Q - Who is exempt from the Nutrition Labeling Requirements?

A - Nutrition labeling is required on most packaged foods. Exemptions have been provided for the following types of foods:

• Foods from small retail businesses that have annual gross sales of less than $500,000 or low-volume food products from small businesses (21 CFR 101.9(j)(1).

• Foods for immediate consumption (e.g., foods sold in restaurants, institutional food service, transportation carriers, bakeries or delicatessens with facilities for immediate consumption, food service vendors) and foods sold for use in such facilities. However, manufacturars must provide nutrition labeling on institutional packs if there is a reasonable possibility that the product will be purchased directly by customers (21 CFR 101.9(j)(2)).

• Ready-to-eat foods that are not for immediate consumption but are processed and prepared primarily on the premises in stores such as delicatessens and bakeries (21 CFR 101.9(j)(3)).

• Foods of no nutritional significance, such as coffee beans, tea leaves, and food colors and flavors (21 CFR 101.9(j)(4)).

• Donated foods (21 CFR 101.9(a)).

• Dietary supplements covered under 21 CFR 101.36. It is anticipated that future regulations will revise 21 CFR 101.36 in response to the Dietary Supplement Health and Education Act.

• Infant formula and medical foods (21 CFR 101.9(j)(7) and (8)).

• Foods shipped in bulk form for use solely in the manufacture of other foods or that are to be processed, labeled, or repacked at a site other than where originally processed or packed (21 CFR 101.9(j)(9)).

• Raw fruit, vegetables, and fish which are covered by a voluntary nutrition labeling program (21 CFR 101.9(j)(10)).

Some of these exemptions are not operative if nutrition claims are made for the product. Refer to the regulations for details.

Food Labeling and Nutritional Information