FDA Food Labeling Review Checklist: A Practical Checklist

Summary. Food labels are among the most prescriptive documents in commercial regulation, and nearly every requirement is a formatting rule with a numerical answer rather than a judgment call — which makes label defects unusually easy to prevent and unusually expensive to discover after a print run. This checklist walks the label panel by panel: statement of identity and net quantity on the principal display panel; ingredient statement, allergen declaration, and manufacturer identification on the information panel; the Nutrition Facts panel and the serving size derived from the reference amount customarily consumed; and then the claims, each with its own definition and substantiation requirement.

What this checklist is for. Reviewing a food or beverage label before printing. For the surrounding framework, see Food and Beverage Regulation: FDA Labeling, the FSMA, and State Cottage Food Laws.

Phase 1 — Confirm which agency labels the product

Is the product a food regulated by FDA, a meat, poultry, or egg product regulated by USDA FSIS (which requires prior label approval in defined circumstances), or an alcohol beverage regulated by TTB?
Note the boundaries: an open-faced sandwich is FSIS and a closed one is FDA; a pizza with meat is FSIS and a cheese pizza is FDA.
Note the alcohol split: wine below 7 percent alcohol by volume and beers not made from both malted barley and hops — which includes most hard seltzers, many ciders, and sorghum beers — are labeled under FDA rules with a Nutrition Facts panel, not by TTB.
Confirm whether the product is a dietary supplement, which uses a Supplement Facts panel and a different regime entirely.
Confirm whether a standard of identity exists for the food, because if the product purports to be that food and does not conform, it is misbranded and must use a different name.

Phase 2 — The principal display panel

Statement of identity — the common or usual name, or the name required by the standard of identity, in bold type and in a size reasonably related to the most prominent printed matter, generally parallel to the base of the package.
Where the food is an imitation of another, the word "imitation" immediately precedes the name.
Net quantity of contents, in both metric and U.S. customary units, in the prescribed type size scaled to the panel area, placed within the bottom 30 percent of the panel, parallel to the base.
Confirm the net quantity is stated by weight for solids, fluid measure for liquids, and count where appropriate.
Confirm any vignette or graphic does not misrepresent the contents.
Confirm the panel is the one most likely to be displayed at retail, and that the requirements are met on any alternate principal display panel.

Phase 3 — The information panel

Immediately to the right of the principal display panel, with no intervening material, in the required order:

Ingredient statement — all ingredients in descending order of predominance by weight, using common or usual names.
Sub-ingredients of compound ingredients declared parenthetically after the compound ingredient, or dispersed into the main list.
Color additives declared by name where required; spices, flavors, and colorings declared per the applicable rules.
Chemical preservatives declared with a statement of function.
Allergen declaration for the major food allergens — milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame — by a "Contains" statement following the ingredient list, or by parenthetical identification within it.
Confirm the specific type of tree nut, fish, and crustacean shellfish is named.
Confirm any precautionary "may contain" statement is not being used as a substitute for declaring an intentional ingredient.
Name and place of business of the manufacturer, packer, or distributor, with a qualifying phrase such as "Distributed by" if not the manufacturer, and a street address unless listed in a current directory.
Nutrition labeling, addressed below.
Confirm the type size and contrast meet the prominence and conspicuousness requirements — required information that is present but unreadable is still misbranding.

Why this matters. Undeclared allergens are the leading cause of Class I food recalls, and the dominant cause is not a formulation error but a label mix-up at changeover or an unnoticed supplier change. Label reconciliation at the line and a change-notification requirement in every supplier agreement prevent most of them.

Phase 4 — The Nutrition Facts panel

Confirm the serving size derives from the reference amount customarily consumed in 21 C.F.R. § 101.12 — not from the manufacturer's preferred portion.
Confirm servings per container is correct and displayed in the required prominence.
Confirm calories appear in the enlarged type the current format requires.
Confirm the mandatory nutrients are declared: total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium — with actual amounts in addition to percent daily value for the vitamins and minerals.
Confirm dual-column labeling where the package contains between one and two servings and could reasonably be consumed in one sitting, or is between 200 and 300 percent of the reference amount.
Confirm the correct format for the package size — standard, tabular, or linear — and that any simplified format is properly justified.
Confirm rounding rules were applied correctly for each nutrient.
Confirm the underlying nutrient analysis is supportable — a laboratory analysis or a documented database calculation, retained.
Confirm whether a small business exemption applies based on units sold and employee count, whether the required notice was filed, and whether the exemption is lost as volume grows.
Note that making a nutrient content claim forfeits most exemptions.

Phase 5 — Claims

Nutrient content claims — "low fat," "high fiber," "good source of," "reduced sodium," "light," "lean" — each has a regulatory definition in 21 C.F.R. Part 101 Subpart D, and the product must meet it. Confirm any required disclosure statement and any disqualifying nutrient level.
Health claims — a relationship between a substance and a disease — must be an authorized claim by regulation, a qualified health claim under a letter of enforcement discretion with the required disclaimer, or an authoritative statement claim with notification. Confirm the model language and the conditions of use, including disqualifying nutrient levels.
Structure/function claims for a conventional food must derive from the food's nutritive value. A claim that the product diagnoses, cures, mitigates, treats, or prevents disease makes it an unapproved new drug — and the evidence is not limited to the label. The website, social media, influencer content, amplified testimonials, and the product name are all evaluated together.
"Natural" — FDA has no formal definition and only a longstanding policy. If the claim is used, maintain a written, defensible basis, and recognize that it invites class action litigation over synthetic preservatives, fermentation-derived acids, and processing aids.
"Organic" — a certified term under the National Organic Program. Confirm certification and the correct tier: "100% organic," "organic" (95 percent), "made with organic ingredients" (70 percent), or ingredient-level identification below that, with only the first two eligible for the USDA seal.
"Gluten-free" — defined by regulation at less than 20 ppm, with testing to support it.
"Healthy" — defined by regulation; confirm the current criteria.
"Non-GMO" — a private certification, distinct from the federal disclosure requirement.
Bioengineered food disclosure under 7 C.F.R. Part 66 — text, symbol, electronic link, or text message option — with exemptions for very small manufacturers and threshold rules.
"Made in USA" — the FTC's "all or virtually all" standard.
For every claim, assemble a substantiation file before the claim is made. A study conducted afterward does not cure the violation.

Phase 6 — Other requirements and the review process

Country of origin labeling for covered commodities.
Juice HACCP warning statements where applicable, and the unpasteurized juice warning.
Infant formula requirements, which are a separate regime.
Proposition 65 warnings if selling into California and a listed chemical is present above the safe harbor level — after testing, because many products are below the threshold.
State ingredient bans with future effective dates, several of which prohibit specific additives.
Menu labeling obligations if the product is sold in a covered establishment.
Confirm food contact packaging materials are approved or otherwise lawful.
Route the label through a documented review with a checklist and a sign-off before the print order, including a claims gate for marketing.
Maintain version control of every label and every artwork revision, with effective dates, so that the label in market on any given date can be reconstructed.
Re-review on any formulation, supplier, packaging size, or claim change — and treat a supplier change as a labeling event, because it is the most common source of undeclared allergens.

Common mistakes

Serving size chosen by marketing rather than derived from the reference amount customarily consumed.
Sub-ingredients omitted from a compound ingredient, which is how allergens go undeclared.
Specific tree nut, fish, or shellfish not named in the allergen declaration.
A hard seltzer or cider labeled under TTB rules when FDA rules and a Nutrition Facts panel apply.
A nutrient content claim that forfeits the small business nutrition labeling exemption, unnoticed.
Health claims made on the website that were carefully avoided on the package.
"Natural" used without a written basis, in a category with active class action litigation.
Required information present but not conspicuous — small type, low contrast, or interrupted by intervening material.
No version control, so the company cannot prove what the label said when a claim is made.
No re-review after a supplier change.

Primary authority

Statutes: the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., particularly adulteration at § 342, misbranding at § 343, the allergen provisions at § 343(w), and the drug definition at § 321(g)(1)(B); the Nutrition Labeling and Education Act; the Food Allergen Labeling and Consumer Protection Act; the FASTER Act (sesame); the Fair Packaging and Labeling Act, 15 U.S.C. § 1451 et seq.
Regulations: food labeling generally, 21 C.F.R. Part 101, including the principal display panel at § 101.1 and § 101.2, the statement of identity at § 101.3, the ingredient statement at § 101.4, name and place of business at § 101.5, nutrition labeling at § 101.9, reference amounts customarily consumed at § 101.12, nutrient content claims at Subpart D, and health claims at Subparts E and G; standards of identity at 21 C.F.R. Parts 130–169; the bioengineered food disclosure standard at 7 C.F.R. Part 66.
Cases: POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014); United States v. Park, 421 U.S. 658 (1975).

This checklist is educational and not legal advice. Labeling requirements are detailed and change, and state ingredient and warning laws vary. Have a label reviewed by qualified food and drug counsel before printing.