Lawsuit seeks to compel FDA to implement FSMA traceability provisions

The Food and Drug Administration (FDA) is being sued by two consumer groups, who want the FDA to implement the traceability provisions in the FDA FSMA (Food Safety Modernization Act). The lawsuit was brought before the U.S. District Court for the Northern District of California by the Center for Food Safety (CFS) and Center for Environmental Health (CEH).

The plaintiffs want the FDA to uphold their FSMA obligation to publish and establish a list of foods that are high-risk, and establish rulemaking that will set forth more traceability recordkeeping requirements. These requirements are for facilities that manufacture, process, pack, or hold certain foods.

The FDA was previously sued in 2012 by CFS and CEH, after it did not meet deadlines for spreading the seven major FSMA regulations. The earlier lawsuit was settled by the FDA, and they subsequently issued regulations by the deadlines. However, that lawsuit didn't encompass statutory deadlines related to the traceability provisions of FSMA, which are the issue in the current lawsuit.

Source: Hogan Lovells memorandum, 10/26/18, "Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Provisions"