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Is freeze-dry breast milk FDA approved?

Understanding Freeze-Dried Breast Milk and FDA Regulations
In recent years, the practice of freeze-drying breast milk has gained popularity among parents looking for convenient ways to store and use this vital nutrition for their infants. However, a critical question arises: Is freeze-dried breast milk FDA approved?
The Freeze-Drying Process
Freeze-dried breast milk is created by removing the water content from human milk, resulting in a powder that resembles infant formula. This method not only extends the shelf life of breast milk—often up to three years—but also preserves many of its nutritional and immunological properties. Companies like Milkify have emerged, offering professional freeze-drying services that promise to maintain the quality of the milk throughout the process.
FDA Oversight and Approval
Despite the growing market for freeze-dried breast milk, it is essential to clarify the FDA’s role in this area. Currently, the FDA does not regulate breast milk freeze-drying services. This means that while companies may claim to adhere to certain safety and quality standards, such as Good Manufacturing Practices (GMP), the FDA does not officially approve these facilities or their processes.
Milkify, for instance, markets itself as a GMP-certified service, which indicates compliance with safety standards promoted by the FDA. However, this certification does not equate to FDA approval of the freeze-drying process itself or the final product.
Medical Community’s Stance
The medical community remains cautious regarding the use of freeze-dried breast milk. Organizations like the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC) have not issued formal statements endorsing the safety or efficacy of freeze-dried breast milk. This lack of endorsement highlights the ongoing debate and the need for further research to establish clear guidelines and recommendations.
Conclusion
In summary, while freeze-dried breast milk offers a practical solution for many parents, it is crucial to understand that it is not FDA approved. The absence of regulatory oversight means that consumers should approach these products with caution, staying informed about the potential risks and benefits. As research continues to evolve, the conversation around the safety and efficacy of freeze-dried breast milk will likely develop, potentially leading to clearer guidelines in the future.

Does freeze-drying breast milk remove nutrients?

Freeze drying is a preservation method that removes the water content from breast milk, leaving behind only the good stuff – the nutrients and enzymes that our babies need.

Can I freeze-dry my breastmilk at home?

How to freeze dry baby milk at home? Cut open all the frozen bags of breast milk. Fit about 9 bags per tray and fill 5 trays to fill the freeze dryer. It takes over 24 hours for the freeze dried to finish. Turns into very dry powder. Put it in a Ziploc bag and smash it up. Grind it up into the finest powder.

What are the disadvantages of freezing breast milk?

Deep freezer.
Keep in mind that research suggests that the longer you store breast milk — whether in the refrigerator or in the freezer — the greater the loss of vitamin C in the milk. It’s also important to note that your breast milk changes to meet your baby’s needs.

How long does freeze-dried breastmilk last?

three-year
Your freeze dried milk has a three-year shelf life and your expiration date is printed on every bag.

Is freeze-dried considered processed?

In contrast, freeze-dried foods, such as fruits, cheese, meat, and seafood are considered processed (since they undergo freeze-drying to remove moisture) but they can be part of a healthy diet. These options are convenient but contain few to no preservatives.

What are the disadvantages of freeze drying?

What is the disadvantage of freeze-drying?

  • Some freeze-dried products are somewhat more expensive than canned or dehydrated products.
  • Some raw materials must be treated before freeze-drying because they are sensitive to the process.
  • Freezing can damage some foods.

How long can freeze-dried breast milk last?

three-year
Your freeze dried milk has a three-year shelf life and your expiration date is printed on every bag.

Does freeze-drying breast milk lose antibodies?

Research finds that nutrients and antibodies are preserved during freeze drying. Research finds regular freezing impacts the nutritional content of human milk and decreases protein and caloric content over time.

Is freeze-dried FDA approved?

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use of a freeze-dried plasma product, octaplasLG Powder, for emergent treatment of hemorrhage or coagulopathy during an emergency …

Is it worth freeze-drying breast milk?

Freeze-drying preserves the nutritional, immunological, and probiotic components of your breast milk. Not only does freeze dried breast milk offer nutrition benefits, it gives you convenience by delivering flexibility and peace of mind – and a three year shelf life.

Natasha Lunn

Tash is an IBCLC and Business Coach helping fellow IBCLCs create fun, profitable businesses that are more than just an expensive hobby. Before becoming an IBCLC and starting her private practice - The Boobala, Tash graduated as an Osteopath in 2008 and has been in Private Practice in South West Sydney. She was also a volunteer Breastfeeding Counsellor and Community Educator with the Australian Breastfeeding Association for 6 years. Through her business, Your Lactation Biz, Tash coaches and creates products to help new and seasoned IBCLCs build businesses that suit their personality and lifestyle.

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