FDA seeks external aid in evaluating its food program amidst discontent on performance

U.S – The Food and Drug Administration (FDA) is planning to commission external agency experts to conduct a comprehensive review of its food program in response to increased calls for improvements, including a bill to create a new agency.

“While America’s food supply is safe, and our foods program experts have significantly contributed to the availability of more nutritious food options for consumers, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain,” Robert M. Califf, M.D., FDA Commissioner, said in a release.

 He pointed out that fundamental questions about the structure, function, funding and leadership need to be addressed. The agency’s inspectional activities related to the program also need to be evaluated, particularly in light of stresses related to the COVID-19 pandemic, he said.

The Reagan-Udall Foundation, an independent partner organization for the agency, will be working with an external group of experts on the evaluation.

The Foundation will report its findings, including an initial assessment of the processes and procedures, resourcing, and organizational structure for the Foods program and CTP, to the agency within 60 business days of initiation.

“It may take some time to implement any recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner.

“It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues we are facing, while preparing for the many scientific challenges and fascinating opportunities of the future,” Califf said.

Call for creation of new agency

The United States House Appropriations Committee had introduced a bill to establish a food safety agency solely responsible for keeping tabs on the food in the market through the Food Safety Administration Act.

Chair of the Committee Rosa DeLauro (D-CT-03) and Sen. Dick Durbin (D-IL) pointed out that there are currently no food policy experts in charge of food safety at the FDA adding that this has contributed to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices, and in many cases, result in consumer illness and death.

“It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues we are facing, while preparing for the many scientific challenges and fascinating opportunities of the future."

Robert M. Califf, M.D., FDA Commissioner Tweet

The Food Safety Administration Act will establish the Food Safety Administration under the Department of Health and Human Services (HHS) by incorporating the existing food programs within FDA into this separate agency: the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA).

Previously Senator Edward J. Markey of Massachusetts had introduced the Ensuring Safe and Toxic Free Foods Act. and called for the creation of a new office at the FDA to assess safety of chemicals in the US food supply.

He accused the FDA of failing to meet its obligations of ensuring food safety with a reference to the recent baby formula crisis where it took four months for the agency’s Deputy Commissioner for Food Policy to learn about the whistleblower complaint.

Backed by Senators Richard Blumenthal of Connecticut and Elizabeth Warren of Massachusetts, Senator Markey urged the FDA to come up with more stringent regulations on “Generally Recognized as Safe (GRAS)” substances used in food products to ensure the safety of the American population.

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