Administrative Procedures Act

Two San Francisco Bay area activist organizations that previously pressured the FDA about keeping the Food Safety Modernization Act (FSMA) rulemaking on a schedule are again pushing for the agency to meet the Act’s mandates.

“FDA’s failure to implement FSMA’s critical food safety regulations by the statutory deadlines is an
Continue Reading Civil action asks judge to order FDA to name ‘high risk’ foods as mandated

The Food and Drug Administration’s penchant for “guidance” documents as opposed to formal rulemaking needs to end, according to a business-oriented public interest legal foundation.

“FDA’s turn away from notice-and-comment rulemaking has an obvious motive: Formal rulemaking can be quite cumbersome, and FDA would prefer where possible to avoid the
Continue Reading Do FDA ‘guidance’ documents skirt the regulatory process?