While breastfeeding predominated in the 19th century, infant feeding practices changed dramatically between the 1880s and the 1940s in the United States towards a broad acceptance of medically-directed artificial infant feeding. Breastfeeding rates reached their lowest point in the 1970s and rates have been rising since then; however, this means that many women do not have mothers or relatives who they can turn to for breastfeeding advice as people did back in the 18th and 19th centuries. Breastfeeding support, counseling, and equipment are covered under many health insurance plans but even for women with a primary care physician or pediatrician, the supply of skilled lactation consultants is low. There are an estimated 5.1 Internationally Board Certified Lactation Consults (IBCLCs) per 1,000 live births in the U.S., falling below the recommended standard of 8.6 per 1,000 live births, and many pediatricians report feeling ill-prepared to provide breastfeeding support to lactating parents. Access to professional lactation support can be critical; many mothers stop breastfeeding earlier than intended due to lactation difficulties and concerns about milk supply. Hospitals play an important role in establishing infant feeding practices. However, the U.S. does not adhere to international standards on formula marketing, enabling formula companies to use aggressive marketing strategies, such as encouraging healthcare workers to distribute free samples to parents. Slightly over a quarter of all U.S. births occur in hospitals designated “Baby-Friendly,” which is viewed as the gold standard for infant feeding practices.

Many mothers in the U.S. are faced with difficult decisions between breastfeeding and paid work. Mothers who return to work full-time and/or shortly after giving birth are less likely to plan to exclusively breastfeed, have lower rates of breastfeeding initiation, and have shorter breastfeeding durations. On the other hand, increased paid family leave has been shown to increase breastfeeding duration and the likelihood of breastfeeding for at least 6 months, yet only about 50% of U.S. mothers who are working at the time of birth report taking some paid leave. Lactating parents who return to work and breastfeed are often met with a lack of professional support.

The U.S. Baby Formula Market

Unlike many other countries, the United States does not regulate most marketing practices of the baby formula industry. It did not sign on to the World Health Organization’s International Code of Marketing of Breast-Milk Substitutes established in 1981 which prohibits marketing infant formula to the public. The Code was developed due to the negative correlation between formula marketing and breastfeeding rates.

The failure of the United States to regulate the marketing practices of the $55 billion formula industry has meant that families in our country are not supported and protected against exploitative messaging at vulnerable times in their lives,

Although 84% of babies in the United States start out being breastfed, just a quarter of infants are exclusively breastfed at six months, according to the latest data from the Centers for Disease Control. Black infants have lower breastfeeding rates than White infants.

The American Academy of Pediatrics recommends exclusive breastfeeding of infants for the first six months of their lives.

There is no need to introduce infant formula or other sources of nutrition for most infants, the organization said in a policy statement calling for more support for breastfeeding mothers

Breastfeeding has been linked to a range of short and long-term health benefits in infants, including decreased rates of lower respiratory tract infections, severe diarrhea, and other conditions. It also carries benefits for mothers, including a reduced risk of breast and ovarian cancer and type 2 diabetes.

Health experts say the lack of robust policies in the United States to support breastfeeding mothers contributes to this dropoff in breastfeeding rates after babies are born and disparities in breastfeeding rates across racial and economic lines.

Most babies in America are not born in hospitals that are “Baby-Friendly,” the global standard set to support breastfeeding. Baby-friendly hospitals employ strategies to promote breastfeeding, such as uninterrupted skin-to-skin contact right after birth, and they do not allow formula except for medical reasons.

After moms leave the hospital, it often becomes difficult to breastfeed – particularly for low-income mothers. Participants in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) account for more than half of infant formula used in the United States.

The United States does not have national paid maternity or family leave. Many workplaces have inadequate pumping stations or none at all, and breastfeeding in public is often stigmatized.

Part of the reason about 40% of formula has been out of stock nationwide is that there are only a handful of domestic formula manufacturers. In the US, 80% of the baby formula sold is from just two companies—Similac and Enfamil. When Similac issued a recall in February and parent company Abbott paused manufacturing at its Michigan plant—the largest of its five formula factories—it had a tremendous impact on the overall supply. There are 14 Infant Formula Manufacturing businesses in the US as of 2023, a decline of -2.6% from 2022. The Infant Formula Manufacturing industry in the US has a high market share concentration and the largest business is Abbott Laboratories.

The Impact Of Baby Formula

Baby formula advantages include convenience and the ability to tailor nutrition for individual babies. The formula also provides an alternative way to nourish a baby if breastfeeding is not recommended by a medical provider. Lactose-free formula and hypoallergenic formula are available for babies with special needs.

Mothers who may need to pause breastfeeding because of medications, illness, or surgeries can formula-feed their babies. Using baby formula may also help preemies with catch-up growth. Studies have shown that preemie formula can help premature babies achieve short-term growth and weight gain.

While breastfeeding is the preferred choice, baby formula is still a nutritionally balanced way to feed your baby. All commercial formulas for sale in the U.S. must adhere to the Food and Drug Administration’s guidelines for nutrition. Experts do not recommend trying to make homemade baby formula, especially from recipes you find online. Babies who consume homemade formula run the risk of being nutritionally deficient and experiencing dangerous electrolyte imbalances.

Formula feeding allows others to help feed the baby, giving mothers precious time to rest, recover, or get more sleep. Formula-fed babies may feed fewer times a day because formula takes longer to digest.

Baby formula disadvantages include its cost, inability to provide antibodies and immune support to babies, and baby formula side effects.

Formula feeding is expensive. It can cost between $800 and $2,800 a year. With inflation, this figure could be higher. Brand-name formulas that babies leave the hospital with can be as much as 66% more expensive than store brands, but mothers are most likely to stick with the brand they know. Baby formula recalls may also cause extra stress because of formula shortages.

Babies who aren’t breastfed miss out on the unique immune and cognitive development benefits breast milk gives them. This includes antibodies and other health protections breast milk provides infants. And while baby formula side effects are typically limited to mild digestive issues, some health risks may be serious or even fatal.

Preemies fed cow’s milk baby formula have a higher risk of a serious digestive disorder called necrotizing enterocolitis than preemies whose main diet is breast milk, and NEC can be fatal. According to one of the first NEC studies published in the Lancet, NEC was six to 10 times more common in exclusively formula-fed babies than in babies fed breast milk alone. Parents whose babies became ill with or died from NEC have filed baby formula lawsuits against the makers of Similac and Enfamil.

The European Baby Formula

European baby formula is an infant formula that is manufactured and distributed in Europe— typically from Germany, the United Kingdom (U.K.), or the Netherlands. While some European baby formula is allowed to be legally distributed in the U.S. via the Food and Drug Administration’s (FDA) enforcement discretion pathway (such as Kendamil or Aptamil), others are not approved for U.S. distribution (including HiPP, Holle, Lebenswert, and more).’

There are a few differences between European and American baby formula, largely relating to regulations and requirements for their respective formula recipes. For European baby formula, ingredients such as goat milk and whole cow milk are allowed in their formulations and have been for years, while whole milk formulas weren’t allowed in the U.S. until 2022. European formula manufacturers are restricted from using corn syrup or corn syrup solids in their recipes and are also limited in the total volume of carbs that can come from sucrose (table sugar).

European baby formulas are also required to have a certain amount of DHA, which is a fatty acid that’s abundant in breastmilk and linked to brain and eye development, while the U.S. has no requirement for DHA at all. Lastly, European baby formulas are staged by age group. This means that once your baby hits a certain age, they can move on to a different stage of formula. Typically, stage 1 formulas are for 0-6 or 0-12 months and include lower levels of iron and more whey protein, while stage 2 formulas are for infants 6-12 months and include higher levels of iron and more casein protein.

Breast milk is naturally sweet, so baby formulas invariably contain sugar.  Understanding what form of sugar formula brands use can help you determine if it’s the best option for your little one; finding one that contains lactose should be your top priority. Lactose is the substance that most closely mimics breast milk.  

Since lactose is an expensive product, many American manufacturers tend to stay away and resort to cheaper, plant-based sweeteners, such as corn syrup. These sweeteners are known for fueling weight gain, type 2 diabetes, and other similar conditions that may be detrimental to health. Hence, European formulas are less likely to lead to childhood obesity and diabetes. 

The European Commission requires that at least 30% of carbohydrates in infant formula come from lactose. They specifically exclude sources from being used, such as:

• Corn syrup
• Fructose
• Rice syrup
• Sucrose
• Carrageenan

Many European baby formulas contain probiotics and prebiotics. Probiotics (such as lactobacillus) are also found in breast milk. This is important for the baby’s gut flora, which helps your baby digest food, absorb those valuable nutrients, and use them as they develop.

All European formulas are made with organic ingredients, and nearly all are certified organic. European formula does not contain any Genetically Modified Ingredients (G.M.O.), sucrose, or pesticides. The grass-fed cows and goats who are needed to manufacture organic cow formula and goat formula are kept outdoors and live a good life.

The only formulas that are not certified organic are those that use protein hydrolysates, such as HiPP Anti Reflux or HiPP Hypoallergenic, as protein hydrolysates are not available in organic form.

All formulas approved by the European Commission must be produced from animal milk containing no hormones, no detectable pesticide residues, and no GMOs. The USFDA only sets out several basic guidelines to include in the baby formula. So, as long as the ingredients are somewhat “safe” and not contaminated, they’re good to go.

Why U.S. Doesn’t Import Baby Formula?

The US imports about 2% of baby formula, mostly from Mexico, Ireland, and the Netherlands. The other 98% is made in the U.S., primarily by four large producers: Abbott Nutrition, which controls 48% of the $2.1 billion U.S. market by itself; Mead Johnson Nutrition, owned by conglomerate Reckitt Benckiser; Nestlé USA and its Gerber subsidiary; and Perrio, which makes generic formula for retailers.

The amount of imports is low because of a combination of regulatory and trade policies, with a dash of market monopolization and a bit of safety concerns. To start, the Food and Drug Administration has approved very few formulas for import. FDA regulation of formula is so stringent that most of the stuff that comes out of Europe is illegal to buy here due to technicalities like labeling requirements, Imports of infant formula are subject to tariff-rate quotas of 17.5% after certain thresholds are met. As the name suggests, tariff-rate quotas are meant to be set high enough that they effectively block additional imports by making it unprofitable to pay the tariff.

European-style baby formula has been trending in the U.S. for quite some time now. Although buying EU formulas is very popular in the US, the FDA has reminded parents here that purchasing EU formulas is illegal and unsafe. Luckily, the US now has products with many of the same features as European formulas. These include being organic and non-GMO. US-made infant formulas are safe, legal, and widely available to American parents.

The market for imported baby formulas has been present, but due to strict FDA requirements, it has remained incredibly small. In fact, of all the food products in the United States, infant formula is considered to be the most regulated. 

Some of the challenges preventing the widespread import of infant formula include:

• Strict formula labeling requirements
• A lack of FDA approval for several major European brands
• Imposed tariff-rate quotas (TRQs) which make imports cost-prohibitive

FDA has a strict list of ingredients for infant formula. 29 different ingredients must be included in all formulas. Each ingredient also has a minimum level requirement. Some of the ingredients also have a maximum level allowed.

The difference between European and American ingredient lists is small, but it keeps brands from approval. Brands made from goat’s milk or based on whole milk, do not have current approval in the U.S.

For others, it’s the ingredients that European formulas don’t have which make them appealing. Corn syrup, a sugar commonly used as an additive in American-made foods, is one example. It’s banned in the European Union from being used in milk-based formulas.

Long before formula shortages were a problem, demand for European infant formulas had been on the rise. As mentioned, many believe that European infant formulas are better for babies. 

Among the things preferred are:

• The lack of corn syrup
• A variety of organic formula options (milk from pasture-raised cows)
• The availability of alternate bases (such as goat milk)
• Regulated amounts of DHA

These are enough to make many parents seek out European brands.