My friend Phyllis Entis, the FoodBugLady over at eFoodAlert, broke a story today that anyone following the Nara Organics infant botulism outbreak needs to read. Let me add some context from where I sit — representing families whose babies were hospitalized.

What the FDA found in Germany

Milchwerke “Mittelelbe” GmbH — the plant that makes Nara Organic’s Whole Milk Infant Formula — has been added to FDA’s Import Alert 40-05, the alert used to detain adulterated and misbranded infant formula at the border. The June 26 entry concluded the powdered formula was adulterated under section 402(a)(4) of the FDCA — held under insanitary conditions such that it may have been rendered injurious to health — with serious deviations from the infant formula requirements in 21 C.F.R. Part 106.

The specifics should stop you cold: no flow diversion valve on the pasteurization system (the safeguard that kicks under-heated milk back instead of letting it flow into the dryer and the finished powder); Cronobacter sakazakii found in a “high-hygiene” zone with no timely corrective action; inadequate environmental monitoring; cracked floors, broken tile, and damaged grout in processing areas; and lapses in basic personal hygiene. A very different picture than the “state-of-the-art” facility Nara advertises.

The part everyone needs to get right

Here is the crucial point, and precision matters: the Nara batches implicated in the botulism outbreak were not made in Germany. The Import Alert is a real and damning finding about that facility — but it is a separate problem from the batches that sickened these babies.

The implicated product appears to have been made in the United States, using organic whole milk powder from the same U.S. supplier that produced the milk powder used in ByHeart’s organic formula — the product at the center of the larger infant botulism outbreak that preceded this one. That is the thread. Two outbreaks, two brands, one shared upstream ingredient source. A contaminated common ingredient does not care whose label ends up on the can, and that shared supply chain is where the answers — and the accountability — are most likely to be found.

Why the German findings still matter anyway

They tell you something about the culture behind the brand. A company marketing premium, “clean,” organic formula while a contract manufacturer runs a line without a working flow diversion valve and ignores Cronobacter over broken tile is a company whose quality assurance was not what its marketing claimed. That gap between what parents were promised and what was actually happening is wide — and FDA’s review of the firm’s corrective responses will generate records that tell the story of what the company knew and when.

Infant formula is, for many babies, the only thing they eat. The regulatory floor under it exists precisely so parents never have to wonder whether the can is safe. When those controls fail, families pay the price, and they are entitled to answers.My thanks to Phyllis for staying on this. Read her full report here. We’ll keep digging