US FDA Food Labeling Regulations (21 CFR Part 101) 101.9-EXEMPT: Nutrition labeling exemptions: small business (fewer than 100 full-time equivalent employees and fewer than 100,000 units) with annual notice, low-volume, foods of no nutritional significance, restaurant and ready-to-eat foods, bulk foods, infant and young children foods, and the loss of exemption when claims are made (101.9(j))

What does 101.9-EXEMPT require?

Nutrition labeling is not required for foods offered by manufacturers with annual gross sales under $500,000 (or food sales under $50,000), for low-volume products of small businesses with fewer than 100 full-time equivalent employees selling fewer than 100,000 units in the United States in the preceding year that file an annual notice with FDA, for food served in restaurants and other establishments for immediate consumption or ready-to-eat food prepared on the premises, for foods containing insignificant amounts of all nutrients subject to the rules (for example coffee, tea, spices), for infant formula and certain foods for infants and children under four (which use the 101.9(j)(5) modifications), for foods in small packages under 12 square inches that give an address or telephone number, for bulk foods shipped for processing, for game meats, and for unit containers in multi-unit retail packages where the outer label complies. Any exemption is lost if a nutrition or health claim or other nutrition information appears on the label or in labeling or advertising.