Chairman Cassidy Expands Investigation into the Safety of Infant Formula

WASHINGTON - U.S. Senator Bill Cassidy (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, demanded answers from Nara Organics for selling potentially unsafe infant formula linked to infant botulism. Following three suspected or confirmed cases of infant botulism in three states, the Food and Drug Administration (FDA) recommended that Nara Organics conduct a voluntary recall.

"Ensuring that parents and their infants have access to safe formula is essential for us to protect our most vulnerable population," wrote Dr. Cassidy. "There should never be any question about the quality of these products. The ongoing safety recall affecting Nara Organics' products undermines access to safe, quality infant formula by putting pressure on the overall supply chain."

Cassidy previously raised concerns with ByHeart's infant formula after their product infected 51 infants across 19 states with infant botulism.

Read the full letter here or below:

Dear Ms. Hallam:

Ensuring that parents and their infants have access to safe formula is essential for us to protect our most vulnerable population. There should never be any question about the quality of these products. The ongoing safety recall affecting Nara Organics' products undermines access to safe, quality infant formula by putting pressure on the overall supply chain.

On June 12, the Food and Drug Administration (FDA) recommended that Nara Organics conduct a voluntary recall due to an outbreak of infant botulism "among infants consuming Nara Organics Whole Milk Organic Powdered Infant Formula."¹ While FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate the outbreak, a total of 3 infants who consumed Nara Organics products across 3 states have been identified with suspected or confirmed infant botulism .²

It is important for the public to not only understand how infants were infected with botulism, but also to determine what steps should be taken to strengthen protections and to ensure the overall safety of infant formula. To that end, I request answers to the following questions, on a question-by-question basis, by July 29, 2026.

1. When did Nara Organics first become aware of safety concerns regarding its infant formula?
2. How is Nara Organics engaging with retailers to ensure that any recalled infant formula batches are no longer being sold?
3. How is Nara Organics engaging with state and federal entities to limit any supply chain impact associated with Nara Organics' safety recall?
4. What safety processes, including testing frameworks, does Nara Organics have in place to ensure infant formula products are safe?
5. 1. Does Nara Organics work with any third-party entities to review and improve safety processes?
   2. Does Nara Organics conduct any proactive inspection of its facilities?
   3. In the last five years, has Nara Organics identified any safety hazards at its facilities in in Stendal, Germany. If so, please provide a list of any identified hazards and steps Nara Organics took to address those.
6. Has Nara Organics voluntarily removed any infant formula batches manufactured in the United States sold in foreign markets?
7. 1. Has Nara Organics received any engagement regarding safety with foreign product regulators?
8. Recent reports have indicated that Nara Organics used a whole milk supplier who had also supplied a manufacturer who had similarly recalled products due to an outbreak of infant botulism.³
9. 1. What safety processes does Nara Organics have in place to ensure ingredients purchased from third parties for its finished infant formula products are free from contaminants?
   2. Has Nara Organics identified any past safety concerns with its whole milk suppliers? If so, how did Nara Organics address those concerns?

Sincerely,

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