Bill Marler

FDA Confirms the Shared Suppliers – but Hasn’t Linked them to the Nara Illnesses – Yet

Today the FDA updated its Nara Organics infant botulism outbreak page with two findings that matter.

First, FDA’s traceback determined that the Nara formula lots fed to the three sick infants were made with milk supplied by Organic West Milk (Organic West) and spray-dried by Dairy Farmers of America (DFA) — the same two suppliers behind the ByHeart botulism outbreak that stretched from December 2023 to November 2025. The shared supply chain is now the government’s own finding.

But the next line matters just as much: FDA says there is “not enough evidence to determine if this is the source or route of contamination,” and no Nara product has yet tested positive for C. botulinum. Let’s be precise about what has and hasn’t been shown. Organic West and DFA are now confirmed as the common suppliers to both ByHeart and Nara outbreak brands — but they have not been linked to the Nara illnesses themselves — yet.

FDA has collected unopened samples from the implicated lots, with results expected “in the coming weeks.” It also inspected the two European firms behind Nara’s formula before the illnesses surfaced and cited deficiencies at both — and Nara and DFA still won’t name them — yet. 

Trade reporting and U.S. customs records identify them as its German manufacturer, Milchwerke Mittelelbe GmbH (trading as Elb-Milch, a Krüger Group company in Stendal), which makes the powder, and its Danish packager, Advanced Nordic Nutrition (formerly Fipros Nutrition ApS), which cans it. FDA corrective actions are under review, though the specific findings aren’t public yet.

Here is the part that should make us all furious. During the 2025 ByHeart outbreak investigation, FDA did the right thing — it ran a traceforward and asked Organic West Milk (and presumably DFA) who else it supplied. The whole point is to find the next brand before the next baby gets sick. Per FDA’s June 26 update, Organic West gave a customer list that was incomplete and did not include Nara, and it has now admitted the list should have listed Nara. DFA has remained silent, as has Nara.

Sit with the timeline. That traceforward happened during the 2025 ByHeart outbreak investigation; the Nara babies got sick in April and May 2026. A complete, accurate list could have put Nara on FDA’s radar months before a single infant showed a symptom. The mechanism to prevent this existed, FDA used it, and an incomplete supplier disclosures defeated it.

It is an open question what Nara knew and when — depositions under oath will shine a light on that. The same will hold true with Organic West and DFA.

We are not guessing about whether this supply chain can carry the organism. FDA’s post-outbreak page reports that in the ByHeart investigation, two samples from one DFA lot of organic whole milk powder matched — by whole genome sequencing — a clinical (baby) isolate and a positive formula sample. And in its March 8, 2023 Letter to Industry, FDA told formula makers — two years before either outbreak — to account for every “reasonably foreseeable” hazard in powdered formula, naming Clostridium botulinum specifically. Anyone sourcing whole milk powder for infants was on notice.

FDA’s traceforward depended entirely on suppliers voluntarily producing an accurate customer list — and there is no real backstop. The Food Traceability Rule under FSMA Section 204 doesn’t even cover whole milk powder or infant formula, and its compliance date has been pushed to July 20, 2028. Meanwhile, FDA still only requires testing finished formula for Cronobacter and Salmonella but not for Clostridium botulinum. If no one is required to look, no one detects, and the duty to report never triggers. Two outbreaks, dozens of paralyzed babies, and the rule hasn’t changed.

This is why litigation matters. Discovery and depositions will force a complete, truthful record when neither the regulations nor a company’s own interests will. FDA got an incomplete list. A courtroom does not accept incomplete lists.

FDA has confirmed the shared suppliers — same milk, same processor, two outbreaks months apart — when an incomplete customer list left Nara off during the ByHeart investigation.

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