Bay Area moms circumvent FDA with imported European infant formulas

I was standing on the back patio of a trendy Marina bar last fall, swirling my mocktail at a happy hour for my oldest child’s preschool, when the talk turned to my heavily pregnant belly.

“If you use formula, Germany’s Holle or HiPP are pricier, but the absolute best,” a mother declared. “My baby’s poop looks and smells incredible since we switched!” All the mothers around me cooed in agreement. One leaned over to furtively whisper the name of a website where she bought her supply.

When researching formula for my first child, now nearly 4 years old, I had never heard of these brands. (I’d never analyzed the quality of his poop, either.) In fact, I’d never asked other mothers about infant formula. In the “breast is best” era, merely to admit I was using it felt stigmatizing. Yet the national Centers for Disease Control and Prevention reports that 83% of babies will take some formula in their first year.

In the Bay Area, affluent, health-conscious mothers are increasingly eschewing American formulas and going to extreme lengths to import organic German formulas not approved by the U.S. Food and Drug Administration. They’re ordering off obscure websites, bartering for boxes on local parenting forums and even flying to Europe on shopping trips.

“This is the most obvious in-your-face black market of our generation,” says Laura Modi, a San Francisco entrepreneur whose startup, Bobbie, will produce formula that Modi says surpasses the German brands in quality. “It’s done by the most respectable group of people we know: new moms.”

The FDA mandates that all infant formulas sold in the United States meet the requirements of the Infant Formula Act and associated regulations, which starts with registration and premarket notification to the FDA. “Without such registration and notification, the products cannot lawfully be distributed in the United States,” an FDA spokesperson says.

Because foreign manufacturers like Holle and HiPP have not taken these preliminary steps, batches are sometimes held up at customs. The FDA spokesperson explains holds are necessary because without FDA review for safety and nutrient content, these formulas could “present a high risk to this vulnerable population.” Additionally, the spokesperson points out, “these infant formulas typically are imported into the United States by third-party distributors, which introduces additional uncertainties about how the infant formulas have been handled.”

For parents not dissuaded by the FDA’s concerns, there are also high international shipping rates and premium product pricing to consider. A box of Earth’s Best Organic Infant Formula, a high-quality U.S. brand, is about $1.20 per ounce at Target compared with $1.77 per ounce for one box of Holle from a website online; Holle is 47.5% more expensive in this scenario, which adds up quickly given how much babies consume.

Why go to these lengths? “When it comes to your child you’ll do anything,” Modi says. Many German formula devotees are doing it to help with their children’s dietary sensitivities.

Karla Moreno, registered dietician at Zuckerberg San Francisco General Hospital, says that a year ago, she had to supplement breast milk with formula for her then 4-month-old son, who had milk allergies. The brand her pediatrician recommended smelled and tasted disgusting, she said. Giving it to him was “going against everything that I believe.” It did little to quell his allergy symptoms.

Despite extensive research she couldn’t find a better option, until a midwife recommended Holle’s hypoallergenic blend. Not only was it more appetizing, but within three bottles her son’s discomfort was gone.

She began importing the formula from a popular online store. For her, it was well worth spending an additional $20 a week to get the premium foreign product. “If you really want to, there’s a lot of ways you can save 20 bucks,” she says.

According to Moreno, American formula brands are all basically the same when it comes to calories, fat, protein and carbohydrate profiles. That’s because the FDA has strict requirements around the nutritional composition of infant formula. Where the formulas differ is in the quality of the ingredients used to satisfy those nutritional components.

She likens standard U.S. formula to supermarket beef and Holle and HiPP, to organic, grass-fed, locally sourced steaks. Holle formula boasts a Demeter certification, meaning it has been produced according to strict biodynamic farming standards. Likewise, Moreno says that not only is HiPP non-GMO, but it “even tests other crops in the area to make sure none of them test positive for GMOs.” This ingredient transparency is hard to find in U.S. brands.

“There’s this huge guilt about switching to formula,” says Nika Manabat, who has partnered with a U.S. importer of Holle and HiPP to sell a reliable supply at Joeys on the Go, her kiosk in Santa Clara, and pop-up in San Ramon, that specialize in eco-friendly baby products. “From my experience, I’ve heard that if moms can provide their babies with the best formula, it lessens that guilt a little bit.”

San Francisco parent Jenny Cohen, who works for an education nonprofit, questions why the guilt is there to begin with. She sees the obsession with the European formulas as yet another step down the slippery slope of mommy shaming.

“As a community, when it comes to parenting, I would love to get away from the concept of ‘best.’” she says. “I think the implicit suggestion if you ask what’s the best is that if someone does something different from that then it’s not the best … there’s this implicit judgment happening.”

Modi, a former employee at Google and Airbnb, admits she used to lie to her San Francisco peers about how she fed her baby, pretending bottles were filled with pumped breast milk instead of formula. “I did not want to come across as a bad parent. In reflection, it’s shocking.” The idea for Bobbie came to her after listening to her family in Ireland speak openly and proudly about using formula. She realized that it didn’t have to be an inferior, shameful sustenance.

When doing research, Modi learned that the European Medicines Agency, the European Union’s equivalent to the FDA, has higher manufacturing and ingredient standards than the FDA. American formula companies frequently rely on corn syrup as a source of carbohydrates and are able to source cow’s milk — a main ingredient — from thousands of dairy farms, making it virtually impossible to track quality.

After an extensive study of the industry, Modi concluded that there were too many hurdles to produce a premium product in the U.S., so she is manufacturing Bobbie’s formula in Germany, using some of the same sourcing as Holle and HiPP. It features fewer ingredients, forgoing all corn syrup and soy and, unlike German brands, eliminates starch as well. Bobbie will be priced to compete with premium USDA Certified Organic brands like Honest Company and Plum Organics.

"Those mothers who have invested all that time into breastfeeding don’t want to feed their kid corn syrup,” Modi says.

When Bobbie launched in May, it had thought itself exempt from FDA approval because it is positioned as a companion formula, designed to supplement breast feeding rather than replace it. However, because it is manufactured in Germany, it does not meet all of the U.S. requirements to be labeled an infant formula. The company has since pulled its product from the market and is working alongside the FDA to re-label as toddler formula instead of infant formula. Its signature recipe will remain unchanged.

Meanwhile, baby-store owner Manabat says formula sales make up about half the total business of her Joeys on the Go, spread entirely by word of mouth. “It’s not that I have to force or convince people to get” these formulas, Manabat says. “They’re looking for it.”

But do they need it? For babies with food sensitivities, anecdotal evidence points to a resounding yes. But for many other babies, it seems to be the parents who need German formulas for the reassurance it gives them — in the quality of the ingredients as much as the implied quality of their parenting.