Do I need a nutrition facts label? a straight answer by business type

The decision path: six questions, in order

Work down the list. Stop at the first step that gives you a verdict.

Step 1. Is the food packaged for retail sale, or is it served for immediate consumption?

Food served in a restaurant, sold from a food truck, or delivered ready to eat is exempt from nutrition labeling under 21 CFR 101.9(j)(2). Deli items, bakery goods, and confections sold to the consumer from the place they were prepared are exempt under 101.9(j)(3).

• Immediate consumption or sold from where you made it → no panel required. Go to Step 6 anyway.
• Packaged food for retail → continue to Step 2.

Step 2. Do the label, the labeling, or the advertising make a nutrient content claim, a health claim, or provide any other nutrition information?

This is the one that catches people. "High protein." "Sugar free." "Only 90 calories." "Supports heart health." On the bag, on your website, in an Instagram caption, in your Amazon copy.

• Yes → you need a compliant Nutrition Facts panel. No exemption below applies. Stop here.
• No → continue to Step 3.

Step 3. Are you a small retailer selling your own food?

Under 21 CFR 101.9(j)(1), food sold by a person making direct sales to consumers is exempt if annual gross sales are not more than $500,000, or annual gross sales of food to consumers are not more than $50,000.

• Under either threshold → exempt, and no filing with FDA is required.
• Over both → continue to Step 4.

Step 4. Fewer than 100 employees and fewer than 100,000 units?

The low-volume exemption at 21 CFR 101.9(j)(18) needs an average of fewer than 100 full-time equivalent employees and fewer than 100,000 units of that product sold in the US in a 12-month period.

• Both true → exempt, but you must file an annual notice with FDA. See the section below.
• Either false → you need a panel.

Step 5. Are you small enough to skip the paperwork too?

If you are not an importer, have fewer than 10 full-time equivalent employees, and sell fewer than 10,000 units of that product a year, FDA requires no notice at all.

• Yes → exempt, no filing.
• No → file the annual notice from Step 4.

Step 6. Does someone other than FDA require a panel anyway?

Amazon, a grocery buyer, a distributor, a co-packer, or a state program can require a panel even when FDA does not. That is contract or state law, not federal exemption, and it still binds you.

• Yes → you need a panel, exemption or not.
• No → you are done. No panel required. Skip to the five things you do need.

Verdict by business type

Cottage food operator / home baker

Verdict: almost certainly no panel required. No state cottage food law we are aware of requires a full Nutrition Facts panel on cottage food products. Programs change, so confirm it with your state agriculture or health department rather than taking our word for it. Your state will require its own label elements, usually a statement like "Made in a home kitchen that is not subject to state inspection." Wording varies, so get that in writing from the same agency.

You cross into needing a panel when one of these five things happens:

1. You make a nutrient content claim ("high protein," "sugar free," "reduced sugar")
2. You make a health claim
3. You outgrow your state's cottage food cap and move to a commercial kitchen
4. You sell wholesale or into retail — cottage exemptions are almost universally direct-to-consumer only
5. You sell on Amazon or another marketplace that requires a panel

A word on "low carb," "low sugar," and "keto," because they come up constantly. Subpart D of Part 101 defines the nutrient content claims you are allowed to make. It defines "sugar free," "no added sugar," and "reduced sugar" at 21 CFR 101.60. It defines no "low sugar" and no "low carbohydrate" at all. 21 CFR 101.13(b) bars a nutrient content claim that is not made in accordance with Subpart D, so "low carb" or "low sugar" on a package is a problem on its own terms, before you get anywhere near your exemption. "Keto" is less settled. FDA has never classified it as a nutrient content claim, and the argument that it implicitly characterizes carbohydrate level has not been tested. Treat "keto" as risky rather than as a decided rule, and get a look at your copy from someone who does this before you print it.

One state-specific warning: California cottage food law prohibits sauces, salsa, meat and jerky, dairy, and canned goods outright. Make those in California and you are not a cottage operation at all — you are a commercial manufacturer, with full labeling obligations.

Farmers market seller

Verdict: no panel required, assuming you sell your own product direct to the shopper under your state's cottage food or farm-direct rules. The federal retailer exemption in Step 3 covers most market sellers on volume alone.

Where it flips: a restaurant buys a case, or the co-op down the street wants to stock you. That is wholesale. See below.

Restaurant selling packaged retail items

Verdict: split. The food you plate and serve is exempt under 101.9(j)(2). The jar of house hot sauce by the register is a packaged retail product and needs a full label. Whether it needs a nutrition panel depends on Steps 3 through 5. Most single-location restaurants clear the thresholds easily.

Separately, FDA menu labeling under 21 CFR 101.11 applies only to chains with 20 or more locations under the same name offering substantially the same menu items. Under 20 locations, menu calorie counts are not federally required.

Food truck

Verdict: no panel on food you serve. Same immediate-consumption exemption as a restaurant, and the 20-location menu labeling threshold almost never catches an independent truck.

The exception is whatever you sell packaged on the side: bottled sauce, bagged spice rub, cookies in a sealed bag. Those follow the packaged-food rules and the same Step 3 to Step 5 analysis.

Meal prep service

Verdict: depends on whether it is ready for immediate consumption. Meals delivered to a home ready to eat fall under 101.9(j)(2). Sealed, refrigerated or frozen meals sold through a retailer, gym cooler, or vending fridge are packaged retail foods.

Most meal prep operators fail Step 2, not Step 4. The macros are the product. If your website lists protein and carb counts per meal, you are providing nutrition information and the exemption does not apply. Publish macros, publish them properly.

Packaged snack startup

Verdict: legally exempt for a while, practically not. A first-year snack brand with three employees and 8,000 units clears both thresholds and does not even need to file. But snack brands make claims, sell to retailers, and list on Amazon. Assume you need a panel inside 12 months and design it in now. Reprinting film or pouches later costs far more.

Supplement brand

Verdict: you need a Supplement Facts panel, and you should assume no exemption. Dietary supplements must bear nutrition labeling under 21 CFR 101.36. A parallel exemption exists at 101.36(h)(2), pointing back at the same 101.9(j)(18) thresholds, but it applies only to products whose labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim.

Almost no supplement is sold without a claim. If your bottle says "supports immune function," you are outside the exemption. Supplement Facts is also a different panel format, with its own rules.

Selling wholesale into retail

Verdict: you need a panel. State cottage exemptions are direct-to-consumer only, so wholesaling removes you from that shelter. And the retailer exemption in Step 3 covers direct sales to consumers, not sales to a store. You may still qualify federally under Step 4, but nearly every grocery buyer, distributor, and broker requires a compliant panel as a condition of the purchase order regardless.

One narrow carve-out, at 21 CFR 101.9(j)(9): bulk food shipped to another manufacturer for further processing before retail sale is exempt, since it never reaches a consumer in that form.

Selling on Amazon, Etsy, or Shopify

Verdict: Amazon yes, Etsy usually not, Shopify depends on you.

Amazon requires product images showing the nutrition panel, ingredient list, allergen declaration, manufacturer information, and net quantity. Enforcement escalates: detail page suppression, then listing removal, then an account warning, then suspension. Documented triggers include missing allergen declarations, non-compliant serving sizes, incorrect panel formatting, disease or drug claims, and missing dual-column labeling on multi-serving products.

Etsy and Shopify impose no panel requirement of their own. But Shopify is your own storefront, so your own product copy is labeling and advertising. A product page that says "high fiber" is a nutrient content claim, and your federal exemption is gone.

Co-packer client

Verdict: you need a panel, and it is your legal responsibility, not theirs. Nearly every co-packer requires a finished, print-ready label before a run. More importantly, the responsible party named on the label is you. If the panel is wrong, it is your recall. Build the panel before you book production time — a label revision after printing is the expensive kind of mistake.

The FDA small business exemption, in full

This is the exemption most food entrepreneurs actually rely on. It lives at 21 CFR 101.9(j)(18).

Mechanics that trip people up:

Employees are full-time equivalents across the firm and its affiliates. FDA's method is total paid hours divided by 2,080. Owners, officers, admin, production, and distribution staff all count. If actual headcount is under 100, just report headcount.

"Units" means packages. A unit is a package, or if unpackaged, the form offered for sale to consumers. Count per product, not across your catalog, summing every package size sold under the same brand name and statement of identity.

The exemption is per product and lasts twelve months. You claim a specific 12-month period on the notice; it expires at the end of that period, and renewal restarts the clock.

Do not count on FDA to remind you. The agency's Small Business Nutrition Labeling Exemption Guide says it in capital letters: "FDA DOES NOT NOTIFY FIRMS WHEN IT IS TIME TO FILE A NOTICE. FDA DOES NOT SEND CONFIRMATION THAT THE AGENCY HAS RECEIVED YOUR COMPLETED NOTICE." FDA's page for the electronic filing system says something different: that firms will receive an electronic reminder when it is time to resubmit. Both are FDA's own words, and they conflict. Treat the guidance as the safer of the two, keep a copy of everything you submit, and build your own reminder. If FDA does not receive a completed notice each year, the exemption stops applying.

Filing is free, through FDA's online system or the model exemption notice form. Set a calendar reminder eleven months out; if an FDA email happens to arrive too, treat it as a bonus rather than the trigger. That is the whole compliance burden, and people still lose the exemption by forgetting it.

The warning: three things that void your exemption instantly

FDA's language is unambiguous. If any nutrient content claim (for example, "sugar free"), health claim, or other nutrition information appears on the label, in labeling, or in advertising, the small business exemption does not apply to that product.

Read that last part again. Advertising. Not just the package.

Your Instagram caption can void it. So can your Amazon bullet points, your Shopify product description, your farmers market chalkboard, your wholesale sell sheet. If any of them characterizes a nutrient level, the exemption is gone for that product and a compliant panel becomes mandatory.

This is the most common way a legitimately exempt brand falls out of compliance, and it is usually the designer or the marketing intern who does it, not the founder. Read what counts as a nutrient content claim before approving any packaging or ad copy.

You may not need a panel. You still need these five things.

An exemption from nutrition labeling is not an exemption from labeling. Every packaged food you sell at retail needs all five, exemption or not.

1. Statement of identity. The name of the food, on the principal display panel, in bold type. Use the common or usual name — "strawberry jam," not "Nana's Summer Dream." Your brand name can sit alongside it, but it is not the statement of identity. See 21 CFR 101.3.
2. Net quantity of contents. On the principal display panel, and under 21 CFR 101.7(f) it "shall be placed on the principal display panel within the bottom 30 percent of the area of the label panel in lines generally parallel to the base on which the package rests." FDA excepts principal display panels of 5 square inches or less from that placement rule, so a very small package has more freedom. Declare it in both US customary and metric units: "NET WT 8 OZ (227 g)." The dual declaration is a Fair Packaging and Labeling Act requirement, added by Pub. L. 102-329 (August 3, 1992), not a 101.7 requirement — 101.7(p) only says the metric figure "may also appear."
3. Ingredient list, in descending order by weight. Every ingredient, by its common name, heaviest first. Sub-ingredients of compound ingredients are declared in parentheses. See 21 CFR 101.4.
4. Allergen declaration. Nine major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, the ninth as of January 1, 2023 under the FASTER Act. Two legal ways to declare: parenthetically inside the ingredient list, or in a separate "Contains" statement. Tree nuts, fish, and shellfish must be named by species — "almond," not "tree nuts." "May contain" is voluntary and replaces neither method.
5. Name and place of business. Name and address of the manufacturer, packer, or distributor. If you are not the manufacturer, qualify it: "Distributed by," "Manufactured for." A street address may be omitted only if it appears in a current city or telephone directory. See 21 CFR 101.5.

Your state cottage food program will likely add a sixth element. Get its required wording in writing.

If you do need the panel itself, Nutrillius builds a 21 CFR 101.9-compliant one from your recipe in about a minute. $39 one time, no subscription, PNG/PDF/SVG, 90 days of edits. Medallion Labs' published price for the same output is $1,609 to $1,724 per sample, and rush doubles it.