June 29, 2023: Stop Foodborne Illness (STOP) is confident that the vote today by the Council of State and Territorial Epidemiologists (CSTE) to include Cronobacter sakazakii on the nationally notifiable diseases list will have meaningful impact on infant mortality. Thank you to the CSTE for its due diligence and acknowledging this important issue.

We urge the Centers for Disease Control and Prevention to quickly adopt this position to begin funding and initiating surveillance of Cronobacter sakazakii infections in infants. There are costs associated with this addition — but funds are needed to educate public health and medical officials nationwide in order to save lives.

Cronobacter sakazakii contamination is responsible for the massive 2022 powdered infant formula recall and the subsequent product shortages in the U.S. that left families scrambling to find food for their newborns. The contamination led to at least two infant deaths and an unknown number of illnesses in infants less than 3 months of age.

Although Cronobacter sakazakii infections are considered rare, no one is exactly sure as there is little data and research associated with this pathogen. With this position, those numbers will become more readily available.

STOP is developing an education campaign for both consumers and medical professionals focusing on how to safely handle powdered infant formula, as it is not a sterile product. Most consumers do not understand what that means and how it could adversely impact their newborn(s). 

Stop Foodborne Illness is a national public health non-profit organization that advocates for enforceable and science- and risk-based federal food safety policy, works with industry to develop positive food safety culture, and engages individuals and families that have been adversely impacted by severe foodborne disease. Stop Foodborne Illness works on behalf of everyone who eats.

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In 2022 alone, two infants have died and five more are extremely ill due to a deadly bacteria called Cronobacter sakazakii. It is in contaminated baby formula that was sold in grocery stores. 

For babies that get infected by Cronobacter bacteria, up to 80% may die [JAMA October 8, 2014]. Botulism, on the other hand, is so toxic that a single case constitutes a public health emergency. The CDC reports that approximately 70 percent are infant cases with an overall mortality rate of only five percent. And, botulism is so rare that from 2001-2017 there were 19 cases, on average, reported each year. [Frontiers July. 16 2021]. 

Shockingly, the deadly bacteria known as Cronobacter sakazakii is not included in the U.S. Centers for Disease Control and Prevention’s (CDC) list of pathogens reported by hospitals, healthcare providers, and laboratories.

• Learn more about Cronobacter

Not having mandatory reporting of the Cronobacter sakazakii (Cro·no·bac·ter sa·ka·za·kii) bacteria slows down outbreak investigations and delays getting tainted food off of store shelves.

Lack of reporting also reduces the ability to discover incidents, identify clusters of illnesses, track down root causes of outbreaks, and medically treat sick babies properly.

CNN health | May 2023: Bacterial infection linked to recent baby formula shortage may join federal disease watchlist

POLITICO | March 2023: 'Lessons have not been learned': FDA knew of positive test months before latest infant formula recall

FDA OVERSIGHT PART I: THE INFANT FORMULA SHORTAGE | March 2023: Testimony from Frank Yiannas, former FDA Deputy Commissioner, Food Policy & Response

HBW INSIGHT PHARMA INTELLIGENCE | February 2023: US Infant Formula Safety Questions Don’t Include Cronobacter National Reportable Disease Listing

WASHINGTON POST | January 2023: Opinion: For the nation’s health, break up the Food and Drug Administration

POLITICO | January 2023: ‘I know firsthand they failed’: Parents decry lack of FDA action on infant formula safety

STOP FOODBORNE ILLNESS | December 2022: Encouraging News from the Reagan-Udall Foundation Report on Human Foods Program of the FDA

CNN | November 16, 2022: FDA lays out plan to combat bacterial contamination of baby formula

WALL STREET JOURNAL | November 15, 2022: FDA Developing Plan to Guard Against Bacteria Outbreaks in Baby Formula

STOP FOODBORNE ILLNESS | March 7, 2022: FDA and CDC: Add Cronobacter sakazakii to the Nationally Notifiable Diseases List

POLITICO | April 28, 2022: Whistleblower warned FDA about formula plant months before baby deaths

POLITICO | April 20, 2022: What else have they been missing? Massive infant formula recall raises questions about FDA inspections

From CDC: Babies are dying and their deaths can be prevented

From CONSUMER REPORTS: King’s Hawaiian Buns Are Recalled Due to Possible Bacterial Contamination

From FDA: Cronobacter-related Recalls

• February 22, 2023: Enfamil Prosobee Simply Plant-Based Infant Formula in 12.9 oz containers
• December 11, 2022: ByHeart brand Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12months
• August 25, 2022: Piantedosi brand Various Dinner rolls, sandwich rolls and bun products
• August 16, 2022: Lyons and other brands Nutritional and beverage products
• August 13, 2022: King's Hawaiian brand Pretzel Slider Buns, Pretzel Hamburger Buns, Pretzel Bites
• July 29, 2022: Lyons Magnus and various brands 53 Nutritional and beverage products
• March 7, 2022: Similac, EleCare, Alimentum brands Powdered Infant Formula
• February 17, 2022: Similac, EleCare, Alimentum brands Powdered Infant Formula