Quick Answer
FDA requires most packaged foods sold in the United States to bear a Nutrition Facts label under 21 CFR 101.9. The label must declare calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium per serving. Allergens must be declared under FALCPA, and the updated label format with added sugars and revised Daily Values is now mandatory for all manufacturers.
Regulatory Authority: 21 CFR Part 101 — Food Labeling; Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA); FASTER Act of 2021
FDA Nutritional Labeling Requirements Overview
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that food labels provide consumers with accurate, useful nutritional information. The Nutrition Labeling and Education Act (NLEA) of 1990 mandated the Nutrition Facts panel on most packaged foods, and FDA's implementing regulations in 21 CFR 101 govern every aspect of what appears on a food label.
In 2016, FDA finalized significant updates to the Nutrition Facts label format to reflect current nutrition science, updated serving sizes, and new requirements for declaring added sugars. These changes became mandatory for manufacturers with $10 million or more in annual food sales on January 1, 2020, and for all other manufacturers on January 1, 2021.
Key Requirements at a Glance
- Nutrition Facts panel: Required on most packaged foods with specific formatting under 21 CFR 101.9
- Serving sizes: Must be based on Reference Amounts Customarily Consumed (RACC) per 21 CFR 101.12
- Mandatory nutrients: 15 nutrients must be declared in a prescribed order
- Allergen labeling: Nine major allergens must be declared under FALCPA and the FASTER Act
- Daily Values: Updated reference values based on 2,000-calorie diet
- Label format: Specific font sizes, bold requirements, hairline rules, and layout prescribed by regulation
Non-compliance with nutritional labeling requirements can result in a product being deemed "misbranded" under Section 403 of the FD&C Act, subjecting the manufacturer to warning letters, product seizures, injunctions, and criminal penalties.
The Nutrition Facts Panel: Required Elements
The Nutrition Facts panel is the most recognizable element of food labeling in the United States. Under 21 CFR 101.9, the panel must follow a strict format and declare specific nutrients in a prescribed order.
| Nutrient | Unit | Daily Value (DV) | Required? |
|---|---|---|---|
| Calories | kcal | 2,000 | Yes |
| Total Fat | g | 78 g | Yes |
| Saturated Fat | g | 20 g | Yes |
| Trans Fat | g | N/A | Yes |
| Cholesterol | mg | 300 mg | Yes |
| Sodium | mg | 2,300 mg | Yes |
| Total Carbohydrate | g | 275 g | Yes |
| Dietary Fiber | g | 28 g | Yes |
| Total Sugars | g | N/A | Yes |
| Added Sugars | g | 50 g | Yes |
| Protein | g | 50 g | Yes |
| Vitamin D | mcg | 20 mcg | Yes |
| Calcium | mg | 1,300 mg | Yes |
| Iron | mg | 18 mg | Yes |
| Potassium | mg | 4,700 mg | Yes |
Format Requirements
The updated Nutrition Facts label format introduced in 2016 includes several key design changes:
- Larger, bolder Calories: The calorie declaration must appear in a significantly larger and bolder font than other nutrients
- Serving size emphasis: Serving sizes must appear in larger, bolder type to draw consumer attention
- Added Sugars line: A separate indented line for Added Sugars with its own %DV is now mandatory
- Updated footnote: The footnote now reads "*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."
- Vitamins and minerals: Vitamin D, calcium, iron, and potassium are mandatory; vitamins A and C are now voluntary
- Actual amounts: Vitamins and minerals must be declared in both actual amounts (mcg or mg) and %DV
Serving Size Determination (RACC)
Serving sizes on the Nutrition Facts label are not recommendations for how much to eat. They are standardized amounts based on Reference Amounts Customarily Consumed (RACC) as established in 21 CFR 101.12. FDA updated many RACC values in 2016 to better reflect current eating habits.
| Food Category | RACC | Label Serving Size |
|---|---|---|
| Beverages (non-carbonated) | 240 mL (8 fl oz) | 1 cup (240 mL) |
| Carbonated beverages | 360 mL (12 fl oz) | 1 can (360 mL) |
| Cereals (ready-to-eat, flaked) | 30 g | 1 cup (varies) |
| Bread | 50 g | 1 slice (50 g) |
| Cookies | 30 g | 2-3 cookies (30 g) |
| Ice cream | 2/3 cup (previously 1/2 cup) | 2/3 cup (89 g) |
| Yogurt | 170 g (previously 225 g) | 1 container (170 g) |
| Snack chips | 28 g | About 15 chips (28 g) |
| Salad dressing | 30 g | 2 tbsp (30 g) |
| Pasta (dry) | 56 g | 2 oz (56 g) |
Dual-Column Labeling
Products that can be consumed in a single sitting but contain multiple servings (such as a 20 oz soda bottle or a pint of ice cream) must use a dual-column format. One column shows "Per Serving" amounts and the other shows "Per Container" or "Per Package" amounts, allowing consumers to see both the per-serving and total nutritional content.
Single-Serving Containers
Products packaged in containers that hold between 100% and 200% of the RACC must be labeled as a single serving. For example, a 15 oz can of soup (RACC = 245 g) would be declared as one serving because 15 oz falls within 100-200% of the RACC.
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Start My RegistrationNutrient Content and Rounding Rules
FDA prescribes specific rounding rules for each nutrient declared on the Nutrition Facts label. These rules, found in 21 CFR 101.9(c), determine how analytical values are converted into the numbers that appear on the label.
| Nutrient | Amount Range | Rounding Rule |
|---|---|---|
| Calories | < 5 per serving | Declare as 0 |
| Calories | 5 to 50 | Round to nearest 5 |
| Calories | > 50 | Round to nearest 10 |
| Total Fat | < 0.5 g | Declare as 0 g |
| Total Fat | 0.5 to 5 g | Round to nearest 0.5 g |
| Total Fat | > 5 g | Round to nearest 1 g |
| Sodium | < 5 mg | Declare as 0 mg |
| Sodium | 5 to 140 mg | Round to nearest 5 mg |
| Sodium | > 140 mg | Round to nearest 10 mg |
| Total Carb | < 0.5 g | Declare as 0 g |
| Total Carb | 0.5 to < 1 g | Declare as "less than 1 g" |
| Total Carb | ≥ 1 g | Round to nearest 1 g |
| Protein | < 0.5 g | Declare as 0 g |
| Protein | 0.5 to < 1 g | Declare as "less than 1 g" |
| Protein | ≥ 1 g | Round to nearest 1 g |
Compliance Tolerances
FDA applies specific compliance tolerances when evaluating whether a Nutrition Facts label is accurate. The agency uses a "class-based" system:
- Class I nutrients (nutrients added to foods): Must be present at 100% or more of the declared value
- Class II nutrients (naturally occurring vitamins, minerals, protein, dietary fiber, potassium): Must be present at 80% or more of the declared value
- Class III nutrients (calories, sugars, total fat, saturated fat, cholesterol, sodium): Must not exceed 120% of the declared value
Common Mistake
Many manufacturers use database values rather than laboratory analysis for their Nutrition Facts panels. While database values are acceptable for initial labeling, FDA may request laboratory verification during inspections. Keep records of how your nutritional values were determined.
Allergen Labeling (FALCPA + FASTER Act)
The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires that food labels clearly identify the presence of any of the major food allergens. The FASTER Act of 2021 added sesame as the ninth major allergen, effective January 1, 2023.
The Nine Major Allergens
Milk
dairy products and casein
Eggs
including albumin and lysozyme
Fish
species must be identified
Crustacean Shellfish
species must be identified
Tree Nuts
specific nut must be named
Peanuts
including peanut flour and oil
Wheat
including spelt and kamut
Soybeans
including soy lecithin
Sesame
added by FASTER Act 2021
Declaration Methods
Allergens may be declared using one of two methods under 21 CFR 101.4:
- Parenthetical declaration: Identify the allergen source in parentheses after the ingredient name. For example: "casein (milk)" or "lecithin (soy)"
- "Contains" statement: A separate statement immediately after or adjacent to the ingredient list. For example: "Contains: Milk, Wheat, Soy"
Important: Advisory Allergen Statements
Precautionary allergen labeling (e.g., "May contain traces of peanuts") is voluntary and not regulated by FDA. These statements must not be used in place of Good Manufacturing Practices to prevent cross-contact. FDA has indicated it may issue rulemaking on precautionary allergen labeling in the future.
Tree Nut and Fish Specificity
For tree nuts, fish, and crustacean shellfish, FALCPA requires that the specific type be declared. You cannot simply label a product as containing "tree nuts" — you must identify the specific variety (almonds, cashews, walnuts, etc.). Similarly, the specific species of fish (bass, cod, flounder) or crustacean shellfish (crab, lobster, shrimp) must be named.
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Start My RegistrationFront-of-Package Labeling (New 2026 Rules)
FDA has proposed a significant new rule that would require standardized front-of-package (FOP) nutrition labeling on most packaged foods. This represents one of the most substantial changes to food labeling since the original NLEA requirements.
What the Proposed Rule Requires
Under the proposed rule, food products that exceed specified thresholds for saturated fat, sodium, or added sugars would be required to display a standardized symbol on the front of the package. The proposed thresholds are:
Saturated Fat
Products exceeding the proposed threshold per RACC would carry a "High in Saturated Fat" indicator
Sodium
Products exceeding the proposed sodium threshold per RACC would carry a "High in Sodium" indicator
Added Sugars
Products exceeding the proposed added sugars threshold per RACC would carry a "High in Added Sugars" indicator
Timeline and Compliance
FDA issued the proposed rule in 2024 and accepted public comments through early 2025. The final rule is anticipated in 2026, with a compliance period likely extending 2-3 years after finalization to allow manufacturers to redesign packaging. Manufacturers should begin evaluating their product portfolios now to understand which products may be affected.
International Context
The United States is joining a global trend toward FOP labeling. Countries including Chile, Mexico, Israel, and several EU member states have already implemented mandatory FOP nutrition warnings. The FDA's proposed approach differs from these international models but shares the goal of providing at-a-glance nutritional information.
Exemptions from Nutritional Labeling
While most packaged foods require a Nutrition Facts label, 21 CFR 101.9(j) provides several exemptions. Understanding these exemptions is critical for manufacturers and importers.
Small Business Exemption
Businesses with fewer than 100 full-time equivalent employees and fewer than 100,000 units sold per product in a 12-month period may qualify. Must file FDA Form 3728 to claim the exemption.
21 CFR 101.9(j)(1) and (j)(18)
Raw Fruits, Vegetables, and Fish
The 20 most frequently consumed raw fruits, vegetables, and fish are exempt from individual labeling. Voluntary nutrition information may be provided at point of purchase instead.
21 CFR 101.9(j)(10)
Foods in Small Packages
Packages with a total surface area of 12 square inches or less are exempt if they provide an address or phone number where consumers can obtain nutrition information.
21 CFR 101.9(j)(13)
Foods Sold by Restaurants and Similar Establishments
Foods served or sold in restaurants, cafeterias, and similar establishments are generally exempt. However, chains with 20 or more locations must provide calorie information under separate menu labeling rules (21 CFR 101.11).
21 CFR 101.9(j)(2)
Custom-Processed Fish and Game Meat
Fish or game meat that is custom-processed for the personal consumption of the consumer who provided it is exempt from nutrition labeling.
21 CFR 101.9(j)(9)
Foods with Insignificant Nutrient Content
Foods like plain coffee, tea, most spices, and flavor extracts that contain insignificant amounts of all mandatory nutrients are exempt.
21 CFR 101.9(j)(4)
Exemption Limits
Making any nutrient content claim (e.g., "low fat," "good source of fiber") or health claim on a food product eliminates the exemption. Once a nutrition-related claim appears on the label, a full Nutrition Facts panel is required regardless of any other exemption criteria.
Common Labeling Violations and FDA Enforcement
FDA actively enforces nutritional labeling requirements through inspections, import examinations, and marketplace surveillance. The following are the most frequently cited violations that result in warning letters and enforcement actions.
Incorrect Serving Sizes
Using serving sizes that do not align with the RACC values in 21 CFR 101.12, or failing to update serving sizes to the 2016 revised RACC values.
Example: Declaring a serving size of 1/2 cup for ice cream when the updated RACC is 2/3 cup
Correction: Cross-reference all serving sizes with the current RACC table in 21 CFR 101.12
Missing Added Sugars Declaration
Failing to include the mandatory Added Sugars line on the updated Nutrition Facts label format.
Example: Using the pre-2016 label format that omits Added Sugars entirely
Correction: Ensure your label uses the current format with Added Sugars indented under Total Sugars with %DV
Incorrect Rounding
Applying wrong rounding increments for nutrient values or failing to round to zero when amounts are below the threshold.
Example: Declaring 3 calories when the actual amount is 4 (should be rounded to 5)
Correction: Apply the rounding rules in 21 CFR 101.9(c) for each specific nutrient
Missing or Incomplete Allergen Declaration
Failing to declare one or more of the nine major allergens present in the product, including from hidden sources.
Example: Not declaring wheat in a product containing modified food starch derived from wheat
Correction: Audit every ingredient and sub-ingredient for the nine FALCPA allergens; use either parenthetical or Contains statement
Outdated Daily Values
Using the pre-2016 Daily Values instead of the updated reference amounts.
Example: Declaring Vitamin D DV as 400 IU (old) instead of 20 mcg (current), or listing Vitamin A and C as mandatory
Correction: Update all DVs to the current reference values published in 21 CFR 101.9(c)(8)(iv)
Nutrient Content Claims Without Compliance
Making claims like 'low sodium' or 'high fiber' without meeting the specific regulatory criteria for those claims.
Example: Labeling a product 'low sodium' when it contains 160 mg per RACC (limit is 140 mg per RACC)
Correction: Verify all nutrient content claims against the criteria in 21 CFR 101.13 and 101.54-101.67
FDA Enforcement Actions
Labeling violations can trigger a range of FDA enforcement responses, escalating in severity:
- Warning letters: Formal notice of violations requiring corrective action within 15 business days
- Import detention: Products held at port of entry pending correction of labeling deficiencies
- Seizure: FDA can seize misbranded products through federal court action
- Injunction: Court order prohibiting further distribution of misbranded products
- Criminal prosecution: In cases of willful or repeated violations, responsible individuals may face criminal charges
International Labeling Comparison
Manufacturers exporting to multiple markets must understand that nutritional labeling requirements differ significantly between countries. A label compliant with US FDA requirements will not necessarily meet the requirements of other jurisdictions.
| Requirement | United States | EU | Canada |
|---|---|---|---|
| Panel name | Nutrition Facts | Nutrition Declaration | Nutrition Facts / Valeur nutritive |
| Serving basis | RACC-based serving | Per 100 g/mL (mandatory) + per portion (optional) | Serving size (CFIA reference amounts) |
| Energy units | Calories (kcal) | kJ and kcal | Calories (kcal) |
| Added Sugars | Mandatory | Not required | Not currently required |
| FOP labeling | Proposed (2026) | Nutri-Score (voluntary in some states) | FOP symbol proposed |
| Allergen labeling | 9 allergens (FALCPA + FASTER) | 14 allergens (EU Regulation 1169/2011) | Priority allergens list |
For food importers bringing products into the United States, labels must be fully compliant with FDA requirements before the product enters US commerce. Products with foreign-format nutrition labels (e.g., EU per-100g format without a US Nutrition Facts panel) will be refused entry.
Learn more about food import compliance requirements and FSMA compliance for imported foods.
How Assurentry Reviews Your Labels
Assurentry provides comprehensive FDA labeling compliance review services designed to catch violations before they become enforcement problems. Our review process covers every aspect of nutrition labeling.
Our Label Review Process
Nutrition Facts Panel Review
Serving Size Verification
Allergen Declaration Audit
Claims Verification
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Start My RegistrationFrequently Asked Questions
What foods require a Nutrition Facts label?
Most packaged foods offered for sale in the United States must bear a Nutrition Facts label under 21 CFR 101.9. Exemptions exist for raw fruits, vegetables, fish, foods produced by small businesses meeting certain criteria, restaurant foods, and foods with insignificant nutrient content (coffee, tea, spices).
What is the updated Nutrition Facts label format?
The updated format features larger and bolder Calories, a mandatory Added Sugars line with %DV, updated Daily Values based on current nutrition science, actual amounts for vitamins and minerals in addition to %DV, and a revised footnote. Vitamin D and potassium are now mandatory; vitamins A and C are voluntary.
How do I determine the correct serving size for my product?
Serving sizes are based on Reference Amounts Customarily Consumed (RACC) established by FDA in 21 CFR 101.12. Look up your food category in the RACC table, then express the serving size in a common household measure followed by the metric equivalent in grams or milliliters.
What allergens must be declared on food labels?
Under FALCPA and the FASTER Act, nine major allergens must be declared: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. For tree nuts, fish, and shellfish, the specific species must be identified.
Can I use a database instead of lab testing for nutrition values?
FDA accepts nutrient values from databases, calculations, and laboratory analysis. However, FDA may request laboratory verification during inspections. The label values must be accurate within FDA's compliance tolerances regardless of how they were determined.
When does the front-of-package labeling rule take effect?
FDA proposed the FOP labeling rule in 2024. The final rule is expected in 2026, with a compliance period of 2-3 years after finalization. Manufacturers should begin evaluating their product portfolios now to understand which products may be affected.
What is the penalty for incorrect nutrition labeling?
A food product with an inaccurate or missing Nutrition Facts label is considered misbranded under Section 403 of the FD&C Act. FDA enforcement actions range from warning letters to import detention, product seizure, injunctions, and criminal prosecution for willful violations.
Do imported foods need a US-format Nutrition Facts label?
Yes. All packaged foods sold in the United States must comply with US labeling requirements regardless of country of origin. Products with foreign-format nutrition labels (such as the EU per-100g format) will be refused entry until relabeled to comply with 21 CFR 101.
What is dual-column labeling and when is it required?
Dual-column labeling shows nutritional information both per serving and per container on a single Nutrition Facts panel. It is required for products packaged in containers that hold between 100% and 200% of the RACC and could reasonably be consumed in one sitting, such as a 20 oz bottle of soda.
Does making a nutrient claim trigger additional labeling requirements?
Yes. Making any nutrient content claim (e.g., 'low fat,' 'good source of fiber') or health claim on a food product requires full Nutrition Facts labeling and eliminates any exemptions. The claim must also meet the specific regulatory criteria defined in 21 CFR 101.13 and 101.54-101.67.
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