If the meal-kit type service meets the definition of a retail food establishment, it is exempt from
registration (see 21 CFR 1.227). A meal-kit type service is a retail food establishment if it sells
food directly to consumers as its primary function. A retail food establishment’s primary
function is to sell food directly to consumers if the annual monetary value of sales of food
products directly to consumers exceeds the annual monetary value of sales of food products to all
other buyers. The definition of retail food establishment also provides that the term ‘‘consumers’’
does not include businesses. Establishments selling food directly to consumers via the Internet or
mail order may be retail food establishments provided that they meet the other criteria of the
retail food establishment definition (21 CFR 1.227).
