Peter B. Hutt

Peter Barton Hutt is a senior counsel in the Washington, DC law firm of Covington & Burling LLP, specializing in Food and Drug Law. He began his law practice with the firm in 1960 and, except for his four years in the government, has continued at the firm ever since.

From 1971 to 1975 Peter was Chief Counsel for the Food and Drug Administration. During his tenure as FDA Chief Counsel, Peter led the transformation of the agency from outdated law enforcement to modern administrative law. He promulgated regulations to implement the review of GRAS food ingredients, require nutrition labeling for half the food supply, to define “imitation” food, to establish the emergency permit controls for low acid canned food, and to modernize food standards; to implement the prescription drug requirements of the Drug Amendments of 1962 following a sweeping victory in four Supreme Court cases and to create the OTC Drug Review for nonprescription drugs; to create a process for reevaluating the safety and effectiveness of all biological products that had been licensed since 1902; to rationalize the application of the Delaney Anticancer Clause to animal drugs; to require ingredient labeling for cosmetics and premarket safety substantiation for all cosmetic ingredients; and to prepare FDA for enactment of the Medical Device Amendments of 1976. He created the requirement of preambles for all proposed and final FDA regulations, initiated the use of guidelines (later named guidance) to establish informal FDA policy, and established the use of regulatory letters (later named warning letters) as an inexpensive and efficient enforcement approach. Just before leaving FDA, he wrote the comprehensive proposed procedural regulations that govern all FDA administrative action to this day.