FDA Announces Enforcement Discretion Policy for Certain FSMA Regulations

The FDA announced today that it intends to exercise enforcement discretion for certain provisions in four of the rules that implement the FDA Food Safety Modernization Act (FSMA). This means that during the enforcement discretion period, the agency does not intend to enforce these provisions as they currently apply to certain entities or activities.

In general, the FDA is exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding the application of these provisions to certain activities or entities. FDA had previously extended the compliance dates for many of the provisions covered by this enforcement discretion guidance (see August 2016 compliance date extension) but is now exercising enforcement discretion.

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