A retail food establishment may manufacture/process food and remain within the “retail food
establishment” definition of 21 CFR 1.227 if the establishment’s primary function is to sell food,
including food it manufactures/processes, directly to consumers. A retail food establishment’s
primary function is to sell food directly to consumers if the annual monetary value of sales of
food directly to consumers exceeds the annual monetary value of sales of food to all other buyers
(such as to farms, which are considered businesses).