Neocate rickets and other skeletal problems may be side effects of these formula products, according to scientific studies and consumer reports.

Neocate formula products are advertised as hypoallergenic alternatives to traditional formula, recommended for infants and children with allergies to milk or soy. The proteins in the elemental formula products are reportedly broken down into amino acids which bypasses any sort of allergic reaction or intolerance to certain proteins.

Nutricia North America sells a variety of Neocate formulas which they claim to support “normal growth and development”. Products in the Neocate line include Neocate Syneo Infant, Neocate Infant DHA/ARA, Neocate Nutra, Neocate Junior, Neocate Junior with Probiotics, and Neocate Splash.

Nutricia states that the formula “is specially formulated for the dietary management of infants with cow milk allergy (CMA), multiple food allergies (MFA) and related GI and allergic conditions, including food protein-induced enterocolitis syndrome (FOIES), eosinophilic esophagitis (EoE) and gastroesophageal reflux (GER).”

Over the past few years, scientific evidence and consumer reports have suggested that the hypoallergenic formula products can lead to Neocate rickets. Rickets is a condition involving the softening or weakening of bones in children and is often associated with long term vitamin D deficiency. Vitamin D assists with the absorption of calcium and phosphorus, two minerals which are essential for bone health.

In 2017, a study was published in the journal Bone reported that children given Neocate presented with hypophosphatemia, a condition of dangerously low phosphate levels. Hypophosphatemia is connected to a low bone density which can, in turn, lead to rickets, skeletal deformities, stunted growth, and broken bones.

The study, which was conducted by Yale University and the Mayo Clinic, found that the phosphate contained in Neocate was not sufficiently absorbed by children. 51 children in North America and Ireland who were fed Neocate infant formulas as their primary source of nutrition were analyzed by the study. Of this number, researchers reported 94 percent of children presented with rickets, broken bones, or low phosphate levels.

Luckily, researchers noted that “most all improved with the addition of supplemental phosphate or change to a different formula.”

Due to their findings, researchers concluded that “bioavailability of formula phosphorus may be impaired” which lead to the malabsorption of phosphate in the studied children.

Since the study was published, Nutricia has recommended that children on Neocate should have their nutrient levels monitored.

“Serum levels of micronutrients, particularly phosphorus, should be routinely monitored by clinicians when Neocate is used as a primary or sole source of nutrition for patients with complex systemic disease involving multiple diagnoses and intestinal disease, especially in combination with tube feeding and/or a history of prematurity,” Nutricia’s website states.

Some consumers argue that, although the company now requires monitoring, it is too little too late. They claim that Nutricia should fully warn parents and doctors of the risk for Neocate rickets, actions that the company has not yet taken. The company reportedly continues to deny that their formulas may cause hypophosphatemia and argue that the small scale of the Yale/Mayo Clinic study means that the results were inconclusive.