Anyone with infants can tell you about the February 2022 closure of an Abbott Laboratories baby formula plant in Michigan due to contamination. The closure was a major factor in a nationwide baby formula shortage that forced parents to source food from doctor’s offices, food banks and friends and neighbors.
Shortly before Abbott closed the Sturgis, Michigan, plant the Food and Drug Administration opened an investigation. What the FDA found was appalling – bacterial contamination including cronobacter sakazakii, which can be deadly to infants; lax safety protocols; and a leaky roof. And stunningly, a history of cronobacter dating back to the fall of 2019 — a history FDA knew nothing about.
Three baby formulas produced at the plant became part of a massive nationwide recall: Similac, Alimentum and EleCare. The plant reopened in June 2022 with limited production.
This past January, the Department of Justice opened its own investigation of the Abbott plant. It remains to be seen if the DOJ uncovers illegal activity in how Abbott operates. Abbott spokesman Scott Stoffel says the company is cooperating in the investigation.
What we do know is the Food and Drug Administration’s food inspection branch let the hot mess in Sturgis fall through the cracks. Last fall, FDA began tracking bacterial infections in infants consuming powered baby formula from the plant.
It wasn’t until Jan. 31 of this year that FDA inspectors arrived on site to visually look for problems. The inspection was originally scheduled for last Dec. 30 but was delayed a month due to workers testing positive for COVID-19 at the facility.
Months and months of delay. Why?
During testimony before Congress, FDA Commissioner Robert Califf tried to deflect blame, including highlighting the COVID-19 outbreak at the plant and a whistleblower complaint that got lost in the mail saying, “Too slow and there were decisions that were suboptimal along the way.”
Suboptimal? You think?
The cronobacter sakazakii baby formula contamination should have been dealt with back in 2019 when it first surfaced. But under current rules, manufacturers are not required to report food contamination in real time to FDA.
Let that sink in a moment.
FDA only learns of product problems during an onsite inspection, audit, or real world illnesses/death after contaminated food is in the supply chain. The classic definition of the horse having already left the barn.
The FDA doesn’t see it that way.
In March, Califf and Susan T. Mayne, director of the Center for Food Safety and Applied Nutrition, sent a letter to the baby formula industry asking it review all its safety protocols and – oh, by the way – “Lastly, FDA asks that firms voluntarily notify the Agency any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been distributed.”
Voluntary? That’s not good enough.
FDA needs to demand – now – mandatory disclosure of contaminated product samples that have not entered the food chain. If FDA and the baby formula industry can’t mutually get their act together, FDA needs to immediately begin the rulemaking process requiring mandatory disclosure. And if the FDA won’t act Congress needs to legislate change.
The public deserves nothing less.
