— OPINION —
I must admit, I seldom borrow anything from the former President or the First Lady, but this seemed to fit all too well.
Late in 2022 the public learned that infants may have been sickened, and possibly died, due to the consumption of Cronobacter tainted infant formula. The possible outbreak and the FDA investigation that followed, caused formula to be pulled from shelves and parents to be worried about how their children were going to be fed. So, what has been the FDA’s response? Tepid at best.
On March 8, 2023, the FDA wrote a letter to the infant formula manufacturers asking the formula industry to Be Best or Be Better. Here is part of the 2023 letter’s “Call to Action”:
This letter is directed 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. illnesses among infants in the U.S. was associated with feeding a certain brand of powdered infant formula. The U.S. Food and Drug Administration (FDA or “the Agency”) inspection of the associated manufacturing facility revealed the presence of Cronobacter spp. within the production environment, as well as other insanitary conditions, leading to a nationwide recall. This recall and the temporary shutdown of the plant was a major contributing factor to the infant formula shortage experienced across the U.S. in 2022. In response, the FDA developed a strategy to prevent future Cronobacter spp. illnesses associated with powdered infant formula and is issuing this letter to share current information to assist industry in improving the microbiological safety of powdered infant formula.
Get this straight, the FDA, despite being humiliated by its own findings, a whistleblower report and the political fallout of babies dying, and shelves empty of formula, asks the industry to “voluntarily” – 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 in every plant 24/7; 2) mandate testing of products and the facility and upload any positive tests to the CDC to compare with illnesses; and 3) work to get Cronobacter a reportable bacterial infection in all states so we know what the scope of the problem is.
Why does the FDA asking an industry to Be Best or Be Better sound a bit too familiar? Let’s go back to the fall of 2005 when the FDA asked the Leafy Green Industry to “Be Best or Be Better.”
In view of continuing outbreaks associated with fresh and fresh-cut lettuce and other leafy greens, particularly from California, we are issuing this second letter to reiterate our concerns and to strongly encourage firms in your industry to review their current operations in light of the agency’s guidance for minimizing microbial food safety hazards in fresh fruits and vegetables, as well as other available information regarding the reduction or elimination of pathogens on fresh produce. We encourage firms to consider modifying their operations accordingly to ensure that they are taking the appropriate measures to provide a safe product to the consumer. We recommend that firms from the farm level through the distribution level undertake these steps.
Months later an E. coli O157:H7 swept through the spinach industry, causing all spinach in the U.S, to be recalled (Mexico banned imports), with over 200 sickened across the U.S., many with acute kidney failure with five dead. Since that disaster, the FDA continues to ignore the “Cow in the Room” – leafy greens grown near cattle operations.
What should the FDA do to help the leafy green industry help itself? 1) gain access to nearby cattle operations and do testing for E. coli and upload any positive tests to the CDC to compare with illnesses; 2) work with both the leafy green industry and the cattle industry to set workable land and water use controls; and 3) scientifically test products and upload any positive tests to the CDC to compare with illnesses.
Will my ideas stop all illnesses – no. Will it bend the curve of illnesses and help businesses help themselves – yes. It is past time for the FDA to ask industries to “Be Best or Be Better.”