Food Safety Matters

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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Alissa Welsher, Ph.D. is a Senior Consultant at Elanco Poultry Food Safety. Dr. Welsher received a bachelor's degree in biological sciences from the University of Pittsburgh, as well as a master's degree in poultry science and a Ph.D. in cell and molecular biology from the University of Arkansas. Her area of expertise is meat and poultry food safety, and she specializes in integrated pest management (IPM).
In this episode of Food Safety Matters, we speak with Dr. Welsher [1:39] about:
The seasonal conditions that allow fly populations to surge and become more difficult to control during the summer months
The food safety risks posed by flies in preharvest poultry operations
The benefits of fitting fly control into a broader IPM strategy
The initial signs of increasing fly activity and the first steps that integrators and applicators should take to respond
How insecticides like Agita can be used in combination with monitoring, sanitation, and other pest management practices for effective fly control.
Resources
Agita® 10 WG
Sponsored by:
Elanco

Alissa Welsher, Ph.D. is a Senior Consultant at Elanco Poultry Food Safety. Dr. Welsher received a bachelor's degree in biological sciences from the University of Pittsburgh, as well as a master's degree in poultry science and a Ph.D. in cell and molecular biology from the University of Arkansas. Her area of expertise is meat and poultry food safety, and she specializes in integrated pest management (IPM).
In this episode of Food Safety Matters, we speak with Dr. Welsher [1:39] about:
The seasonal conditions that allow fly populations to surge and become more difficult to control during the summer months
The food safety risks posed by flies in preharvest poultry operations
The benefits of fitting fly control into a broader IPM strategy
The initial signs of increasing fly activity and the first steps that integrators and applicators should take to respond
How insecticides like Agita can be used in combination with monitoring, sanitation, and other pest management practices for effective fly control.
Resources
Agita® 10 WG
Sponsored by:
Elanco
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Please send us your questions and suggestions to podcast@food-safety.com

Lyle Probst is the CEO of NomadX and an accomplished entrepreneur with more than 25 years of experience in operations, product development, engineering, biodefense, and advanced technology commercialization.
Lyle was previously a scientist at Lawrence Livermore National Laboratory and has founded and led multiple companies spanning technology development, manufacturing, biomedical technology, and biological defense. He was part of the team that developed the U.S. BioWatch program and previously served as CEO of MicroFluidic Systems, which, under a contract with the U.S. Department of Homeland Security, developed the M-BAND biological detection system to continuously monitor for biological threats. The system was ultimately licensed by a major defense contractor. Lyle has also designed and shipped multiple mobile command centers and laboratories around the world for several governments and notable private companies.
Today, Lyle leads NomadX's mission to help food producers prevent contamination through innovative approaches to detection and decontamination. He has spoken at the U.S. National Academy of Sciences, National BioWatch conferences, and has appeared as a contributor on national media outlets. He is the recipient of several awards and certificates of appreciation from the U.S. Government for his work and contributions to the BioWatch program and related projects. Lyle holds a Bachelor of Science in Biology and an MBA in Executive Management.
In this episode of Food Safety Matters, we speak with Lyle [2:18] about:
How his background in biodefense, autonomous pathogen detection, and national security led Lyle into food safety, and lessons from biodefense that can be applied to food production and food safety
The importance of moving beyond a compliance mindset when it comes to food safety and how recalls and food safety events can impact a business beyond direct costs
Industry blind spots related to microbiological contamination control
The advancement of rapid pathogen detection technologies and what it means for real-life applications
Utilizing pathogen detection data to guide root cause analyses, inform targeted interventions, and prevent recurrence
Potential applications for artificial intelligence in food safety
What the future of food safety programs may look like in light of advancements in testing, automation, and data integration
Advice for food safety leaders as they prepare for the future.
Resources
The Three-Pillar Food Safety Solution
Sponsored by:
NomadX
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Please send us your questions and suggestions to podcast@food-safety.com

Alex LeBeau, Ph.D., M.P.H., CIH is the owner of Exposure Assessment Consulting LLC in Orlando, Florida, where he offers toxicology, industrial hygiene, risk assessment, and public health consulting services. Over his 13-year career, he has evaluated environmental and occupational exposures and has performed toxicological evaluations of chemicals and biological agents. He has also performed human health risk assessments of contaminated sites using U.S. Environmental Protection Agency (EPA) and state regulatory guidelines and has monitored remediation activities at those sites. To evaluate the exposure impacts on building occupants, he has performed indoor environmental quality assessments, including Legionella and water quality assessments, at healthcare, residential, and industrial facilities.
Dr. LeBeau has been a co-author on industry guidance for COVID-19 issues. He has also been retained as a testifying expert witness and provided consultation on several occupational and environmental exposure claims. Finally, Dr. LeBeau has authored safety assessments on consumer products, including antimicrobial pesticide registration dossiers, Generally Recognized as Safe (GRAS) determinations for food ingredients following U.S. Food and Drug Administration (FDA) regulations for scientific procedures, and submitted a health claim petition to the FDA that was successfully accepted by the agency.
In this episode of Food Safety Matters, we speak with Dr. LeBeau [26:40] about:
The Healthy Florida First contaminant testing initiative for food products, which has notably raised concerns about arsenic in candy
Gaps around Healthy Florida First's testing methodology, data reporting, and transparency that make the contaminant findings difficult to interpret in a scientific context
How arsenic is typically evaluated in food products and what factors are relevant to determine whether detected levels are significant to human health
Why detection does not always equate to danger (i.e., the difference between hazard identification and risk assessment)
The exposure assumptions and risk calculations that are required to translate contaminant testing results into a realistic assessment of consumer risk
How FDA and EPA typically conduct exposure science and toxicological risk assessments for contaminants in food, and how Healthy Florida First's approach compares
Best practices for the communication of contaminant testing results to ensure the information is accurate, transparent, and responsibly interpreted by both industry and consumers.
News and Resources
News
Novel C. Botulinum Test for Infant Formula Developed After ByHeart Study Reveals Industry Standard Falls Short [1:54]
Infant Formula Brands Behind Botulism Outbreaks Used Same Organic Whole Milk Supplier [3:57]
USDA-FSIS Announces Pilot Program to Evaluate Salmonella Control Strategies in Raw Poultry Establishments [10:29]
EU Report on Food Safety Alerts Highlights Top Hazards, Major Incidents in 2025 [14:04]
California Law Standardizing 'Best By' Dates Now in Effect: What Packaged Food Manufacturers Need to Know [19:16]
Resources
Florida Contaminant Testing Program Raises Concerns Over Arsenic in Candy
Exposure Assessment Consulting
We Want to Hear from You!
Please send us your questions and suggestions to podcast@food-safety.com