Boozman, Marshall, Capito Lead Effort to Promote Increased Competition and Supply of Baby Formula Amid Shortages

WASHINGTON––U.S. Senators John Boozman (R-AR) and Roger Marshall, M.D. and Shelley Moore Capito (R-WV) led their Senate Republican colleagues questioning the U.S. Food and Drug Administration (FDA) regarding the agency’s ongoing strategy to replenish the supply of baby formula across the country.

In particular, the Senators expressed their concerns that the FDA has not approved enough formula applications to restore national baby formula supplies or prevent another shortage from occurring. They wrote in part,

“Despite the numerous flexibilities and resources provided by Congress and temporary import flexibilities outlined in your letter, the infant formula crisis persists nationwide… American families need permanent long-term solutions, and that includes increasing capacity and competition in the U.S. market…Given the delicate nature of the infant formula supply chain, it’s become even more apparent that we need to diversify our commercial capacity by providing other industry manufacturers the opportunity to compete… Under the enforcement discretion authorized by President Biden’s May Executive Orders to address the formula crisis, the FDA approved only 23 infant formula products, or base powder, from 10 unique manufacturers out of dozens of ex-U.S. based formula and milk companies that have applied for short-term FDA approval to provide infant formula to the U.S. marketplace…The last application granted by FDA for enforcement discretion was August 10, over a month ago…it is unclear why the Center for Food Safety and Applied Nutrition has chosen to ignore so many applications for more manufacturers to market infant formula products for interstate commerce.”

The senators concluded their letter by requesting information about FDA’s approval process for formula applications, how many applications have not been answered and why, and if applications for specialty formulas had been considered.

Boozman, ranking member of the Senate Agriculture, Nutrition, and Forestry Committee, has previously led efforts to ensure American families have access to formula. In May, the Boozman-backed Access to Baby Formula Act was signed into law.

Joining Boozman, Marshall and Capito in urging FDA to act were Senators John Thune (R-SD), Thom Tillis (R-NC), Jerry Moran (R-KS), Cynthia Lummis (R-WY), Roger Wicker (R-MS), Rick Scott (R-FL), John Barrasso (R-WY), Kevin Cramer (R-ND), Bill Cassidy, M.D. (R-LA) and Marsha Blackburn (R-TN).

The senators’ full letter can be found here