– OPINION –
I have to admit that I rarely borrow anything from the former president or first lady, but this seemed to fit a little too well.
In late 2022, the public learned that babies may have gotten sick and possibly died due to consuming Cronobacter contaminated infant formula. The potential outbreak, and the FDA investigation that followed, caused formula to be pulled from shelves and parents to worry about how they were going to feed their children. So what has been the response from the FDA? Lukewarm at best.
On March 8, 2023, the FDA wrote a letter to infant formula manufacturers asking the formula industry to do better or better. Here is part of the “Call to Action” from the 2023 letter:
This letter is addressed to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula. In late 2021 and early 2022, a series of Cronobacter spp. illness among infants in the US was associated with feeding a certain brand of powdered infant formula. US Food and Drug Administration (FDA or “Agency”) inspection of the associated manufacturing facility revealed the presence of Cronobacter spp. within the production environment, as well as other unsanitary conditions, leading to a nationwide recall. This recall and temporary plant closure was a major contributing factor to the infant formula shortages experienced in the US in 2022. In response, the FDA developed a strategy to prevent future Cronobacter spp. Diseases Associated with Powdered Infant Formula and issues this letter to share current information to help industry improve the microbiological safety of powdered infant formula.
Get this right, the FDA, despite feeling humiliated by its own findings, a whistleblower report, and the political fallout of infant deaths, and empty shelves of formula, like the industry “willingly” – Be Best or Be Better.
What should the FDA do given the critical nature of infant formula and the fact that there are so few manufacturers? 1) put an inspector on every floor 24/7; 2) order product and facility testing and upload any positive tests to CDC for comparison with disease; and 3) work to obtain Cronobacter a reportable bacterial infection in all states so we know the extent of the problem.
Why is the FDA asking an industry to be better or to be better sounds all too familiar?
In light of the ongoing outbreaks associated with fresh and pre-cut lettuce and other leafy greens, particularly from California, we are issuing this second letter to reiterate our concerns and strongly encourage companies in your industry to review their current operations in light of agency recommendations. guidance to minimize microbial food safety hazards in fresh fruits and vegetables, as well as other available information on the reduction or elimination of pathogens in fresh produce. We encourage companies to consider modifying their operations accordingly to ensure they are taking the appropriate steps to provide a safe product to the consumer. We recommend that companies from the farm level to the distribution level take these steps.
months later E.coli O157:H7 spread through the spinach industry, causing a recall of all spinach in the US (Mexico banned imports), with more than 200 sick in the US, many with kidney failure sharp and five dead. Since that disaster, the FDA continues to ignore the “cow in the room”: leafy greens that grow near livestock operations.
What should the FDA do to help the green leaf industry help itself? 1) Gain access to nearby livestock operations and test for E.coli and upload any positive tests to CDC for comparison with disease; 2) work with the green leaf industry and the cattle industry to establish viable land and water use controls; and 3) scientifically test the products and upload any positive results to the CDC for comparison with disease.
Will my ideas stop all disease?: No. Will they bend the disease curve and help companies help themselves?: Yes. It is time the FDA asked industries to “Be Better or Be Better” top”.