Ingredients of concern in infant formula

What should I know about infant formula contamination?

Infant formula production is highly regulated, but this regulation does not eliminate all the risks. Some common ingredients in infant formula, such as non-lactose sugars and plant-based oils, may be a cause for concern. In addition, infant formula may be contaminated with heavy metals such as lead, arsenic, or aluminum. Other contaminants include bisphenol A, which has effects like those of the sex hormone estrogen, and various kinds of bacteria, which can cause disease and death. Contamination with bacteria can happen during manufacturing or during infant formula preparation in the home. Another problem is counterfeit infant formula, which may have insufficient protein or may have added ingredients that can be dangerous and even deadly.

A) Regulation of infant formula

Infant formula (formula) is the only food some babies receive during a very sensitive growth period. Therefore, governments tend to closely regulate the formula industry. 

Regulatory bodies include the U.S. Food and Drug Administration (FDA) in the United States and the European Food Safety Authority (EFSA). This regulation does not eliminate all risks.

B) Concerns about infant formula ingredients

Formula manufacturing has progressed in the past century. Research, largely driven by industry, continues to make formula more tolerable. Individual ingredients added to formula remain under scrutiny.

1) Fats

Human milk fats are animal fat and have unique structures that are easily absorbed. The oils in formula, used to mimic the fat in human milk, are generally only plant-based.

One common formula ingredient is palm oil, which combines with calcium, which is also present in formula, to create hard, indigestible soaps in the gut. Babies who use formula containing palm oil have been shown to (Bronsky 2019; Lasekan 2017; Manios 2020; Padial-Jaudenes 2020; Souza 2017):

  • Absorb less calcium and fat.
  • Grow more slowly.
  • Temporarily have softer bones.
  • Have harder stools (poop) and more constipation.

2) Excess calories

Unlike breast milk, formula does not change over time. During the first two weeks of life, babies who are bottled with formula take in more milk than babies who are breastfed (Hester 2012). Formula (at 67 calories/100 millilitres) is also higher in calories than colostrum (53 kcal/100 ml) and transitional milk (63 kcal/100 ml).

One study (Hester 2012) estimated that during the first day of life, formula-fed babies could get more than nine times as many calories as breastfed babies. By two weeks of age, this difference is reduced. Early rapid weight gain, especially during the first week of life, is associated with later obesity (Baird 2005; Stettler 2005).

3) Sugar differences

a) Sugars in infant formula

The main digestible sugar in breast milk and cow's milk is milk sugar (lactose).

Fructose is a simple sugar molecule. In nature, it combines with glucose to make fruit sugar (sucrose). This is the ingredient found in table sugar.

Many formula manufacturers replace lactose with other sugars.  These can be glucose or fructose molecules or more complex sugars built out of these two.

Sugar and carbohydrate levels in formula have been found to be higher than breast milk levels (Bridge et al. 2020).

Concerns have been raised about the short- and long-term effects of early exposure to non-lactose sugar. Accordingly, the European Union does not allow non-lactose sugars to be added to regular formula.

Table: Common Sugars Found in Infant Formula

b) Increased levels of illness-causing cholesterol

Compared to lactose, other sugars can cause a much more significant rise in blood sugar (up to 50%).  In addition to increasing insulin levels, this rise can start a cascade of reactions which results in an increase of bad cholesterol (LDL cholesterol) (Zubin Maslov 2021).  

c) Changes in the bacteria of the gut

The gut can contain both health-promoting bacteria and harmful ones (the microbiome)

Non-lactose sugars contained in infant formula have been shown to have a negative effect on gut bacteria (Jones et al. 2020).  

d) Developing a taste for sweeter tasting foods and drinks

Sucrose tastes sweeter than lactose and may predispose babies to preferring sweeter tasting foods or more rapid weight gain (Young 2020).

e) Increased risk of tooth decay

Non-lactose sugars have been found to increase the risk of tooth decay (Tan et al. 2016). 

f) Inability to digest fructose

One in 20,000 babies cannot process fructose. When they are given fructose or sucrose, they may develop liver failure (Li et al. 2018).

4) Prebiotics and probiotics

Human milk contains large amounts of specialized sugars (human milk oligosaccharides [HMOs]) that cannot be digested by the baby. Rather these act as prebiotics and are consumed by helpful bacteria in the gut which prevents the over-growth of harmful ones. HMOs prevent infection in the gut and elsewhere, support the development of a normal immune system, and provide nutrients for growth. There are over 200 types of HMOs and the types of HMOs vary between mothers.

Some formula companies have added manufactured HMOs including 2'fucosyllactose (2’FL) to formula. However 20% of mothers do not make 2’FL meaning that one in five babies using this formula would receive an HMO that they would not have naturally. Furthermore, breastfeeding babies receive a unique blend of a large variety of HMOs that is not available from formula. 

Similarly, formula companies may add certain bacteria to formula (probiotics) that babies may not have received naturally. 

The short- and long-term effects of these differences is unknown.

5) Low levels of cholesterol in infant formula

Breast milk contains significantly more cholesterol than does infant formula. Cholesterol is required for normal body function, but excess amounts can be harmful. While the baby can make cholesterol when it is not provided by milk, the baby may also be accidentally programmed to continue making larger amounts.

6) Variation in cow’s milk

The ingredients and quality of a cow’s diet will impact her milk. The milk of pasture-fed cows has been shown to have higher levels of beneficial nutrients than that of cows fed pre-mixed foods (Alothman 2019).

C) Contamination with metals

Babies may be more sensitive to toxins:

  1. Babies may be less likely to detoxify or eliminate them, because their systems are immature.
  2. Toxins that remain in the baby’s systems have a longer time to act when compared to toxins taken in by adults.
  3. Toxins may have more of an impact on a rapidly growing baby compared to an adult.

1) Heavy metals

Formula, and indeed any type of heavily processed food, may contain unintended items such as heavy metals (arsenic, cadmium, manganese, and mercury) and other contaminants (Frisbie 2019; Gardener 2018). In general, formula is much more likely to have higher levels of heavy metals than breast milk (Martínez 2018; Sipahi 2014). Brown rice syrup, which is used as a sugar, has been identified as a source of arsenic (Jackson 2012).

In 1955, an outbreak of arsenic poisoning due to contaminated milk powder occurred among Japanese infants, with over 2000 being poisoned and more than 100 deaths. Survivors have neurological and psychological problems and are more likely to develop cancer (Dakeishi 2006; Yorifuji 2016). The arsenic was present in a stabilizer that was added to the milk. 

2) Aluminum

The aluminum content of formula is 10 to 40 times higher than the aluminum content of breast milk (Burrell 2010; Chuchu 2013; Fernandes 2015; Redgrove 2019). The sources probably include equipment used for processing and storing ingredients, packaging, and the ingredients themselves. Soy formula in particular has have high levels of aluminum.

Aluminum may have a toxic effect on the brain and nervous system, bones, and blood (Crisponi 2013; Exley 2016; Fanni 2014; Morris 2017; Niu 2018). Long-term exposure to high concentrations of aluminum has been linked to the development of Alzheimer disease (Corkins 2019).

Premature babies who received nutrition containing aluminum directly into a vein (parenteral nutrition) showed poorer brain development and bone health than babies who received nutrition without aluminum (Bishop 1997; Fewtrell 2009). The effect of aluminum in infant formula may be limited as the baby's gut appears to be effective in keeping it from entering the body (Litov 1989).

D) Contamination with chemicals that have estrogen-like effects

1) Describing bisphenol A

Bisphenol A (BPA) is considered an endocrine disruptor. It mimics the hormone estrogen and can interfere with the body’s ability to make, transport, use, and destroy natural hormones.

2) Possible effects of bisphenol A

Bisphenol A has been shown to interfere with the function of the breast and shorten the duration of breastfeeding (Kasper 2016). 

In animal studies, bisphenol A has been found to (EFSA 2010):

  • Cause biochemical changes in the brain.
  • Affect the immune system.
  • Increase the risk of breast tumours.

Infants and young children are said to be especially sensitive to the effects of BPA.

3) Bisphenol A consumption

BPA is one of the most widely manufactured compounds and is taken in along with food (Jalal 2017). BPA is present in hard plastics, the protective lining on the inside of some food cans, carbonated (soda pop) drinks, and cash register receipts. BPA has been found in the lining of formula containers and in plastic baby bottles.

Some governments have changed the acceptable daily limits of BPA (Corrales 2015). However, it remains in formula and is present in higher amounts than in breast milk (Martínez 2018). There are also risks from related chemicals used to replace BPA (Eladak 2015; Onghena 2016; Russo 2018; Simoneau 2011; Usman 2016).

E) Contamination with the bacteria Cronobacter

1) Describing Cronobacter

Until 2007, Cronobacter sakazakii was called Enterobacter sakazakii. 

Cronobacter is a type of bacteria. It can be found in various foods, in the human gut and nose, and in the home environment. It survives well in a dry environment such as dehydrated foods. It does not generally cause illness, except in people with a weakened immune system, such as newborn babies.

Babies infected with Cronobacter may develop serious diseases (Henry 2019; Kalyantanda 2015; Kent 2015):

  • Infection of the lining over the brain (meningitis)
  • Brain abscesses
  • Seizures
  • Blood infection
  • Gut infection
  • Gut disease (necrotizing enterocolitis)
  • Death (Strysko 2020)

Between 40% and 80% of infected newborns die, and survivors can be left with serious complications (Drudy 2006; Kent 2015).

2) Cronobacter contamination of infant formula

Manufacturers have not been able to eliminate all microbes from powdered formula. Cronobacter can contaminate powder in the factory before packaging or in the home once the formula container is opened (CDC 2015).

One study (Fei 2017) tested 2,200 formula samples in China and found that 2.8% were contaminated with Cronobacter. Health agencies have recalled formula because of contamination with Cronobacter (CFIA 2019a; Health Canada 2019a; Health Canada 2019b).

The Centers for Disease Control and Prevention estimate that four to six infants are infected with Cronobacter each year in the United States (Henry 2019).

Growing awareness of Cronobacter infections resulted in the current recommendations for preparing formula with hot water until the baby is at least four months old (WHO 2007).

F) Contamination with the bacteria Salmonella

1) Salmonella

Salmonella is a type of bacteria can cause disease in people. Symptoms of infection develop within 6 to 72 hours and include:

  • Diarrhea and vomiting
  • Fever
  • Abdominal cramps
  • Blood infection
  • Joint infection
  • Pneumonia
  • Meningitis

The illness usually lasts four to seven days, and most people recover without treatment. However, in some people, diarrhea may be so severe that they need to be hospitalized. Salmonella infection can be spread from the intestines to the blood and to other body sites. In this situation, it can be deadly unless treated with antibiotics. People with weaker immune systems, such as babies, are more likely to have a severe infection.

2) Salmonella contamination of infant formula

In late 2017, the French government order the recall of 7,000 tonnes (about 7,700 U.S. tons) of potentially contaminated formula after 35 French babies became sick from infection by Salmonella agona. The recall involved products manufactured by one of the world’s largest dairy companies. It affected 83 countries and many brands (DGCCRF 2017).

There have been other outbreaks caused by Salmonella strains. These occurred in 1985, 1993, 1996, 1996-97, 2000, 2004-05, 2018-19 (Cahill 2008; ECDC and EFSA 2019).

G) Contamination with the bacteria Clostridia

1) Clostridia

Clostridia is a group of bacteria commonly found in soil, dust, and water and can contaminate food. Concern about Clostridia infection is the reason that honey and corn syrup are not recommended for babies under one year of age.

Clostridia can remain dormant until it is exposed to favourable conditions. If a baby swallows it, it can grow in the baby’s bowel. Some strains release a powerful toxin that is absorbed through the gut and stops muscle function. This condition is called botulism and can be deadly. Signs of botulism include:

  • A weak suck
  • The inability to swallow
  • Drooling
  • Paralysis
  • A weak cry
  • Difficulty breathing

The signs can develop within hours or days after being infected.

Botulism occurs sporadically around the world. The United States reported roughly 130 cases each year between 2011 to 2017 (CDC 2020).

2)Clostridia contamination of infant formula

Powdered formulas have been found to contain various members of the Clostridia group and have the potential to contain strains that can make the toxin (Barash 2010). There are a few reported cases of botulism associated with infant formula (Brett 2005; Johnson 2005).  

In 2013, a large dairy producer, recalled 1,000 tonnes (1,100 US tons) of consumer products, including formula across seven countries because of possible Clostridia contamination. Further testing showed that the bacterium was not one of the toxin-producing strains.

H) Other contaminants and manufacturing problems

Some contaminants may be present in soil and water as a result of farming techniques, industry, and mining. These contaminants accidently enter the food chain when plants absorb them and when animals eat the plants. Examples include pesticides and veterinary drugs.

A range of chemical contaminants, including chemicals introduced during heat treatment or packaging, can be present (de Mendonça Pereira 2020).

Formula has been recalled because of insects, metal particles, and other unintended components (FSA 2019).

Manufacturing errors can result in inadequate levels of certain items such as iron, zinc or vitamins (FDA 2016; Siegel-Itzkovich 2004). In July 2020, infant formula sold in Cambodia was found to be low in iron and zinc.

Formula can degrade during storage and the oils can become rancid (CFIA 2019b).

I) Contamination during preparation in the home

Formula can also be contaminated during preparation and storage at home. Contamination can result from:

  • Bacteria added by improper:
  • Bottles and nipples contaminated with (Boué 2018):
    • Bacteria
    • Bisphenols
    • Very small pieces of plastic (microplastics) released from bottles made of polypropylene
  • Contaminants present in water used to dilute formula, including:
    • Arsenic (Carignan 2016)
    • Cadmium (Ljung 2011)
    • Uranium (Ljung 2011)
    • Lead (Shannon 1989)
    • Nitrates (Fossen Johnson 2019; Knobeloch 2000)
    • Perchlorate (Schier 2010)
    • Bacteria, viruses, and parasites (Andresen 2007)

J) Adulterated and fake infant formula

In 2004, counterfeit formula in China was sold without enough protein. As a result, 200 babies were malnourished and 50 died.

In 2008, several Chinese dairy firms were found to have deliberately added melamine to formula as a way of masking watered-down milk (Gossner 2009). Melamine causes kidney stones and kidney failure. This scandal resulted in:

  • Illness in 300,000 babies.
  • The hospitalization of 54,000 babies.
  • The deaths of six babies from kidney damage.

Counterfeit formula has been reported in Pakistan, Brazil, India, California, and Singapore. In December 2017, babies in Malaysia were reported to have developed fevers and a rash after drinking counterfeit formula.

Counterfeit formula has been and will continue to be a problem (Handford 2016).


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