US Government Meddles in Global Infant Formula Regulations

The global infant formula market is worth $70.98 billion as of 2022, and by 2030, is expected to grow to $153.26 billion.¹ There’s such a massive demand for these “convenient” milk alternatives, as many parents have been hoodwinked into thinking that they’re “better and healthier” for their babies.

But as I’ve highlighted in some of my recent articles, infant formulas aren’t as safe or healthy as they seem — yet, the industry continues to thrive. Unsurprisingly, the U.S. government has a hand in this, by interfering with infant formula regulations worldwide.²

The US Government Meddles in Infant Formula Regulations Worldwide

According to an extensive report published in ProPublica,³ the U.S. government is quietly forcing over a half-dozen countries to “weaken, delay or rethink” infant formula regulations, which aim to protect the public’s health. This comes after manufacturers raised complaints that the regulations will significantly impact their sales.

“In the European Union [EU], the U.S. opposed an effort to reduce lead levels in baby formula. In Taiwan, it sought to alter labeling that highlighted the health benefits of breastfeeding.

And in Colombia, it questioned an attempt to limit microbiological contaminants — the very problem that shut down a manufacturing plant in Michigan in 2022, leading to a widespread formula shortage,” ProPublica reports.⁴

The U.S. government’s global meddling was discovered via trade letters that were sent during President Joe Biden’s first two years in office. ProPublica says that the letters carry an “implicit threat,” usually inquiring about the scientific rationale behind the proposed regulations made by the country. “If the U.S. feels a nation’s regulations are not justified, it can initiate a legal fight over trade agreements,” the article reports.

Trade Letters Reveal Biden Administration Interfered with Other Countries’ Formula Regulations

One of the pro-industry missives⁵ dating back to May 2021 revealed how the U.S. rebuffed the EU’s efforts to reduce lead levels in infant formula, based on a risk assessment by a food safety agency. Lead is a neurotoxin that’s associated with neurological in young children and fetuses,⁶ and has no safe level of exposure.

However, the U.S. government advised the EU to wait instead, as an international food standards body is also in the process of reducing the levels of lead in foods.⁷ Despite this advice, the EU pushed forward with this change. They also lowered the limits of cadmium, a potential carcinogen found in infant formula.

Meanwhile, a 2022 letter sent to Taiwan, which was then working to change labeling requirements on formula milk, stated that the U.S. urged them to change the health claim “Breastfed babies are the healthiest babies” to “Breastmilk is the best food for your baby.” The change may seem subtle, but it implies a different meaning.

According to Marion Nestle, professor emerita of nutrition, food studies and public health at New York University:

“These statements may seem identical, but the formula industry wants formula to be viewed as equivalent to or better than breastfeeding. ‘Healthiest’ can seem stronger, and that’s all it takes for formula companies to fight it.”⁸

David Clark, a former legal specialist with UNICEF and an international public health law consultant, likens the U.S. government to a “bully in the playground,” using its strength and power to push its agenda onto other smaller nations. These “interventions” may seem harmless, but they have a significant yet detrimental effect on other countries’ efforts to uphold the importance of breastfeeding.

But the Biden administration isn’t the first administration to do this; there’s a long history of other presidential administrations meddling with as many as 21 countries over infant formula regulations, according to ProPublica.⁹ Apparently, the U.S. government prioritizes industry profit over children’s health worldwide.

Recent Review Shows High Concentration of Heavy Metals in Infant Formulas

Particularly concerning is the high levels of heavy metals and other contaminants found in many formulas. A recent review¹⁰ published in the Science of the Total Environment journal compared the pollutants in breast milk versus formula milk in the last decade. They found that infant formulas, particularly in Asia, Europe and Africa, contain high levels of heavy metals, which are associated with various health risks. The researchers reported:

“Exposure to toxic metals and metalloids in prenatal and postnatal stages can cause a negative impact on the offspring health from birth by leading to cancer, allergy or neurodevelopmental disorders and cognitive impairments.

For instance, the exposure to Pb [lead] during development can lead to several adverse effects on the hematologic, gastrointestinal, and renal systems. In addition, Cd [cadmium], As [arsenic], Pb, and Mn [manganese] have also been linked to anthropometric changes such as lower birth weight, shorter gestational age, or smaller head circumference.”¹¹

Mycotoxins are another threat found in infant formula. These secondary metabolites produced by molds or fungi may have various detrimental effects, as they are carcinogenic, neurotoxic, hepatotoxic, dermatotoxic, estrogenic and immunosuppressive. Based on the featured review, high values of aflatoxin M1 (AFM1) were found in formula milk in America.¹²

“In general, mycotoxins have demonstrated to be able to cross the placental barrier and exert effects on the fetal system. These mycotoxins can impact children health through different mechanisms, and depending on the type, they can cause different effects,” the researchers said.¹³

Recent Independent Study Also Finds Heavy Metals in All Infant Formulas Tested

An independent study¹⁴ published in May 2024 showed similar results. Spearheaded by two nonprofit foundations, GMOScience and Moms Across America, the researchers found five toxic heavy metals in 20 infant formulas from well-known local and international brands, including Similac, Enfamil and Gerber.

The study authors emphasize the importance of their findings, as these heavy metals, which include lead, aluminum and mercury, can cross your child’s blood-brain barrier, which doesn’t fully develop until they’re 6 months old.

“Chronic exposure to these metals, even at low levels, can have cumulative effects on infants, potentially leading to developmental and neurological issues, carcinogenic, as well as initiating the development of chronic diseases later in life.

Given the [crucial] growth period in infants, even small amounts of toxic metals can have disproportionately large impacts as compared to adults,” they stated.¹⁵

What’s more, the researchers warned that heavy metal contamination from infant formula can have a cumulative effect. The levels can also increase during early infant growth, as well as when various nutrient deficiencies are present, such as iron and vitamin D deficiency.¹⁶ In a blog post, Anne Temple of Moms Across America commented:¹⁷

“[W]e are extremely dismayed by the results. We had hoped some formulas would be free from toxic and heavy metals, but they were not. We were shocked to see such high levels of toxic metal aluminum present in goat’s milk formula and urge the manufacturers and the FDA to immediately take action to resolve this issue.”

Crecelac Infant Formula Recalled Over Cronobacter Contamination

Ironically, in the same month the independent study was published, the U.S. Food and Drug Administration (FDA) raised the alarm on Crecelac infant formula, after they found that aside from failing to meet FDA regulations, its products also tested positive for Cronobacter bacterium.^18,19 In babies younger than 2 months, Cronobacter infections can result in developmental delay, motor impairments and brain abscesses. In most cases, this infection is fatal.²⁰

Thankfully, no illnesses associated with the Crecelac recall have been reported,²¹ though the FDA advises parents and guardians to contact their health care provider and seek immediate care if their child appears ill after consuming these infant formulas. Initial symptoms of Cronobacter infection include:²²

Poor feeding	Temperature changes	Irritability
Jaundice	Grunting breaths	Abnormal body movements

July 31, 2024, the FDA posted an update,²³ warning consumers that a nutrient analysis also found elevated levels of potassium and chloride, as well as low levels of vitamin A, in the Crecelac infant formula. According to their website:

“The potassium and chloride levels were significantly above the levels permitted in infant formula in the U.S. and could lead to kidney and/or heart problems if the infant formula is used for an extended period of time. In addition, low vitamin A intake could lead to vision loss from a vitamin A deficiency if the infant formula is used for an extended period of time.”²⁴

If Breastfeeding Is Not an Option, Make Your Own Formula Milk at Home

With all the pitfalls linked to commercial infant formula, it’s just common sense to choose breast milk as your baby’s primary food. Absolutely nothing can compare to breast milk in terms of nutrition, so if you are a new mother and still lactating, breastfeeding would be the best choice for both you and your child.

However, I understand that not all moms can breastfeed. Those who didn’t breastfeed from the start, or who have stopped for weeks or months, may find it difficult to go back to breastfeeding, as you cannot restart lactation at will. In this case, resorting to formula milk may be the only choice. But instead of buying commercially sold infant formula, I recommend making your own formula.

In the video above, health and nutrition educator Sarah Pope of the Healthy Home Economist demonstrates how to make the formula created by Mary Enig, Ph.D., which was published in the book, “Nourishing Traditions.” There are a couple of caveats with Pope’s recipe, though:

To address these caveats, I made adjustments to Pope’s recipe. Below is my preferred dairy-based formula, which will make 36 ounces of milk. If you need to make large batches to last several days, you can do so, but make sure to freeze the finished product. For children who are unable to tolerate milk proteins, I recommend trying my hypoallergenic milk formula instead.

Breast Is Best – Breastfeeding Benefits Both Mother and Child

There’s no doubt that breast milk is the best first food you can give your child, and there’s a growing body of research highlighting its benefits. According to one scientific review published in the I-Manager’s Journal on Nursing:²⁶

“The nutritional composition of breast milk is uniquely tailored to meet the evolving needs of the infant. It provides a balanced mix of macronutrients, including carbohydrates, proteins, and fats, as well as a wide array of micronutrients, hormones, enzymes, and bioactive factors.

Moreover, breast milk offers a first line of defense against infections and diseases through its antibodies, immunoglobulin and other immune-enhancing component.”

The review highlights the benefits of breastfeeding for both the mother and child. In babies, breastfeeding was found to help boost their immune system, providing “passive immunity against a variety of infections and diseases.” Colostrum (the first milk that the mother produces) is a rich source of immune-boosting factors called immunoglobulins.²⁷

Breastfeeding also helps with infant growth and development, and may help reduce the risk of diseases, such as asthma, diabetes, obesity and neurological disorders.²⁸ Meanwhile, mothers who breastfeed are not only more successful with postpartum weight loss, but also have a reduced risk of breast and ovarian cancers. Breastfeeding may also have positive impacts on their psychological well-being.²⁹

While it’s ideal to breastfeed your child’s during their first few years of life, research³⁰ says that 60% of mothers stop breastfeeding sooner than planned. But breastfeeding for a short time is still better than not breastfeeding at all, because even short-term breastfeeding can have profound advantages for your child.

According to one study,³¹ although breastfeeding for six months or less did not directly prevent childhood obesity, babies born to older mothers (aged 35 or older) and were breastfed for a shorter time still had a lower risk of childhood obesity compared to babies that were never breastfed.

“[S]hort-term breastfeeding experience may interact with the timing of formula and cow’s milk introduction, potentially mitigating the negative consequences of early introduction on childhood obesity risk,” the researchers said.³²

Contaminants and PFAS Are Found in Breast Milk

The 2023 review published in Science of the Total Environment highlighted that breastmilk, although the best source of nutrition for your child, can still harbor pollutants. The researchers note that heavy metals and pesticides were the most prevalent contaminants in breastmilk.³³

Another type of pervasive contaminant found in breast milk today is polyfluoroalkyl or perfluoroalkyl chemicals, collectively known as PFAS or “forever chemicals,” which can be transferred to your child. In fact, a recent study³⁴ found that if you compare the amount of PFAS a baby is getting from breastmilk to what a typical adult is getting from their food, the baby is getting 10 times more.

“PFAS were detectable in most of the serum and colostrum samples in mother-child pairs, with the highest level of PFOS [perfluorooctane sulfonate] in maternal serum and the highest level of PFOA [perfluorooctanoic acid] detected in cord serum and breast milk. The placental and breastfeeding transfer efficiencies of PFAS are influenced by carbon chain length.

Infants can be exposed to PFAS through breastfeeding, particularly increasing the health risks of PFOS and PFOA, which necessitates further attention,” the study authors conclude.³⁵

But please note that this doesn’t mean you should avoid breastfeeding, as you will be depriving your child of the best food they can consume in their first few years of life. Halting breastfeeding could cause your baby to miss out on the health benefits mentioned above, most of which continue well into adulthood. Instead, I recommend taking measures to reduce your toxin burden, ideally well before you plan to get pregnant.

Reduce Your Toxin Load to Keep Your Breast Milk as Clean as Possible

Start by buying fresh, whole foods from a source you know and trust, one using safe, nontoxic organic or biodynamic farming methods. Organic fruits and vegetables typically contain fewer pesticides. Eating mostly fresh, whole foods will also help you cut down on exposure to PFAS, which are found in food packaging.

Next, be sure to filter your drinking water, as PFAS are a common water contaminant. I recommend using a high-quality carbon filtration system, and filtering the water both at the point of entry and at the point of use to ensure you’re getting the purest water you can.

Lastly, I recommend avoiding the items listed below to lower your PFAS exposure. You can find more helpful tips in the Environmental Working Group’s (EWG) “Guide to Avoiding PFAS:”³⁶

Items that have been pre-treated with stain repellents and opting out of such treatments when buying new furniture and carpets.

Water- and/or stain-repellent clothing — One tipoff is when an item made with artificial fibers is described as “breathable.” These are typically treated with polytetrafluoroethylene (PTFE).

Items treated with flame retardant chemicals, which include a wide variety of baby items, padded furniture, mattresses and pillows. Instead, opt for naturally less flammable materials such as leather, wool and cotton.

Fast food and carry-out foods, as the wrappers are typically treated with PFAS.

Microwave popcorn — PFAS may not only be present in the inner coating of the bag, it also may migrate to the oil from the packaging during heating. Instead, use “old-fashioned” stovetop popcorn.

Nonstick cookware and other treated kitchen utensils.

Oral-B Glide floss and any other personal care products containing PTFE or “fluoro” or “perfluoro” ingredients.

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