Providing safe nutritional products during the Coronavirus outbreak

As everyone faces the global pandemic of COVID-19, we want to assure you of our commitment to the health and well-being of premature infants.

Our California-based employees in production, lab, and shipping are all essential and will continue to report for work. However, we are taking additional precautions for their health, including adding cleaning measures, adjusting schedules, and increasing distances between employees. We have also trained backup employees who are ready if the need arises.

Below are the proactive actions we are taking to ensure the integrity and availability of Prolacta products:

• Safety: As of now, evidence indicates that pasteurization inactivates SARS-CoV-2 should it be present in breastmilk. All Prolacta products, including pasteurized and nutrient-standardized donor milk, exceed the U.S. Food and Drug Administration’s (FDA) food-product standards. Our products undergo vat pasteurization to ensure the highest quality and safety, using time and temperature profiles defined by the FDA in its Pasteurized Milk Ordinance (PMO) to ensure the destruction of pathogens.  
  
  Published data indicates that pasteurization is an effective way to inactivate Coronavirus.^1,2,3,4 Only human milk products manufactured with the FDA-defined pasteurization process, such as Prolacta’s, are clinically proven to be safe and improve health in the NICU.
  
• Supply: We have an ample supply of our full inventory of products as well as raw materials to produce additional products. We are also taking additional steps to ensure uninterrupted production of our products. 
  
• Shipping and Orders: We maintain multiple shipping partners to ensure delivery schedules continue as planned. We have additional inventory available, and our staff will remain available to handle your orders and any issues that come up. 
  
• Additional Protections: We increased sanitization procedures for our facilities, as well as reconfirmed our stringent cleaning procedures with our donors. To limit the risk of community transmission, we are restricting visitors and canceling facility tours.

The well-being of premature infants is paramount to us. To learn more about our safety and quality control processes please click here.

We are in this together.

References

1. Chambers C, Krogstad P, Bertrand K, et al. Evaluation for SARS-CoV-2 in Breast Milk From 18 Infected Women. JAMA. 2020;324(13):1347-1348. doi:10.1001/jama.2020.15580
2. Conzelmann C, Groß R, Meister TL, et al. Holder pasteurization inactivates SARS-CoV-2 in human breast milk. bioRxiv. Preprint posted online June 16, 2020. doi:10.1101/2020.06.17.155689
3. Unger S, Christie-Holmes N, Guvenc F, et al. Holder pasteurization of donated human milk is effective in inactivating SARS-CoV-2. CMAJ. 2020;192(31):E871-E874. doi:10.1503/cmaj.201309
4. Walker GJ, Clifford V, Bansal N, et al. SARS-CoV-2 in human milk is inactivated by Holder pasteurisation but not cold storage. J Paediatr Child Health.2020. [Epub ahead of print]. doi:10.1111/jpc.15065