yHeart a small-scale manufacturer of infant formula, in a market dominated by a few majors, has recalled all products as a result of contamination with spores of Clostridium botulinum. Since August, 31st 35 cases have been confirmed in infants with at least 70 under investigation. Fortunately, no fatalities have been reported. The diagnosis is based on clinical observations and is followed by effective available treatment.
Similarities with this case and the major 2022 recall from the Abbott, Sturgis, MI. facility are striking. At issue is the failure of the Food and Drug Administration (FDA) to effectively monitor production plants and to enforce either corrective action or closure. The most recent investigation disclosed three isolations of Clostridium spores from 36 unopened containers suggesting a high level of contamination in the Allerton, IA. facility. Disclosures obtained under the Freedom of Information Act confirmed an unsatisfactory situation with regard to the plant dating back to 2022. Deficiencies documented in official warning letters included the presence of pests, defective structures including ceilings and floors, failure to maintain an appropriate pathogen surveillance program, incorporation of untested ingredients, previous isolations of Cronobacter and an observation that “the Byheart plant was not designed to facilitate maintenance and sanitary operations”. It is significant that the company received approximately 2,000 complaints relating mainly to organoleptic quality but also some health-related complaints including nine characterized by the FDA as “sensitive/serious”.
It appears that FDA has not learned anything from the Abbott episode and that the Agency has obvious deficiencies in their oversight of plants manufacturing food products and pharmaceuticals. Regrettably the Agency has been politicized and there is little hope for practical improvement given the exodus of experienced managers, a deliberate reduction in staff, resignations and retirements all prompted by current policies of the Department of Health and Human Services. The appointment of incompetent or unqualified management based on ideology and conformity with non-scientific principles as expressed by Robert F. Kennedy Jr, Secretary of the Department suggest future health problems related to failure of the FDA to fulfil the missions detailed and funded by Congress.