FDA Nutrition Label Requirements: 21 CFR 101.9 Guide

FDA nutrition label requirements under 21 CFR 101.9 prescribe what must appear in a Nutrition Facts panel, the order of the information, wording, type sizes, rule weights and permitted formats. A Nutrition Facts panel is not a design choice. You can get the arithmetic right and still have a misbranded label if the required format is wrong.

This guide covers the Nutrition Facts label requirements for the panel itself: who needs one, exactly what must appear and in what order, which of the six approved formats you can use, and the exemptions that may allow you not to print one.

Two related topics are covered separately. If you need requirements for the entire food label, our FDA food labeling requirements checklist covers the ingredient statement, allergens, net quantity and claims. If you need the arithmetic, our rounding rules guide works through every increment in 101.9(c).

Who has to meet FDA nutrition label requirements

The default is that every packaged food offered for sale in the United States must carry FDA nutrition labeling. The regulation then provides a long list of exemptions in 101.9(j), and small producers frequently qualify for one without realizing it.

The exemptions that matter most in practice are summarized below.

Exemption	Who it covers	Conditions
Small business, 101.9(j)(18)	Firms with fewer than 100 full-time equivalent employees	Fewer than 100,000 units of that product sold in the US in a 12-month period, and an annual notice filed with FDA. Lost immediately if any nutrient content or health claim is made.
Very small package, 101.9(j)(13)	Packages with less than 12 square inches of surface area available for labeling	Must give an address or phone number for nutrition information. If nutrition labeling is provided voluntarily, abbreviated formats are allowed.
Insignificant nutrients, 101.9(j)(4)	Foods containing insignificant amounts of all the nutrients required to be declared	Coffee beans, tea leaves, plain unsweetened instant coffee and tea, most spices and flavour extracts. A statement of calories and any nutrient present in a significant amount is still required.
Restaurant and ready-to-eat food, 101.9(j)(2)	Food served or sold for immediate consumption	Separate menu labeling rules apply to chains with 20 or more locations.
Bulk and shipping containers, 101.9(j)(9)	Product shipped for further processing or repackaging	Not for sale to consumers in that form.
Raw produce and seafood, 101.9(j)(10)	The 20 most-consumed raw fruits, vegetables and fish	Covered by a voluntary point-of-purchase programme rather than package labeling.
Dietary supplements, 101.9(j)(6)	Anything marketed as a dietary supplement	Uses a Supplement Facts panel under 101.36 instead. See our side-by-side comparison.

The small business exemption is particularly easy to misunderstand. It is not automatic and it is not permanent. The notice must be filed with FDA every year, both thresholds must be met, and the exemption disappears for that product when the package makes a claim such as "low sodium" or "good source of fiber."

Many producers planning to enter retail choose to provide nutrition labeling voluntarily anyway because buyers ask for it.

FDA Nutrition Facts label requirements: what must appear and in what order

The order of the Nutrition Facts panel is fixed by 101.9(c). You cannot rearrange nutrient lines for aesthetic reasons, and you cannot remove a mandatory line simply because its value is zero.

Reading from top to bottom, the required order is:

Line	Notes	%DV shown?
Servings per container	Above the serving size, in bold	No
Serving size	Household measure followed by metric weight in parentheses, in bold	No
Calories	The largest type on the panel after the heading	No
Total Fat	Bold nutrient name	Yes
Saturated Fat	Indented	Yes
Trans Fat	Indented, italicised "Trans"	No DV exists
Cholesterol	Bold nutrient name	Yes
Sodium	Bold nutrient name	Yes
Total Carbohydrate	Bold nutrient name	Yes
Dietary Fiber	Indented	Yes
Total Sugars	Indented, no DV	No DV exists
Includes Xg Added Sugars	Double-indented under Total Sugars	Yes
Protein	Bold nutrient name	Only if a protein claim is made, or the food is for children under 4
Vitamin D, Calcium, Iron, Potassium	Below a thick rule, with absolute amounts and %DV	Yes

The four mandatory micronutrients changed with the 2016 rule. Vitamins A and C were removed from the mandatory list, while vitamin D and potassium were added because national intake data showed shortfalls in the latter pair and not the former.

Other vitamins and minerals are voluntary unless they are added to the food or are the subject of a claim. In those cases, declaring them becomes mandatory.

Protein needs separate attention. For general foods intended for adults, the protein amount in grams is mandatory but the %DV normally is not.

If you make a claim such as "high in protein" on the front of the package, protein %DV becomes mandatory. That percentage must be corrected for protein quality using PDCAAS, which can produce a markedly lower value for many plant proteins than the raw gram amount might suggest.

Nutrition label requirements for serving size and %DV

Two inputs drive most of the Nutrition Facts panel: serving size and Daily Value.

Serving size comes from the Reference Amount Customarily Consumed for your product category under 21 CFR 101.12. It does not come from the portion size you would prefer to show. You can find your category using the RACC lookup.

The %DV column comes from the Daily Value tables in 101.9(c)(8)(iv) and (c)(9), using a 2,000 calorie reference diet for anyone aged 4 and older.

Both subjects have their own detailed rules. See FDA serving size requirements for how a RACC becomes the serving size printed on the panel, and Nutrition Facts Daily Values for the full reference table.

The short version includes:

• Sodium: 2,300 mg.
• Total carbohydrate: 275 g.
• Dietary fiber: 28 g.
• Added sugars: 50 g.
• Saturated fat: 20 g.
• Total fat: 78 g.

The DV calculator applies the correct rounding ladder for each nutrient. Macronutrients and micronutrients do not use the same rounding ladder.

Below the micronutrients is the prescribed footnote: "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."

The old footnote table showing values for both 2,000 and 2,500 calorie diets was removed in 2016 and must not be restored to current artwork.

Nutrition Facts label requirements for formatting

Of all the Nutrition Facts label requirements, the typography rules in 101.9(d) are among the most prescriptive. This is where labels with otherwise correct nutrition data can still be rejected by retail buyers or FDA reviewers.

• The heading. "Nutrition Facts" must appear in bold type no smaller than the largest type on the panel, set flush left and right within the box.
• Minimum type sizes. Most of the panel must use eight point type or larger. Six point is permitted only for the footnote and for the panel on small packages.
• Rule weights. Use a hairline rule between nutrient lines, a bar of at least seven point after the serving-size block, a bar of at least seven point after the added-sugars block, and a hairline above the footnote. These bars are functional parts of the format, separating the calorie, nutrient and micronutrient sections.
• Type and background. Use black type on a white or neutral contrasting background in a single easy-to-read typeface. Do not use reversed-out panels, colored type or condensed novelty faces.
• Leading. Use at least one point of leading and at least four points between the heading and the rest of the panel.
• Placement. Place the panel on the information panel immediately to the right of the principal display panel, or on the PDP itself. Do not put it on the bottom of a can where the shopper must pick up and turn the package unless its shape leaves no alternative.

Which Nutrition Facts label format can you use?

There are several approved Nutrition Facts layouts. The format you can use depends on package geometry and product type rather than design preference.

Format	When you may use it
Standard vertical	The default. Always acceptable.
Tabular	Packages with 40 square inches or less of labeling space where the standard panel will not fit.
Linear	Packages with less than 12 square inches, or under 40 square inches where neither vertical nor tabular fits.
Simplified	Foods containing insignificant amounts of eight or more of the fifteen listed nutrients. Requires the "Not a significant source of ..." statement.
Dual column	Mandatory for packages containing between 200% and 300% of the RACC. Also used for as-packaged and as-prepared products.
Aggregate	Variety packs and assortments where several distinct foods share one outer package.

The dual-column requirement causes frequent mistakes.

A 20 ounce bottle of soda is not three servings anymore. At 167% of the 12 fluid ounce RACC, it is below 200%, which makes it a single-serving container. The Nutrition Facts panel therefore reflects the entire bottle.

When a package contains more than 150% but less than 200% of the RACC, you may voluntarily add a per-serving column to the left of the whole-container column.

The mandatory dual-column format, with one column per serving and another per container, starts at 200% and continues through 300% of the RACC. A 24 ounce bottle therefore takes that layout.

You can preview the available layouts in the label template library, or start with the standard vertical template.

Compliance dates, records and FDA enforcement

The compliance dates for the 2016 Nutrition Facts rule have passed. They were 1 January 2020 for manufacturers with 10 million dollars or more in annual food sales and 1 January 2021 for everyone else.

Every label in the market today should therefore use the current format. If an old artwork file still includes "Calories from Fat" or treats vitamins A and C as mandatory, that artwork is nine years out of date.

Two recordkeeping obligations behind the panel are easy to overlook.

Under 101.9(g), when a nutrient value depends on a calculation rather than direct analysis, you must be able to show the supporting work. Added sugars declarations specifically require records when a food contains both naturally occurring and added sugars, or when added sugars are consumed through fermentation or non-enzymatic browning because the analytical result will not equal the amount originally added.

For enforcement, FDA compares declared values with laboratory analysis of market samples using defined tolerances.

• Class I nutrients, meaning added vitamins and minerals, must be present at 100% or more of the declared amount.
• Class II naturally occurring nutrients must reach at least 80% of the declared amount.
• For calories, sugars, total fat, saturated fat and sodium, the measured amount must not exceed 120% of the declared value.

Declaring conservatively in the appropriate direction for each class is a legitimate and widely used strategy.

FDA nutrition label requirements that commonly get missed

1. Invented serving sizes. Choosing 15 g for a snack because it produces a more attractive calorie number when the RACC for the category is 30 g.
2. A missing dual column. Failing to use the required format on a package containing between 200% and 300% of the RACC.
3. Omitting a zero line. Trans fat at 0 g still requires a line. Only the specific omissions allowed under 101.9(c) may be made, and each carries a required footnote.
4. Wrong rule weights. A common error is using a hairline where a seven point bar belongs, removing the required visual hierarchy of the panel.
5. Rounding each ingredient before summing. Calculate the recipe at full precision, total the nutrients, then round once at the end.
6. Claiming an exemption while making a claim. The small business exemption disappears when the front panel says "good source of fiber."
7. Leaving the old footnote table. Current artwork should not contain the former 2,000 and 2,500 calorie columns.
8. Declaring protein %DV without PDCAAS correction. When a protein claim makes %DV mandatory, the percentage must account for protein quality.

You can build a compliant panel without manually setting these elements. Enter your recipe in the free label generator, which applies the 101.9 order, rounding, rule weights and type minimums for every approved format. You can also check an existing label against the requirements using the FDA label checklist.

FDA nutrition label requirements: frequently asked questions

Do I need a Nutrition Facts panel if I only sell at farmers markets?

Possibly not. Food sold directly to consumers for immediate consumption is exempt, and a producer below both small business thresholds that makes no nutrient content or health claims can file for the small business exemption. The exemption is per product, requires an annual FDA notice and disappears when you make a claim. State cottage food laws can impose separate labeling requirements.

Can I put the Nutrition Facts panel anywhere on the package?

No. The panel belongs on the information panel immediately to the right of the principal display panel as the consumer faces the product, or on the PDP itself. It may be placed elsewhere only when the package shape makes those locations genuinely unusable. Placement is therefore part of the Nutrition Facts label requirements, not simply an artwork preference.

Does the Nutrition Facts panel have to be black and white?

Effectively yes. The regulation requires black type on a white or neutral contrasting background. A light background color can be used when sufficient contrast is maintained, but colored type and reversed-out Nutrition Facts panels are not compliant. The requirement is intended to preserve the standardized appearance and readability of the nutrition information.

Is laboratory analysis required for FDA nutrition label compliance?

No. You may derive nutrient values from a validated nutrient database using your actual formulation. What matters is whether the declared values survive FDA's compliance tolerances when a market sample is tested. Database calculations can be defensible for stable formulations. Laboratory analysis becomes more useful for products with variable raw materials or nutrients close to claim thresholds.

Will FDA nutrition label requirements change the front of the package too?

Not yet. FDA proposed a front-of-package "Nutrition Info" box in January 2025 that would classify saturated fat, sodium and added sugars as Low, Med or High. It has not been finalized, and FDA leadership said in March 2026 that the proposal was under reassessment. Nothing on the front of your package is required to change today. Our front-of-package guide tracks its status.