Should We Cry Over Spilled Baby Formula?

What in the Operation Stork is going on?!

This week brought significant developments in infant nutrition that have many parents concerned and confused. On Tuesday, March 18, two major announcements hit the news: Consumer Reports released findings from an investigation into contaminants in infant formula, and in what appears to be a related move, the Department of Health and Human Services (HHS) and the FDA announced "Operation Stork Speed," a new initiative to enhance oversight of infant formula. As a public health scientist and mother who breastfed my children while supplementing with formula (and would do it again without question), I understand these concerns from both professional and personal perspectives.

I, Jess, am collaborating with a team of medical experts on this topic. Our co-authors, as noted in the article byline, include Dr. David Higgins (pediatrician) and Jeff Dewey (neurologist). We've also received valuable input from Drs. Dina DiMaggio (pediatrician) and Anthony Porto (pediatric GI physician), who are not on Substack. Let's discuss...

Disclaimer: Although a team of clinicians contributed their perspectives and helped co-author this piece, neither this nor any of our content constitutes medical advice. We are simply providing a summary of available evidence and population-level data. For medical questions or concerns, please consult with your personal healthcare provider.

Setting the Stage: Two Breaking Developments

The infant formula landscape in the United States has been under scrutiny since the 2022 Abbott facility shutdown that created nationwide shortages. Now, with new findings about potential contaminants and a government initiative to address formula safety and nutrition, parents are understandably seeking reliable information. Let's break down what we know about both developments.

Consumer Reports Investigation: What Was Found

Consumer Reports tested 41 different powdered infant formulas for heavy metals (arsenic, lead, cadmium, mercury), BPA, acrylamide, and PFAS. The investigation revealed that while most formulas tested had low or no detectable levels of these contaminants, some formulas did contain concerning elements:

Arsenic was found at elevated levels in a few specialized formulas, with Abbott's EleCare Hypoallergenic measuring 19.7 parts per billion (ppb) of inorganic arsenic and Similac Alimentum measuring 15.1 ppb. For context, the EPA limits inorganic arsenic in drinking water to 10 ppb, while the European Union allows up to 20 ppb in powdered infant formula. Eight of the 41 formulas tested had arsenic levels exceeding Consumer Reports' risk threshold.

Lead was detected in 34 of the 41 formulas, ranging from 1.2 ppb to 4.2 ppb, with Enfamil Nutramigen showing the highest levels. None exceeded California's Maximum Allowable Dose Level, the standard Consumer Reports used for safety evaluation, though 18 formulas had lead levels at 50-100% of this threshold.

PFAS (per- and poly-fluoroalkyl substances) were detected in almost all formulas tested, though Consumer Reports acknowledged that only one sample of each brand was tested, making it difficult to draw definitive conclusions about specific formulas as many formulas and lots of formulas were not tested.

BPA and Acrylamide were found in only one formula—Enfamil Nutramigen—a specialized formula often recommended for babies with cow's milk protein allergies.

Importantly, the majority of standard formulas that most families use tested in the "Top Choices" category with low or no detectable levels of all contaminants. This included popular options like Enfamil NeuroPro, Enfamil Gentlease, Similac Advance, Kirkland ProCare, and Bobbie Organic among others.

Operation Stork Speed: The Government Response

On the same day as the Consumer Reports release, HHS Secretary Robert F. Kennedy Jr. and Acting FDA Commissioner Sara Brenner announced "Operation Stork Speed," an initiative focused on ensuring "safe, reliable, and nutritious infant formula for American families." This program includes several key components:

1. Beginning the first comprehensive review and update of infant formula nutrients since 1998

2. Increasing testing for heavy metals and other contaminants in infant formula and other foods children consume

3. Extending the personal importation policy for formula

4. Encouraging formula manufacturers to work with the FDA on increased transparency and clearer labeling

5. Collaborating with the National Institutes of Health on scientific research regarding health outcomes associated with formula feeding

The FDA emphasized that this initiative is part of a broader effort to ensure that the "U.S. infant formula supply ranks best in the world" and aligns with the administration's "Make America Healthy Again" agenda.

The Bigger Context

When evaluating these developments, it's critical to understand several important points:

First, environmental contaminants like heavy metals are unfortunately pervasive in our environment. They occur naturally in soil and water and can be increased through industrial activities, meaning they can be found at some level in virtually all foods, including breast milk. The key question is whether the levels found pose a health risk. This depends in part on the brand of formula but also on total formula intake throughout infancy and overall entry into body tissues from all sources during this period.

Additional important considerations from a data science perspective include:

• Sample size limitations: Each formula was tested with only a single sample, preventing analysis of lot-to-lot variation or determination of whether findings represent outliers or typical values.

• Lack of clinical correlation: The study does not connect detected contaminant levels to any clinical outcomes in infants, making it difficult to assess real-world health implications.

• Missing bioavailability analysis: The testing identified the presence of contaminants but did not assess bioavailability—how much is actually absorbed by an infant's body versus passed through.

Second, most of the formulas tested by Consumer Reports met or exceeded European standards, which are often cited as the "gold standard" for food safety. Even those with higher levels of arsenic fell below EU limits for infant formula.

Third, while any level of contaminants in infant food is concerning, the manufacturing companies point out that the detected levels are measured in parts per billion—extremely small amounts that reflect our improved ability to detect trace substances rather than necessarily indicating new risks.

Finally, a notable limitation of the Consumer Reports investigation is the absence of breastmilk samples as a comparison control. Without testing breastmilk using the same methodology and parameters, we lack crucial context for interpreting these findings. Research shows breastmilk can also contain environmental contaminants, making direct risk comparisons between formula and breastmilk impossible from this data alone.

Reducing exposure to heavy metals is undoubtedly a good thing, particularly for developing infants. However, it's important to understand that zero exposure is unrealistic given how pervasive these elements are in our environment. Heavy metals enter our food supply through multiple pathways: they exist naturally in soil and groundwater and levels can be markedly raised through industrial pollution, mining operations, agricultural practices, and even through water pipes. This is why we find trace amounts in everything from rice and vegetables to drinking water and, yes, even breast milk. The FDA's "Closer to Zero" initiative, launched in 2021 to reduce childhood exposure to heavy metals in food, acknowledges this reality in its very name—the goal is to continually reduce exposure, not to achieve the impossible standard of complete elimination.

What Should Parents Do?

If you're currently using infant formula, consider these evidence-based recommendations:

1. Keep perspective: Environmental pollutants are unfortunately widespread in our food supply. The findings don't suggest that formula is suddenly unsafe if it wasn't before. Currently, pediatricians have not encountered an increase in heavy metal poisoning in formula-fed babies. To reduce exposure to heavy metals, if your baby is also on solid foods, offer a variety of fruits, veggies, and grains, and limit exposure to foods that tend to have higher levels of heavy metals, such as rice. (A note from co-author, Dr. Dina DiMaggio: The good news is that the majority of formulas tested at low levels of contamination, and thankfully, although we should always strive to be close to zero contamination, I have never had a baby with arsenic or mercury poisoning throughout my clinical practice.)

2. Check the list: Most standard formulas tested well, with low or undetectable levels of contaminants. If you're concerned, Consumer Reports published their complete findings, which you can reference.

3. Consult your pediatrician: If you're considering switching formulas, talk to your child's doctor first, especially if your baby is on a specialized formula for medical reasons. If concerned, your pediatrician can guide you on whether a change is indicated and ensure that if you change, you choose a similar type of formula.

4. Never attempt to make homemade formula or change the formula recipe: The risks of improper nutrition including severe health problems and even death far outweigh any potential benefits. Commercial infant formulas are specifically formulated to meet precise nutritional requirements according to strict FDA guidelines, with carefully balanced proteins, carbohydrates, fats, vitamins, and minerals essential for infant development. (One of our co-authors, Dr. David Higgins shared that he has hospitalized several babies whose parents tried homemade formula and sadly even saw one die.)

5. Use clean water: If mixing powdered formula, ensure you're using properly filtered or tested water, especially if you use well water.

As both a mother and a scientist, I (Jess) understand the anxiety these reports can cause. When I was feeding my children, I opted to breastfeed for 5-6 months while supplementing with formula. This was a personal choice that worked for my family, based on the scientific evidence available at the time. The truth is that both breast milk and formula can provide the nutrition infants need, and both can contain trace environmental contaminants. What matters most is making informed choices based on your family's specific circumstances and your baby's individual needs.

New moms can seek early support from lactation consultants or healthcare providers to address breastfeeding challenges and build confidence. They can also connect with peer support groups for encouragement and shared experiences.

Note: The Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provide essential nutrition support for low-income families, supporting healthy growth and development during the early months and years of life. Unfortunately, both WIC and SNAP are currently facing potential funding cuts.

Looking Forward

The FDA's announced nutrient review process and increased testing for contaminants represent important steps toward ensuring infant formula safety and quality. As updates become available through Operation Stork Speed, we can expect more detailed information about formula ingredients, labeling, and potential regulatory changes.

Future investigations would benefit from simultaneous testing of breastmilk samples from diverse populations using identical methodologies, establishing appropriate reference ranges, and conducting longitudinal studies to track actual exposure and health outcomes.

The conversation around infant formula should be driven by quality data and scientific evidence rather than speculation and fear. As a public health scientist, I'll continue monitoring these developments and providing updates as more information becomes available.

Stay Curious,

Unbiased Science

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