規制ガイド

FDA food labeling: the mandatory elements explained

The five required elements under 21 CFR Part 101, the nine major allergens, type-size rules and what FSMA 204 traceability changes for lot codes.

この記事は英語とスペイン語で提供されています。

Packaged food sold in the United States is regulated by the FDA under 21 CFR Part 101 (meat, poultry and processed egg products fall under USDA-FSIS instead). The rules define what must appear, where, and how large. Most rejections at import or retail are not about exotic requirements — they are missing net quantity units, an allergen not declared, or an ingredient list in the wrong order.

The two panels

The Principal Display Panel (PDP) is the part of the package the consumer sees on the shelf; it must carry the statement of identity and the net quantity. The Information Panel is immediately to the right of the PDP and carries the ingredient list, allergen statement, Nutrition Facts and the manufacturer's name and address. These elements must appear together, without intervening material.

The five mandatory elements

• Statement of identity: the common or usual name of the food, in bold type parallel to the base of the package, prominently on the PDP.
• Net quantity of contents: in the bottom 30% of the PDP, in both US customary and metric units (e.g., NET WT 16 OZ (454 g)). Minimum type size depends on the PDP area: 1/16 inch up to 5 sq in, 1/8 inch up to 25 sq in, 3/16 inch up to 100 sq in, 1/4 inch up to 400 sq in.
• Ingredient list: every ingredient by its common name, in descending order of predominance by weight; sub-ingredients of compound ingredients in parentheses.
• Nutrition Facts: the 2016 format is mandatory since 2020/2021 — calories in large type, Added Sugars declared, vitamin D and potassium required, updated serving sizes and dual-column labels for packages that could be eaten in one or several sittings.
• Name and place of business of the manufacturer, packer or distributor, with city, state and ZIP; if not the manufacturer, qualified with "Manufactured for" or "Distributed by".

Allergens: nine, not eight

FALCPA (2004) defined eight major allergens; the FASTER Act added sesame effective 1 January 2023. The nine are: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. They must be declared either in a "Contains" statement immediately after the ingredient list or in parentheses within it — and for fish, shellfish and tree nuts the specific species must be named. "May contain" advisory statements are voluntary and do not replace the mandatory declaration.

Dates, lot codes and FSMA 204

Federal law does not require date labels except on infant formula; the FDA recommends the phrase "Best if Used By" to reduce food waste. Lot codes are required for low-acid canned foods and infant formula and strongly recommended everywhere because they make recalls possible. The FSMA Food Traceability Rule (Section 204) goes further: for foods on the Food Traceability List — leafy greens, fresh-cut fruits and vegetables, shell eggs, nut butters, soft cheeses, finfish, crustaceans, molluscan shellfish and others — companies must assign a Traceability Lot Code and record Key Data Elements at each Critical Tracking Event (harvesting, cooling, initial packing, shipping, receiving, transformation). The FDA extended the compliance date to 20 July 2028, but the lot code must be printed on the case label and travel with the product, so label templates need the field now.

Other requirements worth knowing

• Country of origin on imported food, required by US Customs (CBP), conspicuous and in English.
• Bioengineered food disclosure under the USDA National Bioengineered Food Disclosure Standard (text, symbol or digital link), mandatory since 2022.
• Nutrient content and health claims ("low fat", "good source of") have exact definitions; using them without meeting the criteria is misbranding.
• The UPC barcode is not an FDA requirement — retailers require it — but it must not displace mandatory information.

How EtikStudio handles this

FDA-format templates lay out the two panels with the correct type-size ratios, pull ingredient and allergen lists from your product master so the "Contains" line is generated from data instead of typed, print lot codes and dates from the ERP, and keep every template version with its print history — the evidence an FDA inspector or a retailer audit asks for.

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