baby formula essay

Choosing a Baby Formula

By: George J. Fuchs III, MD, FAAP & Steven A. Abrams, MD, FAAP

To keep baby formulas safe, the U.S. government and the Food and Drug Administration ( FDA ) have rules about what goes into them and how they are made and sold. When shopping for infant formula, you'll find several basic types.

Baby formulas may contain cow's milk, goat's milk or soy protein. The FDA requires infant formula to have 30 nutrients that your growing baby needs.

Types of infant formula

Cow's milk–based baby formula.

Cow's milk–based formulas account for a majority of the formula sold. Although cow's milk is the basis for such formulas, the milk has been changed dramatically to make it safe and nutritious for infants. It is treated by heating and other methods to make the protein more digestible. More milk sugar (lactose) is added to make the concentration equal to that found in breast milk. Also, the butterfat is partly or completely removed and usually replaced with vegetable oils and other fats that infants can more easily digest and are better for infant growth.

Goat's milk baby formula

Previously not permitted by the FDA in the United States, there are now several manufacturers who produce goat's milk based infant formula that can be purchased and used. These goat's milk infant formula products are adapted for baby formula to support normal growth and development in infants.

Some people believe that goat's milk baby formula may be tolerated better than formula based on cow milk or soy protein, with less upset stomachs or allergic responses, but that's not certain.

Infants who are allergic to cow's milk (formula) should not use products made with goat's milk or milk from other mammals because of high rates of cross-reactivity with cow's milk proteins and risk for allergic reactions.

Why iron-fortified baby formula is important

Extensively hydrolyzed baby formula.

Another type of formula is extensively hydrolyzed formula. This type of formula is often called "predigested," since the protein content has already been broken down into smaller proteins that can be digested more easily.

Ask your pediatrician to recommend a brand of hypoallergenic formula if your baby needs it for allergies or other conditions. However, these extensively hydrolyzed formulas tend to be costlier than regular formulas.

Soy formulas for babies

Soy formulas contain a protein (soy) and carbohydrate (either glucose or sucrose) different from milk-based formulas. They are sometimes recommended for babies unable to digest lactose . Lactose is the main carbohydrate in cow's milk formula although this is very uncommon. (See more about lactose intolerance below.)

Specialized baby formulas

There are specialized formulas for infants with specific disorders or diseases, including for premature babies. If your pediatrician recommends a specialized formula for your infant, follow their guidance about feeding requirements (amounts, scheduling, special preparations), since these may be quite different from regular formulas.

What about toddler "formulas," milks or drinks?

Baby formulas supplemented with probiotics.

Some formulas also are fortified with probiotics , which are types of "friendly" bacteria. Others are now fortified with prebiotics in the form of manufactured oligosaccharides. Formulas fortified with these prebiotics attempt to mimic the natural human milk oligosaccharides, which are substances that promote healthy intestinal lining and gut function. There is no strong evidence of benefit from the use of these formulas.

Common concerns & considerations when choosing a baby formula

Lactose intolerance

A few infants have brief periods when they cannot digest lactose, particularly following bouts of diarrhea, which can damage the digestive enzymes in the lining of the intestines. But this is usually only a temporary problem and does not require a change in your baby's diet.

It is extremely rare for babies to have a significant problem digesting and absorbing lactose (although it tends to occur in older children and adults). While lactose-free formulas are fine sources of nutrition, check with your pediatrician before starting your baby on a lactose-free formula, since whatever problem they may be having is likely due to something else and lactose is the natural sugar in breast milk and may be ideal for nearly all babies.

Milk allergy

With a true milk allergy causing colic, failure to thrive, vomiting, or even bloody diarrhea, the allergy is to the protein in the cow's milk formula. In this case soy formulas may seem like a good alternative. However, soy formulas are not recommended in infants with cow milk allergy because up to half the infants who have milk allergy are also sensitive to soy protein and therefore must be given specialized formula (such as amino-based or elemental) or breast milk. Always discuss with your pediatrician before selecting these expensive formulas that are often widely overused.

Galactosemia

The AAP believes that there are few circumstances in which soy formula should be chosen instead of cow's milk–based formula. However, one of these situations is in infants with a rare disorder called galactosemia; children with this condition have an intolerance to galactose, one of the two sugars in lactose. These babies cannot tolerate breast milk and must be fed a lactose-free formula.

All states include a test for galactosemia in routine newborn screening after birth.

Vegetarian & vegan concerns

Some strict vegetarian and vegan parents choose to use soy formula because it contains no animal products. Remember that breastfeeding is the best option for vegetarian families. And while some parents believe a soy formula might prevent or ease the symptoms of colic or fussiness, there is no evidence to support this.

More information

Is Homemade Baby Formula Safe?

Recommended Drinks for Children Age 5 & Younger

Formula Feeding

AAP: Most Toddlers Don't Need Toddler Formula

Ask the Pediatrician: Why are we seeing baby formula brands on the shelves from companies I haven’t heard of before?

Why breastfeeding isn't a solution to the formula shortage

The infant formula shortage is an ongoing nightmare for American families with young babies as parents find themselves without the basic food and fluids to keep their infants alive and healthy. As a pediatrician and mother, it’s horrifying to see that, rather than unifying the country in a concerted effort to address this emergency, the shortage is being used by many people to further the stigma against infant formula — and the shaming of parents who use it and the babies who need it. 

I’m here to set the record straight. The popular conception that parents can simply rely on breastmilk — and that breastfeeding is the only way mothers should be feeding their babies in the first place — is misguided and dangerous. Many, if not most, infants will need at least some amount of formula supplementation to reach their optimal health, and even to reach a parent’s breastfeeding goals.

Even as a pediatrician, a part of me had been convinced that formula was the enemy. As a result, these pressures worsened my own postpartum depression and anxiety.

In some instances, maternal or infant biology means that providing an infant exclusively with breastmilk from the first days of life isn’t an option for mom or baby. Not all parents are biological parents, and even some biological mothers are unable to safely provide breast milk — a variety of infections, medications and genetic conditions can take breastfeeding off the table entirely. 

Even more common is low milk supply . Potential obstacles to being physiologically able to produce enough milk to nourish an infant include having had a C-section , infertility issues and dozens of maternal health conditions (like thyroid disease, postpartum bleeding, polycystic ovarian syndrome — the list goes on) that interfere with the intricate biological ballet that matches a postpartum body’s milk supply with an infant’s demands. 

Babies themselves are sometimes not able to tolerate breast milk or to survive on it alone, with common conditions like jaundice and low blood sugar frequently making formula use a medical necessity. In these cases, using a safe, regulated breast-milk substitute that has been designed to contain the exact amount of micro- and macronutrients, salts, sugar and water that a delicate newborn body needs — i.e., commercial infant formula — is the only way to prevent starvation, dehydration and death.

Providing formula can even be important in allowing mothers to rely on breastmilk as the primary or almost exclusive source of nutrition. Savvy breastfeeding supporters — lactation consultants and pediatricians — know that, for many, formula can actually be an essential tool in establishing breastfeeding in the first place. 

More often than not, introducing some amount of formula is the only way to keep infants healthy and happy enough that they can actually learn how to breastfeed. And there are times when a breastfeeding mother’s own postpartum needs — troubleshooting why it’s painful when the baby latches on to her breast, or getting enough rest to help with physical and emotional postpartum healing — make bottle feeding a breast-milk-promoting intervention. 

Yet too many moms equate using formula with failure. I remember one mother I worked with whose daughter was born premature and couldn’t get the hang of latching even after weeks of work with a skilled lactation consultant. She pumped every three hours (even setting an alarm overnight), causing prolonged exhaustion that made it impossible to bond with her newborn, let alone engage in the treatment she urgently needed for her emerging postpartum depression and anxiety. When I recommended using formula supplementation as the only way to optimize both maternal and infant well-being, she immediately began to cry. 

The stigma against formula is so deep-seated that I felt it myself when I gave birth, despite all the information to the contrary at my disposal. I was completely committed to exclusive breastfeeding, but a variety of factors — my daughter’s jaundice and low sugars, my relatively low milk supply, her prematurity and her struggle with latching — took exclusive breastfeeding off the table. 

Like so many mothers, I cried needlessly when combined breast and formula feeding became our necessary reality. Even as a pediatrician, a part of me had been convinced that formula was the enemy. As a result, these pressures worsened my own postpartum depression and anxiety. This is common, as the pressure of breastfeeding and the negative experiences with it are associated with a higher risk of postpartum mental health issues.

Amid the present formula shortage, I’ve seen little understanding of these nuances and more doubling down on exclusive breastfeeding promotion. Disturbingly, many justify this approach with the erroneous claim that in the past there was only breastfeeding and people managed fine. But those were not the good old days: It was a time of more infant deaths.

On top of everyday breastfeeding struggles back then, mothers frequently died or became critically ill during childbirth. If other lactating community members didn’t step in (the use of “wet nurses” was a common, widespread and frequently coercive practice throughout history) infants died without a safe, alternative source of nutrition. Some people made their own formula to fill the gap, which sometimes worked but was overwhelmingly unsafe , often leading to serious disability or death. 

When I see TikTok videos providing recipes for homemade formula as the supply chain crisis persists, I feel transported back to this darker time. I have personally treated cases of hospitalized infants who have suffered from near-fatal complications of unregulated formula use — emergent electrolyte imbalances, serious bacterial infections and malnutrition that can lead to permanent bodily damage. 

More often than not, introducing some amount of formula is the only way to keep infants healthy and happy enough that they can actually learn how to breastfeed.

It’s no wonder that the invention of infant formula in the last century saved lives . But as formula companies pushed their product on parents — as well as doctors — it became the norm for infants to receive manufactured formula instead of breast milk. The response was a “breast is best” movement that, while based on the correct assertion that breast milk has health benefits , became extreme in and of itself. The tragic result was that in the early 2000s some babies, including in the United States, were denied the additional food and fluid they needed in a misguided attempt to promote breastfeeding and died from dehydration . 

There are additional hardships imposed by our modern world that make it hard for even the most determined parents to exclusively breastfeed. Infants need formula or breast milk for a full year. Providing all of a baby’s needs through breast milk is nearly impossible over this stretch in this day and age — and not always in the best interest of a baby or lactating parent. The barriers to sustained breastfeeding are real and challenging: workplaces that don’t support pumping, inadequate parental leave, insufficient long-term breastfeeding support from expert lactation consultants and, of course, lack of supply.  

As a society we can — and should — promote breastfeeding as a way to support infant health without taking a simplistic and dangerous black-and-white stance. When I observe parents stigmatized for using formula, mom-shaming on social media or just a generalized misconception that formula is the enemy of breastfeeding, I see these as the biggest obstacles to helping parents meet breastfeeding goals and optimize infant health.

Dr. Rebekah Diamond is a hospital pediatrician in New York City and an assistant professor of pediatrics at Columbia University. She is the author of the forthcoming book  “Parent Like a Pediatrician.”  Follow her on Instagram  @parentlikeapediatrician  and on Twitter  

The New York Times

Magazine | the baby-formula crime ring, the baby-formula crime ring.

By CHRIS POMORSKI MAY 2, 2018

It’s pricey, it’s portable, its users need it constantly, and retailers love to buy it at a discount. All of which makes it a perfect product to steal.

The Money Issue

The pain hustlers.

Insys Therapeutics paid millions of dollars to doctors. The company called it a “speaker program,” but prosecutors now call it something else: a kickback scheme.

The Billion-Dollar Bank Job

In 2016, a mysterious syndicate tried to steal $951 million from Bangladesh’s central bank - and laid bare a profound weakness in the system by which money moves around the world.

The Man Who Cracked the Lottery

When the Iowa attorney general’s office began investigating an unclaimed lottery ticket worth millions, an incredible string of unlikely winners came to light - and a trail that pointed to an inside job.

The White-Collar-Crime Cheat Sheet

How the biggest scammers get away with it.

By CHRIS POMORSKI Illustrations by FRANCESCO FRANCAVILLA MAY 2, 2018

New Port Richey, perched on a knuckle of Gulf Coast 35 miles northwest of Tampa, is a typically Floridian enclave of strip malls, subdivisions and brackish waterways. During the 1920s, it enjoyed a brief period of glamour when professional golfers and silent-film actors bought land, built handsome homes and socialized with visiting stars from Broadway and vaudeville at the Hacienda Hotel. But the town owed much of its success to the first of Florida’s many real estate bubbles, and the fantasy ended around 1925, dashing forever New Port Richey boosters’ hopes of its becoming a kind of Hollywood East.

By November 2005, when Alexis and Ronald Dattadeen bought a home there — a cozy ranch house shaded by a generous oak — it was just another Tampa suburb. Alexis and Ronald, who were in their mid-20s, had recently welcomed their first child, A., and within a few years they had another son, D. (The children in this article are identified by their first initial only.) Like his brother, D. had dark hair and big brown eyes. But D. also had a rare genetic disorder that would require many visits over the years to gastroenterologists, neurologists and hospitals.

Ronald worked long hours for low pay, maintaining pools during the day and scrubbing operating rooms at night. Alexis, who had held jobs sterilizing medical equipment and wrangling phone lines at a hospital, found D.’s unpredictable need for medical attention incompatible with even part-time employment. You could change schedules only so many times before exasperating even the most understanding manager. And she soon found upsides to staying home — napping with D. during the day; the satisfactions of a clean car, folded laundry, the waft of pot roast from the oven. But homemaking could be boring and lonely — and Dattadeen wasn’t earning any money, further limiting her life outside the house.

In 2011, when D. was 2, Dattadeen had a realization: She could be selling her excess baby formula. D. needed an expensive brand called EleCare, which was designed for easy digestion. Dattadeen got it through Medicaid, and it arrived at her home automatically from a medical supplier. She always ended up with extra cans, so she posted an ad on Craigslist and quickly found a buyer, a man who indicated that the formula would go to a child in need. But before long, a second buyer — a buyer who would prove far more lucrative — responded to the ad. Her name was Alicia Tondreau-Leve.

Dattadeen and Tondreau-Leve first met in a McDonald’s parking lot about an hour’s drive from New Port Richey. Soon Tondreau-Leve became a repeat client, meeting Dattadeen every few weeks to buy some of the EleCare. During one of their first meetings, Tondreau-Leve explained that she had a business distributing excess powdered formula to needy families. Dattadeen expressed interest in the venture, and Tondreau-Leve soon agreed to bring her aboard — emphasizing, though, that she wasn’t an employer. Dattadeen would be an independent contractor, sourcing formula for resale to Tondreau-Leve. As in a multilevel marketing operation, her success would depend on her ability to create a large network. Still, for Dattadeen, the benefits would be manifold: She could set her own hours, earning an income while tending to D.’s appointments.

Like Mary Kay or Amway, Tondreau-Leve provided a start-up guide. She showed Dattadeen how to replicate a Craigslist ad she had been posting to promote the business. It had an elegant logo — a silhouette of a woman with flowing hair holding an infant aloft. “Formula Mom,” it read. “Helping Other Moms ... Helps You!” The ad outlined Formula Mom’s services: free pickups and cash payments for brands including Gerber, Enfamil and Similac. Dattadeen would swap in her own phone number and a Formula Mom email address that Tondreau-Leve suggested she create. There was an invoice template and a price guide with photos of the formulas Tondreau-Leve accepted. She instructed Dattadeen not to stray far from the Tampa area and advised her to meet sellers in public places. Later, she even provided business cards.

To help her get started, Tondreau-Leve gave Dattadeen a few leads. Craigslist ads — answering and posting them — yielded additional sellers, and Dattadeen’s first weeks were successful. Attentive and patient, Tondreau-Leve guided her by phone and text. “That’s great that you are so willing to help,” Dattadeen texted her in early 2012. “We will make a great team.”

“Yes we will,” Tondreau-Leve replied, “You have the same drive that I have.”

Dattadeen was included in business decisions, providing input on flyer design and marketing. One day, she had an idea of her own. To make things more official and to better track sales, she thought, they should provide sellers with receipts. Taking initiative, she went to an Office Depot and designed a prototype. But before returning to print copies, she mentioned the idea to Tondreau-Leve, who saw things differently. Receipts wouldn’t work for Formula Mom, Tondreau-Leve said, because that would leave a paper trail.

Some $4.3 billion worth of infant formula was sold in the United States last year, a vast majority of it in powdered form. Between factory and baby aisle, its cheap ingredients (dehydrated milk and vitamins) become steeply, even mysteriously expensive. Basic types run about $15 for a 12.5-ounce can, amounting to perhaps $150 a month for a fully formula-fed infant. Specialty recipes like EleCare can cost two or three times as much. Strict Food and Drug Administration regulations govern formula production, and three companies dominate. Abbott Laboratories, which makes Similac, and Mead Johnson, which makes Enfamil, each control about 40 percent of the market. The Nestlé-owned brand Gerber holds a roughly 15-percent share.

A market with so little competition is bound to have generous margins, and formula makers have grown richer still because a single buyer accounts for roughly half of all domestic sales: the United States government. The Special Supplemental Nutrition Program for Women, Infants and Children, commonly known as WIC, provides needy mothers with cash assistance for certain foods, including powdered formula. When it began, in 1972, WIC represented a fresh, lush source of inelastic demand, by effectively eliminating from the formula market those customers most sensitive to price. During the ’80s, formula prices rose by more than 150 percent, vastly outpacing increases in milk costs. By the middle of that decade, formula was absorbing 40 percent of WIC’s food budget, prompting shortfalls that shunted many eligible families to a waiting list.

In the ’90s, the Senate Subcommittee on Antitrust, Monopolies and Business Rights; the Federal Trade Commission; and attorneys general from 19 states pursued formula manufacturers for price-fixing and illicit marketing. Multimillion-dollar fines were assessed, but no firm admitted wrongdoing. Even today, formula prices bear the imprint of yesteryear’s state-enabled gouging; according to a 2009 report by the Notre Dame economist David Betson, “the WIC program accounts for 91 percent of the increase in the growth of real formula prices” between 1981 and 2002.

Products like formula — expensive but with slim retail margins — are vulnerable to black-marketeers. Independent store owners, for example, don’t buy enough formula to qualify for the bulk discounts that manufacturers offer big chains. But if they can acquire off-market formula at subwholesale prices and resell it for the usual rates, they can improve their bottom lines.

By the middle of 2012, Dattadeen’s formula business began to thrive. But certain irregularities emerged in her supply chain. Some of her “customers,” as she called the people from whom she bought formula, would sell her three to 10 cans every few weeks. That seemed about right. Why, after all, would anyone have more leftover formula than that? But others routinely had much more. There was a woman named Julie who met Dattadeen regularly, sometimes with more than $1,000 worth of formula. A couple named Krystal and Chris offered 80 to 150 cans at each transaction. Another couple, Brian and Jessica, often showed up to meetings with so much formula that they had to load it into their trunk.

Dattadeen listened to explanations from such sellers about their sources: an aunt with a baby store, a warehouse-based wholesaling business. But when Dattadeen voiced reservations about them to Tondreau-Leve, Tondreau-Leve suggested that she accept the stories at face value, or adopt a don’t-ask-don’t-tell attitude. This all seemed out of step with a business predicated on buying up surplus product, but it soon became clear that Formula Mom did not function quite as advertised; Tondreau-Leve seemed most interested in “customers” who could offer formula in bulk. To ensure that Dattadeen could handle these large purchases, Tondreau-Leve had her set up an account with Bank of America, and wired her cash in advance of sales. Tondreau-Leve even began making requests. “I need 35 Similac Advance cans,” she wrote in a text message. “Can you see if Julie can get that for us?”

Dattadeen quickly found good uses for her new income. In June 2012, she traveled to a medical conference in Illinois for D. That July, she bought a new minivan, texting a photo to Tondreau-Leve. “I still can’t believe my dream is parked up in my driveway,” she wrote. She bought a walker for D. and enrolled A. in the Cub Scouts. A. “is going to call you tonight, to try and sell you popcorn for boyscouts,” Dattadeen texted Tondreau-Leve soon after. “Its more of a teaching thing for him so don’t feel obligated to buy. I just had him make a list of everyone we are close to.”

Dattadeen’s social life had been limited, and perhaps as much as her job, she seemed to value the friendship that had blossomed between her and Tondreau-Leve. “I missed talking to you today!!!! GIRLFRIEND,” she texted in October 2012. “Do u realize we’ve known each other for like a year now.”

Fifteen years older than Dattadeen, Tondreau-Leve had studied computer science at college; she was logical and organized — everything Dattadeen wasn’t. But like Dattadeen, she had two sons. Her husband, a salesman, was often away from home, so she, too, was frequently alone. In Dattadeen she’d found an openhearted protégée, ever eager to please. Dattadeen sometimes called her Momma. Once, when Tondreau-Leve was swindled by an out-of state seller, she called Dattadeen in tears. When Dattadeen fought with her husband, Tondreau-Leve offered counsel. “Don’t feel bad for pushing him away,” she texted. “He has to see that you still love him, but he has to build the relationship again.” Outside work, they met for dinner at the Cheesecake Factory, took their boys camping and saw a Trans-Siberian Orchestra concert. In 2013, Dattadeen took her first real vacation in years, staying not far from Tondreau-Leve’s home on the Atlantic coast so that they could spend time together. On her last night in town, Dattadeen sent her a text: “You are the best friend a woman can have.”

In spring 2012, Kevin Shultz, a loss-prevention manager for Publix Supermarkets, received the first of what would be many reports that year concerning a mysterious plague of thefts. Initially, the missives trickled in from stores around Tampa, where Shultz is based. But Publix has more than 1,000 locations scattered through the Southeast. Some 400, mostly in Florida, fall under his purview, and soon, he was getting similar reports from all over the state: Cape Coral, Fort Myers, Orlando, Miami. The thieves seemed to be multiplying — and all they wanted was baby formula.

Loss prevention is the rare topic about which competing retailers will trade intelligence, and from talking to his counterparts at Walmart, Target and Walgreens, Shultz learned that they were losing large volumes of formula, too. That sort of overlap tended to rule out the employee theft that often accounts for large-scale pilferage. To store-security officers and local cops, who were addressing the crimes on a case-by-case basis, the incidents didn’t appear related. But Shultz had a unique perch, and as he dug deeper, the thefts began to take on a pattern — the work, he believed, of organized crime.

Shultz joined Publix in 2006 after a long, varied career in law enforcement — time on the homicide squad in Plant City, Fla.; stints embedded with the United States Marshals and the Drug Enforcement Administration — and was soon assigned to a newly created position, Organized Retail Crime (O.R.C.) Investigator, to help stem what retailers had come to recognize as a growing problem. Bob Moraca, the vice president of loss prevention at the National Retail Federation (N.R.F.), a trade group, says that in the last few years, O.R.C., which accounts for $30 billion in annual losses in the United States, has overtaken “internal shrink” — that is, employee theft — as the greatest threat to retailers’ bottom line. A 2016 survey by the N.R.F. found that 100 percent of respondents — a sample representing thousands of stores — had been victimized in the last 12 months by organized crime, more than in any other year.

Retail-crime groups generally share a pyramidal structure: a boss up top, captains and lieutenants below and professional shoplifters, or “boosters,” at the base. The internet has been catalytic, providing those without underworld ties new ways of fencing goods: auction sites and payment methods that facilitate anonymity. Prime targets include clothing and handbags — expensive, high-demand goods that are relatively easy to conceal — as well as top-shelf liquor, pain-killers and laptops. Pharmacy wares are favorites, too. In 2008, Shultz helped neutralize a theft ring dealing in health and beauty products. The following year, he broke up a group of middle-aged Florida men who sometimes feigned infirmity — affecting a limp, using a motorized cart — to help them relieve retailers of countless razor blades. The third-most-targeted item, according to the 2016 N.R.F. report, was infant formula.

Shultz’s formula inquiry began in the usual way, with information flowing to him from lower-level personnel — mostly video and photo stills depicting shoplifters in various stages of the act. Shultz noted that the thefts did not seem attributable to people stealing for personal use — they were taking way too much. And they were craftier than your run-of-the-mill smash-and-grabber. One man, in Orlando, liked to select an opaque, lidded storage bin from a sales display, fill it with formula, then proceed through the exit doors, brandishing a phony receipt for the bin. Others worked in teams. One couple used their children as camouflage, stowing their take in a specialized diaper bag that retained its shape empty or full. Another hid formula in a stroller with a spacious undercarriage. Many thieves favored reusable Walmart bags, which had the advantage of a substantial, precise capacity: 18 12.5-ounce cans of formula (three layers of six), or nine 1.45-pound tubs (three layers of three).

As Shultz identified repeat offenders, he circulated the footage to other stores he considered likely targets for the same thieves. But clever boosters are difficult to apprehend; store-security officers serve a largely deterrent purpose, and cashiers and stock clerks cannot be expected to confront criminals. To improve its prospects, Publix stepped up inventory checks in formula aisles, enabling the company to zero in on the window during which a theft occurred, alert nearby stores and swiftly fold the data into the case file.

One night in July 2012, Shultz got a break — a phone call from a Publix in Pinellas County, about 20 miles from Tampa. Police officers there had apprehended a couple trying to steal 13 cans of formula. Shultz recognized them from security footage. They made a striking pair; slender, with brown hair, the woman looked slight beside her partner, a lumbering man with an ex-lineman’s physique. Now, under arrest, they had names: Jessica Gordon and Brian Oliver, both about 30. Shultz hoped they could provide some clue about the organization he suspected they were working for. In an interview with Gordon arranged by the Pinellas County Sheriff’s Office, he learned that the couple had two buyers. One proved, after a brief investigation, to be an online business trading in quantities too small to explain the losses retailers were seeing.

The other was a 32-year-old woman named Alexis Dattadeen.

Dattadeen read online about the arrests. She was frightened — by then, she’d bought formula from Gordon and Oliver at least 10 times. But when she told Tondreau-Leve what had happened, Tondreau-Leve seemed unruffled, concerned mostly with coaxing Dattadeen back to work — and Dattadeen didn’t want to disappoint her. Encouraging and sympathetic at times, Tondreau-Leve could also be stern. She had become increasingly focused on high productivity, bristling at mistakes. A sizable haul was one thing that Dattadeen could be sure would make her happy, and so, when Oliver contacted her some weeks later, offering to sell more formula, she agreed to meet.

One evening in September 2012, Dattadeen pulled her minivan into a Walmart parking lot in Palm Harbor, a community south of New Port Richey. Soon, Oliver arrived, driven by someone Dattadeen had never met. She got out of her car and greeted Oliver, who hulked over her in a green polo shirt. “Nice to see you again,” she said, hugging him. The other man was introduced as Donnie. His real name was George Moffett — and he was a Pinellas County sheriff’s deputy. From an unmarked car, another officer filmed the exchange. “I’ve stolen a lot of [expletive] in my day,” Moffett says in the video. “But this [expletive] was hard.” Dattadeen smiles bashfully, but doesn’t otherwise respond. Moffett presents himself as Oliver’s source. In his trunk are 90 tubs and 18 cans of Similac formula, which had been provided to the sheriff’s department by Publix. “So you’re the guy who’s been getting all this?” Dattadeen asks. “Do you have a number — I could call you?”

In the coming weeks, Dattadeen met “Donnie” three more times. In recordings of their interactions, she speaks in a high, soft voice, with the scattered animation of a teenager. Details about Formula Mom pour forth: Dattadeen has a partner, near Orlando, whom she meets on Mondays; the formula is shipped to Massachusetts, and also to China. “She’s not as easygoing as I am,” she said once, referring to Tondreau-Leve. “I can tell you that.”

In October, Shultz drove to a gas station off Interstate 4, which connects Orlando and Tampa. He had been guided there by the Pinellas County Sheriff’s Office, which had relayed intelligence to him about Dattadeen’s movements gleaned from a GPS tracker that it had attached to her van. At the rear of the parking lot, he found Dattadeen’s van backed against a white fence, with slats spaced widely enough that he could shoot video through them. Beside it, another van had backed in. Both trunks yawned open. Dattadeen and a woman unknown to Shultz moved formula from one van to the other. “White female, appears to be middle-aged — late 40s, early 50s, shorter hair,” Shultz narrates, describing the stranger over a Rascal Flatts song playing from his radio. “Multiple cans of formula,” he says. “Multiple, multiple stacks.” After the transfer was complete, Shultz followed the older woman to a house about 15 miles away, taking down a license-plate number that he traced to a rental contract signed by one Alicia Tondreau-Leve.

Tondreau-Leve arrived in Florida with her two adolescent sons in July 2011, becoming one of the roughly 800 new residents the state absorbs per day, an aspirant lured by its redblooded interpolation of Californian mythos: sun, surf, opportunity. Having recently endured a difficult period, the family had come from Freetown, Mass., a quaint village of about 9,000, where Tondreau-Leve’s husband, Alan Leve, remained in his sales job while he looked for work in Florida. In 2010, Alan realized a long-held dream of opening a restaurant. But the business failed, and the family filed for bankruptcy. Sonoma at Viera, the subdivision 45 miles southeast of Orlando where the Leves settled, might reasonably have seemed an auspicious place to start again. Diminutive palms lined its streets, which bumpered neat lawns garnished by flowering shrubs. Backyards were generously puddled with artificial ponds. Everything was new.

Not long before Tondreau-Leve moved to Florida, Alan’s cousin, Michael, presented her with an opportunity. He knew the secondary retail market well, having for years run a store in Massachusetts that took a commission for selling customers’ goods on eBay. He suggested that formula might earn her some extra money: She could buy unused cans from Florida moms and ship them to him. Initially, Tondreau-Leve had little sense of how to go about things, so she simply did what she could; if she had to drive 15 miles to buy two cans, so be it. Gas costs could exceed the value of her purchases, but she viewed the legwork as an investment. Eventually, she learned to schedule all her deals in a given metro area — Tampa, say — on the same day. When she’d gathered enough formula to fill a moving box, she shipped it to Michael, profiting about $2 per can.

If Tondreau-Leve ever began to sense that her business was mutating from a wholesome D.I.Y. venture into something malignant, there was little in her outward presentation to suggest it. Soon after moving in, she told Cindy Lashomb, who lived next door with her husband, about a company she’d started, dealing in surplus infant formula. There was nothing secret about it, Lashomb told me; Tondreau-Leve even affixed a magnet advertising the business to her car. Another neighbor, Donald Egan, knew about the business, too; he discerned in Tondreau-Leve the makings of a mogul, once describing her as “the pants in the family. She ran everything. You could tell by her attitude and the way she approached you that she was the alpha male, so to speak.”

In the spring of 2012, Lashomb began to suspect that something was not quite right next door. Suddenly, it seemed, trucks were always coming and going, picking things up or dropping them off. Lashomb complained to Tondreau-Leve, but the traffic worsened — UPS deliveries gave way to tractor-trailers. Once, an 18-wheeler blocked the Lashombs’ driveway, trapping them at home.

Tondreau-Leve eventually shifted operations to a storage facility, renting a single unit, then a double, filling it to capacity with head-high stacks of formula. By early 2013, Formula Mom had statewide reach. A woman named April covered Fort Myers. A man named Angel, who owned a consignment store, handled Miami. Giulyanna took care of Orlando. To each subcontractor, Tondreau-Leve provided the same start-up guide. Each set up a Bank of America account. Having some experience with consignment stores, Dattadeen voiced concerns about Angel’s supply, which arrived in huge quantities — a fact she happened to notice during a drop-off at Tondreau-Leve’s storage unit. But Tondreau-Leve dismissed them. Having expanded her network, Tondreau-Leve was less dependent on Dattadeen, and she had cooled on her, berating her over botched invoices, and comparing her unfavorably with her other deputies.

Demand had meanwhile grown alongside supply. That year, Tondreau-Leve stopped selling to Michael in favor of a California woman named Lissette, who ran a formula-wholesale business. Lissette had contacted Tondreau-Leve online, offering her a much better price than Michael did. By playing Lissette off yet another buyer, in Wisconsin, Tondreau-Leve negotiated an even better rate. Buyers from New York and New Jersey materialized, too. Tondreau-Leve did not much trouble herself about what became of her formula after she sold it, but the buyers mostly seemed to be wholesalers, redistributing the product to small stores. At least one owned a Brooklyn bodega, and Tondreau-Leve knew that Lissette had customers in China, where a tainted-formula scare in 2008 had stoked demand for foreign brands, which were seen as safer.

Between January 2012 and July 2014, records from several freight carriers indicate that Tondreau-Leve shipped a total of roughly 60 tons of product. During that period, she received nearly $300,000 from her California client, $300,000 from buyers in Wisconsin and nearly $1 million from New York City buyers. No longer a neophyte, she proved herself an able businesswoman, adept at navigating complex logistics. In missives to underlings, she presents as a sober, precise manager. “I appreciate everyone’s patience over the last couple of months,” she once wrote. “Because of the Chinese market not taking formula from the U.S., it has left a surplus of Nutramigen and Alimentum in everyone’s hands. Hopefully now that the doors are open again in China, we will see some of this product move.”

Shultz continued to watch formula disappear from his shelves in 2013, but the mechanics of the operation remained unclear. Late that year, he approached Jeff Newcomb, an agent with the Orange County Sheriff’s Office, which covers metropolitan Orlando, with a lead that he believed was connected to much of the area’s missing baby formula: a Formula Mom Craigslist ad, with contact information for a “Julie.” By then, the Florida Department of Law Enforcement, as Florida’s state police is known, had joined the case in a supervisory role, synchronizing police efforts in different jurisdictions. F.D.L.E. agents had coordinated additional surveillance, following Dattadeen to meetings beyond Pinellas County, and trailing Tondreau-Leve through Central Florida. A prosecutor from the attorney general’s office had also been assigned, adding subpoena power to an investigation that would produce mountains of paper evidence: bank and phone records, wire transfers, emails. Bit by bit, law enforcement was working toward a case against Formula Mom under Florida’s RICO Act, a version of the 1970 federal anti-racketeering law designed to cripple the mafia.

Having worked several previous RICO cases, Newcomb was familiar with the methods of the genre — turning lowly button men against capos and so on. But this time, rather than work up the chain of command, Newcomb would establish a pattern of criminality at the base of the pyramid, sketching a fuller portrait of the enterprise. Using a criminal informant to conduct a controlled sale, Newcomb quickly identified “Julie” as 30-year-old Giulyanna Guzman, Tondreau-Leve’s Orlando deputy.

A single mother with a 2-year-old daughter, Guzman was organized and hardworking, often waking early and retiring late. She spent the hours between seeking out formula sellers online and distributing the business cards Tondreau-Leve had given her. Since starting with Formula Mom in early 2013, she had developed a stable of fruitful sources. But like Dattadeen, she had concerns about a number of them. Guzman was meeting some people every day, sometimes more than once. They would demand to see her on short notice, urgently and at odd hours. In some cases, she did not feel right about their being around her daughter; they seemed off.

One such supplier was Janine Piccirillo, who’d learned the formula racket from a friend: what to look for; how to get it; and, most important, that there was a woman named Julie who would always buy it. Piccirillo could often manage to make off with two Walmart bags full of formula at a time — roughly $550 worth at retail. She worked with a driver, Jennifer Day, who would obscure her license plate with a sheet of paper and wait outside. They might hit three stores in a day. After selling their haul to Guzman, Piccirillo and Day usually drove straight to see their dealer.

One day in 2013, Day was dope-sick, and went to work alone, visiting a Publix in the morning. Noticing someone filming her with a phone, she left and drove to Walmart. Her symptoms were worsening, and she resolved to steal as much as she could, leaving the store with a bag on each arm. But when she reached the parking lot, she was swarmed by masked police officers with their guns drawn.

When I met him recently at an Orange County police station, Newcomb grinned at the memory, explaining that they’d thought Day might be armed — she’d been surveilled for about a month, and had once been observed leaving a gun shop. During the arrest, Guzman, who was listed in Day’s phone as Formula Mom, called repeatedly — Day was late for their meeting. She also had numbers saved for Alicia and Alan Leve. In all, Newcomb said, he identified about 15 boosters associated with Guzman. I asked how many were drug users. He paused, considering. “I don’t think there was a single one who wasn’t,” he said. Most if not all were addicted to opioids — using heroin, prescription painkillers or both.

In the summer of 2014, the F.D.L.E. staged a dramatic final scene in Operation Baby Burp, as their investigation ultimately came to be known. They had by then developed an intricate understanding of Formula Mom. But much of the evidence against Tondreau-Leve was circumstantial. The police could barely ever connect her directly to thefts. Several officers who worked the case suggested to me that — like many dons before her — Tondreau-Leve had “insulated herself.” If they got the case to trial, the question of her guilt would turn largely on what she knew or should have known — Florida’s standard for dealing in stolen property — and on a legal concept known as willful blindness, or the “deliberate avoidance of positive knowledge.” For juries, though, such esoterica does not play nearly as well as one last, spectacular bust. (Tondreau-Leve declined to be interviewed for this article. Most of her and Dattadeen’s story comes from court documents.)

That April, an F.D.L.E. agent named Shawn Sloan went to the Dattadeens’ home, accompanied by Shultz, hoping to turn Dattadeen against Tondreau-Leve. They did not lack leverage; Dattadeen had repeatedly discussed buying stolen property on tape. When her predicament was made clear to her, she quickly agreed to cooperate. Following Sloan’s instructions, in a recorded meeting later that month — a meeting during which she was terribly nervous — Dattadeen told Tondreau-Leve that she didn’t want to work with her anymore. Some of her suppliers, she said, were making her uncomfortable, particularly a man named Steve, who had said he could get whole shipping pallets’ worth of formula.

The ploy worked. Soon after their conversation, Tondreau-Leve contacted Dattadeen to ask for Steve’s number. Dattadeen obliged. The phone number she provided belonged to William Powell, an F.D.L.E. agent posing as a supplier. “Good morning,” Tondreau-Leve texted him in early May. “My name is Alicia, and I received your number from Alexis.” Powell/Steve wrote back: “I can get it pretty regular, and Alexis said you’re reliable.”

The next day, Powell met Alicia and Alan in a CVS parking lot near their home, selling them 65 Similac tubs, which he indicated he’d gotten from his brother, a Publix employee. As represented to Powell, Tondreau-Leve’s vision of Formula Mom had changed markedly; she made no mention of needy mothers, of redistributing formula in the community. “I’m the go-to person here in Florida,” she says in a recording of the meeting. “I have an endless amount of money basically.” Over the next month, they met twice more. Tondreau-Leve repeatedly sought assurances: “Please confirm that these cans are acquired legally!” she texted when she first made contact. But when Powell equivocated, as invariably he did, she didn’t seem deterred. “I’d love to know where he’s getting it from,” she says during their second meeting, meaning the brother. When Powell tells her, “Everything’s good, Alicia,” for a moment on the recording, she appears flustered: “No, not ‘everything’s good,’ because, you know, I don’t steal — I don’t buy stolen.” Then she resumes loading her purchase.

On July 2, Tondreau-Leve arranged to meet Powell in a Lowe’s parking lot for what was to be the largest deal of her career: 3,300 tubs of formula — six pallets’ worth. The load had a retail value of about $85,000. Tondreau-Leve had agreed to pay $33,000 in cash, which she stored for some days before the transaction in a coffee can on her kitchen counter. In the days beforehand, she seemed to overcome her trepidation about the formula’s origins, texting Powell requests for future orders: 2,000 Similac Advance cans, 400 Enfamil boxes, Similac Go-and-Grow. But on the morning of the deal, after the pallets were transferred from Powell’s truck to the one Tondreau-Leve had rented, she and her husband, who accompanied her that day, were arrested. Amid a blare of sirens from unmarked cars stationed in the lot, the police descended from all sides. Still in character, Powell cried out, “What’d you do to us, Alicia?”

In August 2016, a jury convicted Tondreau-Leve of charges including racketeering, dealing in stolen property and money laundering. Alan was convicted of conspiracy to commit racketeering. The judge, Wayne Durden, sentenced Tondreau-Leve to 20 years in prison, citing, among other factors, her refusal to acknowledge wrongdoing. Alan received a seven-year term. (At trial, Alexis Dattadeen and Giulyanna Guzman gave extensive, notably contrite testimony; both received probation.) The Leves’ sentences struck me as severe, and I asked Pam Bondi, the Florida attorney general, if she agreed. “I wish she’d been locked up for as long as humanly possible for what she did,” she said of Tondreau-Leve. “Had she used her wits to start a legit business, she could have been incredibly successful — a true entrepreneur.”

We were sitting in a sparsely decorated corner suite in Bondi’s Tampa office with Paul Dontenville, the lead prosecutor in the case, and Nicholas Cox, Florida’s statewide prosecutor. Before us on a table lay a binder of Formula Mom price lists and invoices. The documents made a polished, professional presentation. They suggested pride of ownership, looking to me not at all like the work of someone trying to hide something. I asked Dontenville if, for an organized crime boss, Tondreau-Leve hadn’t gone about things in a rather unusual fashion. She had registered her company with the state — displaying related paperwork inside her rented storage unit — and handled payments via commercial wire transfer. She had printed business cards and sent email that amounted to evidence of conspiracy. Clean cut and rigidly matter-of-fact, Dontenville declined to ruminate on the subject. He’d been surprised, though, when he received discovery materials from the defense, that they included Tondreau-Leve’s text messages, which she hadn’t been required to provide. Tondreau-Leve evidently considered them exculpatory; Dontenville found them useful in making his case.

Before trial, the prosecutors presented a deal that would have meant much less prison time for Alicia and mere probation for Alan. But the charges to which they were asked to plead apparently did not comport with their sense of their actions, or of themselves. They turned the deal down. Soon after, the Leves met for a voluntary pretrial interview with prosecutors, during which they insisted stubbornly that Alicia had run a legitimate business. She had worked hard and become successful. If she’d erred, it had been through naïveté, trusting the wrong people. She was a business owner like any other, victimized by dishonest underlings.

Last July, I went to see Dattadeen at her house in New Port Richey. When I pulled up, she was outside, hanging wet towels and bathing suits. She wore a tank top and had a reddish tan, her hair damp and straight. From the corner of her mouth, she smoked a cigarette. She spoke in a high, soft voice — the voice from the surveillance footage — but she’d grown less trusting than she was then, regarding me warily and declining to speak in detail about her experiences with Tondreau-Leve. Formula Mom had been a mistake, and she was moving on with her life. Ronald came outside and we talked in the deepening dusk under a full yellow moon. When Dattadeen went to make a call, Ronald asked me, a little bashfully, about “the lady,” meaning Tondreau-Leve. When I told him she was in prison, he looked sorry. Then he said: “The others admitted they were wrong. She was in denial.”

When Dattadeen and Tondreau-Leve were still close, Tondreau-Leve often spoke to her of her anger at losing the home she and her husband had owned in Massachusetts — a stately four-bedroom Colonial on an acre of land. Visiting from Florida, while Alan was still living there, she found it so upsetting to be in the house, which she knew by then that they would lose, that she sometimes preferred to spend time in a rented R.V. Formula Mom became a means of redemption and reinvention. The Leves had been renting in Florida, but about five months before their arrest, they began thinking of buying property: Lot 6HH at Tralee Bay Estates, a new development where the homes had granite countertops, Bosch appliances and “Tuscan-inspired architecture.”

When law-enforcement officers spoke of Tondreau-Leve “insulating” herself, they meant it in a legal sense, that the layered structure of Formula Mom had made prosecuting her more difficult. But Tondreau-Leve’s regional deputies also largely buffered her from the sad, grimy underpinnings of her business: the furtive meetings in parking lots; the twitching, nauseated victims of dope-sickness. In a way, the architecture of her organization had insulated her too from a damning kind of self-knowledge, even as her daily duties — arranging cross-country shipments, negotiating rates, collating spreadsheets, tracking policy changes — encouraged her to indulge an entrepreneurial delusion. It seemed likely that what Tondreau-Leve knew or should have known had been at least partly occluded by what she badly wanted to believe.

On July 2, 2014, when she drove to the Lowe’s parking lot, Tondreau-Leve took with her an immaculate-looking receipt made out to Steve Riley, the full name provided to her by Agent Powell. It had been perhaps two years since she’d told Dattadeen not to pick up her prototype receipt from Office Depot, and Formula Mom had become a different kind of company. In the pretrial interview, she would tell Dontenville that in her last transaction, she believed she was buying from Publix at a wholesale rate. At the top of the receipt for Riley, she’d printed the Formula Mom logo — the woman with flowing hair holding an infant aloft.

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Chris Pomorski is a freelance writer who has contributed to The Guardian, New York, and Bloomberg Businessweek. This is his first feature for the magazine.

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Breastfed and Formula-Fed Infants: Need of a Different Complementary Feeding Model?

Margherita caroli.

1 Independent Researcher, Francavilla Fontana, 72021 Brindisi, Italy

Andrea Vania

2 Independent Researcher, 00162 Rome, Italy

Maria Anna Tomaselli

3 Nutrition Unit, Department of Prevention, Azienda Sanitaria Locale Brindisi, 72100 Brindisi, Italy; ti.orebil@67tanna

Immacolata Scotese

4 ASL Salerno, Campagna, 84022 Salerno, Italy; [email protected]

Giovanna Tezza

5 F. Tappeiner Hospital, Merano, 39012 Bolzano, Italy; [email protected]

Maria Carmen Verga

6 ASL Salerno, Vietri Sul Mare, 84019 Salerno, Italy; ti.oiligriv@asagrev

Giuseppe Di Mauro

7 ASL Caserta, Aversa, 81031 Caserta, Italy; ti.sppis@aznediserp

Angelo Antignani

8 Department of Food Science, University of Naples Federico II, 80100 Napoli, Italy; [email protected]

Andrea Miniello

9 School of Allergology and Immunology, University of Bari, 70124 Bari, Italy; ti.oohay@aerdna_olleinim

Marcello Bergamini

10 AUSL Ferrara, 44121 Ferrara, Italy; moc.liamg@45agrebollecram

Associated Data

Suboptimal nutrient quality/quantity during complementary feeding (CF) can impact negatively on infants’ healthy growth, even with adequate energy intake. CF must supplement at best human milk (HM) or formulas, which show nutritional differences. Considering this, a differentiated CF is probably advisable to correctly satisfy the different nutritional needs. To assess whether current needs at 6–24 months of age can still be met by one single CF scheme or different schemes are needed for breastfed vs. formula/cow’s milk (CM) fed infants, protein, iron and calcium intakes were assessed from daily menus using the same type and amount of solid food, leaving same amounts of HM and follow-up formula at 9 and again 18 months of age, when unmodified CM was added. Depending on the child’s age, calcium- and iron-fortified cereals or common retail foods were used. The single feeding scheme keeps protein intake low but higher than recommended, in HM-fed children while in formula/CM-fed ones, it achieves much higher protein intakes. Iron Population Recommended Intake (PRI) and calcium Adequate Intakes (AI) are met at the two ages only when a formula is used; otherwise, calcium-fortified cereals are needed. ESPGHAN statements on the futility of proposing different CF schemes according to the milk type fed do not allow to fully meet the nutritional recommendations issued by major Agencies/Organizations/Societies for all children of these age groups.

1. Introduction

The complementary feeding (CF) period accounts for a difficult and vulnerable time, a time when limited gastric capacity is combined with high energy needs to ensure growth and health. Suboptimal nutrient quality and quantity can have a negative impact on growth and neurodevelopment, even when overall energy intake is adequate [ 1 ]. It is, therefore, necessary that complementary foods supplement as best as possible human milk or formulas.

Human breast milk (HM) is the ideal nutrition for infants, but some of them are formula fed and, although the composition of all baby formulas (either derived from cow milk [CM] or with vegetal protein source) has improved a lot over time, differences still remain between formulas and HM, not only in the amount of some macro and micronutrients, but also in terms of functional factors that are not fully understood yet [ 2 ].

Table 1 summarises the differences in main macro and micronutrients among HM, follow-up formulas, young child formulas (YCF), and CM.

Composition of human breast milk, follow-up formulas, young child formulas (YCFs), and cow milk (CM).

* Values from [ 3 ]. ^ Edited from [ 4 ], for formulas available in Italy. ° From [ 5 ]. § Beside lactose, YCFs may contain, in varying and not always declared proportions, complex carbohydrates (maltodextrins, starch, cereal flour) as well as simple carbohydrates (sucrose, dextrose, glucose, fructose), thus it is not possible to calculate any average content of simple sugars.

Another key difference between formulas and HM is that formulas have a pre-set composition and a taste that is always the same (although it may differ from one formula to another one), whereas HM varies in composition and taste—not only throughout the whole breastfeeding period, but also during the day, and during each feeding—depending on a wide range of factors, including age of the infant, mother’s diet (at least in part), her age, weight, and, most likely, her genetic background [ 6 ]. Research on the macronutrient composition of HM was mainly carried out in the 1980s and 1990s [ 7 , 8 , 9 ] and was mainly focused on the composition of milk in the first 6 months of lactation, whereas there are far fewer studies on the composition of HM beyond 6 months up to (and beyond) the first year of life [ 10 , 11 , 12 ].

Studies on HM composition, conducted in different countries across five continents, show a fairly similar range of energy and nutrient values, from which standard values are often extrapolated to make calculations easier when assessing energy and nutrient intakes. In general, during the first year of life, protein content of HM decreases as breastfeeding goes on, while fat and carbohydrate contents remain stable [ 11 , 13 , 14 ]. A recent, interesting, study reports longitudinal changes in the macronutrient concentration of milk from healthy women from 0 to 48 months of lactation. The results of this study suggest that, after 18 months of breastfeeding, concentrations of lipids and proteins increase compared to that of milk produced in the first 12 months (lipids 5.80 g/100 mL at 24 months vs. 3.46 g/100 mL at 12 months; proteins 1.24 g/100 mL at 24 months vs. 1.00 g/100 mL at 12 months) while the concentration of carbohydrates decreases (6.6 g/100 mL at 24 months vs. 7.1 g/100 mL at 12 months). Then, from 24 months to 48 months, macronutrient concentrations remain stable [ 15 ]. However, the study has a sampling bias, since milk analysis was performed on one single sample per day, taken in the morning and, therefore, not representative of the average daily composition. Another study [ 16 ], biased by the inclusion of only 19 women, also reported that the protein content increased during the second year of lactation (1.6 g/100 mL at 11 months vs. 1.8 g/100 mL at 17 months). Given these methodological problems, the results of these studies, albeit very interesting and apparently in line with the increased growth needs of children, need to be corroborated before they can be considered conclusive and useful in clinical practice.

Differences between HM and formulas are also qualitative, e.g., in terms of casein and serum protein types, aminoacidic profile and fatty acids. Finally, HM contains many molecules and components with a range of biological functions that are absent and so far, non-replaceable, or anyway present in different amounts, in formulas [ 13 ].

All these differences must be taken into account when considering complementary foods, as they may have. different effects on body composition from the very first months of life into adulthood and may influence long term health outcomes.

Many years ago, it was convincingly demonstrated that formula-fed infants gain more weight (but not more length) in the first year of life when compared to breastfed infants [ 17 , 18 ]. What is new is that it has been shown quite recently [ 19 ] that the weight difference is due to the larger amount of lean mass compared to that of breastfed infants, which is observed from the age of 3 months and is still detectable at 7 months of age. The amount of fat mass is similar in the two groups, but differs in distribution, as breastfed infants have a greater amount of subcutaneous fat than formula-fed infants, who exhibit a greater amount of visceral fat [ 20 ], with the first condition (more subcutaneous than visceral fat) seeming to be a protective factor in the development of metabolic changes at later ages [ 21 , 22 ].

The reasons for this different body composition are still unclear. They could be linked, for instance, to the different macronutrient composition: a higher protein intake from infant formulas (particularly, a higher intake of casein, which contains the highest amount of insulinogenic amino acids) [ 23 , 24 ] could stimulate greater insulin and IGF-1 secretion and promote visceral fat deposition [ 25 ]. A totally different explanation might be the ascertained fact that formula-fed infants have a different profile of appetite-regulating hormones than breastfed infants: one study has shown that breastfed infants have lower serum levels of ghrelin, leptin and insulin, hormones associated with fat mass and its changes as compared with formula-fed infants [ 26 ]. In addition, the higher fat content in hind-milk vs. fore-milk in breastfed infants may also contribute to appetite regulation in addition to hormones [ 27 ].

Another important difference is that HM has only 13% casein, the lowest casein concentration of all the mammalian species studied, which could explain the slow growth of breastfed human infants [ 28 ].

Given the different body composition observed in the two different feeding patterns (breastfeeding vs. formula feeding) and given the different nutritional properties of HM and formulas, CF most likely needs to be differentiated between the two groups precisely because it is “complementary” to two very different foods. The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) has acknowledged this difference and its implications on terms of CF but has stated that “Because the composition and health effects of breast milk differ from those of infant formula, on a theoretical basis it may seem sensible to give different recommendations on CF to breastfed versus formula-fed infants. Despite these theoretical considerations, devising and implementing separate recommendations for the introduction of solid foods for breast-fed infants and formula-fed infants may, however, present practical problems and cause confusion among caregivers” [ 29 ]. However, this statement is not based on any scientific evidence, nor have any studies been conducted since the publication of the ESPGHAN position paper to confirm these concerns, so it remains an arbitrary assumption.

2. Objectives

Aim of this paper is to assess whether, in light of the new knowledge, the nutritional needs and recommendations proposed by the major Agencies/International Health Organizations can still be met by one single infant feeding scheme with the breastfed infant serving as the ideal example, or whether there should be different schemes for breastfed infants and for formula-fed infants (either fed follow-up formulas or YCF or CM) up to 24 months of age. The evaluated nutritional needs and recommendations are specific to protein, calcium, and iron due to their major impact on infants’ present and future health status.

3. Materials and Methods

In line with WHO recommendations [ 30 ], CF is supposed to start not before six months of age. Our nutritional analysis took into account only protein, iron, and calcium intake, not because all other nutrients are unimportant, but because these are the nutrients most frequently studied when assessing the nutritional status of children from 6 to 24 months of age in consideration of their impact on future health.

For checking the extent to which the nutritional needs of the schemes proposed are met, the European Food Safety Authority (EFSA) recommendations [ 31 ] were used because they are the most recent ones and those with the broadest list of references to official documents issued by other national and international agencies/organizations. The reference weight of infants was derived from WHO growth standards [ 32 ].

The weight calculation, reported in the tables, is based on the average of the 50th percentile weight at the youngest age and that at the oldest age in each of the two groups (6–12 months and 12–24 months). The resulting average weight was used to calculate the protein intake per kg of body weight. For the first two years of life, this simplified approach did not affect the results, as the authors also compared the intakes at both the lowest and highest weights and no significant difference was found in terms of results obtained (data not shown).

HM composition was taken from Picciano et al. [ 3 ]. Formula composition was calculated as the average composition of follow-up and YCF formulas available on the Italian market, respectively. Formulas with added biscuits or other foods/ingredients outside formula basic composition were not included. CM composition was taken from CREA (Italian Council for Agricultural Research and Analysis of Agricultural Economics) food composition tables [ 5 ]. Values of the average daily milk intake at different ages were taken from Dewey’s observational data [ 33 ]. The portion size of solid foods used for menus’ calculations come from portion sizes suggested in the recently published document on CF issued by the Italian Society of Preventive and Social Paediatrics (SIPPS) [ 34 ].

Daily menus were created with the same type and amount of solid food, leaving the amount of HM and formula unchanged in the first year of life. Unmodified CM was added to HM between 12 and 24 months of age. In the first age group, calcium- and iron-fortified cereals were used whereas, in the second year of life, common retail foods were used since fortified foods are less widely used. The vitamin D intake was not calculated in the two groups because 90% of the vitamin D present in the body comes from its production in the skin thanks to the sun’s rays and only 10% comes from food. So, for this irrelevant quantity the tables and the text have not been burdened.

All calculations made for the menus submitted are presented as Supplementary Materials Table S1 .

Table 2 , Table 3 , Table 4 , Table 5 , Table 6 and Table 7 give the results based on the different intake values across the different menus.

Different protein intake for a 6–8-month-old infant when breastfed or formula-fed, with a single solid food intake scheme, assuming a body weight between 7.3 and 8.6 kg [ 32 ] and a PRI for protein of 1.3 g/kg/day [ 35 ]. The amount of milk * is defined according to Dewey’s observational data [ 7 ].

Different iron intake for a 6–8-month-old infant weighing between 7.3 and 8.6 kg [ 32 ] when breastfed or formula-fed, considering only one single complementary feeding scheme and an iron PRI of 11 mg/day [ 35 ]. The amount of milk * is defined according to Dewey’s observational data [ 7 ].

Different Ca intake for a 6–8-month-old infant weighing between 7.3 and 8.6 kg [ 32 ] when breastfed or formula-fed, considering only one single complementary feeding scheme and an AI for Ca of 280 mg/day [ 34 ]. Milk quantity * is defined according to Dewey’s observational data [ 7 ].

Different protein intakes for an infant of around 18 months of age weighing approximately 10.2–10.9 kg [ 32 ] when breastfed, fed with YCF or CM, using a single scheme of intake of solid foods commonly used by the family, and the same portion of milk, and considering a PRI for protein of 10.1–13.7 g/day (1.0–1.3 g/kg) [ 34 ]. The amount of milk * is defined according to Dewey’s observational data [ 7 ].

Different iron intakes for an infant of around 18 months of age weighing approximately 10.2–10.9 kg [ 32 ] when breastfed, fed with YCF or CM, using a single scheme of intake of solid foods commonly used by the family, and the same portion of milk, and considering a PRI for iron of 8 mg/day [ 3 , 4 , 5 , 7 , 35 ]. The amount of milk * is defined according to Dewey’s observational data [ 7 ].

Different Ca intakes for an infant of around 18 months of age weighing approximately 10.2–10.9 kg [ 32 ] when breastfed, fed with YCF or CM, using a single scheme of intake of solid foods commonly used by the family, and the same portion of milk, and considering a Ca AI of 450 mg/day [ 3 , 4 , 5 , 7 , 35 ]. The amount of milk * is defined according to Dewey’s observational data [ 7 ].

Table 2 shows that the PRI for proteins is exceeded by both breastfed and formula-fed infants, although in formula-fed ones the excess is bigger, if the same solid food intake scheme is used (Δ + 0.2 g/kg/day at 6 months and +0.36 at 12 months with HM; +0.64 at 6 months and +0.8 at 12 months with a formula).

Table 3 and Table 6 show that the PRI for iron is almost met at the two considered ages only when a formula is used (Δ–1.2 and 0.8 mg/day at 6–8 and 18 months of age, respectively), but not if the infant is fed HM (Δ–7.6 and −5.4 mg/day at 6–8 and 18 months of age, respectively) or CM (Δ–5.2 mg/day at 18 months of age).

Table 4 and Table 7 show that calcium intakes, calculated in terms of Adequate Intake (AI), are met in the first age group in both HM and formula-based feeding, but in breastfed infants only thanks to the addition of calcium-fortified cereals, providing some extra 60 mg of calcium per day. It must be stressed that in formula-fed infants the use of calcium-fortified cereals is unnecessary since the AI is already met thanks to the formula (Δ +319 mg/day with fortified cereals, yet +259 with no surplus from cereals). As for the second year of life, calcium intake is never adequate in breastfed infants (Δ–309.5 mg/day), whereas formula-fed infants are close to the AI (Δ–22 mg/day), and in CM fed infants the AI is by far exceeded(Δ +159 mg/day). No correction was made, though, for the lower bioavailability of Ca from CM.

5. Discussion

5.1. complementary feeding between 6 and 12 months of age, 5.1.1. proteins.

Using a single solid food intake scheme, regardless of the type of milk feeding, protein intake always exceeds recommended levels. With breastfeeding, protein intake is closer to PRI values, but it increases considerably with formula feeding and even more with CM. Energy intake from protein is generally recommended not to fall below 6% and not to exceed 14% of the total daily calorie intake and safer if it stays between 8 and 12% [ 36 ]. With both HM and formula feeding, protein energy intake remains below 14% of the total calorie intake in the 6–8-month age group, reaching 6.8% and 9.2%, respectively. Additionally, in the 18-month age group with breastfeeding protein-derived energy intake is well below 14%, reaching only 9%, while with formula feeding it reaches about 12%, and almost 15% with CM. However, another more accurate way to assess intake adequacy, which is independent of energy intake and more personalised, consists of considering protein intake per kg and checking how much it departs from the PRI, which is 1.4 g/kg/day at 6–8 months and 1.03 g/kg/day at 18 months. Protein intake per kg is almost one and a half times the PRI in breastfed infants (1.5 g/kg/day) but increases and almost doubles to 1.9 g/kg/day in the case of formula-fed infants in the 6- to 8-month age group.

At 18 months, protein intake should be 1.03 g/kg/day as PRI/kg. In a HM based feeding, protein intake is 1.7 g/kg/day, i.e., one and a half times the recommended level; in the case of formula feeding, it is twice as high, i.e., 2.1 g/kg/day and, finally, when CM is used, it reaches three times the recommended level, i.e., 3 g/kg/day.

According to EFSA [ 35 ], it is not possible to establish a maximum daily intake level for protein and, for adults, an intake of twice the PRI is still considered safe. However, in the first two years of life, an excess of protein intake appears to be a risk factor for the development of obesity later in life [ 35 ].

Of all proteins, CM proteins have been shown to promote higher growth rates [ 37 ].

Thus, the use of a single CF scheme, based on breastfed infants, shows adequate protein intakes for breastfed infants and an excess for formula-fed ones, and even more so when CM is used, thus putting these infants at risk of developing obesity later in their life, a risk linked to both the amount and quality of their protein intake.

Consequently, when a single complementary feeding scheme is used for both breastfed and formula-fed infants, it becomes immediately evident that, while the protein intake of breastfed infants can be considered adequate, it turns out to be too high for infants fed follow-up formulas. Since follow-up formula-fed infants already have higher protein intakes than breastfed infants, it is not advisable to add protein-rich foods such as meat or fish or cheese to CF from the start (at 6 months). Quite the contrary, protein-rich foods are recommended from the start of CF for breastfed babies. When deciding between meat and fish, the latter should certainly be preferred for its higher AGE content and lower protein load.

If soy-based formulas are used, the situation does not change significantly since, due to the different amino acid composition, the protein content is even slightly higher than the CM-based formulas, while the iron content does not change significantly.

5.1.2. Iron

The second half of the first year of life is the period with the greatest need for iron, both because of the increase in blood volume and because iron is needed for neuro-cognitive development.

The amount of iron absorption is determined mainly by the body’s iron reserves and the bioavailability of the iron taken in. The lower the iron reserve, the higher, within certain limits, the percentage of iron absorbed. Beyond the well-established bioavailability of haem iron (15–25%) [ 38 ] and non-haem iron (4–7%) [ 39 ], in the CF period it is also important to know the amount and bioavailability of the iron from iron-fortified cereals (3%) [ 40 ] and especially from human milk (34%) [ 41 ] and formulas (20%) [ 42 ]. With this information it is possible to check the adequacy of the total intake without invasive procedures and to detect possible risk factors.

As iron absorption increases when vitamin C intake is added to foods and is inhibited by the presence of Ca salts, tea, proteins, phytates, and Mn, attention should be paid, for example, to the Mn content of ready-to-eat cereals, which often contain Mn levels between 1 and 4 mg/100 g [ 43 ].

Meeting iron intake needs in this period of life is not easy and, to increase iron intake, despite the (yet poor) bioavailability of Fe with some specific iron-supplemented infant foods other than formulas, the use of the latter can still be helpful. It is important not to expose the infant to the risk of an inadequate iron intake and, therefore, of developing Iron Deficiency (ID) and Iron Deficiency Anaemia (IDA), as iron therapy can only remedy haematological abnormalities, but not brain damage, which is irreversible [ 44 , 45 , 46 ].

Table 3 indicates that from 6 months onwards a breastfed baby (despite the high bioavailability of iron in HM) will also need to be given Fe-rich foods to help with its absorption or to receive Fe supplements. However, any increase in the portion of meat to increase Fe intake will not be helpful, as even tripling the amount of meat may not achieve the PRI value for Fe, while increasing protein intake excessively.

5.1.3. Calcium

According to EFSA, Ca AI is 280 mg [ 35 ]. BM has a lower Ca content (23 mg%) than follow-up formulas (70 mg%), but its 50% bioavailability is much higher than that of follow-up formulas where it reaches only 30–35%.

For adequate intakes to be achieved, iron-fortified cereals are not critically necessary for formula-fed infants, whereas they may be useful in the case of breastfed infants, even though HM calcium has a higher bioavailability than other foods.

5.2. Complementary Feeding between 12 and 24 Months of Age

In the second year of life, the number of questions to the paediatrician to receive information, clarifications, and advice on a child’s diet reduces considerably, while the risk of an incorrect (by over- or under-coverage) coverage of nutritional needs of the baby is still high, in a period of life that is still particularly sensitive in terms of long-term outcomes. Foods rich in added sugar and salt are easily introduced instead of healthier foods such as fruit and vegetables. The reasons for such behaviour may be found both in the widespread advertising of infant food, as well as in the widespread belief/desire of mothers (and grandmothers) that their child is “all grown up” and can and should eat much more foods suitable for older children.

The World Health Organisation (WHO), in its paper on CF of the breast-fed child [ 30 ], states that breastfeeding can continue into the second year of life but gives no indication about what to do should HM no longer be available. Again the WHO, in its now quite outdated paper on the feeding of non-breastfed babies [ 47 ], states that “Acceptable milk sources include full-cream animal milk (cow, goat, buffalo, sheep, camel), Ultra High Temperature (UHT) milk, reconstituted evaporated (but not condensed) milk, fermented milk or yogurt, and expressed breast milk … Commercial infant formula is an option when it is available, affordable, can be safely used, and provides a nutritional or other advantage over animal milk … Semi-skimmed milk may be acceptable after 12 months of age”. While this paper is primarily addressed to developing countries, it cannot be overlooked that different animals produce significantly diverse types of milk, and more importantly, they produce types of milk that differ from HM. Nor does this document help in the choice, after 12 months of age, of a milk source for non-breastfed children living in industrialised countries. Furthermore, the inclusion of even semi-skimmed CM at this age may expose infants, especially those from families with disadvantaged educational and socio-economic backgrounds, to a significant reduction in terms of total daily energy intake.

In a paper published in 2013, EFSA [ 48 ] states that “No unique role of young-child formulae with respect to the provision of critical nutrients in the diet of infants and young children living in Europe can be identified, so that they cannot be considered as a necessity to satisfy the nutritional requirements of young children when compared with other foods that may be included in the normal diet of young children (such as breast milk, infant formulae, follow-on formulae and cow‘s milk)”. Furthermore, in the same paper, EFSA recognises that “However, at this age (after the first year of) cow‘s milk consumption is no longer discouraged and no recommendations for replacement of this food category by other alternatives exist from medical societies at European level”.

Therefore, EFSA also lumps together HM, starting and follow-up formulas and even CM as alternatives to each other, without considering their significantly different nutritional properties.

Finally, ESPGHAN [ 49 ] states that “based on available evidence there is no necessity for the routine use of YCF in children from 1-3 years of life, but they can be used as part of a strategy to increase the intake of iron, vitamin D and n-3 PUFA and decrease the intake of protein compared to unfortified cow’s milk. Follow-on formulae can be used for the same purpose”.

In conclusion, the leading scientific societies and international institutions (WHO, EFSA) give freedom when it comes to the consumption of whatever infant formula or milk may be available, but no data are available to confirm the nutritional adequacy of the different types of milk used to supplement solid food consumption between one and two years of age. However, it should be emphasised that beyond one year of age, milk (of whatever kind) is no longer the main food to be supplemented, but rather milk could be said to be the food that complements solid food intake. Therefore, the portions of the latter should be adjusted to the composition of the different types of milk. Even so, given that during this period of life milk shares energy and nutrient intakes with many other foods, the total nutrient intake may vary greatly, depending on whether one chooses HM, CM, or YCFs.

One issue arises from the fact that YCFs are not regulated (yet) on a national or European basis in their nutrient and energy composition, thus reflecting a heterogeneous group of formulations, some of which are more targeted to the specific nutritional needs of children of this age, while others appear to be just a marketing gimmick [ 50 ].

In the 2018 ESPGHAN paper [ 49 ], it is further stated that there are no obstacles to the use of follow-up formulas also in feeding children beyond one year of age and that, therefore, it may not be necessary to define special regulations and values for YCF.

Finally, any regulation of YCF composition should take into account that the regular intake of food for the whole family may differ across European countries and families and the reduction in milk intake depends very much on the child’s diet preferences and the family’s eating habits. Therefore, when choosing to use one of these formulas, paediatricians should be able to assess its nutritional adequacy and usefulness within the context of the whole child’s diet.

The most common nutritional problems in the diets of children between 12 and 24 months of age are likely to be related to an insufficient intake of Fe and an excessive intake of protein and Na. The problem of excessive protein intake is the most studied, and there is some limited evidence [ 51 ] that excessive protein intake in the first two years of life promotes the development of obesity later in life.

Of all proteins, those from milk and dairy products appear to play the most important role, not only because of their specific quality, but also because, although meat, fish, and eggs contain higher protein percentages, the overall amounts of milk consumed at this age are still likely to make milk the most important source of the total protein intake.

While breastfeeding has been shown to be a protective factor for the development of obesity, the intake of unmodified CM, even at this age, is definitely a risk factor not only for obesity but also for iron deficiency on the grounds that Fe is almost totally absent in CM. YCFs are at lower risk than CM for both diseases, given their lower protein content and higher Fe content.

However, given the great variability in the eating habits of families, examples of how to meet the recommendations for protein, Fe, and Ca are given above ( Table 5 , Table 6 and Table 7 ) for an 18-month-old child fed HM, fed YCF, or fed unmodified CM, but with the same portions of both milk and solid foods and with the same energy intake. Protein intake is the lowest with HM (1.7 g/kg), it increases to 2.1 g/kg with YCF, but reaches 2.9 g/kg with CM, almost tripling the PRI for protein. Fe intake is inadequate with both HM and CM, whereas it is met with YCF. Finally, Ca intake is met with both CM and YCF, whereas with breastfed infants it may be useful to use Ca-fortified cereals.

These schemes are based on observed intakes of healthy infants and also correspond, as far as CM is concerned, to the proposal of several international societies/organizations which, in view of the possible risks linked to excessive consumption of CM even in the second year of life, recommend that the daily intake of CM should not exceed 500 mL/day. As can be inferred from the tables presented here, this limit does not remedy excessive protein intake.

Strengths and limitations of the study. Limitations: The menus used for calculations may not represent the variety of menus offered to children in a certain community, and they may not respect the use of local foods. Our aim, however, is to show that the use of one single model of introducing complementary foods is not adequate for both breastfed and formula-fed infants, irrespective of the menus used. Since we want to stress the principle that CF should be differentiated in breastfed vs. formula-fed infants, we kept the menus as simple as possible; for this reason, we avoided considering specific eating habits. In any case, indeed, the use of local foods would be similar in both groups of children and will result in the same nutritional problems. Another limitation of this study is that we limited the nutritional analysis to specific types of milk, i.e., we did not consider a diet with simultaneous intake of different types of milk (HM, formula, or CM). The combinations of mixed feeding are innumerable and illustrating all the different combinations would have made this paper excessively long. Hence, it is of paramount importance for the paediatrician to evaluate thoroughly what kind(s) of milk the single infant takes and in which quantity. This way the health professional will be able to tailor the infant’s diet to his/her real needs without exceeding them or, on the contrary, staying below them. Strengths: This is the first study, to our knowledge, that analyses the intakes of certain nutrients in breastfed vs. formula-fed infants using a single solid food intake pattern. This article can be helpful in providing better advice on offering solid foods for both breastfed and formula-fed infants to allow them the best possible growth.

6. Conclusions

The type of milk (or formula) the infant is fed from six to twelve months of age should determine the quality of the solid foods the infant in question is offered.

Exclusively breastfed infants should, therefore, be offered protein-rich foods such as meat, fish, pulses, cheese, and eggs from the beginning of the CF period. However, as these foods, in adequate quantities, do not meet iron and calcium requirements, the use of fortified cereals may be helpful.

Exclusively formula-fed infants, on the other hand, should not be offered such naturally rich or enriched foods from the beginning, since formula milk contains more than enough protein, iron, and calcium. On the contrary, formula-fed infants should be offered a greater variety of fruit and vegetables from the beginning to promote the development of their taste for different flavours, given that the formula flavour experience is more monotone.

In the second year of life (12 to 24 months), if HM is not available, a YCF can more easily meet the age-related nutrient intake recommendations than unmodified CM. Additionally, in this age group, it is important to avoid excessive protein intake and insufficient iron and calcium intake.

In conclusion, the statements of ESPGHAN [ 49 ] on the futility of proposing complementary feeding schemes that vary according to the type of milk feeding (because of fear of possible confusion on the part of adults) do not allow to fully meet the needs and nutritional recommendations issued by the main Agencies/Organizations/Societies for all children within this age group.

Furthermore, the proposals of WHO [ 47 ] and EFSA [ 48 ] on the possibility of using any type of milk from mammals available in the different regions of the world for infants in the 12- to 24-month age group, while understandable from the point of view of respecting local culture and local supply, should be accompanied by a few simple dietary recommendations to help meet the nutritional requirements of infants as best as possible, given the different compositions of milk from different mammals.

Since nutrition in this period of life is of crucial importance for the development of adult life and especially for a sound psycho-neuro-motor development of an individual, all existing scientific knowledge must be used at best to allow each child to reach his/her full genetic potential.

Acknowledgments

This article was written as a part of the scientific activities of the Italian Society of Preventive and Social Paediatrics. The authors thank Lucia Sollecito for the translation of the text. The authors also want to thank the (blind) reviewers, all of whom just spent nice words on our work: thanks to their wise suggestions, this paper could be improved much.

Supplementary Materials

The following are available online at https://www.mdpi.com/article/10.3390/nu13113756/s1 , Table S1: Supplement_Material_1_calculations_on_menus.pdf.

Author Contributions

Conceptualization, writing—original draft preparation and review and editing, M.C. and A.V.; formal analysis and data curation, M.A.T.; methodology, M.C.; resources, I.S., G.T., A.A., and A.M.; writing—original draft preparation and review and editing, M.C.V., G.D.M., and M.B. All authors have read and agreed to the published version of the manuscript.

This research received no external funding.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Conflicts of interest.

The authors declare no conflict of interest. Authors have not been financially supported for the design of the study; the collection, analyses or interpretation of data; the writing of the manuscript.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Home — Essay Samples — Social Issues — Breastfeeding in Public — Assessment of Nursing vs. Baby Formula

Assessment of Nursing Vs. Baby Formula

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Dairy Manufacturers Inc. Is Notifying Consumers About a Safety Concern With Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1) That is Part of an Ongoing Recall – Expansion of Previous Recall

COMPANY ANNOUNCEMENT

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Company Announcement

Dairy Manufacturers Inc., of Prosper, TX – 6/3/24, is notifying consumers about a safety issue associated with a product that is an extension of an ongoing voluntary recall ( https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-due-non-compliance-requirements-under-21 ). D-M initiated a voluntary recall on 05/24/24. Crecelac Infant 0-12 with an expiration date of 08/2025 was manufactured at D.M. Mexicana Sa De Cv in Monterey, Mexico and is part of this ongoing recall. D-M is now alerting consumers that a sample of this product has tested positive for Cronobacter spp .

Cronobacter is a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively. Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.

Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.

Crecelac 12.4 oz containers were distributed primarily in March, April, and May of 2024. The product was distributed through retail stores in the state of Texas only. The recalled product is labeled as infant formula and packaged in a 12.4 oz. cardboard and aluminum can.

Only the lot listed below had samples containing Cronobacter spp .

The recalled product can be identified by the batch code on the bottom of the can.

There have been no reports of injuries or adverse reactions due to consumption of these products.

Consumers who have purchased Crecelac Infant 0-12, should discontinue use of the recalled product and return it to the place of purchase for a full refund. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers with questions may contact the company at 1-972-347-2341 (Monday to Friday, 9:30 a.m. to 5 p.m. EST).

This recall is being made with the knowledge of the Food and Drug Administration.

We sincerely apologize for any inconvenience or concern this may cause and assure our customers that we are taking all necessary steps to ensure the safety, quality, and compliance of our products.

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FDA took months to react to complaint about Abbott infant formula factory, audit finds

FILE - A sign at an Abbott Laboratories campus facility is displayed, April 28, 2016, in Lake Forest, Ill. A report released on Thursday, June 13, 2024, says the U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide shortage of infant formula. (AP Photo/Nam Y. Huh, File)

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The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide shortage of infant formula, a new audit shows.

The Department of Labor received the email and three days later forwarded it to an FDA address specifically for such complaints. But one of several staff members charged with managing the FDA inbox at the time “inadvertently archived” the email in February 2021, and it wasn’t found until a reporter requested it in June 2022.

The episode is one of several that led the Department of Health and Human Services’ Office of Inspector General to conclude in a report Thursday that the FDA’s policies and procedures to address the issues at the Abbott plant were inadequate.

The FDA took some actions and did follow-up inspections but “more could have been done leading up to the Abbott powdered infant formula recall,” the auditors wrote. The FDA needs better policies for reporting the status of complaints to senior leaders and to make sure that inspections are done quickly, the report concluded.

“The key is, moving forward, FDA should be doing better, and the American public should expect better,” Assistant Inspector General Carla Lewis said in an interview.

Several infants were hospitalized, and two died, of a rare bacterial infection after being fed the powered formula made at Abbott’s Michigan plant, the nation’s largest. The FDA shuttered the site for several months starting in February 2022, and the company recalled several lots of popular formulas including Similac, Alimentum and EleCare.

FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols, but the agency never found a direct link between the infections and the formula.

The new report also found it took 102 days for the FDA to inspect the factory after receiving a different whistleblower complaint in October 2021. In that time, the agency received two complaints — one of an illness and another of a death — among infants who consumed formula from the plant, but formula samples were negative for cronobacter, the bacteria in question.

The FDA said in a statement that it agreed with the inspector general’s conclusions. In its own 2022 report, the agency acknowledged that its response was slowed by delays in processing a whistleblower complaint and factory test samples.

“It should be noted that the OIG’s evaluation represents a snapshot in time, and the FDA continues to make progress,” an FDA spokesperson said.

The FDA established a “critical foods investigator cadre, which will solely focus on the inspection and oversight of the infant formula (and other critical foods) industry,” the spokesperson said. It also started improving how it tracks hard-copy mail items, which can include complaints, the FDA said.

Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, said he agreed with the report’s recommendations, which include that Congress should give the FDA the power to require manufacturers report any test showing infant formula contamination, even if the product doesn’t leave the factory.

“Like anything else, there were mistakes made. But the government is working very hard, including the FDA. It’s fixing the gaps that existed,” Abrams said. “People have to be comfortable with the safety of powdered infant formula.”

AP Health Writer JoNel Aleccia contributed to this report.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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Lawmaker says watchdog’s report on fda handling of infant formula crisis confirms panel’s findings.

A House Oversight subcommittee says a federal watchdog’s audit of the Food and Drug Administration’s handling of the 2022 infant formula crisis verifies the panel’s findings that the agency bungled its response.

The report by the Inspector General of the Health and Human Services Department comes two years after the FDA’s investigation into the Abbott baby formula contamination that caused nine infant deaths and triggered a nationwide formula shortage in 2022.

“The long-awaited audit by HHS’ OIG confirms findings by the House Oversight Committee that the 2022 nationwide infant formula crisis was exacerbated by dysfunction and delay within the FDA ,” said Rep. Lisa McClain, Michigan Republican and chair of the subcommittee on Health Care and Financial Services.

“This audit confirms testimony by multiple former FDA officials before the subcommittee that the FDA’s failure to heed whistleblower warnings, failure to conduct adequate inspections, and slow responsiveness had serious implications,” she said.

Ms. McClain released documents obtained by the committee during a recent hearing with FDA Commissioner Robert Califf indicating that Biden administration officials knew about the infant formula shortage months before they took action.

Following the temporary closure of Abbott Nutrition in Sturgis, Michigan, a panic set in across the country when mothers sought baby formula for their infants, only to come across empty store shelves or sold-out website pages.

According to the report released last week by the HHS IG, the FDA either lacked policies or had inadequate policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection and recall processes.

The IG says the FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints in an efficient and effective manner, and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint.

Additionally, the FDA did not push forth an October 2021 whistleblower complaint to senior leadership, resulting in a nearly four-month delay before senior leadership was aware of the complaint.

The IG also found that the FDA did not have policies and procedures to establish timeframes for the initiation of “mission-critical inspections.”

The IG made nine recommendations to the FDA , including that it conduct better staff training on whistleblower policies, require periodic reporting to senior leaders about whistleblower complaints, and implement policies specific to the agency’s authority to recall infant formula.

The FDA , according to the IG report, agreed with the IG’s recommendations and findings that the agency had “inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes.”

The agency told the IG it did not have the “authority to require individuals and manufacturers to provide information that may have helped FDA to identify and respond to risks to the infant formula supply and that it “strongly agrees that adequate policies, procedures, and authorities are needed.”

Sen. Gary Peters, Michigan Democrat, in an effort to prevent another crisis, introduced legislation in early June called “Protect infant formula from contamination,” or the PIFCA Act.

• Kerry Picket can be reached at [email protected] .

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FDA "inadvertently archived" complaint about Abbott infant formula plant, audit says

By Kate Gibson

Edited By Anne Marie Lee

June 14, 2024 / 2:02 PM EDT / CBS News

The Food and Drug Administration "inadvertently archived" a whistleblower's complaint regarding conditions at an Abbott Nutrition plant that produced powdered baby formula recalled in 2022 due to bacteria that killed two infants, an audit shows.

An early 2021 email raised red flags about the plant in Sturgis, Michigan, that became the focal point of a nationwide shortage of infant formula when it was temporarily shuttered the following year . 

An FDA employee "inadvertently archived" the email, which resurfaced when a reporter requested it in June 2022, the U.S. Department of Health and Human Services Office of Inspector General said Thursday in a report .

"More could have been done leading up to the Abbott powdered infant formula recall," noted the auditor. 

It took 102 days for the FDA to inspect the plant after getting a separate whistleblower complaint in October 2021. During those months, the FDA received two complaints, one of an illness and the second a death, of infants who consumed formula from the facility. Yet samples tested negative for Cronobacter sakazakii , the bacteria in question. 

Several infants were hospitalized and two died of a rare bacterial infection after drinking the powdered formula made at  Abbott's Sturgis factory, the nation's largest . The FDA closed the plant for several months beginning in February 2022, and well-known formulas including Alimentum, EleCare and Similac were recalled.

FDA inspectors eventually found violations at the factory including bacterial contamination, a leaky roof and lax safety practices, but the agency never found a direct connection between the infections and the formula. 

The FDA concurred with the report's findings, but noted it was making progress to address the issues behind delays in processing complaints and testing factory samples. 

Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, agreed with the report's recommendations, including that Congress should empower the FDA to require manufacturers to report any test showing infant formula contamination, even if the product doesn't leave the factory.

"Like anything else, there were mistakes made. But the government is working very hard, including the FDA. It's fixing the gaps that existed," Abrams told the Associated Press. "People have to be comfortable with the safety of powdered infant formula."

Separately, recalls of infant formula from varied sources have continued. 

In January, 675,030 cans of Reckitt/Mead Johnson Nutrition's infant formula sold in the U.S. were recalled after health authorities confirmed cronobacter was found in cans imported into Israel from the U.S. 

More recently, a Texas firm earlier this month expanded its recall of Crecelac, a powdered goat milk infant formula, after finding a sample contaminated with cronobacter.

—The Associated Press contributed to this report.

Kate Gibson is a reporter for CBS MoneyWatch in New York, where she covers business and consumer finance.

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