Imported and homemade formulas rising in popularity, causing concern

Search the Internet for homemade infant formula and a number of highly regarded recipes will soon appear. For whatever reason, more and more parents are looking beyond the standard offerings in the United States: they make their own formulas or import foreign formulas. Even the New York Times reported on the growing trend of imported formulas from Europe1, but whether these formula options offer a better choice is a matter of debate and concern.

Steven Abrams, MD, a professor of pediatrics at the Dell Medical School at the University of Texas Austin, has written guidelines on imported and homemade formulas for the American Academy of Pediatrics and says some parents are looking for unconventional formula options in an effort to food allergies, but there are bigger concerns.

First, when it comes to allergies, Abrams warns that “hypoallergenic” has different criteria by European Union standards compared to those of the U.S. Food and Drug Administration (FDA). So parents may not be getting what they think they’re getting in terms of allergy avoidance. Dietary standards may also differ, but Abrams says the importation of foreign formulas and the lack of regulation of these and homemade options are more concerning.

“The nutritional standard may be a little different, but that’s actually not the main concern,” he said. “It’s not just about what’s in the formula, but how it’s imported.”

FDA-approved imported formulas are held to strict standards when it comes to how they are stored and transported, and what shelf life is acceptable. While the formulas themselves may be nutritionally good, Abrams said there are concerns about how formulas imported outside of FDA’s oversight are entering the country.

“FDA regulation on infant formula is the strictest of any nutritional product out there, and for good reason. If you get rid of those regulations, you have challenges,” Abrams said. If you meet American standards, where do you draw the line? Moreover, there are no particular advantages to these formulas.”

The Centers for Disease Control and Prevention3 and the FDA4 warn both parents against buying imported formulas, echoing Abrams in saying that imported options have no proven health benefits.

Some parents may be tempted by the simple labeling and branding of imported formulas, or the claim that they are more milk-based. However, Abrams says that some of these formulas are actually identical to brands made in the United States.

Homemade formulas are another cause for concern. While homemade formulas made from cow’s milk and canned milk were quite common in the 1950s, there’s now a trend to make formulas from other “milk” products that are vegan or even hemp-based, he says.

“We advise even more strongly against homemade formulas,” he cautioned, citing an FDA case study on infants fed a homemade hemp-based formula who developed severe hypocalcemia and rickets.5

Cost isn’t usually the issue that drives parents when it comes to imported or homemade formulas, he explained. In fact, many parents pursuing these options are on the higher end of the income spectrum.

“It’s generally higher-income parents who don’t trust the government or believe what they read online. They think the FDA isn’t doing as well as it is in Europe. If the United States loses the power to regulate, you’re in a mess, to say the least.”

Pediatricians should ask questions in a non-judgmental manner about the formulas parents use for their babies and educate them about safety concerns.

If the reason is financial — this happens more with homemade or diluted formulas — refer them to organizations and programs that can help them provide formula resources, he says.

For families who distrust the government or have nutritional problems, it is vital that pediatricians provide education, focusing on the lack of oversight of the nutritional content, production and storage of these products.

“If you let someone market something like infant formula, you’re going to have problems,” Abrams said.


1.Szalinski C. Why American parents choose European baby food. Published March 12, 2021. Accessed October 8, 2021.

2. Abrams S. Is Homemade Baby Food Safe? Updated March 5, 2021. Accessed October 8, 2021.

3. Centers for Disease Control and Prevention. Choosing an infant formula. Accessed October 8, 2021.

4. US Food and Drug Administration. FDA advises parents and caregivers not to make or give homemade infant formula to infants. Published February 24, 2021. Accessed October 8, 2021.

5. Calello DP, Jefri M, Yu M, Zarraga J, Bergamo D, Hamilton R. Notes from the field: vitamin D-deficient rickets and severe hypocalcemia in infants receiving homemade alkaline diet formulas – three states, August 2020 – February 2021. MMWR Morb Mortal Wkly Rep 2021; 70: 1124-1125. doi: 10.15585/mmwr.mm7033a4

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