TL;DR
Get kitchen staples and gadgets delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
Food safety attorney Bill Marler is seeking public comments on a draft citizen petition asking FDA to require testing for botulinum toxin-producing bacteria in powdered infant formula and dairy ingredients. The proposal follows two formula-linked outbreaks in which 52 infants were hospitalized; the petition has not yet been filed, and its proposed testing requirements are not FDA rules.
Food safety attorney Bill Marler is seeking comments on a draft citizen petition that would ask the Food and Drug Administration to require testing for botulinum toxin-producing bacteria in powdered infant formula and its dairy ingredients. The proposal follows two outbreaks in which 52 infants were hospitalized; the petition is still a draft, and the agency has not adopted its proposed requirements.
Marler says he plans to file the petition with 23 parents whose infants were hospitalized after consuming powdered formula: 21 cases associated with the ByHeart outbreak and two associated with the Nara Organics outbreak. He represents the families in litigation, according to the draft petition. The document includes 31 footnotes and four appendices and is available through a link in the original report.
The draft asks FDA to add botulinum neurotoxin-producing clostridia to the organisms covered by the finished-product testing rule. Its proposed plan calls for at least thirty 200-gram samples per production aggregate, or an equivalent plan, with none detected. It also seeks lot testing of specified dairy ingredients before use, one-business-day reporting of confirmed positive results, a finalized testing method within 180 days, and stronger supplier and farm-level records.
Marler is requesting comments from scientists, laboratories, public health officials, formula makers, dairy processors, pediatricians and parents. Questions include whether the sample plan is workable, which ingredients should be covered, how traceability could be implemented, and what evidence exists on test performance, cost and laboratory capacity. Comments are requested by email at bmarler@marlerclark.com by Friday, October 30, 2026.
Potential Changes to Formula Safety Testing
If FDA adopts requirements along the lines proposed, manufacturers could face mandatory testing of both finished formula and dairy ingredients, alongside new reporting and traceability duties. That could change how contamination is detected before products reach infants, whose formula may be a primary or sole source of nutrition.
The proposal also raises practical questions for manufacturers and suppliers: how to obtain enough representative samples, whether laboratories can process them reliably, and how to document the origins of milk and milk powder. These are questions for public comment, not settled findings. The petition does not seek a ban on any product or brand.
The draft also points to a possible connection with federal legislation. It says Senate bill S. 272, which the source reports passed the Senate unanimously in April 2026, would require one-business-day notice for organisms on FDA’s testing list. According to the petition, adding botulism-causing bacteria to the list could bring them within that notice requirement. The scope and effect of any legislation would depend on its final status and terms.
As an affiliate, we earn on qualifying purchases.
Outbreaks and Existing FDA Rules
Under 21 C.F.R. § 106.55(e), infant formula manufacturers must test finished product for Cronobacter and Salmonella. The draft says FDA added Cronobacter to the list in 2014, citing concern that voluntary industry testing might not be sufficient for a food relied on by infants. In March 2023, the FDA commissioner wrote to the powdered formula industry and identified Clostridium botulinum as a hazard to consider when designing controls.
The source report says the ByHeart outbreak involved 48 infants in 17 states, with illness onsets from December 2023 through November 2025. Four infants in California, Pennsylvania and Washington were linked to Nara Organics formula in April and May 2026. FDA reported on August 27, 2026, that whole-genome sequencing linked the outbreaks. The report says both products were made with milk supplied by Organic West Milk and spray-dried by Dairy Farmers of America, and that FDA’s evidence pointed to a common source.
The draft contrasts environmental sampling at ByHeart’s plants, which the company said produced 472 negative samples, with FDA’s reported finding of the organism in a lot of organic whole milk powder linked by sequencing to a sick infant. It also says FDA found two positive samples among 48 powdered milk samples from four suppliers tested in February 2026. These details are presented in the petition and source report; they do not establish the proposed rule or resolve responsibility for contamination.
Testing Plan Still Under Review
The petition has not yet been filed, and FDA has not decided whether to accept or implement its requests. The proposed sample count, ingredient coverage, traceability rules and reporting deadline remain recommendations open to comment. The source says FDA presented an interim testing method at a July 2026 roundtable, but that method was still awaiting validation.
It is also not clear from the available material how FDA would respond to the proposal, how long any agency review would take, or whether testing requirements would use the petition’s exact terms. The source report says a milk supplier gave FDA an incomplete customer list during the 2025 investigation and that FDA traced the milk to 22 dairies that had not been publicly identified. The identities of those dairies and further details of the investigations were not provided in the material.
Comments Before Petition Filing
Marler is asking for emailed comments by October 30, 2026, including suggested edits and redlines. He says readers who want a Word version for markup can request one by email. The source material does not give a filing date beyond saying he intends to submit the petition after seeking comments.
After filing, FDA would determine how to handle the petition; no decision or schedule is described in the source. Any future agency action would be separate from the current request for public input, and the existing testing rules remain the requirements described in the report unless FDA changes them.
Key Questions
Has FDA required botulism testing in infant formula?
No such requirement is described in the source. The draft petition asks FDA to add botulinum toxin-producing clostridia to its infant formula testing list; the proposal is not an adopted rule.
Who is asking for comments, and when are they due?
Food safety attorney Bill Marler is seeking comments on the draft. They should be emailed to bmarler@marlerclark.com by October 30, 2026.
What testing does the draft propose?
It proposes testing finished formula using at least thirty 200-gram samples per production aggregate, or an equivalent plan, with none detected. It also proposes testing each lot of specified dairy ingredients before use.
Why does the draft focus on dairy ingredients?
The source report says FDA found the organism in a lot of organic whole milk powder linked by whole-genome sequencing to a sick infant, while ByHeart reported that 472 environmental samples from its plants were negative. The petition argues that ingredient testing should be part of the proposed controls.
Would the petition ban a formula brand?
No. The draft petition asks for testing, reporting, method and traceability requirements. It explicitly does not ask FDA to ban any product or brand.
Source: rss
NFL season / tailgating Picks
team gear
As an affiliate, we earn on qualifying purchases.
