After Baby Formula and Juul Troubles, FDA Weighs Oversight Changes

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After Baby Formula and Juul Troubles, FDA Weighs Oversight Changes
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The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.

What Led to the U.S. Baby Formula Shortage − and How Officials Are Trying to Prevent It From Happening Again

Califf said he agreed with critiques that the food program has been underfunded compared with FDA's drug program, which receives more than $1 billion annually in industry user fees. The agency recently sought more food funding and authority to help track supply chains in order to head off future shortages.

Califf again cited funding challenges, pointing out that the FDA cannot collect user fees from vaping companies who submit their products. The agency has asked Congress for that authority. Sen. Dick Durbin, an Illinois Democrat, suggested Califf should resign if the agency can’t swiftly remove such products.

Califf previously predicted the formula shortage could last until July. He said Tuesday that retail data show that supplies have improved with increases in both U.S. production and imports. FDA’s food program has a byzantine leadership structure in which there is a director for food and a separate deputy commissioner for “food policy and response.” The deputy commissioner has more of a safety focus, but has no direct authority over food center staff nor regional personnel who inspect plants.DeLauro, a Connecticut Democrat, said Tuesday the FDA’s evaluation must contain input from non-FDA experts and interest groups to be credible.

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