("reduced," "less," "more," "light") require identification of the reference food and the amount of difference. Implied claims are also regulated under 21 CFR 101.65.

09 Health Claims Authorized, Qualified, and Structure/Function

Three Categories of Health-Related Claims

Authorized Health Claims

Significant Scientific Agreement (SSA)

Supported by the totality of publicly available scientific evidence. FDA-approved through rulemaking. Highest evidentiary standard. Must meet nutrient content requirements for the claim.

Qualified Health Claims

Emerging / Credible Evidence

Supported by some evidence but does not meet SSA standard. Approved by FDA through petition process. Must include qualifying language (disclaimer) about the level of evidence.

Structure/Function Claims

No FDA Pre-Approval Required

Describe the role of a nutrient in maintaining normal body structure or function. Cannot claim to diagnose, treat, cure, or prevent disease. No FDA approval needed but must be truthful and not misleading.

Authorized Health Claims -- Selected Examples Relevant to GFS

Claim Relationship	Model Claim Language	Food Requirements
Calcium + Vitamin D & Osteoporosis	"Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."	High in calcium (≥20% DV); must also contain Vitamin D
Sodium & Hypertension	"Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."	Must meet "low sodium" criteria (≤140mg)
Dietary Fat & Cancer	"Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers."	Must meet "low fat" criteria (≤3g per RACC)
Saturated Fat + Cholesterol & CHD	"Diets low in saturated fat and cholesterol may reduce the risk of heart disease."	Must meet "low saturated fat," "low cholesterol," and "low fat" criteria
Fiber-Containing Grain Products & Cancer	"Low fat diets rich in fiber-containing grain products may reduce the risk of some types of cancer."	Must be a grain product; good source of fiber; low fat
Fruits/Vegetables & Cancer	"Low fat diets rich in fruits and vegetables may reduce the risk of some types of cancer."	Must be fruit or vegetable; low fat; good source of fiber, Vit A, or Vit C

Structure/Function Claim Examples

"Calcium builds strong bones."
-- Acceptable: describes role of nutrient in body function

"Supports digestive health."
-- Acceptable: describes general body function

NOT Permitted: "This cheese prevents osteoporosis" or "Cures calcium deficiency" -- these are disease claims requiring FDA drug approval. Structure/function claims cannot reference specific diseases.

■ 21 CFR 101.14 (general requirements), 101.70-101.83 (specific authorized claims). Qualified health claims: FDA Enforcement Discretion Letters. Structure/function claims: 21 CFR 101.93.

10 Statement of Identity 21 CFR 101.3 -- Common/usual name, standards of identity

Product Identity Requirements

Every packaged food must bear a "statement of identity" -- the common or usual name of the food -- on the Principal Display Panel (PDP). This name must accurately describe the food and not be misleading. For foods with an FDA standard of identity, the standardized name must be used.

Category	Rule	GFS Example
Standard of Identity	Must use the name specified in the federal standard (21 CFR Parts 131-169)	"Cheddar Cheese" (21 CFR 133.113), "Butter" (21 CFR 131.110)
Common/Usual Name	If no standard exists, use the name commonly used by the public	"Frozen Pancakes," "Whey Protein Concentrate"
Descriptive Name	If no common name exists, an appropriately descriptive name or illustration	"Seasoned Cheese Spread with Jalapeno Peppers"
Imitation Products	If a food resembles and substitutes for a standardized food but is nutritionally inferior, it must be labeled "imitation"	"Imitation Cheese" -- if it does not meet the standard of identity for cheese
"Made with..." Claims	Must be truthful. "Made with real cheese" requires the product to contain actual cheese as defined by standard of identity.	"Made with Aged Cheddar"
Process Cheese Terms	Specific regulatory terms: "Pasteurized Process Cheese" (21 CFR 133.169), "Pasteurized Process Cheese Food" (133.173), "Pasteurized Process Cheese Spread" (133.179)	"Pasteurized Process American Cheese"

■ Statement of identity must appear on the PDP, in bold type, in a size reasonably related to the most prominent text. 21 CFR 101.3. Standards of identity for dairy products: 21 CFR Parts 131 (milk), 133 (cheese).

11 Net Quantity of Contents 21 CFR 101.105 -- Weight, volume, count

Net Quantity Declaration Rules

Rule	Requirement
Placement	Lower 30% (bottom 1/3) of the Principal Display Panel
Dual Declaration	Both metric (g, mL) and US customary (oz, fl oz) required
Solid Foods	Weight: avoirdupois ounces and grams (e.g., "NET WT 16 OZ (454g)")
Liquid Foods	Volume: fluid ounces and milliliters (e.g., "1 QT (946mL)")
Count Items	By count and weight/volume (e.g., "12 SLICES, NET WT 8 OZ (227g)")
Prominence	Must be conspicuous, easily read, and in a line generally parallel to the base

Minimum Type Size (Based on PDP Area)

PDP Area	Minimum Height
≤5 sq in	1/16 inch (1.6mm)
>5 to ≤25 sq in	1/8 inch (3.2mm)
>25 to ≤100 sq in	3/16 inch (4.8mm)
>100 to ≤400 sq in	1/4 inch (6.4mm)
>400 sq in	1/2 inch (12.7mm)

GFS Examples

NET WT 640 LB (290 kg) -- Barrel Cheddar
NET WT 1 LB (454g) -- Butter Print
NET WT 12 OZ (340g) -- Process Cheese Slices
NET WT 2 LB (907g) -- Frozen Pancakes

■ 21 CFR 101.105. Fair Packaging and Labeling Act (15 USC 1451 et seq.). Net quantity must not include the weight of the container, wrapper, or packing material. Abbreviations: "oz," "lb," "g," "kg," "fl oz," "mL," "L."

12 Manufacturer / Distributor Information 21 CFR 101.5 -- Name and place of business

Name and Place of Business Requirements

Element	Requirement
Name	Name of the manufacturer, packer, or distributor
Address	Street address, city, state, and ZIP code. Street address may be omitted if listed in a current city or telephone directory.
Qualifying Phrase	"Manufactured by," "Distributed by," "Packed by," or "Manufactured for" -- required if the name is not that of the manufacturer
Country of Origin	Required for imported foods under FPLA and customs regulations

GFS Standard Label Blocks

Manufactured by:
Global Food Solutions, Inc.
131 Heartland Blvd
Edgewood, NY 11717
(877) 728-5550

Distributed by:
Global Food Solutions, Inc.
131 Heartland Blvd
Edgewood, NY 11717

When GFS distributes products manufactured by a co-packer or third party, the label must read "Distributed by" or "Manufactured for" -- not "Manufactured by." This is a critical compliance distinction. Products manufactured at the Hermitage, PA facility (2500 Freeland Road, Hermitage, PA 16148) should use that address when labeled "Manufactured by."

■ 21 CFR 101.5. Phone number is optional but recommended for consumer inquiries. Website URL also optional. If both HQ and manufacturing facility addresses are used, clarify which is which with appropriate qualifying phrases.

13 Country of Origin Labeling (COOL) USDA COOL / "Product of USA" 2024 Rule

COOL Requirements

Country of Origin Labeling (COOL) is administered by USDA's Agricultural Marketing Service (AMS) under the Agricultural Marketing Act of 1946. COOL applies to specific covered commodities sold at retail, requiring disclosure of the country of origin.

Covered Commodity	Requirement
Muscle cuts of meat (beef, pork, lamb, goat, chicken)	Country where born, raised, and slaughtered
Ground meat	All countries of origin of source material
Wild + farm-raised fish and shellfish	Country of origin; wild or farm-raised; production method
Fresh + frozen fruits and vegetables	Country of origin
Peanuts, pecans, macadamia nuts, ginseng	Country of origin

"Product of USA" Final Rule (2024)

Effective March 2024, USDA FSIS finalized a rule requiring that "Product of USA" and "Made in the USA" labels on meat, poultry, and egg products can only be used when the product is derived from animals born, raised, slaughtered, and processed in the United States. This ended the previous practice of labeling imported meat re-processed in the US as "Product of USA."

GFS COOL Status

Cheese (retail): Subject to COOL if sold at retail -- declare country of milk origin
Cheese (foodservice/wholesale): Typically exempt from COOL (not sold at retail)
Butter: Same as cheese -- COOL at retail level
Frozen vegetables: Subject to COOL at retail
Frozen pancakes: Processed food item -- generally exempt

■ COOL: 7 CFR Part 65. Processed food items are generally exempt from COOL (processing transforms the commodity). GFS bulk/foodservice products typically sold B2B are not subject to retail COOL requirements.

14 Date Marking Best By, Use By, Sell By -- Federal and state guidance

Date Labeling -- Current Federal Framework

There is no uniform federal requirement for date labeling on food products except for infant formula (21 CFR 107.20). Date labels ("Best By," "Use By," "Sell By") are generally voluntary and vary by state law. However, FDA and USDA have encouraged the industry to standardize on "Best if Used By" for quality and "Use By" for safety. GFS follows these best practices for all products.

Date Type	Meaning	Federal Requirement	GFS Usage
Best if Used By / Best By	Product quality -- when product will be at its best flavor/quality. Not a safety date.	Voluntary (except infant formula)	All retail products
Use By	Last date recommended for use while at peak quality. Can indicate safety for perishables.	Mandatory for infant formula only	Perishable dairy products
Sell By	Tells the store how long to display the product. Not a safety date for consumers.	Voluntary	Not used by GFS (industry moving away from this)
Freeze By	Indicates when a product should be frozen to maintain quality.	Voluntary	Used on fresh cheese for freezer transition

GFS Date Format Standard

Recommended Format

            BEST BY 06/15/2026
          

Format: MM/DD/YYYY. Always use 4-digit year. Month/day/year order per US convention. Must be legible, printed in a color that contrasts with background, and in type size not smaller than the ingredient list.

Lot Code Requirements

            LOT: 2026-138-A2
          

GFS lot code format: YYYY-JJJ-XX (Year-Julian Date-Line/Shift). Required by 21 CFR 113.60(c) for low-acid canned foods; best practice for all products. Essential for traceability and recall readiness.

■ FDA supports the industry-wide adoption of "Best if Used By" for quality dates per the 2019 guidance. Some states (20+) have mandatory date labeling laws for specific products like dairy, shellfish, and eggs. Always verify state-specific requirements for retail distribution.

15 Bioengineered Food Disclosure National Bioengineered Food Disclosure Standard (NBFDS)

National Bioengineered Food Disclosure Standard -- Effective January 1, 2022

The National Bioengineered Food Disclosure Standard (NBFDS, 7 CFR Part 66), administered by USDA AMS, requires food manufacturers, importers, and retailers to disclose bioengineered (BE) foods and food ingredients. This replaced the patchwork of state GMO labeling laws with a uniform national standard.

Aspect	Requirement
Definition	"Bioengineered" = food that contains genetic material modified through in vitro rDNA techniques for which the modification could not otherwise be obtained through conventional breeding or found in nature
Threshold	Detectably bioengineered material present. Highly refined ingredients where modified DNA is not detectable may use "derived from bioengineering"
Disclosure Methods	Text on package, USDA BE symbol, QR code (digital link), phone number / text message, URL
Labels	"Bioengineered food" or "Derived from bioengineering"
BE Food List	USDA maintains a list of BE crops: corn, soybeans, cotton, canola, sugar beets, alfalfa, papaya, summer squash, apples (Arctic), potatoes (Innate), pink pineapple, salmon (AquAdvantage), sugarcane, eggplant

Exemptions

Very small food manufacturers (<$2.5M annual receipts)
Restaurant and similar retail food establishment food
Meat, poultry, and egg products (USDA FSIS jurisdiction)
Animal feed
Food certified as USDA Organic
Foods where no BE version of the ingredient is commercially available

GFS Product Assessment

Natural Cheese: No BE disclosure required (milk from cows fed BE corn/soy does not trigger disclosure)
Butter: No BE disclosure required
Frozen Pancakes: Evaluate soybean oil source -- may require disclosure if from BE soybeans
WPC-80: No BE disclosure required

■ 7 CFR Part 66. Administered by USDA AMS, not FDA. Mandatory compliance since January 1, 2022. The USDA BE symbol is a green circle with sun, farm, and smile motif. QR codes must link to a landing page with BE disclosure within one click.

16 Organic Labeling USDA National Organic Program (NOP)

USDA Organic Labeling Tiers -- 7 CFR Part 205

Label Tier	Organic Content	USDA Seal	Certification Required	Requirements
"100% Organic"	100%	Yes	Yes	All ingredients must be certified organic. No non-organic processing aids.
"Organic"	≥95%	Yes	Yes	≥95% organic ingredients by weight (excluding water and salt). Remaining 5% from National List of allowed substances.
"Made with Organic [Ingredient]"	≥70%	No	Yes	≥70% organic ingredients. May list up to 3 organic ingredients on PDP. Cannot use USDA seal.
Organic Ingredients Listed	<70%	No	Depends	May identify organic ingredients in ingredient list only. No organic claims on PDP.

Organic Certification Key Points

Required For Organic Claims

USDA-accredited certifying agent must certify the operation
Annual inspection and renewal required
Organic system plan documenting practices
Records of inputs, handling, and sales
No prohibited substances for 3+ years (land transition)
No irradiation, sewage sludge, or GMOs

Penalties for Misuse

Civil penalty up to $11,000 per violation for knowingly selling non-organic product as organic
USDA can revoke organic certification
State organic programs may impose additional penalties
Operations with <$5,000 annual organic sales exempt from certification but must comply with NOP standards

■ 7 CFR Part 205 (National Organic Program). GFS does not currently hold USDA organic certification. Any future organic product lines would require full NOP certification from a USDA-accredited certifying agent before any organic claim can be made.

17 GFS Product Label Templates 4 complete label mockups for core products

Complete Label Mockups -- FDA-Compliant

Global Food Solutions

Natural Barrel Cheddar Cheese

KEEP REFRIGERATED

Aged Cheddar -- Mild to Medium

Nutrition Facts

About 10,368 servings per container

Serving size 1 oz (28g)

Calories110

% Daily Value*

Total Fat 9g12%

Sat. Fat 5g25%

Trans Fat 0g

Cholesterol 30mg10%

Sodium 180mg8%

Total Carbohydrate 0g0%

Fiber 0g0%

Total Sugars 0g

Includes 0g Added Sugars0%

Protein 7g

Vitamin D 0mcg0%

Calcium 200mg15%

Iron 0mg0%

Potassium 20mg0%

* The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Ingredients: Pasteurized milk, cheese cultures, salt, enzymes.

Contains: Milk.

NET WT 640 LB (290 kg)

Manufactured by:
Global Food Solutions, Inc.
131 Heartland Blvd
Edgewood, NY 11717

LOT: 2026-138-A2

BEST BY 12/15/2026

0 00000 00000 0

Template 01: Barrel Cheddar -- 640lb barrel, retail portioned

Global Food Solutions

Pasteurized Process American Cheese

Individually Wrapped Slices

Nutrition Facts

16 servings per container

Serving size 1 slice (21g)

Calories70

% Daily Value*

Total Fat 5g6%

Sat. Fat 3g15%

Trans Fat 0g

Cholesterol 20mg7%

Sodium 310mg13%

Total Carbohydrate 1g0%

Fiber 0g0%

Total Sugars 1g

Includes 0g Added Sugars0%

Protein 4g

Vitamin D 0mcg0%

Calcium 150mg10%

Iron 0mg0%

Potassium 40mg0%

* The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Ingredients: Cheddar cheese (pasteurized milk, cheese cultures, salt, enzymes), water, milkfat, sodium citrate, salt, sorbic acid (preservative), annatto and paprika extract (color).

Contains: Milk.

16 SLICES, NET WT 12 OZ (340g)

Distributed by:
Global Food Solutions, Inc.
131 Heartland Blvd, Edgewood, NY 11717

LOT: 2026-140-B1

USE BY 07/20/2026

0 00000 00000 0

Template 02: Process Cheese Slices -- 12oz retail package

Global Food Solutions

Butter, AA Grade

Salted -- 80% Butterfat Minimum

Nutrition Facts

About 32 servings per container

Serving size 1 tbsp (14g)

Calories100

% Daily Value*

Total Fat 11g14%

Sat. Fat 7g35%

Trans Fat 0g

Cholesterol 30mg10%

Sodium 90mg4%

Total Carbohydrate 0g0%

Fiber 0g0%

Total Sugars 0g

Includes 0g Added Sugars0%

Protein 0g

Vitamin D 0mcg0%

Calcium 0mg0%

Iron 0mg0%

Potassium 0mg0%

* The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Ingredients: Pasteurized cream, salt.

Contains: Milk.

USDA Grade AA

NET WT 1 LB (454g)

Manufactured by:
Global Food Solutions, Inc.
2500 Freeland Road
Hermitage, PA 16148

LOT: 2026-135-C1

BEST BY 11/01/2026

0 00000 00000 0

Template 03: Butter AA Grade -- 1lb print, Hermitage PA facility

Global Food Solutions

Whole Wheat Frozen Pancakes

KEEP FROZEN

USDA Foods -- Material 110393

Nutrition Facts

About 36 servings per container

Serving size 2 pancakes (220g)

Calories230

% Daily Value*

Total Fat 6g8%

Sat. Fat 1g5%

Trans Fat 0g

Cholesterol 35mg12%

Sodium 420mg18%

Total Carbohydrate 38g14%

Fiber 3g11%

Total Sugars 6g

Includes 4g Added Sugars8%

Protein 8g

Vitamin D 0mcg0%

Calcium 80mg6%

Iron 2mg10%

Potassium 150mg4%

* The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Ingredients: Whole wheat flour, water, eggs, soybean oil, sugar, nonfat dry milk, leavening (sodium bicarbonate, sodium aluminum phosphate), salt.

Contains: Wheat, Eggs, Soy, Milk.

USDA FOODS -- NOT FOR INDIVIDUAL SALE

72 PANCAKES, NET WT 17.4 LB (7.9 kg)

Packed for:
Global Food Solutions, Inc.
131 Heartland Blvd, Edgewood, NY 11717

LOT: 2026-152-P1

BEST BY 05/15/2027

0 00000 00000 0

Template 04: Frozen Pancakes -- USDA Foods, case pack

■ All label mockups follow 21 CFR 101 requirements. UPC codes shown as placeholders -- actual GTINs assigned per product registration. Nutrition data approximate, based on USDA FoodData Central and manufacturer specifications.

18 Label Placement & Typography PDP, information panel, type sizes, language

Label Panel Layout Requirements

Panel	Required Elements	Location
Principal Display Panel (PDP)	Statement of identity, net quantity of contents, any required graphic (USDA mark, organic seal, etc.)	Part of the label most likely seen by consumers at time of purchase
Information Panel	Nutrition Facts, ingredient list, allergen statement, name/address of manufacturer	Panel immediately to the right of the PDP (as displayed to consumer). If that panel is too small, the next panel to the right.
Other Panels	Cooking instructions, promotional content, UPC barcode	Any remaining panel not occupied by required labeling

Typography Requirements

Element	Minimum Type Size	Notes
Statement of Identity	Prominent, bold	Reasonably related to most prominent text on PDP
Net Quantity	Varies by PDP area	See PDP area table in Section 11
Ingredient List	1/16 inch (1.6mm)	Minimum for all required info panel text
Nutrition Facts	6pt minimum	8pt for "Nutrition Facts" heading
Allergen Statement	Same as ingredients	Must be at least as prominent as ingredient list
Name/Address	1/16 inch (1.6mm)	General minimum for required label text

Prominence & Conspicuousness

Required information must be prominent, conspicuous, and easily read
Sufficient contrast with background (typically dark text on light background)
Not obscured by vignettes, crowding, or other text
Information panel text in a single, easy-to-read type style

Language Requirements

English required for all mandatory label statements
If any label text appears in a foreign language, all mandatory information must also appear in that language
Bilingual labeling (English + Spanish) common for US retail distribution
For export products, destination country requirements take precedence

■ 21 CFR 101.2 (information panel), 101.15 (food; prominence of required statements), 101.105 (net quantity placement). Type size measured as the height of the lowercase "o" in the type face used.

19 Rounding Rules 21 CFR 101.9(c) -- Complete nutrient rounding table

FDA Nutrient Value Rounding Rules -- Nutrition Facts Label

Nutrient	Range	Rounding Increment	Express As
Calories	<5 cal	--	"0"
	5-50 cal	Nearest 5 cal	e.g., "25," "30," "45"
	>50 cal	Nearest 10 cal	e.g., "110," "230"
Total Fat	<0.5g	--	"0g"
	0.5 to <5g	Nearest 0.5g	e.g., "2.5g," "3g"
	≥5g	Nearest 1g	e.g., "9g," "12g"
Saturated Fat	<0.5g	--	"0g"
	0.5 to <5g	Nearest 0.5g	e.g., "1.5g," "3g"
	≥5g	Nearest 1g	e.g., "7g"
Trans Fat	<0.5g	--	"0g"
	0.5 to <5g	Nearest 0.5g	e.g., "1g," "2.5g"
	≥5g	Nearest 1g	e.g., "5g"
Cholesterol	<2mg	--	"0mg"
	2 to 5mg	--	"less than 5mg"
	>5mg	Nearest 5mg	e.g., "30mg," "75mg"
Sodium	<5mg	--	"0mg"
	5 to 140mg	Nearest 5mg	e.g., "85mg," "140mg"
	>140mg	Nearest 10mg	e.g., "180mg," "470mg"
Total Carbohydrate	<0.5g	--	"0g"
Total Carbohydrate	≥0.5g	Nearest 1g	e.g., "31g"
Dietary Fiber	<0.5g	--	"0g"
Dietary Fiber	≥0.5g	Nearest 1g	e.g., "3g"
Total Sugars	<0.5g	--	"0g"
Total Sugars	≥0.5g	Nearest 1g	e.g., "6g"
Added Sugars	<0.5g	--	"0g"
Added Sugars	≥0.5g	Nearest 1g	e.g., "4g"
Protein	<0.5g	--	"0g"
Protein	≥0.5g	Nearest 1g	e.g., "7g"
Vitamin D	<0.1mcg	--	"0mcg"
Vitamin D	≥0.1mcg	Nearest 0.1mcg (<1) or nearest integer (≥1)	e.g., "0.3mcg," "2mcg"
Calcium	<5mg	--	"0mg" (to nearest 10mg)
Calcium	≥5mg	Nearest 10mg (<100) or nearest 50mg (≥100)	e.g., "80mg," "200mg"
Iron	<0.1mg	--	"0mg"
Iron	≥0.1mg	Nearest 0.1mg (<1) or nearest integer (≥1)	e.g., "0.4mg," "2mg"
Potassium	<5mg	--	"0mg"
Potassium	≥5mg	Nearest 10mg (<100) or nearest 10mg (≥100)	e.g., "20mg," "235mg"
% Daily Value	All nutrients	Nearest 1% (expressed as whole number)	e.g., "12%," "25%"
% Daily Value	<1% DV (non-zero)	--	"<1%" (optional: may use asterisk)

Key Principle: Rounding rules are designed to prevent misleading precision. Values at or near zero are expressed as zero ("0g") to prevent consumer confusion. The "less than" declaration (e.g., "less than 5mg cholesterol") is used only for cholesterol in the 2-5mg range and trans fat in the <0.5g range when the food meets "cholesterol free" or "trans fat free" claim criteria.

■ 21 CFR 101.9(c). All rounding applies to the per-serving amount as declared on the label. Nutrient values for compliance purposes are based on analytical data (composite of 12 subsamples), not rounded values.

20 Label Compliance Checklist Interactive verification for GFS team

GFS Label Review Checklist -- Click Items to Mark Complete

Use this checklist before approving any new or revised GFS product label for production. Every item must be verified before the label is released to the printer. Progress is saved locally.

0 of 20 items checked

Nutrition Facts panel present and uses current FDA format (2020 rules)Nutrition Facts
Serving size matches RACC for product category (21 CFR 101.12)Serving Size
All mandatory nutrients declared (Fat, Sat Fat, Trans Fat, Cholesterol, Sodium, Total Carb, Fiber, Total Sugars, Protein)Nutrition Facts
Added Sugars line included with % DV (required since January 1, 2020)2020 Update
Vitamin D and Potassium declared as mandatory nutrients (required since January 1, 2020)2020 Update
Calories displayed in largest/boldest type; serving size in bold per updated formatTypography
Allergen statement present -- all 9 major allergens reviewed (includes sesame per FASTER Act 2023)Allergens
Sesame specifically evaluated as ingredient and cross-contact risk (FASTER Act, effective Jan 1, 2023)Allergens
Allergen declaration uses Method 1 ("Contains: ...") or Method 2 (parenthetical) per FALCPAAllergens
Ingredient list present, in descending order of predominance by weightIngredients
All ingredients use common/usual names; chemical preservatives state functionIngredients
Statement of identity on PDP in bold, prominent typeIdentity
Net quantity on lower 1/3 of PDP in both metric and US customary unitsNet Quantity
Manufacturer/distributor name and address present with correct qualifying phraseManufacturer
Date marking present (Best By or Use By) in MM/DD/YYYY formatDate Marking
Lot code present for traceability (YYYY-JJJ-XX format)Traceability
Bioengineered food disclosure included if product contains BE ingredientsBioengineered
Gluten-free claim verified if present (<20 ppm gluten, 21 CFR 101.91)Claims
All nutrient content claims meet 21 CFR definitions (good source, low, free, etc.)Claims
All text meets minimum type size; adequate contrast; English language presentTypography

■ Checklist progress saved to browser localStorage. This checklist covers federal FDA requirements. State-specific requirements (e.g., California Prop 65, state dairy labeling rules) must be verified separately for each distribution market.

21 Regulatory References Primary source links and CFR citations

Primary Regulatory Sources

Source	Citation	Link	Subject
21 CFR Part 101	Title 21 CFR Part 101	eCFR	Food Labeling (comprehensive)
21 CFR 101.9	Section 101.9	eCFR	Nutrition labeling of food
21 CFR 101.12	Section 101.12	eCFR	Reference amounts (RACC)
FALCPA	Public Law 108-282, Title II	Congress.gov	Food Allergen Labeling and Consumer Protection Act
FASTER Act	Public Law 117-11	Congress.gov	Added sesame as 9th major allergen
21 CFR 101.91	Section 101.91	eCFR	Gluten-free labeling of food
FDA Food Labeling Guide	FDA Guidance Document	FDA.gov	Comprehensive labeling guidance (industry)
USDA COOL	7 CFR Part 65	eCFR	Country of Origin Labeling
NBFDS (BE Disclosure)	7 CFR Part 66	eCFR	National Bioengineered Food Disclosure Standard
NOP (Organic)	7 CFR Part 205	eCFR	National Organic Program
"Product of USA" Rule	USDA FSIS Final Rule	FSIS.usda.gov	"Product of USA" / "Made in the USA" for meat/poultry
21 CFR Parts 131-133	Dairy Standards of Identity	eCFR	Standards of identity for cheese products
USDA FoodData Central	USDA FDC	fdc.nal.usda.gov	Nutrient composition database (source for NFP data)
FDA Allergen Guidance	FDA Guidance	FDA.gov	Allergen labeling guidance and Q&A

Document Control

Document ID: GFS-2026-NUT
Version: 1.0
Effective Date: May 18, 2026
Owner: Global Food Solutions, Inc.
Prepared by: Regulatory Affairs
Review Cycle: Annually or upon regulatory change
Classification: Internal Use -- Regulatory Reference
Next Review: May 2027 or upon publication of new FDA final rules

■ All regulatory references current as of May 2026. Laws and regulations are subject to change. Always verify current CFR text at ecfr.gov before making labeling decisions. This document is a reference guide and does not constitute legal advice.