On November 3, 2017, The U.S. Food and Drug Administration (FDA) issued guidance to allow co-manufacturers additional time to implement the Food Safety Modernization Act (FSMA).
FDA announced in the guidance that it did not intend to take enforcement action for two years against non-compliant co-manufacturers that meet the following conditions for supplier approval and supplier verification:
- A brand owner conducts supplier approval activities;
- The co-manufacturer describes these activities in its food safety plan;
- The co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner;
- A brand owner determines and/or conducts supplier verification activities for its co-manufacturer;
- The co-manufacturer describes these activities in its food safety plan;
- The co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner.
FDA states that it does not intend to take enforcement action until November 6, 2019, and has stressed that the guidance does “not establish legally enforceable responsibilities.”
FDA’s Guidance can be found here:
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm583475.htm
The FDA announcement can be read here:
https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm583453.htm
The Federal Register Notice can be found here:
