When Nutrition Labels Are Required in the US (and Common Exemptions)

Most packaged food sold in the US needs a Nutrition Facts panel. Two federal exemptions cover many small producers: gross sales of $500,000 or less (or food sales to consumers of $50,000 or less), which needs no paperwork, and fewer than 100 full-time equivalent employees with fewer than 100,000 units of a product a year, which needs an annual notice to the FDA. Any nutrient content or health claim ends both.

The two exemption routes

Low sales: exempt, nothing to file

Annual gross sales of $500,000 or less, or annual sales of food to consumers of $50,000 or less. You do not file a notice.

Low volume: exempt once you file

Fewer than an average of 100 full-time equivalent employees, and fewer than 100,000 units of that product sold in the US in 12 months. You must file a notice with the FDA every year, for each product. If you have fewer than 10 full-time equivalent employees and sell fewer than 10,000 units, no notice is needed, unless you are an importer.

What ends an exemption

• A nutrient content claim ("low sodium", "sugar free"), a health claim, or any other nutrition information on the label, your website, or your advertising. The exemption is gone for that product.
• Crossing a threshold. Sales and unit counts are measured over 12 months, so a good year can move you out.
• A retailer that asks for a panel as a condition of listing. That is a contract term, not a law, but the effect is the same.

Other exemptions

• food served in restaurants and similar establishments (chains with 20 or more locations have separate menu labelling rules)
• food prepared and sold on the premises of a small retailer, such as a bakery selling its own bread
• plain coffee and tea, and some spices and flavourings with no significant nutrient content
• raw fruit, vegetables, and fish, which are covered by voluntary point-of-purchase information
• infant formula and medical foods, which have their own rules

State cottage food laws

Cottage food laws set what a home-based producer can sell and what the label must carry. Most states require an allergen statement, the producer's name and address, and a home-kitchen statement in the exact wording the statute gives, and do not require a Nutrition Facts panel. An ingredient list is required in many states and not in others. State rules apply on top of the federal ones, so check your state's department of agriculture or health.

For the state-by-state detail, see cottage food label requirements by state, which covers how the state rules and the federal panel question interact.

Decision list

1. Is the product packaged for sale? If not, no panel.
2. Any nutrient content or health claim anywhere? If yes, you need a panel.
3. Under the sales threshold? Exempt, nothing to file.
4. Under the employee and unit thresholds? Exempt once the annual notice is filed.
5. Otherwise, you need a panel in the FDA format.

What to do in Nutrifax

1. Build or import the recipe and check each ingredient match.
2. Set the serving size from the RACC for your category.
3. Generate the US format panel and export PDF or PNG.
4. Save the audit report with the recipe version so the calculation is on file.

Related pages

• US Nutrition Label Requirements: Who Needs One
• US FDA Nutrition Label Requirements for Small Producers
• Serving Size and Rounding Rules (US FDA)
• How to Generate and Print Nutrition Labels in Nutrifax
• FDA nutrition label generator

Sources

• FDA: Small business nutrition labeling exemption guidance
• FDA: Food labeling and nutrition
• FDA: What's on the Nutrition Facts Label
• eCFR: 21 CFR 101.9 (Nutrition labeling of food)

Disclaimer

Educational content only; not legal advice. Confirm the final label against current regulations for your product and jurisdiction.