The U.S. Food and Drug Administration has issued guidance on its intent not to enforce certain provisions of five rules that implement the Food Safety Modernization Act.

The Food Safety Modernization Act (FSMA) of 2011 grants the FDA  more authority to regulate the way foods are grown, harvested, and processed. The law grants the FDA a number of additional powers, such as mandatory recall authority. The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.

As it began implementation of these FSMA rules, FDA  said it 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 FDA works 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.

The purpose of the guidance document is to state that at this time and based on the agency’s current understanding of the risks, the FDA does not intend to enforce certain regulatory requirements as they currently apply to certain entities and/or activities.

The applicable requirements are established in FDA’s regulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR Part 507); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR Part 117); “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 CFR Part 1, Subpart L (FSVP)); “Mitigation Strategies to Protect Food Against Intentional Adulteration” (21 CFR Part 121); and “Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption” (21 CFR Part 112).

Section II of the document describes certain enforcement discretion policies that were issued previously and are relevant to the enforcement policies discussed in sections III.B and III.C. Section III describes new or extended enforcement discretion policies. Section III. A describes the extension of FDA’s enforcement discretion in certain circumstances when a receiving facility that is a contract manufacturer/processor is not in compliance with certain supply-chain program requirements for food manufactured for a brand owner.

Section III.B describes the FDA’s intent not to enforce requirements of the Intentional Adulteration regulation for facilities under the preexisting farm-activity related enforcement policy. Section III.B also announces that FDA does not intend to enforce the Intentional Adulteration regulation’s requirement for reanalysis in certain circumstances— for example, when there is a single failure that is addressed through the implementation of corrective action procedures. Section III.C describes that FDA does not intend to enforce the supplier approval and verification requirements in part 117, part 507, and the FSVP regulation with regard to supplier compliance with requirements that are already associated with an enforcement discretion policy.

FDA is issuing this guidance consistent with its good guidance practices regulation (21 CFR 10.115). This guidance is immediately effective because FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)), on the basis that the guidance presents a less burdensome policy that remains consistent with FDA’s public health mission. As with all guidance documents, the public can comment on the guidance at any time (21 CFR 10.115(g)(5)). If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate (21 CFR 10.115(g)(3)(ii)).

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance means that something is suggested or recommended, but not required.

In this guidance, pronouns such as “you” refer to entities that are covered by this guidance.

Download the Guidance