The Food and Drug Administration recently published draft guidance regarding written disclosure statements required by four of the seven Food Safety Modernization Act final rules.

The rules include requirements related to disclosing the presence of hazards that have not been controlled, and the draft guidance covers FDA’s recommendations for how to describe the hazard and explains the type of documentation that is necessary for making the disclosure.

Members may login to read more in a memorandum from Hogan Lovells US LLP, IDFA’s outside legal counsel. 

For additional questions, contact John Allan, IDFA vice president of regulatory affairs and international standards, at jallan@idfa.org.