21 CFR 101.9 is FDA's primary regulation governing the content and format of the Nutrition Facts panel on conventional packaged food products. It was substantially revised in the 2016 Nutrition Facts Label final rule, with the updated format mandatory for large manufacturers (annual food sales ≥ $10M) since January 1, 2020, and for small manufacturers (annual food sales < $10M) since January 1, 2021.
For dietary supplements, the parallel panel — Supplement Facts — is governed by 21 CFR 101.36, not 101.9.
Who Must Include a Nutrition Facts Panel
Nutrition labeling is required for most packaged conventional food products sold at retail. Exemptions include:
Small businesses — manufacturers with annual food sales below $50,000 (prior to 2016 update threshold) or fewer than 100 full-time employees and fewer than 100,000 units sold annually — though many choose to label voluntarily
Raw produce and seafood — subject to voluntary nutrition labeling guidelines
Restaurant food — not required on menus unless a nutrient content or health claim is made (see 21 CFR 101.10)
Custom-order products — food prepared for a specific individual upon request
Products sold in bulk — food sold in bulk bins to be repackaged by retailers
Mandatory Nutrients Under the 2016 Updated Format
Under 21 CFR 101.9(c), the following nutrients are mandatory declarations in the Nutrition Facts panel:
Calories (declared per serving, highlighted in large bold type)
Total Fat (grams)
Saturated Fat (grams, indented under Total Fat)
Trans Fat (grams, indented under Total Fat)
Cholesterol (milligrams)
Sodium (milligrams)
Total Carbohydrate (grams)
Dietary Fiber (grams, indented under Total Carbohydrate)
Total Sugars (grams, indented under Total Carbohydrate)
Added Sugars (grams, indented under Total Sugars — new with 2016 update)
Protein (grams)
Vitamin D (mcg — replaced Vitamins A and C)
Calcium (mg)
Iron (mg)
Potassium (mg — replaced Vitamin A)
The 2016 update removed mandatory Vitamins A and C (now voluntary) and added Vitamin D and Potassium based on public health priorities. Added Sugars is an entirely new mandatory element.
Serving Size Requirements
Serving sizes under 21 CFR 101.9(b) are not based on manufacturer preference — they must be derived from the Reference Amounts Customarily Consumed (RACC) published in 21 CFR 101.12(b), which represents amounts typically consumed per eating occasion.
Key serving size rules:
Single-serving containers: Any package containing less than 200% of the RACC must be labeled as a single serving — the entire package is one serving
Dual-column requirement: Packages containing 200–300% of the RACC must include a dual-column Nutrition Facts panel showing both per-serving and per-container amounts
Household measures: Serving size must be expressed in common household measures (cups, tablespoons, pieces, etc.) with the equivalent metric weight in grams
The 2016 update significantly increased serving sizes for many categories. For example, the reference amount for soda increased from 8 fl oz to 12 fl oz. This resulted in higher calorie and nutrient declarations for many beverages and snacks.
Format Requirements
Under 21 CFR 101.9(d), the Nutrition Facts panel must meet specific formatting requirements:
Heading: "Nutrition Facts" must appear at the top, in a type size larger than all other information except Calories
Calories: Displayed in large, bold type — numeric value must be at least 22 point; the word "Calories" must be at least 16 point
Bold headers: "Total Fat," "Cholesterol," "Sodium," "Total Carbohydrate," and "Protein" must be in bold; indented components (Saturated Fat, Trans Fat, Dietary Fiber, Total Sugars, Added Sugars) are not bolded
% Daily Value column: Right-aligned, headed with "% Daily Value*" in bold
Hairlines: Horizontal hairlines separate each nutrient; a thicker bar separates Calories from the % DV column
Footnote: Must include — "*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."
Color: All in black (or one color) on white or neutral contrasting background
Small Package Formats
For packages with less than 40 square inches of total surface area, modified formats are permitted:
Tabular (side-by-side) format — nutrients listed in two columns to reduce vertical space
Linear format — all information presented in a single horizontal line, used for very small packages
For packages with fewer than 12 square inches, nutrition labeling may be omitted if a phone number or address is provided for consumers to request the information.
Voluntary Nutrients
In addition to mandatory nutrients, manufacturers may voluntarily declare:
Vitamins A and C (no longer mandatory)
Other vitamins and minerals with established RDIs
Polyunsaturated fat and Monounsaturated fat
Soluble fiber and Insoluble fiber (subcategories of Dietary Fiber)
Sugar alcohols
Other carbohydrate
If a voluntary nutrient is declared, it must comply with all applicable format requirements for that nutrient.
Rounding Rules
21 CFR 101.9(c) specifies precise rounding rules for each nutrient:
Calories: Rounded to nearest 5 calories for amounts ≥ 50 calories; to nearest 1 calorie for amounts < 50 calories; may declare "0" if < 5 calories
Total Fat: Rounded to nearest 0.5g for amounts < 5g; to nearest gram for 5–50g; to nearest 5g for > 50g
Sodium: Rounded to nearest 5mg for amounts < 5mg; to nearest 5mg for 5–140mg; to nearest 10mg for > 140mg
Total Carbohydrate, Dietary Fiber, Protein: Same as Total Fat
These rounding rules affect the declared values and can affect whether nutrient content claims (e.g., "fat free," "low sodium") can be made.
How Truli Helps with Nutrition Facts Compliance
Format verification: Truli checks Nutrition Facts panel formatting against 21 CFR 101.9 requirements, including type sizes, bold declarations, and hairline placement
Mandatory nutrient completeness: Truli flags missing mandatory nutrients — particularly Added Sugars, Vitamin D, and Potassium, which are commonly omitted on labels updated before the 2016 rule
Serving size validation: Truli flags serving sizes that appear inconsistent with RACC reference amounts for the product category
Single-serving container identification: Truli flags multi-serving labels on packages that qualify as single-serving under the 200% RACC rule
Related Regulations
21 CFR Part 101 — Overview of all FDA food labeling requirements
21 CFR 101.36 — Supplement Facts Panel — Parallel panel requirements for dietary supplements
21 CFR 101.13 — Nutrient Content Claims — Requirements for claims like "low fat" and "high fiber"
FALCPA and FASTER Act — Allergen declaration requirements that apply alongside the Nutrition Facts panel
Frequently Asked Questions
Does the Nutrition Facts panel have to be on a specific panel of the label?
Yes. Under 21 CFR 101.9(j), nutrition information must appear on the information panel — the panel immediately to the right of the principal display panel, or in another location if the information panel is too small. The panel must appear in its entirety — it cannot be split across multiple panels.
Do I need to update my labels to the 2016 format?
If your labels still use the pre-2016 format (showing Vitamins A and C instead of Vitamin D and Potassium, and not declaring Added Sugars), your labels are out of compliance. The compliance deadline for all manufacturers passed January 1, 2021.
Can I list a serving size smaller than what people typically eat?
No. Serving sizes must be based on FDA's reference amounts (21 CFR 101.12(b)) representing typical consumption — not the manufacturer's preferred portion. Using an artificially small serving size to make calorie or nutrient numbers look better is a labeling violation.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. Reflects 21 CFR 101.9 as of April 2026. Truli monitors FDA guidance on Nutrition Facts label requirements. Book a demo to see how.
