Right now one of the biggest anxieties facing caregivers of infants (as if we needed another one!) is the formula shortage. It was caused by a combination of supply chain issues and the Similac recall which led to a manufacturing plant for Abbott being closed. Abbott is the company that makes Similac, and the facility that closed was their largest in the US. Now there is a scramble to track down nutrition for our babies. Floating around Facebook there are a number of homemade baby formula recipes, some of which were even distributed by hospitals in the 60s and earlier or have been passed down through families. These may seem like a suitable alternative despite health officials warning against it. After all- it was used for years before the formulas we now have today. We know that everyone is trying to do the best they can for the babies they love with the information and resources available, and we wanted to help. In creating both this blog post and the informative posts on our social media we consulted with a board-certified pediatrician of 30 years and information from the American Academy of Pediatrics.
Firstly, let's talk about the main concerns associated with homemade formulas. If mixed improperly, which is much easier to do when using a DIY recipe, they can cause electrolyte imbalances in infants. This can lead to seizures, heart arrhythmias, and other dangerous medical issues. It’s surprisingly easy to disrupt a baby’s system because especially those under 6 months, babies have underdeveloped kidneys. Even just a little too much water can throw things off and create a dangerous situation for your baby. There is also a much higher risk of a bacterial infection or illness when using homemade formulas. Further, evaporated or condensed milk and Karo (corn syrup) do not contain all the vitamins, minerals, and other nutritional components required by the FDA to be in formulas in order to meet an infant's nutritional needs. Back in the 60 when this recipe was circulated by hospitals, it was the best alternative to breast milk we had. However, in the last 60 years (it really has been 62 years since 1960!) we have accumulated a vast amount of knowledge and advanced our abilities, and we can make formulas that very closely mimic human breast milk. This includes enzymes, proteins, fats, and different vitamins and minerals all necessary for a baby to reach their full developmental potential. The most widely spread recipe in question also includes instructions to give babies tea and orange juice on the bottom. We now know that this is not a safe or healthy practice for our infants either. Baby formula is one of the greatest medical advancements of our century, allowing women who underproduce, families who adopt, and moms who have other reasons for not breastfeeding to adequately nourish their babies. The idea that the homemade formula is equal to or better than store-bought formulas is very easily debunked by comparing nutrition labels. They may have some of the same or similar ingredients, but store-bought formulas are far more robust and nutritionally complete. Here is some information on how the FDA regulates formulas and what their rules are directly from their website:
What is an Infant Formula? The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk" (FFDCA 201(z)). FDA regulations define infants as persons not more than 12 months old (Title 21, Code of Federal Regulations 21 CFR 105.3(e)). Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.
How does FDA regulate Infant Formulas? Because infant formula is a food, the laws and regulations governing foods apply to infant formula. Additional statutory and regulatory requirements apply to infant formula, which is often used as the sole source of nutrition by a vulnerable population during a critical period of growth and development. These additional requirements are found in section 412 of the FFDCA and FDA's implementing regulations in 21 CFR 106 and 107. To view the FFDCA and regulations in 21 CFR, see FDA Federal Register Documents, Code of Federal Regulations & Food, Drug, and Cosmetic Act. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.
Does FDA have nutrient specifications for infant formulas? Yes, FDA has requirements for nutrients in infant formulas, which are located in section 412(i) of the FFDCA and 21 CFR 107.100. These nutrient specifications include minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. If an infant formula does not contain these nutrients at or above the minimum level or within the specified range, it is an adulterated product unless the formula is "exempt" from certain nutrient requirements. An "exempt infant formula" is "any infant formula which is represented and labeled for use by an infant who has an inborn error of metabolism or low birth weight, or who otherwise has an unusual medical or dietary problem" (FFDCA 412(h)(1). Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.
Let's compare the nutritional facts of 3 types of the most common formula brands to the homemade recipe:
Here we have Enfamil Neuropro
This is the liquid concentrate of Similac Advance
This is Earth’s Best Organic Original Formula
These are the two components of the homemade formula recipe aside from water.
The recipe calls for 13oz evaporated milk, 20oz of water, and 2 tablespoons of Karo, or corn syrup to fill six 4oz bottles.
This is a table with the direct comparison of the contents of each (keep in mind that I did not include every single mineral and vitamin in the store-bought formulas to keep the table under a certain size, but I did include everything in the homemade recipe):
*Vitamins and minerals were listed in percentage of daily requirement for a 2000 calorie diet on the homemade formula ingredients and by amount in IU, mcg or mg on the formula cans. I did find conversions online so that they would all be consistent for the sake of easier comparison.
It’s very easy to see in this format that homemade formula is lacking in a lot of areas. It’s also worth noting that some vitamins and minerals are only absorbed well when paired with others, which is considered in the amounts required to be in infant formula. That’s not to say that parents who used it for their kids in the past were neglectful or wrong for doing so. In the ’60s that was often the best available option! Parents did their best to make loving and careful choices for their babies. It’s simply another example of how recommendations for diet and other health issues have changed as we learn more. Think also of the recommendations for car seats 60 years ago- parents did what they knew to be a safe option at that point. However, we would not do the same things now that we did in 1960 when putting our kids in the car.
A common response to evolving safety recommendations is “We did it before and we were all fine!”. This is rooted in something called survivor bias. This means only the people who were not affected are around to give their opinion on whether or not it is safe. Lots of babies did survive the old ways of doing things, but if you look at infant mortality and illness rates over time, both have significantly decreased as practices have evolved. This means more babies are surviving and thriving now than before, which is a result of enhanced safety practices, such as the advancements in infant formula and pediatrics. This is demonstrated in the chart below which lists infant mortality rates from 1950-2010. The most current infant mortality statistic is from 2019 which was 6 per 1000 live births. Keep in mind, this chart is only for infant deaths, not illness and injury, which have also decreased. It also doesn’t cover the improvements in overall wellbeing, intelligence, and growth.
When it comes to our kids, we all get protective. We want to make sure they are safe, healthy, and happy. In order to make the best choices in an emotionally charged and scary situation, it’s important to look at all the available information to make your decision.
If you are affected by the formula shortage and struggling to find what your baby needs, there are several steps you can take. Contact your local WIC organization, your pediatrician, or the food banks in your area. You can also get breast milk from a donor bank with a prescription from your child’s pediatrician. Hospitals may also have samples available. There are multiple Facebook groups that have been created to help families source formulas, so check a moms group or search for a formula-finding group in your area. Families from Rochester and the surrounding areas can check out the SEMN Formula Finder Group, Minnesota Formula Exchange, and the Rochester Mom Community Conversation page on Facebook. For Minnesota, you can find WIC on this website Women, Infants and Children (WIC) Program - Minnesota Dept. of Health (state.mn.us). You can also dial 211 from your phone to be connected with community resources to help you locate or pay for formula. Steps are being taken to address this situation and it should be resolved in the next several weeks, but in the meantime mommas, caregivers, and doctors everywhere are working together to help get needs met. Reach out to those around you for support, know it’s normal to be anxious, and remember that it’s not going to last forever!