The U.S. Food and Drug Administration (FDA) has published a Guidance document that explains its food safety regulations as they apply to so-called small entities.
Published in October 2016, this FDA’s Small Entity Compliance Guide is intended to provide information on the Agency’s preventive controls for human food (PCHF) regulations as they apply to specified food producers and importers whose size or limited scope of activities result in a reduced safety risk to consumers.
FDA guidance documents do not establish legally enforceable responsibilities, but are solely intended to describe the Agency’s thinking on a given topic. As such, they provide important information that can help manufacturers and importers achieve compliance with the Agency’s requirements.
The complete text of the FDA’s Guidance for Industry on its regulations applicable to small entities is available here.