Enforcement Discretion

  •  After the publication of its May 2022 Enforcement Discretion Guidance (discussed here), FDA issued letters of enforcement discretion to various companies for marketing specific infant formula products in the

Continue Reading New FDA Guidance Allows Companies to Continue Marketing Infant Formula Under an Enforcement Discretion Letter Beyond November 14, 2022


  • We reported on the Food and Drug Administration’s (FDA) November 2017 guidance giving certain co-manufacturers two more years to comply with requirements for a supply-chain program for certain raw materials

Continue Reading FDA Will Extend Enforcement Policy Allowing Some “Co-Manufacturers” Additional Time to Implement Certain FSMA Supply-Chain Program Requirements