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 have John Wallingford, PhD on the Medolac Laboratories team 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 continues to help Medolac advance its efforts to meet the challenges of the current regulatory environment. 

Having the only shelf-life stable human milk that doesn’t need to be refrigerated potentially solves several issues with the feeding of infants in emergencies.  We stand ready to work with government and relief agencies but also have a commitment to the responsible use of our products in such situations.  For example, we will always refer product requests to the lead relief agency responsible for coordinating nutrition activities before providing aid.  It is essential that our product only be used appropriately in emergency settings and that it is coordinated so that supplies are adequate, of high quality, sustainable and can be used hygienically.  Take a look at paragraph 8 of our commitment to responsible conduct at www.medolac.com/corporate-responsibility.html for more information.

How cooperatives fit in as partners in community, regional and global initiatives is not always well understood, but we think that needs to change.  Their ability to address social and economic challenges is powerful, not only for their membership but those who benefit from their goods or services.  A UN panel for international development heard a strong case to embrace cooperatives as partners. 

“Cooperatives can do anything a for-profit business can do, with one caveat: they can do it better,” said panelist Mike Beall, president and CEO of National Cooperative Business Association. “They can do it ethically, they can do it by not overly seeking profit, and they can do it by involving community.”

Our motivation for developing the Mothers Milk Cooperative, the first cooperative of its kind is twofold.  First, we saw the cooperative as a way to increase the supply of human donor milk to address the tragic shortage for premature infants in clinical settings that has existed for many years.  Second we saw an opportunity to provide a voice and fair compensation for donors as coop members. 

The Mothers Milk Cooperative continues to grow at more than 15% per month and has become one of the largest milk banks in the USA in its first year of existence.  For the first time, we now see a viable pathway that has the potential to end the chronic shortage of human milk for premature infants.  Without the cooperative model this would not be possible.

The impact that cooperatives can have on community efforts is too great to ignore.  We have been working hard to develop new partnerships that reflect our vision to promote breastfeeding, access and economic inclusion. Co-ops, like the Mothers Milk Cooperative, can become key partners in community efforts to improve the health and well being of infants suffering from lack of access to donor milk and to encourage the social and economic empowerment of breastfeeding mothers.   

Although Co-op Donor Milk, processed by Medolac Laboratories, is simply 100% human milk with nothing added, we have raised the bar when it comes to our safety standard for donor screening as well as raw milk testing compared to traditional milk banking practices.  Our partnership with the American Red Cross National Testing Laboratories has enabled us to utilize a more robust donor screening program and we have expanded donor blood testing to include screening for West Nile Virus and Chagas Disease (T. Cruzi) in addition to HIV 1 and 2, HTLV I and II, HBV, HCV and syphilis.  Our testing is repeated twice in the first year of donor participation.  We have also raised the bar for donor milk testing and continue to expand our testing as we examine and report on a variety of areas including microbiological and viral safety, environmental toxins, drugs of abuse, heat stable toxins, prescription drugs and ethanol.

We are an evidence based company and as such, we believe that it is necessary to have a comprehensive understanding of the risks inherent in human milk banking in order to take decisive and effective action to lower or mitigate such risks.  Such a risk case has not been done.  While human milk is truly miraculous, it is not magic.  If not handled properly, it can become contaminated with high levels of bacteria and associated toxins plus spores that cannot be removed using any heat treatment and could result in serious illness.  We will be sharing our research with the medical community to promote a better understanding of the potential risks and benefits of donor milk.   After years of studying this, we believe that anything short of commercial sterility is unacceptable in the neonatal intensive care unit.

The Mother’s Milk Cooperative was launched with the goal of ending the donor milk shortage and providing economic empowerment to healthy nursing mothers blessed with surplus milk.  Shortly after the launch, we started enrolling members and collecting milk. 

Today, we are a nationwide program, with Co-Op members in 47 states.  Co-Op donors represent a wide range of ethnicities, cultures and economic status.   Although diverse in many ways, Co-Op donors feel strongly about three key issues; they share a passion for breastfeeding their own children, they have the ability to produce a volume of milk over and above their own baby’s needs and they want to help babies in need. 

We are proud of the positive impact we’ve had on nursing mothers, their families and especially the babies who have been receiving milk from us for several months now.  Although the Co-Op milk money program has been a huge success, many of our donors also donate milk under the Pay It Forward program, without compensation.  We process that milk and make it available free of charge to babies in need. All of the babies who have benefited from this program were referred to us by their physicians and have been turned down for donor milk because of strict rationing due to the longstanding shortage.  You can read some of their stories here.

Together, we are putting an end to donor milk scarcity and making it increasingly possible for every baby in need to obtain donor milk.

We are advocates for a global effort to significantly reform milk banking practices by supporting the development of independent breast milk cooperatives, owned by nursing mothers, as an important framework to help ensure that donor interests are not marginalized. Unlike ad hoc breast milk donations, donor milk cooperatives are, "based on the principles of empowerment, education, and community.  Co-ops operate laterally promoting participation, both within their own organization, and through a focus on community interaction, and support." (learn more about cooperatives at the Co-operative Learning Center www.learningcentre.coop)

At Medolac, our corporate policy is to support the formation of independent donor milk cooperatives that first and foremost represent the interests of donors, enabling an environment where the highest standards in health, safety and wellness for donors and infants can be maintained.  We believe that by developing and running our business in a responsible, ethical and transparent manner, we will create an ample and affordable supply of donor milk to serve the 15 million preterm babies in need throughout the world.   

At Medolac, we support the United Nations’ Millennium Development Goals 3, 4 and 5, which seek to empower women and improve health outcomes for both women and children.  Despite concerted worldwide efforts, in 2012, 6.6 million children died before their 5th birthday and much work remains to be done, particularly with regard to premature infants in the developing world. 

In fact, a recent report published by the WHO, "Born Too Soon", indicates that, "global progress in child survival and health to 2015 and beyond cannot be achieved without addressing preterm birth." Greater access to human milk could play a vital role as it has been shown to increase survival in preterm infants.   Despite this fact, donor milk is often inaccessible, particularly in resource poor settings and the benefits of shelf-life stable supply of human donor milk like ours in these situations would be quite significant. 

Medolac has already met with several prominent global aid agencies to find ways to advance the availability of donor milk and adapted human milk in resource poor settings and is committed to working in partnership with governments, international agencies and NGOs to do our part in helping address the urgent need to improve health outcomes for infants globally.