The U.S. Food and Drug Administration sent warning letters Wednesday to three infant-formula manufacturers. The FDA was monitoring the industry to ensure that infant formula is produced in the safest possible conditions.

ByHeart, Mead Johnson Nutrition, LLC, and Perrigo Wisconsin, LLC received letters from the FDA. The FDA warned them of violations under the Federal Food, Drug, and Cosmetic Act and FDA infant formula regulations. The findings are based on the inspections of the facilities in the past few months. During inspections, FDA made observations and monitored each manufacturer’s recalls. Recalls were made in December 2022 and February 2023. Infant formula products could have been contaminated by Cronobacter.

The FDA released a statement.

Donald Prater said that the FDA was committed to identifying and addressing issues early in order to prevent firms from reaching the same level of concern as last year, which led to a large-scale recall and a shortage of infant formula.

It’s not because we’ve never been here. Biden’s America can sometimes look like a Third World nation, and that was definitely the case in 2022 when there was a shortage of baby formula. Mayor Pete’s work to fix the supply chain problems during the pandemic included getting baby formula onto retail shelves. Baby formula shortage in America? Before then, it was unimaginable. Imagine being a young mother who goes from store to shop trying to find baby formula for her child. Abbott recalled three popular powdered formulas for infants.

A nationwide recall was issued after bacteria infected baby formula during manufacturing. There was also only one major producer in the country: Abbott. Options were therefore limited. Four babies were hospitalized at that time and two died later. The manufacturer of infant formula, Abbott, did not maintain clean surfaces when handling and producing the powdered formula. Cronobacter Sakazakii, a rare bacteria, was contracted by the babies. This is a common bacterium that carries a higher risk for very young infants.

The slow and inept reaction of the Biden administration to the announcement about the baby formula was evident. The administration ignored warning signs that existed before the nationwide recall, but did not try to find alternative sources. The Biden administration has a reactive approach, and is not proactive. It is likely that some administration staff had babies in their homes and noticed the lack of formula on the shelves. The situation deteriorated to the point that one day, everyone was panicking about the shortage of baby formula.

The FDA wants to make it appear that they are on the ball, conducting inspections and overseeing. Why was the announcement made on Wednesday, when the inspections which raised concerns about contamination took place in December 2022 and February 2023 as well as March 2023. The FDA shut down Abbott’s plant last time without considering where the baby formula would be sourced without the major manufacturer. The supply of formula for babies dried up. When stores were restocked, there was no fresh stock to order.

Press release from the FDA:

The FDA is not advising parents or caregivers at this time to avoid buying any infant formula. The FDA is unaware of any product that has been distributed where contamination was confirmed. They believe the recalls have had a positive impact on removing potentially contaminated batches from the market. These warning letters do not relate to any recalls currently underway, and the FDA does anticipate that the availability of infant formulation on the market will not be affected.

These letters are being sent out by the FDA as part of their normal regulatory process. They want to remind these companies of the importance of taking corrective action when they detect pathogens in order to comply with FDA laws and regulations. In order to comply with FDA regulations, firms are required, among others, to conduct thorough root cause investigations, and then perform cleaning and sanitation procedures. Before releasing a product, companies must also evaluate their cleaning and hygiene practices, schedules and procedures. The FDA will give each company 15 days to respond and explain the corrective measures they are taking. The FDA will evaluate the corrective measures taken by the companies during its review of their responses, and also at the next FDA inspection. The FDA will inspect each facility to verify that the corrective measures taken by companies have been implemented.

“Infant Formula Manufacturers are responsible for making safe products. The agency has been in continuous discussions with the industry to address its concerns.” Donald Prater is the acting director of FDA’s Center for Food Safety and Applied Nutrition. He said that the FDA was committed to identifying and addressing issues early in order to prevent firms from reaching the same level of concern as last year, which led to a large-scale recall and caused a shortage of infant formula. Over the past year, the FDA has increased its oversight of powdered formula facilities. These letters reflect this increased oversight and are meant to help the industry improve their manufacturing practices so that parents and caretakers can feel confident that the formula their children are fed is safe and nutritious.

The FDA does not want to be blamed for parents throwing out potentially contaminated formula. The FDA wants to be credited for recalling products. No recalls are currently underway. The FDA wants Americans know that it works with Congress to improve regulations. The FDA wants to increase funding for monitoring the industry and works with CDC “to support the Council of State and Territorial Epidemiologists’ decision to add invasive Cronobacter infection among infants younger than one year of age on the Nationally Notifiable Condition List.” It also hires more staff, including investigators of infant formula and an Office of Critical Foods. God bless you. Democrats increase bureaucracy, and spend taxpayers’ money to solve problems. Adding more regulations and staff sounds like a way to exacerbate the problem. YMMV. How did baby formula suddenly become popular?