Last verified 16 Sep 2026 · Sources
If you package food and offer it for sale, FDA’s default answer is yes: you need a Nutrition Facts label. 21 CFR 101.9(a) requires nutrition labeling on food intended for human consumption and offered for sale unless the product fits one of the specific exemptions listed in 101.9(j) (21 CFR 101.9). Those exemptions cover things like very small retailers, restaurants, small packages, and small businesses under specific unit and employee thresholds, but nearly all of them share one condition: the moment a nutrient content claim or health claim shows up anywhere, the exemption stops applying and a full panel is required.
| Quick facts | Nutrition labeling requirement |
|---|---|
| Regulation | 21 CFR 101.9(a), 101.9(j) |
| Applies to | Anyone packaging food for sale, including cottage-food makers going wholesale |
| Key numbers | Retailer: ≤$500k/≤$50k sales; small business: <100 FTE & <100,000 units/yr; packages <12 sq in |
The rule
The base requirement is broad on purpose. 101.9(a) states that nutrition information “shall be provided for all products intended for human consumption and offered for sale” unless 101.9(j) says otherwise. That means the question isn’t “does my product need a label,” it’s “does my product qualify for one of the listed exemptions, and am I willing to make no nutrition claims to keep it.”
The main exemptions in 101.9(j), each with its own conditions:
- (j)(1) Retailer exemption: annual gross sales of $500,000 or less, or food/dietary-supplement sales to consumers of $50,000 or less, provided the food carries no nutrition claims.
- (j)(2) Restaurant/food-service exemption: food served in restaurants; food served in establishments where it’s served for immediate consumption (institutional food service, transportation carriers, bakeries, delis, and confectionery stores with on-premises consumption facilities, food-service vendors like lunch wagons, ice cream shops, mall cookie counters, vending machines, sidewalk carts, convenience stores, and home or office delivery); food sold only in or used only in such facilities; and distributors that sell principally to such facilities, provided the food bears no nutrition claims or other nutrition information. Restaurants remain subject to 101.11 menu labeling.
- (j)(3) Ready-to-eat food prepared on site: ready-to-eat food of that same (j)(2) type, sold to consumers but not for immediate consumption, processed and prepared primarily in a retail establishment and not sold outside it (independent delis, bakeries, and confectionery stores without on-premises seating, in-store deli/bakery/candy departments, and self-service salad bars), again provided the food bears no nutrition claims or other nutrition information. Also subject to 101.11 menu labeling.
- (j)(4) Insignificant nutrients: food with insignificant amounts of every required nutrient is fully exempt if it carries no claims (plain coffee, tea, and spices are FDA’s own examples).
- (j)(13) Small packages: under 12 square inches of label space can skip the panel entirely with no claims and an address or phone number for nutrition information; up to 40 square inches gets simplified tabular or linear formatting instead.
- (j)(18) Small business exemption: under 100 FTE employees and under 100,000 units of a product sold per year, with an annual notice to FDA (see small-business-exemption for the full mechanics, including the tier that skips the notice).
The numbers
| Exemption | Who it covers | Key condition |
|---|---|---|
| (j)(1) Retailer | Small direct-to-consumer sellers | ≤$500,000 total sales or ≤$50,000 food sales; no claims |
| (j)(2) Restaurant | Food served for immediate consumption | Bears no nutrition claims or other nutrition information; subject to 101.11 menu labeling |
| (j)(3) On-site prepared | Ready-to-eat bakery/deli items made and sold at one retail location | Not sold outside that establishment; bears no nutrition claims or other nutrition information |
| (j)(4) Insignificant nutrients | Foods like plain coffee, tea, spices | Insignificant amounts of every required nutrient; no claims |
| (j)(13) Small package | Packages <12 sq in of label space | No claims; phone/address for nutrition info |
| (j)(18) Small business | Under 100 FTE and 100,000 units/yr | Annual notice to FDA (below 10 FTE/10,000 units, no notice needed) |
Any claim (“low sodium,” “high protein,” “heart healthy,” even an implied claim like “light”) reopens the requirement for a full panel regardless of which exemption above would otherwise apply.
On the label
Say you sell a few bottles of hot sauce a month at one farmers market, well under the (j)(1) and (j)(18) thresholds. That bottle can skip the Nutrition Facts panel, as long as nothing on it says “low sodium” or “no added sugar.”
Then you sign with a regional grocery chain wanting the product in 40 stores. Unit volume climbs toward or past 100,000 a year, pushing the small business exemption out of reach, and the retailer’s own vendor checklist usually calls for a full panel regardless of federal exemption status. Either way, the move is the same: build the real panel with the correct serving size (set by the RACC in 21 CFR 101.12, not your preference) and %DV.
Mistakes we see
- Assuming “small batch” means “exempt.” Exemption status depends on the specific unit-volume, revenue, and employee-count thresholds above, not on how the product is made.
- Adding a claim without checking what it does to the exemption. “No added sugar” on an otherwise-exempt product cancels the exemption instantly.
- Confusing state cottage-food rules with the federal exemption. A state’s cottage-food program and FDA’s 101.9(j) exemptions are separate frameworks; meeting one doesn’t satisfy the other, and a retailer can require a panel that neither one mandates.
- Not re-checking status after a sales jump. The (j)(18) thresholds are checked annually; a good year can push a product out of exemption the next cycle.
- Skipping the panel on a small package that still carries nutrition information. The under-12-square-inch exemption only applies with zero nutrition claims or information; adding even a calorie count forfeits it.
Related rules
Once a product needs the panel, what-is-racc sets the legal serving size, and nutrient-content-claims covers which numeric thresholds a term like “low sodium” must hit. For anything beyond a simple nutrient claim, see health-claims. For the small-volume path in depth, read small-business-exemption next.
Check your product
Knowing where your product lands means you can answer a retailer’s vendor checklist the day it arrives. Enter your recipe and see what your label needs: your calories, the claims you qualify for and your allergen line are free, no card required, every other value and %DV stays hidden until you unlock, and $29 unlocks every other nutrient value and %DV, every FDA format your product qualifies for, and your ingredient statement and allergen declaration. If you run several SKUs, the Studio plan ($299 a year: every product you make, plus the compliance binder and PDF reports) tracks unit volume and claims across a whole line, and the Co-packer plan ($1,199 a year: everything in the Studio plan plus client folders and white-label documents) fits anyone labeling other companies’ products. Start your label free or see pricing for every plan.
FAQ
Does every packaged food need a Nutrition Facts label?
Almost. 21 CFR 101.9(a) requires nutrition labeling on food intended for human consumption and offered for sale, unless the product qualifies for one of the specific exemptions in 101.9(j), and even then, adding a nutrient content or health claim generally cancels the exemption.
Are restaurants required to have a Nutrition Facts label?
Food served in restaurants and other food-service establishments falls under a separate exemption, 21 CFR 101.9(j)(2), which reaches restaurants, institutional food service, transportation carriers, and similar operations, as long as the food bears no nutrition claims or other nutrition information ([21 CFR 101.9](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.9)). Restaurants stay subject to the separate menu-labeling rule at 101.11.
Is my home bakery, selling under a cottage-food license, exempt from a Nutrition Facts label?
Cottage-food sales are governed by state law, which is separate from FDA's federal exemptions. Once your product moves into interstate wholesale or a retailer requires a panel, the federal rule and the retailer's own requirement both come into play.
Does a small package ever skip the Nutrition Facts panel entirely?
Packages with less than 12 square inches of available labeling space can skip the panel under 21 CFR 101.9(j)(13)(i), provided the package carries no nutrition claims and lists an address or phone number for nutrition information on request.
What instantly cancels an exemption?
Any nutrient content claim (like 'low sodium') or health claim on the package, in labeling, or in advertising. The exemptions in 101.9(j) are consistently conditioned on the product carrying no such claims.
Related rules
Small business exemption, Nutrient content claims, Health claims, USDA vs FDA Jurisdiction. See the full all labeling rules.