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We're Building Our Regulatory and Safety Expertise to Help Address Global Donor Milk Shortages

4/10/2021

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By: Elena Medo, CEO Medolac

At Medolac, we are committed to providing the safest donor milk and adapted human milk products for clinical use, meeting the highest levels of quality and building the regulatory expertise required to ensure that the health and well-being of patients comes first.  We continue to align ourselves with top experts to address these issues and remove the barriers to the use of donor milk in neonatal clinical settings worldwide.  

The lack of regulatory clarity has negatively impacted secure and safe access to human milk both domestically and globally. Most States do not regulate human milk banking nor do they consider donor milk to be a food.  So, even the most basic food safety regulations are not imposed on milk banking operations.  In 3 States, regulation is through the State tissue banking license which, while providing some guidance and regulation, creates confusion over whether donor milk is a human tissue or a food.  We feel that preterm babies deserve a better safety net than what is currently being provided and we continue to call for greater policy insight into existing milk sharing and milk banking environments.

We are proud to announce that John Wallingford, PhD has joined Medolac Laboratories as its lead regulatory affairs adviser.  Dr. Wallingford brings a wealth of worldwide regulatory expertise and scientific acumen in key areas relating to foods for special dietary uses including neonatal pediatric nutrition.  His expertise will help Medolac advance its efforts to meet the challenges of the current regulatory environment. 
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