FDA recently published a proposal to amend its regulation on registration of food facilities. The current regulation requires food facilities that manufacture/process, pack, or hold food for consumption in the United States to register with FDA. However, exemptions exist for "retail food establishments," defined as an establishment that sells food products directly to consumers as its primary function. The proposed rule would update the definition to expand the number of establishments that meet that definition and are therefore not required to register with FDA or comply with the requirements of the Food Safety Modernization Act ("FSMA"). The proposed rule clarifies that roadside stands, farmers' markets, Community Supported Agriculture programs, and other direct-to-consumer sales platforms would also be included in the definition. For facilities not exempt from registration, the proposed rule codifies certain administrative provisions of FSMA, such as email contact, biannual registration, allowance for inspections, and improvements to the food facility registration system. FDA is currently accepting public comments to the docket.
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