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There’s a lot of conversation about infant formula right now, including a recent Food and Drug Administration (FDA) (RFI) to begin the nutrient review process for infant formula.

As a leader in infant formula science and innovation in the U.S., ������Ƶ wants to provide some helpful information to parents and families at a time when they’re hearing a lot about this topic.

Let’s start with breast milk. Breast milk, also known as human milk, is the gold standard for feeding infants and provides the best nutrition for infant growth and development. It contains carbohydrates, proteins, fats, micronutrients (vitamins and minerals) and several other immunologic and bioactive elements that contribute to a baby’s overall growth and development.

However, some mothers are unable or choose not to breastfeed or prefer to combo-feed their infants. For these moms and families, safe infant formulas have been developed as a breast milk alternative.

������Ƶ makes high-quality infant formulas. Based on careful research, innovation and scientific breakthroughs over the course of 100 years, we’ve been able to increasingly bring infant formula closer to breast milk. Scientifically based infant formula is the next-best option (and the only safe alternative) when human milk isn’t one.

What is infant formula? Where did it come from? Is it safe? And how is it regulated?

Now let’s focus in on infant formula. Before commercially available infant formula existed or was widely adopted, the options were limited for families that didn’t have access to their own breast milk.

Workarounds included wet nurses, goat’s and cow’s milk, and suboptimal homemade baby formula recipes. The nutrient profiles in a lot of these homemade blends were either too low to meet the essential nutrient needs of infants or too high for the infant’s body to process.

When modern infant formula arrived, it represented a safe, innovative alternative when breastfeeding was not possible.

Today, infant formula is a special type of food scientifically formulated for babies in their first year of life. Infant formula is made in liquid and powder forms, and both versions are modeled after breast milk so they can provide a safe and suitable substitute if needed.

The U.S. Food and Drug Administration (FDA) these products for safety and requires that infant formula contain specific nutrients to meet babies’ nutritional needs for the first year of life as sole-source nutrition.

Ensuring infant formulas are safe is so important that an act of Congress was passed in 1980 to protect this very delicate period of life from birth to 12 months of age. The FDA regulations for infant formulas include strict rules on their composition, testing, packaging, labeling, manufacturing and pre-market review.

What are “routine” infant formulas?

“Routine” infant formula (also sometimes called “standard” infant formula) is made for healthy term babies without dietary restrictions or specific dietary needs. It contains proteins, fats, carbohydrates, and a balance of vitamins and minerals needed for babies’ growth and development.

Most of the infant formula you see on store shelves or online is routine infant formula. Parents should consult with their pediatrician on which formula is best for their baby, but for most healthy full-term babies, a routine milk-based formula is a good place to start if breastfeeding is not an option.

What other formulas can I consider when I run into feeding challenges?

Thankfully, today's parents have a range of formula options to support their baby’s growth and development during the first year of life even if the baby has digestive sensitivities, diet restrictions, food allergies, malabsorption issues, or a medical condition requiring a special feeding.

Some of the ������Ƶ offers to meet the needs of these babies and their families are low lactose formula, lactose-free formula, soy formula, spit-up formula, partially hydrolyzed protein formula, extensively hydrolyzed protein formula, and amino acid-based formulas such as EleCare.

In addition to those, ������Ƶ has for infants, children and adults who have inborn errors of metabolism such as phenylketonuria and other medical conditions.

What carbohydrates are used as ingredients in infant formula?

Carbohydrates are an important source of energy to infants. Breast milk is the best option to feed a baby, and lactose is the primary carbohydrate found in all mammals’ milk, including human breast milk. Milk is nature’s way for mammals, including humans, to nourish their young, and most infants are born with the ability to digest lactose. Lactose is an important source of energy for babies, providing a little more than 40% of the calories in each feeding.

To model the nutritional makeup of breast milk, ������Ƶ uses lactose, sourced from cow’s milk, in our routine formulas.

But some infants with digestive sensitivities or a diet restriction may have a lactose sensitivity or allergy to cow’s milk. Our gentle and specialty formulas may include carbohydrate sources other than, or in addition to, lactose.  

Sucrose, maltodextrin, corn syrup and/or corn syrup solids (but not high fructose corn syrup, which ������Ƶ doesn’t use in its infant formulas) are used as alternate sources of carbohydrates in these formulas to supply the energy that the baby needs and is not getting from lactose. These carbohydrate sources have been shown in clinical studies over many years to be safe for infants and well tolerated, and they comply with regulations.

Both corn syrup and corn syrup solids come from breaking down corn starch. The main difference is the form: corn syrup is a liquid and corn syrup solids are dry powders. Although high fructose corn syrup is also made from corn, its production includes an extra step that converts a portion of the ingredient into fructose, making it sweeter than both corn syrup and corn syrup solids.

Talking about carbohydrates brings us to some recent confusion we’ve seen on social media about infant formula ingredients. In general, it centers on the mistaken claim that “table sugar,” or sucrose, is the first ingredient in the U.S.’s top-selling infant formula (i.e., Similac).

That’s not true.

To set the record straight: Our most consumed infant formulas in the U.S. are Similac Advance and Similac 360 Total Care: routine/standard infant formulas that, like breast milk, contain lactose, not sucrose. The same is true of our other standard infant formulas, including Pure Bliss by Similac Irish Farms, Pure Bliss by Similac Organic, and Pure Bliss by Similac Organic A2.

Fats and seed oils — why are they used?

Seed oils are also much discussed and sometimes misunderstood when it comes to the role they play in infant formula.

As far as we are aware, all infant formulas in the U.S., Europe and other regions of the world contain seed oils. That’s because one of the key components in infant formula (and, again, in breast milk, the gold standard for feeding infants) is fats. The oil blends from seed oils provide essential fatty acids that infants require for brain development, cell growth and the developing immune system.

Fats make up approximately 50% of calories in routine infant formula, a composition modeled after breast milk. Oils from edible plants are commonly called “vegetable oils.”

Seed oils are oils extracted from seeds of plants such as nuts, fruits, cereal grains, and vegetables. They all are derived from plant seeds, thus the term “seed oils.”

The key is the nutrients these oils provide. Essential fatty acids are fats that the human body cannot make but are required for normal physiological functions (things like the formation of the membrane that surrounds each cell in your body). Since humans can’t make these fats, they must consume them from foods. Linoleic Acid (LA) and Alpha-Linolenic Acid (ALA) are two essential fatty acids necessary for your baby’s growth and development, and these are provided through the use of seed oils.

Why not just remove these oils, or find others to swap in?

While today there are other oils that adults have begun to incorporate into their diets — such as avocado, sesame, hempseed, and walnut oil — they haven’t been shown to meet necessary nutritional requirements for healthy development in babies or studied enough to understand if they pose a risk of allergic reaction.

Similac infant formulas contain a fat blend supported by decades of data from clinical trials involving thousands of infants. Every ingredient serves a purpose and fits together with the rest to support excellent absorption of calcium and fats, promote softer stools, and support brain development.

But that’s not to say ������Ƶ is standing still. When the scientific literature and our own team of physicians, scientists and nutritional experts find new ingredients that lead to improved formulations to bring our formulas closer to breast milk, we go in the direction of scientific advancements.

What are HMOs and why are they important?

Breast milk is referred to as the gold standard for infant nutrition because it contains a variety of components that support a baby's growth and development. One of these components is (HMOs), which are unique prebiotics and the third-most abundant solid component in breast milk. HMOs can support the growth of beneficial bacteria in the gut.

For more than 30 years, ������Ƶ has been researching to understand the benefits of HMOs in infants. Our team of scientists has more than 65 publications, including 10 clinical trials^1-10, on these prebiotics.

������Ƶ was the first company to introduce HMO prebiotics to infant formula in the U.S. in 2016. Then, in 2022, we the first and only infant formula in the U.S. with a blend of five HMOs, our closest prebiotic blend to that of breast milk.

Our commitment to research has resulted in Similac 360 Total Care and Similac 360 Total Care Sensitive, infant formulas with our five-HMO blend* and five clinically demonstrated benefits: normal growth, tolerance, immune support, brain development**, and gut health.

*Not from human milk.

**In infants fed Similac 360 Total Care with 5 HMOs at or during the first 6 months of age and cognition at 12 months of age. Brain development refers to clinically shown benefits in language and social development like breastfed babies^{11, 12}.

What about organic infant formulas?

Just as with food for adults, organic infant formula is a consumer preference. Research has shown that organic and conventional foods have similar nutritional value, but for some parents choosing an organic infant formula could be the most important consideration, and we offer options if that is the case.

To keep up with evolving preferences, ������Ƶ , Pure Bliss by Similac Organic and Pure Bliss by Similac Organic with A2 Milk. And to give parents a choice of where the milk used in their formula comes from, we offer a non-organic formula made with milk from Europe: Pure Bliss by Similac Irish Farms.

What is the difference between whole milk and skim milk?

Not much, from a formula standpoint. Whether whole milk or skim milk, the ingredient provides a source of protein to infant formula. Whole milk contains milk fat and is added to a formula “as is.” Skim milk is the same as whole milk but has milk fat removed.

Both whole and skim milk are added to infant formula to provide a source of protein for your baby. Infant formulas made with whole or skim milk have been shown to support normal growth and are tolerated by most infants.

Using skim milk allows manufacturers to blend different oil sources to provide a fat profile similar to what’s in breast milk, and formulas made with whole milk also use added seed oils to deliver the essential omega-3 and omega-6 fatty acids.

No matter which type of milk is used, all infant formulas must undergo a rigorous review process by the FDA before hitting the shelves. And just as with organic and non-organic formulas, whole milk versus skim milk comes down to consumer preference.

What’s the difference between U.S. and European infant formulas?

Let’s start with the similarities between U.S. and European formulas:

• All contain carbohydrates, fats and proteins, vitamins and minerals.
• All contain essential vitamins and minerals needed for healthy infant growth and nutrition. Examples include Vitamin A, Vitamin D, Vitamin E, Vitamin K, B vitamins, Calcium, Iron and Phosphorus.
• As far as we are aware, all contain seed oils, which, for the reasons we explained earlier, give babies the fats they need, including essential fatty acids (such as omega-6 and omega-3) for growth and development of the brain and immune system. Some seed oils found in both U.S. and European formulas include sunflower oil, soybean oil, canola oil, safflower oil, palm oil and palm kernel oil.
• Most contain DHA, which is a long-chain omega-3 fatty acid for brain, visual and immune system support.
• All contain carbohydrates, which are important for infants because they provide the energy needed for healthy growth and development. Formulas in both the U.S. and Europe can contain lactose, or other carbohydrates such as sucrose (table sugar), corn syrup or corn syrup solids (not the same as high fructose corn syrup) as a source of carbohydrates. Non-lactose carbohydrates are especially common in formulas intended to help with sensitivities or tolerance issues (scroll up to the section above titled “What other formulas can I consider when I run into feeding challenges?” for more on that).
• You can find organic and non-organic infant formulas in both regions.
• Partially and extensively hydrolyzed cow’s milk protein, soy protein, and amino acid-based formulas also exist in both regions.

Where there are differences, they tend to relate to regulations (the process by which the product is brought to market or updated after it’s been on the market) and the quantity of certain nutrients found in infant formula. Some examples include:

• The European Union requires the addition of DHA at a minimum level (a nutrient that provides an omega-3 fatty acid to support brain and eye development and is also found in breast milk), whereas in the U.S., DHA addition is optional (though many formulas contain DHA). In fact, the U.S. infant formula manufacturers pioneered the addition of DHA in infant formula two decades ago.
• Some ingredients might be found in slightly different concentrations. For example, some U.S. formulas contain higher levels of iron than European formulas.
• Finally, the process to bring a routine infant formula to market is different in the U.S. compared to Europe. In the U.S., new infant formulas are required to undergo both preclinical and clinical study, as well as a pre-market review by FDA. The process in Europe does not mandate the same level of preclinical and clinical study, but manufacturers are required to notify the local regulatory body before placing the new formula into the market.

What about heavy metals?

In a recent article by Consumer Reports, heavy metal testing results were reported on a variety of infant formulas, including a small sample of ������Ƶ infant formulas. The article reported that very low amounts of heavy metals (namely, lead, cadmium and arsenic) were detected in almost all infant formulas tested — both the ������Ƶ formulas and the non-������Ƶ formulas.

This result should not be surprising. Heavy metals occur naturally in the Earth’s crust and are found throughout the environment where foods are grown — including in soil, water, and air. As a result, they are present at low levels in almost everything we eat or drink, including in baby food, all brands of infant formula, fruits and vegetables, and proteins like meat and fish. They are even found in human breast milk.

Importantly, that does not mean that any of these foods are unsafe. As the FDA has stressed, what matters isn’t whether heavy metals are present in a food (and, again, they almost always are present). It’s the amount that matters.

All of the test results reported for ������Ƶ’s formulas in the Consumer Reports article meet the regulations for heavy metals already set by the European Commission. They are lower than the levels of heavy metals that have been found in many fruits and vegetables, and lower than the levels that have been found in some women’s breast milk. The bottom line is that ������Ƶ’s infant formulas are safe, and parents can use them confidently.

While the U.S. hasn’t set limits for heavy metals in infant formula yet, we support the U.S. FDA’s “Closer to Zero” initiative and are confident that our products will comply with the limits FDA establishes.

������Ƶ has a multi-step quality process to ensure that levels of heavy metals are below the relevant regulatory requirements in the countries we serve. This begins with requiring suppliers we work with to undergo our supplier qualification program.

In addition, individual ingredients that we believe may contain trace heavy metals (due to absorption from the natural environment) are tested during the qualification process before we approve them for use in our products.

We also have an ongoing surveillance testing program after the qualification process. It’s designed to periodically test samples of ingredients and finished products to make sure our supplier and ingredient qualification processes are working as intended.

Is there a benefit to a diverse portfolio of infant formulas?

Infant formula needs are varied. At ������Ƶ, our philosophy is to have options for the unique needs of babies and their families.

While most babies do just fine on routine formulas, sometimes a baby has a special dietary need or restriction.

We make hypoallergenic, tolerance, and amino acid-based formulas for infants and children with food allergies, gastrointestinal disorders, lactose intolerance and sensitive tummies, or other protein sensitivities. We also offer a portfolio of formulas for babies who were born prematurely, including a formula that is designed to be used after hospital discharge.

As covered earlier, we make organic and European-produced infant formulas, as well as leading formulas that get closer to breast milk through our innovative use of HMOs.

And we even offer a special class of metabolic formulas, which are specifically designed to support the dietary management of individuals with metabolic disorders. In some cases, these formulas are only used by a handful of people.

Beyond the types of formulas, we also offer formulas in various formats and sizes to make life easy for parents and best suit a baby’s needs. These include powder infant formula, liquid ready-to-feed infant formula, and concentrated liquid formulas.

What if I want to learn more?

We know there is a lot of information out there and some of it may be conflicting. Here is our advice:

• Talk with your pediatrician. That’s who we recommend you work with when it comes to figuring out what’s right for your baby.
• Cross-check information about infant formula with experts who have credentials that can be verified. This is why we start by recommending a conversation with your pediatrician.
• Visit the consumer website .

You can also find helpful resources on ������Ƶ’s :

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