This checklist is structured as a pre-print review process for food and supplement brands. It separates format compliance — required elements, placement, and formatting — from claims compliance, which requires regulatory interpretation rather than a checklist lookup. Both need to happen before a label goes to print.

Use this as a working document alongside the actual label artwork, not as a post-production review. Finding a format error after 50,000 units are printed is expensive. Finding a disease claim violation after the product is in distribution is more expensive.

Section 1 — Principal Display Panel (PDP)

The PDP is the part of the label most likely to be examined under customary retail display conditions, defined at 21 CFR 101.1.

Statement of identity

• The common or usual name of the food appears on the PDP

• If the product is a dietary supplement, the label includes "Dietary Supplement" or the appropriate supplement category (e.g., "Herbal Supplement") as part of the statement of identity

• The statement of identity is in bold type and prominent relative to the rest of the label

Net quantity of contents under 21 CFR 101.7

• Net quantity appears in the bottom 30% of the PDP

• Declared in both metric and U.S. Customary units (e.g., "16 fl oz (473 mL)")

• Type size meets the minimum based on PDP area (1/16 inch minimum for PDPs up to 5 sq in; larger minimums for larger PDPs)

• For multiunit packages: both total net quantity and per-unit count declared

PDP claims review

• Every claim on the PDP has been evaluated against the claims checklist in Section 4

Section 2 — Information Panel

The information panel is the label panel immediately to the right of the PDP under 21 CFR 101.2. It must carry the Nutrition Facts or Supplement Facts panel, ingredient list, allergen declaration, and manufacturer information — all grouped together without intervening unrelated material.

Nutrition Facts panel under 21 CFR 101.9

• Serving size matches FDA's reference amounts customarily consumed (RACC) for the product category under 21 CFR 101.12

• Servings per container accurately reflects the total units divided by serving size

• All required nutrients declared with correct Daily Value percentages using current (2020 update) Daily Values

• Added sugars declared separately from total sugars

• Vitamin D, calcium, iron, and potassium declared with %DV

• Panel format matches FDA's current format specifications (type size, bold/non-bold, dividing lines)

• If qualifying for small business exemption under 21 CFR 101.9(j), eligibility confirmed

Supplement Facts panel under 21 CFR 101.36 (supplements only)

• Panel header reads "Supplement Facts" not "Nutrition Facts"

• Serving size and servings per container declared

• Each dietary ingredient listed with quantity per serving

• Ingredients with established Daily Values (vitamins, minerals) show %DV

• Proprietary blends declared as a blend with total weight; individual ingredients listed within the blend in descending order of predominance

Ingredient list under 21 CFR 101.4

• All ingredients listed in descending order of predominance by weight

• Ingredient blends and compound ingredients declared correctly (sub-ingredients in parentheses)

• Water added as a processing aid that remains in the finished product is included

• Spices, natural flavors, and artificial flavors declared using those terms (or specific names if required)

• Color additives declared by name (not as "color" or "coloring")

Allergen declarations under FALCPA and the FASTER Act

• All nine major allergens present in the product are declared: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, sesame

• Allergens declared either in the ingredient list using the common name (e.g., "wheat flour") or in a "Contains:" statement immediately following the ingredient list

• Tree nuts declared by specific type (e.g., "almonds," "cashews")

• Fish and shellfish declared by species (e.g., "salmon," "shrimp")

• Contract manufacturer's allergen cross-contact risk has been assessed and documented

Name and place of business under 21 CFR 101.5

• Name of the manufacturer, packer, or distributor appears on the label

• Address includes street address (if not in a current city directory or phone book), city, state, and ZIP code

• If the product is distributed by a company other than the manufacturer, the label includes "Distributed by" or "Manufactured for" with the appropriate name

Section 3 — Type Size and Prominence Requirements

Under 21 CFR 101.15, required label statements must be prominent, conspicuous, and easy to read.

• Minimum type size for required label statements: 1/16 inch for labels on packages with ≤12 sq in of total surface; larger minimums for larger packages

• All required statements appear in English (additional languages may be added but cannot replace English)

• No required statement is obscured by graphics, design elements, or color contrast issues

• For supplements: FDA disclaimer appears in boldface type and is not smaller in type size than the accompanying structure/function claim

Section 4 — Claims Review

This section requires regulatory evaluation, not just a checklist lookup. Each claim type has its own compliance framework — verify which framework applies before checking compliance against it.

Structure/function claims (dietary supplements) under 21 CFR 101.93

• Every structure/function claim has been reviewed against FDA's disease claim criteria under 21 CFR 101.93(g)

• No claim explicitly or implicitly names a disease, names a disease population, describes characteristic signs or symptoms of a disease, or uses clinical/medical terminology implying drug effects

• The required FDA disclaimer appears on the label, prominently and in boldface: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

• Disclaimer placement meets requirements: adjacent to the claim or linked by a referencing symbol

• FDA has been notified of structure/function claims within 30 days of first marketing under 21 CFR 101.93(a)

Nutrient content claims (food and supplement) under 21 CFR 101.13 and related sections

• Each nutrient content claim (e.g., "high fiber," "low sodium," "good source of vitamin C") meets the defined threshold for that term

• "High" or "excellent source" claims require ≥20% DV per serving

• "Good source" claims require 10–19% DV per serving

• "Free" claims meet the applicable threshold (e.g., "fat free" requires <0.5g fat per serving)

• "Healthy" claims satisfy the updated 21 CFR 101.65 criteria (food group requirement + sodium/saturated fat/added sugar limits)

Health claims under 21 CFR 101.14

• Any claim about the relationship between a nutrient or food and a disease is either an FDA-authorized health claim or a qualified health claim with the appropriate disclaimer

• If an authorized health claim: the product meets all qualifying criteria (nutrient thresholds, food category eligibility)

• If a qualified health claim: the required disclaimer accurately reflects the level of scientific evidence supporting the claim

General marketing language

• "Natural" claims reviewed against FDA's informal policy (nothing artificial or synthetic added that would not normally be expected)

• "Clean" or "clean label" language reviewed — no FDA definition exists; litigation risk assessed

• Environmental/sustainability claims reviewed against FTC Green Guides (see Section 5)

• "Non-GMO" claims reviewed — no FDA definition; USDA BE disclosure requirements assessed

Section 5 — Digital Channel Review

FDA's definition of "labeling" extends to product websites and promotional materials. FTC's truth-in-advertising standards apply across every marketing channel. The label review isn't complete until the same review has been applied to:

• Brand website — every health claim, function claim, and benefit statement reviewed against the same standards as the physical label

• Amazon listing — title, bullet points, product description, and A+ content reviewed for disease claim language; required disclaimers present if structure/function claims appear

• Social media profiles and posts — disease claim language, testimonials citing health outcomes, influencer content reviewed

• Email marketing and advertising — claim language consistent with what the physical label supports

• Influencer partnerships — sponsored content reviewed for undisclosed disease claims; FTC disclosure language confirmed

Section 6 — Retailer-Specific Requirements

Major retailers impose label requirements beyond FDA and FTC that function as additional compliance layers for brands seeking distribution.

• Whole Foods Market: formulation reviewed against Whole Foods unacceptable ingredients list; any ingredients on the banned list addressed before submission

• Amazon: supplement listings reviewed for disease claim language in all text fields; Amazon's SCP program requirements reviewed if applicable

• Costco and club channels: package size and net quantity labeling requirements for club format reviewed

• Natural channel retailers (Sprouts, Natural Grocers, Fresh Market): retailer-specific formulation and claim standards confirmed with buyer or retailer compliance documentation

Section 7 — Pre-Print Approval

Before the label file goes to the printer:

• Format compliance confirmed by someone with knowledge of 21 CFR Part 101 requirements

• Claims compliance confirmed against the applicable regulatory framework for each claim type

• Label artwork file matches the final approved version — no unapproved changes between the reviewed version and the print file

• Allergen review confirmed with current contract manufacturer documentation

• For new supplement products: FDA structure/function claim notification submitted or calendar reminder set for within 30 days of first sale

Run this checklist through Truli before print

Truli's label compliance scanning runs the format and claims review simultaneously — checking mandatory element placement, evaluating every claim against FDA's regulatory framework, flagging disease claim language and missing disclaimers, and extending the same scan to website and Amazon copy. For brands preparing a new label for print or reviewing an existing label before scaling, Truli surfaces what the checklist would flag, faster and more consistently than a manual review.

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.