Free FDA Label Requirement Checklist

A US retail food package has to carry a fixed set of elements, and each one comes from a specific section of 21 CFR Part 101: the statement of identity (§ 101.3), the net quantity of contents (§ 101.105), the ingredient statement (§ 101.4), the name and place of business of the manufacturer, packer or distributor (§ 101.5), and nutrition labeling (§ 101.9). The major allergen declaration comes from FALCPA, as amended by the FASTER Act to add sesame.

Each row in the checklist names the element, says why it is required, shows which panel it belongs on and gives the section that requires it. The citation is there so the requirement can be read at its source rather than taken on trust - the checklist summarises the rule, the regulation states it.

The list is not the same for every product, which is why the tool asks before it answers. Each answer either adds a requirement or adds a caveat; none of them removes an obligation, except where a requirement does not apply by definition - a single-ingredient food, for example, needs no separate ingredient list.

• Food or dietary supplement. A supplement carries a Supplement Facts panel under § 101.36 rather than Nutrition Facts, and its statement of identity has to include the words "dietary supplement".
• More than one ingredient. The ingredient statement in § 101.4 applies to foods made from two or more ingredients. A genuinely single-ingredient product does not need a separate list.
• Contains a major allergen. Brings in the allergen declaration, either within the ingredient list or as a Contains statement beside it.
• Made or packed by someone else. When the name on the label is not the manufacturer's, § 101.5 requires it to be qualified with a phrase showing the connection, such as "Manufactured for" or "Distributed by".
• Low volume or few employees. Adds a separate block about the § 101.9(j) exemptions.

The ingredient and allergen questions start ticked. A product whose answers have not been given is shown the stricter list, not quietly passed.

Tick each element already on your artwork. The counter shows how many of the required elements are accounted for, and the line beneath it names everything still unticked. Change an answer and the ticks on elements that remain required are kept, so you can revise the product description without starting again.

Rows that depend on a measurement link to the tool that calculates it. The "Check these yourself" block has no checkboxes at all: exemptions turn on unit volume, employee count and a notice filed with FDA, none of which the checklist can see, so it points to the rule instead of pretending to decide it.

Incomplete labels are usually missing something structural rather than something obscure. Working through the list one element at a time brings out the gaps that a visual review of finished artwork passes over:

• A co-packed product printing the brand owner's name and address with no "Manufactured for" or "Distributed by" qualifier.
• A supplement laid out with a Nutrition Facts panel because the artwork was adapted from a food label.
• A front panel designed around brand and imagery, with the net quantity moved, shrunk or dropped late in the design.
• An allergen in the formula that never reached the artwork because the label was prepared from an older recipe.

Two things are deliberately left to other tools. Minimum type sizes depend on the area of the principal display panel, so the checklist never asserts one - the PDP calculator works them out from real dimensions. Whether an exemption from nutrition labeling actually reaches you depends on your own figures, and the exemption checker walks through the paragraphs of § 101.9(j) that might.

Beyond that, the checklist establishes that each element is there, not that it is right. A name can imply a standard of identity the food does not meet, and a claim on the front can be one the product does not qualify for. Read the cited section before printing.