What Are You Feeding Your Baby????

European Baby Formula That Is Illegally Sold in the United States Carries Risks, Pediatricians Warn

HiPP, Holle and other brands are not registered with the F.D.A., but that hasn’t stopped parents from buying them from third-party vendors.

By Christina Caron and Jessica Grose

For Jessica Bates, 40, a first-time mother in Washington, D.C., it was an easy decision to stop feeding her 2-month-old son American infant formula and to switch to HiPP, a brand headquartered in Germany: Not only did her nanny recommend it to ease digestion, mothers were raving about European formulas on social media.

Buying HiPP online was also easy.

Deciphering the German label was not.

Ms. Bates and her husband could not understand the directions. Further complicating matters, they lost the scoop that came with the container. So they grabbed the scoop from a container of American formula, only to later learn it was larger than the scoop HiPP provided.

“Basically we made it too thick for him the first couple of times and he projectile vomited all over us and we were like, ‘Oh my God, what have we done?’”

They soon figured out the right ratio of powder to water. And even though each 500g container of organic HiPP formula cost nearly $40 — about 80 percent more than the organic American brand Earth’s Best — they stuck with it.

“I think in the moment I was just desperate to make things go as well as possible for him,” said Ms. Bates, who had struggled to breastfeed after her emergency C-section and ended up relying exclusively on formula. To her, the European formulas seemed “more natural,” she said — more like breastfeeding.

In searching for the best alternative to breastfeeding, some parents are turning to formulas produced by European brands like HiPP and Holle, which are assumed to be superior to those made by American companies. But according to representatives from HiPP, Holle and Töpfer, these products are not registered with the Food and Drug Administration and do not have official distribution channels in the United States. That means importing and selling these formulas in the United States is illegal, the F.D.A. said. But they are still entering the country via third-party vendors.

The potential dangers are numerous. Children can fall ill or become malnourished if parents inadvertently use an incorrect formula-to-water ratio; unofficial formula vendors may not store the powdered formula properly, raising the possibility of bacterial contamination, product deterioration or loss in nutrient density; there is no system in place to notify consumers in the United States if any of these formulas are recalled; and while many European formulas contain the nutrients required in the United States, some do not. In addition, parents in the United States may not realize that European formulas labeled hypoallergenic aren’t meant for children with cow’s milk allergies.

Dr. Steven Abrams, chair of the committee on nutrition at the American Academy of Pediatrics and director of the Dell Pediatric Research Institute in Austin, Tex., said he would “strongly discourage” parents from using formulas that aren’t regulated by the F.D.A.

Infant formula “has to be absolutely nutritionally complete and handled in a very safe way, from the moment of manufacture to the moment it gets into their house and into the baby,” Dr. Abrams said. “The laws and the rules exist for a reason. And that’s because even a single mistake in any of this will just have terrible outcomes for babies.”

Bypassing F.D.A. requirements

It is unclear whether any American infants have become ill after consuming European infant formula because products that are not registered with the F.D.A. are not monitored by the agency. However, in 2016 and 2017, the F.D.A. was notified of six adverse events linked to imported European formulas: three from HiPP, two from Holle and one from Lebenswert. The complaints included fever, vomiting, diarrhea, lethargy and salmonellosis. While there is no conclusive link between these products and the reported illnesses, the adverse events were concerning to Dr. Dina M. DiMaggio, the lead author of a recent study that compared European formulas with F.D.A labeling and nutrient requirements.

In the study, published in May in the Journal of Pediatric Gastroenterology and Nutrition, Dr. DiMaggio and her colleagues contacted third-party vendors selling to United States consumers to determine their most popular European infant formulas. They then examined 14 of the most frequently purchased European powdered formulas imported into the United States, including ones distributed by HiPP, Holle, Lebenswert and Töpfer. None of the 14 formulas studied met all of the F.D.A.’s labeling requirements: nine of the formula labels, for example, were not written in English and 10 of the 14 formulas did not have all of the required nutrients listed on their labels.

“Parents should turn to their pediatricians to find out what’s the best formula,” she said. “We’re finding that that’s not the case. A lot of pediatricians don’t know that parents are using European formula.”

The study also noted another potential problem: European formulas labeled hypoallergenic, like HiPP HA Combiotik, contained partially hydrolyzed milk proteins. Although these proteins were once believed to prevent food allergy, they are not meant for children with cow’s milk allergies and would not be labeled hypoallergenic in the United States.

“In the U.S., for a formula to be considered hypoallergenic it has to undergo clinical research trials and be able to demonstrate that 90 percent of those with cow’s milk allergies will tolerate it,” said Marion Groetch, the director of nutrition services at the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai in New York City. These formulas, which are either extensively hydrolyzed or amino acid-based, are usually only available via prescription in Europe, Ms. Groetch added.

‘Parents are being misled’

The F.D.A. maintains a “red list” of international infant formulas that will be detained if they are imported into the United States because they fail to meet the F.D.A.’s nutrient and labeling requirements. It includes formulas from HiPP and Holle.

But third-party vendors keep bringing them into the country. The formulas can be found on eBay, European websites that ship to the United States and American websites that import the formula for commercial use despite the F.D.A.’s restrictions. And once this formula leaves a company’s official distribution channel, the “chain of control” is lost, said Dr. Anthony F. Porto, a pediatric gastroenterologist and associate professor of pediatrics at Yale University who was one of Dr. DiMaggio’s co-authors.

Holle’s website even includes a disclaimer for consumers in the United States.

“We regret that we are not able to address any of your concerns,” the website says, adding that if customers in the United States have purchased Holle from a retailer not listed on the company’s homepage, “kindly direct your inquiry at the retailer from whom you have purchased the product.”

The laws on infant formula importation are somewhat hazy. While Customs and Border Protection says on its website that commercial imports of baby formula require registration with the F.D.A., it also notes that “these requirements do not apply to food accompanying a traveler into the U.S. or sent by an individual to someone in the U.S.”

“I didn’t really care what the science said or nutritionally what was in there as long as he was taking it and it was sustaining him,” said Dr. Christina Garza, 40, who used Holle after her breastfed son developed blood in his stool. “There was all this pressure to produce this ‘pure’ food for my kid that wasn’t going to upset his digestive tract.”

Online testimonies expounding on the benefits of European formula are numerous — in some cases, the formulas are touted by bloggers who partner directly with the third-party sellers and profit from affiliate links.

Dr. DiMaggio and Dr. Porto became interested in European formulas after they noticed parents choosing to give their infants HiPP and Holle — and saw the brands popping up in conversations in Facebook parenting groups.

The HiPP & Holle Formulas Parent Support Community Facebook group, for example, has nearly doubled since last year and now has more than 10,000 members.

In a separate study presented in April at a national pediatrics conference, the two doctors collaborated with Dr. Nan R. Du, a pediatric resident at Yale New Haven Children’s Hospital, and other colleagues to survey 552 families at Pediatric Associates of NYC, a large private pediatric practice where Dr. DiMaggio works. Of the 372 families who used formula, 20 percent said they were currently using European infant formulas. The survey, which was conducted between November 2017 and March 2018, showed that the two most commonly used brands were HiPP and Holle, the researchers said.

White mothers with college degrees and household incomes greater than $200,000 were the ones most likely to use European infant formulas, according to the survey.

The families’ reasons for choosing European brands included the perception, perpetuated by blogs and social media groups, that European infant formulas contained higher-quality ingredients. In some respects, food safety standards for products sold in the European Union are stricter than those imposed by the F.D.A. But there’s no scientific evidence that imported European formulas are better for babies, pediatricians have said.

“Parents are being misled in their exhausted, 3-o’clock-in-the-morning-my-child’s-not-sleeping-Googling-state,” Dr. Porto said.

Buyer beware

Although the F.D.A. does not approve infant formulas, all formulas marketed in the United States must meet federal nutritional requirements.

Each of the European formulas in the May study met these requirements except for Töpfer Bio 1, which listed less than the F.D.A.-required amounts of vitamin A and copper, the study authors reported. The researchers also noted that they could not determine the levels of linoleic acid, a fatty acid that is important for brain development, for 10 of the 14 formulas because they were not listed on the manufacturer’s websites nor on the labels. Those that did include linoleic acid on the label had levels that fell within the accepted F.D.A. range.

Overall, the researchers’ main concern was not necessarily with the formulas’ composition, but with the way they are entering the country and how the labels are being interpreted.

If a formula were recalled in Europe, consumers in the United States would be unlikely to hear about it right away. The French dairy company Lactalis pulled more than 7,000 tons of potentially contaminated baby formula and other powdered milk products across more than 80 countries during 2017 and 2018. This year it issued another recall.

The European Union has been criticized for lax oversight of industrial food companies and weak reporting standards, especially since European governments generally allow food companies to self-report problems to regulators. In the Lactalis case, neither the company nor regulators identified the problems before they reached consumers.

One centralized place to find recall information in Europe is the Rapid Alert System for Food and Feed consumer portal, but it does not disclose the names of companies or brands. Those can be found in the alerts generated by each country.

Routine monitoring of powdered infant formula is especially important because powdered formulas cannot be sterilized and are at risk for contamination.

“If you’re getting them from the internet, you don’t know where they’ve been stored, you don’t know how they’ve been transported,” Ms. Groetch said. “You don’t know whether they’re going to last until their expiration date if they’ve been held at very high heat.”

Felix Kurichithanam, a spokesman for Holle, said the company is making plans to register with the F.D.A. and enter the American market in 2020. It aims to make its formula available in brick-and-mortar stores and also online through the company’s distribution channel, currently not available in the United States.

Are European formulas any better?

According to Dr. Abrams, the United States has such a wide variety of infant formulas there’s no need to purchase it from Europe.

“There isn’t something magical about these European formulas. Every single type of formula that they have there exists in numerous different versions in the United States,” he said.

Parents who are looking for organic formula or formula derived from grass-fed cows can find those options in the United States as well, he said, although there is no research to suggest that those types of formula aremore nutritious.

“It’s not like you’re buying cow milk off the shelf,” Dr. Abrams said. “All these formulas, especially the partial hydrolysates, are heavily processed. What the cow’s eating doesn’t really affect much of anything.”

Some babies tolerate certain formulas better than others, so it’s common for parents to experiment a bit to find the best one — especially if their child appears to be uncomfortable.

Dr. Garza, whose son was experiencing gastrointestinal distress, used American formulas before discovering that her son seemed to like Holle better.

“Even as someone who’s trained in evidence-based medicine — you know what? If it’s working anecdotally for someone and it will get me sleep and my kid will not be pooping blood, I’ll try it,” she said.

But Dr. Abrams cautioned parents to first speak with their pediatricians and try a brand that is registered with the F.D.A. rather than a European brand sold by a third-party vendor.

“There simply is not any suggestion of a health benefit that is provided by these formulas that is not provided by a U.S. formula,” he said.

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