Ep. 222. Elena Medo: Food Safety Lessons From the Global Infant Formula Cereulide Recall

Elena Medo, M.B.A. is an entrepreneur, researcher, and inventor who has spent nearly 40 years transforming neonatal care through leadership and innovation. She has secured numerous patents, raised over $40 million across four companies, and built a legacy of firsts, including the first commercially available shelf-stable donor breast milk product; the first milk bank owned exclusively by nursing mothers; and the first medical device designed to analyze human milk. Today, as CEO and co-founder of Leonie Health PBC, established in 2023 with her daughter, Adrianne Weir, Elena is developing a revolutionary product that replicates the immune properties of colostrum to protect preterm infants against the three deadliest neonatal infections—necrotizing enterocolitis (NEC), ventilator-associated pneumonia (VAC), and sepsis—which together claim the lives of more than 30,000 hospitalized infants per year.

Elena's work is driven by an unwavering commitment to ensure that human milk's unparalleled bioactive benefits reach the world's most vulnerable patients. Companies she has founded—including Prolacta Bioscience, Medolac Laboratories, North American Instruments, and White River Concepts—have applied disruptive technologies to serve the 15 million preterm infants born each year. A frequent speaker at neonatal, women's health, and leadership conferences, Elena holds an M.B.A. degree in Healthcare Management from the University of California, Irvine's Paul Merage School of Business and is widely recognized for assembling world-class teams to solve critical challenges in infant health.

In this episode of Food Safety Matters, we speak with Elena [38:58] about:

• Her work in human milk science and the founding of Leonie Health, which offers bioactive infant nutritional products mimicking colostrum to support neonatal health and early development
• Reflections on the recent global infant formula recall due to cereulide contamination, which affected 99 countries and multiple brands
• Why U.S. disease surveillance systems might miss or misclassify infant foodborne illness cases
• What the cereulide incident reveals about risks for infants in neonatal intensive care (NICU) and donor milk settings
• Improvements to public health and laboratory systems that would enable earlier detection and response to infant formula contamination incidents and related illnesses
• The importance of infant-specific toxicological reference values for contaminants like cereulide, such as those recently established in the EU, and how the EU's response could influence regulatory approaches to other emerging hazards in infant foods
• Leonie Health's process for verifying the safety of donor milk
• Key principles for clinicians, hospitals, and parents to consider when making decisions about infant feeding when contamination events affect commercial formula products.

News and Resources

News

U.S. Cyclosporiasis outbreak [2:46]:

• Experts Set Record Straight on FoodNet, CDC Cuts as Senators Press RFK Jr. for Answers Amid Cyclospora Outbreak
• Michigan, Ohio Together Report More than 9,000 Cyclosporiasis Cases; CDC Outbreak Count Exceeds 4,000
• Taylor Farms Lettuce Named as Source of U.S. Cyclospora Outbreak
• How the U.S. Cyclospora Outbreak Reflects a Strained National Foodborne Illness Surveillance System
• Senator Klobuchar Urges CDC, FDA to Restore Food Safety Programs Amid Cyclosporiasis Outbreak
• CDC Reports Up to 7,000 Cyclosporiasis Cases Across U.S., Identifies Large Midwestern Outbreak Cluster
• Cyclospora Cases Climb, But Actual Number Unclear as CDC Reporting Lags Behind States
• Foodborne Parasite Cyclospora Sickens Thousands Across U.S.

Codex Alimentarius news [28:30]

• Codex Publishes Strategic Plan for 2026–2031
• Codex Adopts Internationally Harmonized Precautionary Allergen Labeling at CAC49

Following Infant Formula Incidents, FDA Urges Manufacturers to Implement Stronger, Substantive Supplier Oversight [29:53]

USDA-FSIS to Expand Testing for Metals in RTE Foods Under National Residue Program [33:59]

Resources

Infant formula cereulide contamination incident:

• EFSA Reviews Cereulide Infant Formula Incident, Says Likelihood of Exposure is Low
• EFSA Sets Safety Thresholds for Cereulide Toxin in Infant Formula
• EFSA to Advise on Cereulide Levels in Infant Formula Following Global Recall

U.S. Cyclosporiasis outbreak:

• "Cyclospora cayetanensis: An Emergent Public Health Threat and an Enigma for Traceback Investigation," Food Safety Magazine
• "Please Don't Stop Eating Vegetables and Fruits Because of Cyclospora," The Washington Post
• "Cyclospora Spreads Through Human Feces. How Did it Get Into Our Food Supply?" The New York Times
• "Publisher's Platform: The Traceability Rule was Supposed to be Law in January. This Cyclospora Outbreak Started in May." Food Safety News

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