Senate HELP Committee passes FDA user fee bill, including new oversight of infant formula, medical foods

Statement of CSPI president Dr. Peter G. Lurie

The events of the past six months have made it abundantly clear that the Food and Drug Administration is ill-equipped, both in terms of resources and authority, to ensure a safe and steady supply of infant formula and other medically necessary foods to American families.

That is why the Center for Science in the Public Interest is glad that the FDA Safety and Landmarks Improvement Act has advanced in the Senate Committee on Health, Education, Labor, and Pensions. The bill comes with provisions to help ensure that infant formula is free from contamination, and that FDA has adequate warning of problems that could lead to shortages of formula and other specialized medical foods.

Besides creating a new Office of Critical Foods within FDA, the bill has more stringent annual inspection requirements for inspecting facilities that produce infant formula. It also requires manufacturers of infant formula and medical foods to notify FDA of potential disruptions, and to create risk management plans to address potential shortages of these products.

There’s more to improve in this sprawling, must-pass legislation, particularly with regard to the regulation of dietary supplements and laboratory-developed tests. But we’re glad the HELP committee has included these important reforms for formula and medical foods.