FIRST ON FOX: A House Republican pressed the Department of Agriculture (USDA) and Food and Drug Administration (FDA) about the agencies’ "apparent lack of an effective strategy" to combat the ongoing baby formula shortages.
Rep. Dusty Johnson, R-S.D., sent a letter to the USDA and FDA regarding the ongoing shortages that have left shelves and bottles bare, pointing to the "out-of-stock rate of over 50%" in his state in a press release exclusively obtained by FOX Business.
In the release, Johnson also accused the agencies of being "aware of contamination at Abbott Nutrition as early as September 2021" and finding "an increased level of bacteria in January 2022." The Abbott Nutrition formula was eventually recalled in February 2022.
"I believe FDA dropped the ball given these concerns date back to 2021. This possible negligence has directly put infants in harm’s way," Johnson said in the press release. "Twenty-six states, including my home state of South Dakota which has an out-of-stock rate of over 50%, are struggling with supply."
"By comparison, the out-of-stock rate for infant formula was between 2% and 8% in the first half of 2021 – as of April 2022 it is up to 40% nationwide, according to Datasembly," the congressman continued. "The FDA needs a robust contingency plan in place to prevent these shortages from happening."
"Between September 24, 2021, through December 18, 2021, FDA received three additional consumer complaints. But a follow-up facility inspection did not begin until January 31, 2022. Why was there a 44-delay to initiate this inspection?" Johnson asked.
In the letter, Johnson writes about his "concerns regarding the extreme shortage of infant formula across the country" and the agencies’ "roles in helping find solutions."
"It is the responsibility of your administrations to protect infant health and ensure access to safe formula," Johnson wrote. "I am deeply concerned with the apparent lack of an effective strategy to mitigate shortages like the one we are experiencing that risks the lives of infants across the country."
Johnson pointed to the "four adverse events and two deaths allegedly associated with Abbott Nutrition powdered infant formulas from its Sturgis, Michigan, facility" and said that the bacteria causing the infections "were found in the facility during the course of a January 2022 – March 2022 inspection."
"Prior to this, documentation from FDA has shown instances of potential contamination from facilities or personnel in September 2021," the congressman wrote. "These observations are alarming given the health risk posed to some of our nation’s most vulnerable."
"While I appreciate FDA’s current efforts to lower the risk of ingesting contaminated formula, I believe FDA dropped the ball given these concerns date back to 2021," he continued. "This possible negligence has directly put infants in harm’s way."
Johnson wrote that the "product recall and near-shutdown of the Sturgis facility has impacted availability of infant formula and significantly driven up the price" and that 26 states, including his own, "are struggling with supply."
"By comparison, the out-of-stock rate for infant formula was between 2% and 8% in the first half of 2021 – as of April 2022 it is up to 40% nationwide, according to Datasembly," he wrote. "The FDA needs a robust contingency plan in place to prevent these shortages from happening."
The South Dakota Republican asked the agency heads several questions about the shortage and said that he respects "the difficult job you and your staff have in managing this crisis, but time is of the essence to find solutions."
An FDA spokesperson told FOX Business that they have "received the letter and will respond to the Representative directly."
"The FDA remains committed to using all available tools to oversee the safety, effectiveness and quality of FDA-regulated products and help ensure that Americans have access to essential and safe products," the spokesperson said. "Our first and foremost priority is ensuring that any recalled product remains off the market and are working with the U.S. Department of Agriculture and manufacturers to ensure that parents have access to alternative, safe infant formula."
"We will and must continue focusing on taking all steps possible to protect the health of those who rely on safe powdered infant formula," they continued.
The spokesperson also pointed to the agency's February 17th warning about the product recalls from the Michigan Abbott Nutrition plant and the announcement of the voluntary recall. Additionally, the FDA spokesperson pointed to a Tuesday press release on the agency's "work to increase the availability of infant and specialty formula products."
A USDA spokesperson told FOX Business that the department knows "that this situation is causing stress and anxiety for many families."
"USDA takes seriously its role in safeguarding the health of families served by our WIC Program, which has been heavily impacted by the infant formula recall and resulting supply issues," the spokesperson said. "USDA has and will continue to work with FDA and proactively engage with program stakeholders, retailers, and industry partners, including infant formula manufacturers, to maximize support for WIC Program participants and program providers."
"USDA is committed to providing technical assistance and maximum flexibility, including regulatory waivers, for State agencies as they work with their infant formula rebate contractors and other stakeholders to respond to the recent recall," they continued.