At a minimum: the product name, the ingredient list, the name and place of business of the manufacturer, packer or distributor, the Nutrition Facts panel and the allergen declaration. All of it must be in English if the product leaves Puerto Rico.
The product name goes on the principal display panel (21 CFR 101.3). Ingredients are listed by common name in descending order by weight (21 CFR 101.4). If your company did not make the product, its name must be qualified with a phrase such as "Manufactured for" or "Distributed by" (21 CFR 101.5). Nutrition labeling is required unless an exemption applies (21 CFR 101.9). The FDA has small business exemptions: one for sellers with annual gross sales of no more than $500,000, or no more than $50,000 in food sales to consumers, and a low-volume one for firms with fewer than 100 full-time equivalent employees on average selling fewer than 100,000 units of the product in 12 months, which requires an annual notice to the FDA. Low-volume products that bear nutrition claims do not qualify. The allergen declaration covers the nine major allergens, including sesame since January 1, 2023.
Official sources
- 21 CFR 101.3 (nombre del producto)
- 21 CFR 101.4 (lista de ingredientes)
- 21 CFR 101.5 (nombre y dirección del fabricante)
- 21 CFR 101.9 (información nutricional)
- FDA: Small Business Nutrition Labeling Exemption
- FDA: Food Allergies
- 21 CFR 101.15 (idioma de la etiqueta)
Sources verified on November 11, 2026.
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