https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-gui...

https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-guidance-enforcement-discretion-policies-certain-fsma-regulations

Constituent Update

March 11, 2022

Today the U.S. Food and Drug Administration (FDA) issued guidance on its intent not to enforce certain provisions of five rules that implement the FDA Food Safety Modernization Act (FSMA). As we began implementation of these rules, the FDA received questions and comments from stakeholders regarding specific provisions. In certain situations the FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health. As we work on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance.

The enforcement discretion policies announced today are specific to provisions in the following rules:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food,
• Foreign Supplier Verification Program (FSVP),
• Produce Safety (PSR), and
• Intentional Adulteration (IA).

In many instances, this guidance builds upon previously announced enforcement policies.

Extension of Enforcement Discretion Policy for Supply-Chain Program Requirements Applicable to Contract Manufacturers of Human and Animal Food

On November 6, 2019, the agency announced it would continue an enforcement discretion policy described in a November 2017 guidance for certain FSMA supply-chain program requirements applicable to receiving facilities that are contract manufacturers of human and animal foods, while the agency considered issues relating to supplier verification and approval challenges. This guidance formally extends the enforcement discretion policy. While the FDA considers these issues it does not intend to enforce certain supply-chain program requirements for food manufactured for the brand owner by a contract manufacturer/processor.