TL;DR
Food safety attorney Bill Marler is seeking comments through October 30 on a draft citizen petition asking FDA to require testing for botulism-causing bacteria in powdered infant formula and dairy ingredients. The petition follows two outbreaks in which 52 infants were hospitalized; it has not yet been filed, and FDA has not adopted the requested requirements.
Food safety attorney Bill Marler is seeking comments on a draft petition asking the U.S. Food and Drug Administration to require testing for botulism-causing bacteria in powdered infant formula and its dairy ingredients. The proposal follows two formula-linked outbreaks in which 52 infants were hospitalized; the petition has not yet been filed, and the requested rules are not currently in effect.
Marler said he plans to file the petition with 23 parents of infants hospitalized with botulism after being fed powdered formula: 21 families connected to the ByHeart outbreak and two connected to the Nara Organics outbreak. He represents the families in litigation, according to the draft petition. The document, which includes four appendices and 31 footnotes to public sources, is available for review before filing.
The petition asks FDA to add botulinum neurotoxin-producing clostridia to the organisms covered by the finished-product testing rule for infant formula. Its proposed plan calls for no detection in at least 30 samples of 200 grams each per production aggregate, or an equivalent plan. It also asks for testing of each lot of specified dairy ingredients before use, including whole milk powder, nonfat dry milk, milk protein concentrate and whey.
Other proposed measures include one-business-day reporting to FDA of confirmed positive results, completion of a validated test method within 180 days, and lot-level records identifying drying facilities and dairy farms. The draft would make environmental monitoring a secondary control. Marler says the petition would not ban any product or brand. He invites comments from scientists, laboratories, public health officials, manufacturers, dairy processors, pediatricians and parents by email at bmarler@marlerclark.com by Friday, October 30, 2026.
Why Ingredient Testing Is Central
The proposal focuses on a potential route of contamination that testing only inside formula plants may miss. According to the draft, ByHeart reported that 472 environmental samples from its plants tested negative. FDA, however, found the organism in a lot of organic whole milk powder that whole genome sequencing matched to an ill infant. That contrast is the basis for the petition’s emphasis on testing dairy ingredients before they enter production.
The stakes are high because powdered formula is a primary food source for infants, who can become seriously ill from botulism. A federal testing requirement could make controls less dependent on each company’s voluntary practices. Marler says ByHeart conducted about 5,000 tests during its investigation and now tests dairy ingredients, bulk powder and finished product before release, but he argues that no rule currently requires those measures across the industry.
The petition also links the requested listing to reporting. The source says Senate bill S. 272, which passed the Senate unanimously in April 2026, would require one-business-day notice for organisms on FDA’s list. If botulism-causing bacteria were added, that reporting provision would apply to them under the bill. That connection is conditional: the petition has not been filed, FDA has not acted on it, and the source does not establish that the bill has become law.
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Outbreaks Behind the Proposal
Federal rules at 21 C.F.R. § 106.55(e) require infant formula manufacturers to test finished product for Cronobacter and Salmonella. The draft says FDA added Cronobacter to the list in 2014, citing the vulnerability of infants and concern that voluntary testing might not be sufficient. On March 8, 2023, the FDA commissioner wrote to the powdered formula industry and identified Clostridium botulinum as a hazard to consider in designing controls.
The draft reports that ByHeart formula was linked to 48 infant illnesses in 17 states, with onset dates from December 2023 through November 2025. A separate Nara Organics outbreak involved four infants in California, Pennsylvania and Washington in April and May 2026. All 52 infants were hospitalized, according to the petition. FDA reported on August 27, 2026, that whole genome sequencing linked the outbreaks and that formula from both brands used milk supplied by Organic West Milk and spray dried by Dairy Farmers of America.
The petition also cites FDA sampling in February 2026: of 48 powdered milk samples from four suppliers to formula makers, two tested positive for a Clostridium carrying a botulinum toxin gene. It says the milk supplier provided an incomplete customer list during the 2025 investigation, omitting Nara’s manufacturers. Those details inform the petition’s call for ingredient testing and traceability records, but the draft’s account is not an FDA rule or a final agency finding on every point.
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Testing Plan and Evidence Questions
The draft is a request for comment, not a filed petition or an FDA decision. It remains unclear whether Marler will change the proposal before filing, whether FDA would grant any part of it, or on what schedule the agency might respond. The source also does not provide a final, validated testing method; it says FDA presented an interim method at a July 2026 roundtable and that validation is pending.
Several technical and operational questions are open. The petition asks whether 30 samples of 200 grams is the right finished-product plan, which dairy ingredients should be covered, and how any exemption for ingredients processed through validated spore reduction should be defined. It also seeks input on laboratory capacity, test performance, costs, farm-level traceability and the usefulness of environmental monitoring when ByHeart’s reported plant samples were negative. FDA’s findings and the outbreak links are described in the source, but the available material does not resolve each question about contamination pathways or responsibility.
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Comments Before Petition Filing
Marler is asking interested parties to send comments to bmarler@marlerclark.com by October 30, 2026. He says edits and redlines are welcome and that he can provide a Word version for people who want to mark up the draft. The stated next step is filing the citizen petition with the 23 parents after the comment period; the source does not give a specific filing date.
After filing, FDA would decide how to handle the request. The draft asks the agency to adopt the proposed controls or, alternatively, grant measures that can be implemented sooner, prioritizing ingredient testing and a finalized method. Until FDA acts, manufacturers are not subject to the new requirements requested in the draft, and it remains unknown whether the agency will adopt, modify or reject them.
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Key Questions
Has the petition been filed with FDA?
No. Marler is seeking comments on a draft petition before filing it. He has not provided a filing date.
What would the petition require?
It asks FDA to require testing for botulism-causing bacteria in finished powdered formula and specified dairy ingredients, along with positive-result reporting, a validated test method and supply-chain records. These are proposed requirements, not current rules.
Why does the draft emphasize dairy ingredients?
The draft says FDA found the organism in an organic whole milk powder lot matched to an ill infant, while ByHeart reported negative results from 472 plant environmental samples. Marler argues that ingredient testing could address a contamination route that plant-only monitoring might miss.
How many infants were hospitalized in the outbreaks described?
The draft reports 52 hospitalizations: 48 associated with ByHeart formula and four associated with Nara Organics formula. FDA reported that sequencing linked the two outbreaks, according to the source material.
How can people comment on the draft?
Comments, edits and redlines can be emailed to bmarler@marlerclark.com by Friday, October 30, 2026. Marler says a Word version is available on request.
Source: rss
