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Guthrie, Griffith Send Oversight Letter to FDA to Address Regulatory Failures that Exacerbated Baby Formula Crisis

Washington, September 19, 2022 | S.K. Bowen (202-225-3501)

WASHINGTON, D.C. - Congressman Brett Guthrie (KY-02) and Congressman Morgan Griffith (VA-09) sent a letter to Food and Drug Administration Commissioner Robert M. Califf, M.D. on resolving long-standing regulatory issues that exacerbated the baby formula crisis.

“We are writing to you today with continued concerns involving the systemic problems within the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response. Recent controversies resulting from failed regulatory frameworks, as you yourself described it, have caused significant marketplace disruptions and threatened the health and well-being of millions of Americans, most notably infants, as a result. As leader of the FDA, you are responsible for addressing these policy failures and we request details on how you are working to resolve long-standing regulatory issues,” wrote Guthrie and Griffith.

The Members in the letter provide an overview of the FDA’s failures with addressing the baby formula crisis, despite FDA having multiple warning signs. 

“The entire mishandling of this infant formula crisis is unacceptable and jeopardizes the health and well-being of millions of infants and those who rely on medically necessary metabolic formulas produced by Abbott Nutrition,” the members continued.

The Members also express interest in the Reagan-Udall Foundation’s review of regulatory failures within the FDA; however, regardless of the independent review, the Members tell FDA Commissioner Califf that he will still be responsible for ultimately fixing these issues and then answering to Congress on FDA’s efforts to address these issues.

“While we are interested in the Reagan-Udall Foundation’s findings, this report should not be used as a substitute for you, as the leader of the agency, to fix FDA's issues internally. Regardless of the findings, you will still be responsible for addressing these issues within FDA and answering to Congress for the decisions being made at FDA under your leadership,” the members wrote.

Guthrie and Griffith also ask for responses on the FDA’s process for inspections, process to address whistleblower complaints, and new regulatory flexibilities and ask for feedback on baby formula crisis legislation. 

Click HERE to read the full letter.