Fancy Baby Foods Claim to Protect Kids From Developing Allergies. They’re a Scam.
Reading Time: 6 minutesParents, Don’t Get Caught Up in This Expensive Baby Food Craze, Why SpoonfulOne and Inspired Start have me worried as a doctor., How baby food products like SpoonfulOne that claim to protect against allergies can backfire
In my allergy clinic this past spring, the 7-month-old infant, Ava, was calm, but her parents were nervous. A month earlier, they had given her SpoonfulOne, a product that introduces babies to small doses of allergenic ingredients early on, with the hope it will prevent future bad reactions from occurring.
Within a few minutes of ingestion, Ava (not her real name) had facial swelling and wheezing, and her parents called 911. After an epinephrine injection, she was monitored in the emergency room for several hours until her symptoms resolved. Now they were in my clinic.
Sadly, this child is not unique. Over the past few years, I’ve been seeing such cases with increasing frequency. Adding to my frustration is that there is no evidence that SpoonfulOne, the most popular commercial product for early food introduction, or its competitors—Ready, Set, Food! and Inspired Start— actually accomplish their stated purpose of protecting babies against food allergies. In fact, SpoonfulOne has, under scrutiny about its effectiveness, paused its operations in the United States, though already-distributed products remain on shelves. (The company claims that the pause is due to demand being ‘higher in international markets,’ and notes on an FAQ page that ‘like any food, it’s possible a child could have a reaction to SpoonfulOne if they’ve already developed a food allergy when they try it.’)
Products from these brands are supposed to be ingested daily. Usually the food allergens are placed in powders, which can then be mixed with food, breast milk, or formula. For some products, the food allergens are already blended into food pouches, oat crackers, or food puffs.
These foods and powders have sprung up in response to the epidemic of food allergies currently exploding across the United States. Whereas food allergies were incredibly rare a generation ago, researchers now estimate 1 in 13 children in the US—5.6 million—have food allergies. This results in over 200,000 emergency room visits and multiple deaths every year.
I see these children as patients everyday. Many are anxious, and feel socially ostracized from activities—sports, camps, birthday parties—their friends take for granted. Their stressed-out parents are desperate for solutions. The reason for the rise in food allergies is unclear, but a possible explanation posits that our environment is hyper-sanitary, so kids aren’t exposed to microbes that help regulate the immune system.
The early-food introduction movement began in 2015, when a landmark study found that introducing peanuts between the ages of 4 and 11 months reduced the risk of developing peanut allergy by 70 to 80 percent. This finding was specific to infants with risk factors for peanut allergy, such as severe eczema or egg allergy. It directly contradicted what the American Academy of Pediatrics (AAP) had been recommending between 2000 and 2008, when it advised delaying peanut introduction until age three. This now erroneous guidance likely contributed to the skyrocketing rates of peanut allergy, which tripled between 1997 and 2008. In 2017, the AAP shifted to recommending that infants at high risk for developing a peanut allergy be introduced to peanut products as young as four months, which the organization noted could have ‘a potentially huge public health impact.’ As a result, researchers started asking whether the early introduction of other allergens could make a difference, too.
Companies like SpoonfulOne ostensibly formed to solve a serious societal problem. Keen to cash in on the early food introduction craze, their promise of all-in-one convenience, combined with slick advertising and favorable media coverage—Ready, Set, Food! famously procured an investment from Mark Cuban on Shark Tank—dupes upwardly mobile families into shelling out large sums, including more than $800 a year for a supply of SpoonfulOne.
Costs aside, introducing SpoonfulOne or its competitors to a child runs counter to current national allergy society and Centers for Disease Control and Prevention guidelines. After 6-month-old infants demonstrate an ability to successfully eat common foods like carrots, squash, and peas, doctors advise that allergenic foods can be introduced into the diet gradually, one new food every three to four days, with the idea that, as in the case of peanuts, introducing all allergenic foods early in life may prevent food allergies. Also, this way, if an allergic reaction does occur, the culprit is easy to identify—a concept early food-introduction products, presenting multiple food allergens at the same time, carelessly ignore. Upon reviewing the sixteen allergenic ingredients in SpoonfulOne, I realized it was going to be tough figuring out which food—or foods—elicited my patient Ava’s reaction.
But it’s not just that these products can be risky—they also might not work. In October 2020 the FDA sent Before Brands, the manufacturers of SpoonfulOne, a warning letter for making unauthorized health claims; SpoonfulOne had declared it was ‘the most complete food allergy protection system’ and that it ‘helps protect children from developing a food allergy.’ The FDA pointed out that any claims of mitigating the risk of acquiring food allergies had to be limited to a single scenario: an infant with egg allergy and/or severe eczema, where data showed that the early introduction of peanuts definitively reduced the likelihood of an allergy. After the letter, SpoonfulOne walked back their assertions, instead stating that using their products increased the production of food-specific IgG4, a protective antibody—an obscure fact that, while at least true, doesn’t necessarily tranMediaDownloader into meaningful differences in avoiding the development of food allergies. Nevertheless, most parents I talk to still believe, in a testament to the success of its sales pitch, that SpoonfulOne is a panacea against food allergies.
A 2022 study was particularly damaging to SpoonfulOne’s claims. Scientists analyzed the protein content of a number of different early introduction food products. They found that peanut, cashew, hazelnut, walnut, milk, and sesame allergens were incredibly low in the SpoonfulOne food puffs: less than 1 microgram of food allergen per gram of food puff. Amounts of food allergen protein in Inspired Start products that the researchers tested were similarly miniscule. Importantly, these products not only had levels lower than what would theoretically be needed to be protective, but also had levels far lower than what was stated on the packing. In October 2022, these conclusions along with other factors inspired a class-action lawsuit against Before Brands for making fraudulent claims; shortly after SpoonfulOne ceased its operations in the US.
Meanwhile, over in England, a consortium of allergy organizations, led by the British Society for Allergy and Clinical Immunology, voiced similar concerns as the FDA, casting doubt on the questionable marketing and insufficient quantities of food protein. In response, SpoonfulOne immediately suspended their plans to roll out their products in the UK. This was in 2021. If only the American Academy of Allergy, Asthma, and Immunology, our national allergy organization, was similarly principled in taking a stand, we would not be in this current quagmire, where parents of young children in the US pay exorbitant sums for problematic products.
From my perspective, products like SpoonfulOne are all downside. At best, a child will have no reaction and may or may not be protected in the future. And when a child has a bad reaction, it can result in a traumatizing trip to the ER, and then the ongoing dilemma of figuring out the culprit allergen. Indeed, while levels of food allergens may be low in these products, it is still all too possible for a child to have an adverse reaction to them. The majority of the time, skin tests can suss out the causative food. However, when the skin testing is equivocal, I order blood tests, and if necessary, perform oral challenges, where a child is given a food in increasing doses over three or four hours, under my supervision, so I can treat any reactions that occur.
For Ava, due to her eczema, the initial skin testing was indeterminate, so we performed five oral challenges over two months, until I identified an almond allergy. In addition to being a time sink for Ava’s family, the sheer number of oral challenges prohibited other children from getting timely appointments–with a dearth of allergists nationwide, it can take months to schedule an oral challenge. When Ava turned two, her parents opted for oral immunotherapy, and she is now able to tolerate almond well enough that an accidental ingestion won’t land her in the emergency room.
To prevent experiences like Ava’s from occurring, the best thing is to avoid these products altogether. Instead, like our ancestors have been doing for thousands of years, parents should feed young children mashed up or cut-up bits of the actual foods themselves, one at a time, rather than expensive mystery products.
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