Two infant botulism outbreaks linked to powdered infant formula. Seven months apart. Forty-eight infants sickened in the first, three in the second. Both involving organic whole-milk powdered formula. Both sharing the same ingredient supplier.
Congress now has a bill in front of it that would have required the testing that could have prevented both.
H.R. 7867 — the Infant Formula Safety Modernization Act of 2026 — was introduced on March 9, 2026, by Representative Rosa DeLauro (D-CT), with bipartisan support. The bill emerged in direct response to the ByHeart Nutrition infant botulism outbreak of 2025, which hospitalized 48 babies across 17 states — the largest infant botulism outbreak in United States history.
Then, while the bill was pending before the House Energy and Commerce Committee, the Nara Organics outbreak struck. Three more infants in California, Pennsylvania, and Washington were hospitalized in the spring of 2026.
"Something we previously had not thought was likely, or even possible, now has caused two outbreaks with two separate companies within the same year," Rep. DeLauro said in a June 16, 2026 statement calling for the bill's immediate passage. "The food we give our babies must meet the highest standard of safety. Right now, it does not, and the gaps in the system are clear."
Why This Matters
The regulatory gap that H.R. 7867 addresses is specific and documented. Current FDA regulations for infant formula manufacturers require testing for only two pathogens: Cronobacter and Salmonella. Clostridium botulinum — the bacterium responsible for both outbreaks — is not on the required testing list because, until 2025, it was not considered a hazard "reasonably likely to occur" in powdered infant formula.
The FDA had, in fact, warned the industry about this risk in writing in March 2023 — two years before the first ByHeart baby became ill. A Call-to-Action letter, signed by the FDA Commissioner and the Director of the agency's food-safety center, named Clostridium botulinum by species and instructed manufacturers to account for it as a potential hazard. The letter was sent to every manufacturer, packer, distributor, importer, and retailer of powdered infant formula in the country.
That warning did not translate into a mandatory testing requirement. As food safety attorney Bill Marler noted in testimony submitted to Congress on June 24, 2026: "The hazard was on the government's own record — in writing — years in advance."
What the Bill Would Do
According to the DeLauro office's announcement and Food Safety Magazine's legislative analysis, H.R. 7867 would:
Expand required pathogen testing. Direct the FDA to develop a comprehensive list of pathogens and microorganisms that infant formula manufacturers must test for — moving beyond the current requirement of only Cronobacter and Salmonella. Clostridium botulinum would be specifically required to be on that list.
Mandate environmental testing. Require standardized environmental monitoring inside infant formula facilities — testing of floors, equipment, air ducts, and other environmental surfaces where pathogens can establish persistent contamination. This type of testing is standard in other high-risk food manufacturing sectors but is not currently required by law for infant formula.
Set consistent testing frequency standards. Specify how often environmental testing must occur so that all manufacturers operate under the same FDA-set frequency, rather than each company setting its own schedule. This removes the current incentive to test as infrequently as possible.
Require early FDA notification. Compel manufacturers to notify the FDA of any positive pathogen test — even if the affected formula has not yet left the manufacturing facility. Current rules allow companies significant discretion in when and how they notify regulators of contamination events.
The Case Bill Marler Made to Congress
Food safety attorney Bill Marler, whose firm has represented families in both the ByHeart and Nara outbreaks, submitted detailed testimony to Congress on June 24, 2026, laying out the direct case for the bill's passage.
"A single dose of BabyBIG — the antitoxin that is the only treatment for infant botulism — costs $69,300 per dose," Marler wrote, "(some need at least two) and every one of the 48 ByHeart and three Nara infants needed it. Add to that the intensive-care stays, the air-ambulance transports — one family was flown by medevac from Idaho to a children's hospital in Utah — the months of feeding tubes and physical therapy, the nationwide recalls, the plant shutdowns, and the litigation that inevitably follows."
He also noted that the testing the bill would mandate is not a theoretical or impractical requirement: "After these outbreaks, manufacturers began screening for spore-formers on their own. Nara itself quietly added 'spore-forming organisms' to its published testing list after its recall. If industry can test for this hazard once babies are hurt, it can test for it before a single can ships."
Who Supports the Bill
The Infant Formula Safety Modernization Act is endorsed by:
- American Academy of Pediatrics
- Consumer Reports
- Consumer Federation of America
- Environmental Working Group
- Center for Science in the Public Interest
- STOP Foodborne Illness
- Association of Public Health Laboratories
- Prolacta
The breadth of endorsements — spanning pediatric medical professionals, consumer advocacy organizations, and public health laboratory experts — reflects the unusual degree of consensus around the bill's core provisions.
What the Evidence Shows — and What It Does Not
H.R. 7867 directly addresses the testing gap confirmed by the ByHeart outbreak: standard industry testing protocols did not detect Clostridium botulinum spores before contaminated formula reached infants. The same testing gap contributed to the Nara Organics outbreak seven months later.
What the bill does not address is every possible source of future infant formula contamination — it specifically targets pathogen and microorganism testing and facility environmental monitoring. Other aspects of the infant formula supply chain — including international ingredient sourcing and the oversight of foreign manufacturers — are addressed through related but separate regulatory discussions.
What You Can Do Now
- If you want to support passage of H.R. 7867, contact your congressional representative through congress.gov and ask them to support the Infant Formula Safety Modernization Act.
- Follow the bill's progress at govtrack.us/congress/bills/119/hr7867 .
- If your infant consumed Nara Organics formula, stop using it immediately — all lots are recalled. See our full coverage of the Nara Organics outbreak at MedicalDaily.
What Happens Next
The bill had a committee hearing on April 29, 2026, and was referred back to the House Energy and Commerce Committee after the Nara outbreak renewed attention. The Nara Organics outbreak, which occurred while the bill was pending, has significantly increased legislative urgency. Whether the bill advances to a House floor vote before the next congressional recess is not yet clear. MedicalDaily will report on any committee markup, floor vote scheduling, or Senate companion legislation developments.
The Bottom Line
Two infant botulism outbreaks in seven months exposed a specific, documented regulatory gap in how infant formula is tested before it reaches store shelves. The Infant Formula Safety Modernization Act would close that gap by requiring pathogen testing for Clostridium botulinum and mandatory environmental monitoring in every facility. The bill was pending when the second outbreak struck. The evidence for its passage is now written in the medical records of 51 hospitalized infants.
