The infant formula crisis is doing what some said cannot be done.
Partisan divisions are giving away to share to the outrage about the formula shortage that lawmakers are learning isn’t going away anytime soon. And the shortage is not only impacting infants but diets for special needs.
At a subcommittee of the House Committee on Appropriations on Wednesday afternoon, there was almost uniform agreement that the shortage is going to go on for weeks more, if not months.
Members of Congress who serve on the Appropriations subcommittee were reaching out to one another as they heard the damage reports with the likelihood that the formula shortage crisis will worsen before it gets better.
The committee heard that infants aren’t the only ones dependent on formula. Sarah Chamberlin Executive Director, of the National PKU News, told the committee about Phenylketonuria (PKU) is an inherited disorder of metabolism that causes an increase in the blood of a chemical known as phenylalanine.
Chamberlin told how the formula is required to keep her 4-foot, 80-pound daughter alive.
Phenylalanine comes from a person’s diet and is used by the body to make proteins. Phenylalanine is found in all food proteins and in some artificial sweeteners. Without dietary treatment, phenylalanine can build up to harmful levels in the body, causing mental disability and other serious problems.
Women who have high levels of phenylalanine during pregnancy are at high risk of having babies born with mental disability, heart problems, small head size (microcephaly), and developmental delay. This is because the babies are exposed to their mother’s very high levels of phenylalanine before they are born.
In the United States, PKU occurs in 1 in 10,000 to 1 in 15,000 newborn babies. Newborn screening has been used to detect PKU since the 1960s. As a result, the severe signs and symptoms of PKU are rarely seen.
Ginger Carney, Director of Clinical Nutrition, at St. Jude Children’s Research Hospital in Memphis, said cronobacter infection should be made into a reportable disease so that it might be trackable. Only Minnesota requires reporting of Cronobacter infections at this time.
Michael Gay, Owner and Manager of Food Fresh, a grocery store in rural Georgia, said USDA’s WIC program, which purchases about half the state’s infant formula, should be more flexible during both natural emergencies and those like the current crisis.
Gay, speaking for the National Grocers Association, said the formula shortage is widespread.
Brian Ronholm, the former deputy undersecretary for food safety who is now director of food policy at Consumer Reports, told the committee that FDA needs to consolidate its food programs under a deputy commissioner.
Ronholm was speaking for several consumer groups in addition to CR in favor of a reorganization to pin responsibility down for food programs.
Meanwhile, Appropriations Committee Chairwoman Rosa DeLauro, D-CT, responded to reports that FDA was blaming delays in acting upon a whistleblower report on “COVID-19 mailroom issues.” DeLauro said that’s an excuse that is “convenient, but not compelling enough.”
“Here’s what we know,” DeLauro said.
“On October 19 and 20, 2021, a 34-page confidential disclosure was sent through FedEx to seven senior FDA officials. Three of those seven officials were also notified of the disclosure via email on October 21, and officials at FDA confirmed receipt of the disclosure in a detailed email the very same day.
“So why wasn’t the disclosure immediately escalated once received via email when the email received outlined specific people it should be forwarded to? Why wasn’t the whistleblower contacted by FDA until December?
“In what is outlined by the testimony, I can attest from the documentation that not all people who received the email are acknowledged, so what else are we missing?
“Additionally, the FDA claims the whistleblower had health issues that prevented them from conducting the interview. We have confirmed these claims are exaggerated and have documentation to prove that the whistleblower was accommodating, willing, and able to meet with the FDA to discuss these serious allegations.
“My question for the FDA is a simple one: who is in charge? We need accountability for this delayed response to serious allegations of contamination, not excuses. We need to know why there was a failure to immediately act to protect lives. In the virtual world of email, blaming COVID-19 mailroom issues just isn’t enough.”
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