Science & Research

Formula Safety

It has been recognized that families seeking something else are resorting to potentially dangerous practices, such as homemade infant formulas or attempting to access European formulas.  Else toddler formula addresses product and ingredient concerns that often lead families down this path. While Else toddler nutrition is intended for use in babies older than 12 months, Else scientists recognize the need for a similar infant formula and have initiated product development for FDA submission.  

 

Suggested Readings:

DiMaggio DM, Du N, Scherer C, et al. Comparison of imported European and US infant formulas: labeling, nutrient and safety concerns. J Pediatr Gastroenterol Nutr. 2019;69(4):480-6. This study was conducted in response to reports of concerns from the AAP regarding trends in use of non-FDA registered and imported infant formulas.  The authors identified pertinent blogs and vendors to determine most frequently recommended brands and compared the formula label to FDA labeling and nutrient requirements. Of 16 identified formulas, none met all FDA labeling requirements and no formula listed nutrients in the US required unit of measurement. For nutrients that were listed on the formula label, the label claimed levels fell within FDA requirements for 15 of the 16 formulas. Only 5 of 16 formula labels were in English. This study highlights the need to address safety of imported formulas as well as alternative formula options to address needs of families seeking imported infant formulas. 

Abrams SA, Daniels SR. Protecting vulnerable infants by ensuring safe infant formula use. J Pediatr. 2019;211:201-6. This commentary article describes the conundrum between avoidance of marketing for breast milk substitutes and the hazards of not providing proper education on formula use to parents. The authors reveal an increasing distrust on the internet of FDA regulated infant formulas by American families.  This has led to illegal importation of European and other non-FDA regulated formulas.  The authors suggest six specific actions to improve formula safety in the US: (1) Provide multidimensional education programs to clinicians and parents; (2) Increase information via government and industry sources regarding contamination risks; (3)Protect WIC from potential perceived threats; (4) Mandate that the government provide clarity on infant formula costs; (5) Fund research via DHHS and USDA for comprehensive aspects of formula feedings; (6) Monitor social media misinformation and utilize HCPs to provide correct information. 

Hojsak I, Bronsky J, Campoy C, et al. Young child formula: a position paper by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2018;66(1):177-85. ESPGHAN conducts a review systematically on young child formula (YCF) designed for children ages 1-3.  The composition of YCF is not regulated like follow-on formula or infant formula in Europe and therefore can provide a range of nutrient concentrations.  ESPGHAN notes that the risk of overnutrition exceeds that of undernutrition in European countries; therefore, the authors call for a decrease in protein and energy concentrations of YCF based on animal protein. ESPGHAN also recommends limiting added sugars to these formulas, and that they be no sweeter than lactose nor greater than 5% added sugar.  

The authors note that while YCF may not be indicated for most children, YCF may be beneficial for those needing nutritional balance or fortification of foods with vitamins/minerals. Particularly, this may be pertinent for children on plant-based diets or those needing an enhanced nutrient supply of omega-3 fat, iron, iodine, and vitamin D.  ESPGHAN suggests avoidance of calling plant-based YCF “milks” and encourage the use of the term “formulas”.  ESPGHAN is working with CODEX ALIMENTARUS to further address these gaps internationally. 

Koletzko B, Baker S, Cleghorn G, et al. Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group. J Pediatr Gastroenterol Nutr. 2005;41(5):584-99.  This International Expert Group (IEG) was coordinated through ESPGHAN and the Codex Alimentarius Committee of the FAO. The IEG worked to consult international scientific community to provide evidence-based recommendations for the global composition of infant formula in comparison to healthy, exclusively breastfed infants. The expert group aimed to update Codex Standard 72 for infant formula, which was based on research from the 1970s. The authors revised recommendations into two categories: (1) normal infant nutritional requirements; (2) infants with special dietary requirements due to disease.  

IEG recommended that infant formula only contain components shown to have benefit or nutritional purpose as to not otherwise burden the metabolic/physiologic functions of the infant. Of note, the authors emphasize that unnecessary solutes burden the infant’s developing renal function and may reduce safety margins under physiologic stress.  The IEG set minimum and maximum recommendations for nutrient components, accounting for bioavailability and shelf life. The group emphasized that formula should not be modified beyond established standards without review by independent scientific groups. 

 This IEG provided thorough recommendations for vitamins/minerals and macronutrients.  Furthermore, the group defined limits for L-carnitine, inositol, choline, taurine, nucleotides, n3: n6, Ca: P, lauric + myristic acid, trans fatty acids, erucic acid, and essential amino acids.  Recommendations were further specified based on protein sources: cow’s milk protein, soy protein isolates, and hydrolyzed cow’s milk proteins.

Dupont C, Bocquet A, Tome D, et al. Hydrolyzed rice protein-based formulas, a vegetal alternative in cow's milk allergy. Nutrients. 2020;12:2654.

This article reviews the need for non-soy, non-dairy plant-based protein formulas as a formula for special medical needs, with a focus on the use of rice hydrolysate infant formulas in Europe for cow’s milk protein allergy (CMPA).  When the limiting amino acids were individually added to these formulations, infants studied in Italy, France, and Spain demonstrated growth comparable to infants fed standard formulas. Rice hydrolysate formulas are strictly regulated in the European Union as a food for special medical needs regarding content of arsenic or other contaminants.  However, since hydrolysates often increase intraluminal water secretion, thickeners such as pectin or corn starch must be added. This article outlines the importance of an alternate protein source for formulas in the United States, such as that of Else Nutrition products.   Dietary surveys have noted nutritional gaps in children ages 2-5 years with CMPA; the authors attribute this to a potential nutritional gap during diagnosis and management of CMPA between ages 0-24 months. 

Atkinson SA, Jiminez EY, Perez-Escamilla R. Evidence gaps and research need in current guidance on feeding children from birth to 24 months. Appl Physiol Nutr Metab. 2021; 46:294-297.

Atkinson et al. review recommendations from the 2020 National Academies of Science report with attention to potential gaps in evidence. Two topics in particular were identified to have inconsistencies in recommendations: introduction of allergenic foods and use of fortified formulas or supplements for vegan infants/toddlers.  The authors directly note that, "Use of supplements of certain nutrients for vegetarian/vegan infants and toddlers was often recommended but a need for fortified products or nutrient supplements was rarely discussed."  Future research questions should address how to fulfill nutritional gaps in the diets of these specific populations.