FDA Releases Draft Guidance on “Disclosure Statement” Provisions of Four FSMA Rules

Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances in which FDA would expect covered entities to utilize the “disclosure statement” provisions, explains how the covered entity should describe the identified hazard, and discusses what type of documents may be used for the disclosure statement. Additionally, FDA reminds industry stakeholders that the entity receiving such a disclosure statement is responsible for taking appropriate steps to ensure that the identified hazards are controlled before the food reaches the consumer.