Generic Hypoallergenic Formula Can Help Ease Financial Burden for Formula-Feeding Families

Todd Mahr, MD

Director of Pediatric Allergy/Immunology
Gundersen Health Systems
La Crosse, Wisconsin


The first year of an infant’s life is perhaps the most important, as babies will triple their birth weight. That is why the US Dietary Guidelines for Americans and the American Academy of Pediatrics (AAP) recommends breastfeeding for the first 6 months of life, with continued breastfeeding when introducing complementary foods until 12 months old. 

But the reality of breastfeeding for long periods of time can be challenging, with 75% of babies receiving some formula by 6 months of age, according to the Centers for Disease Control and Prevention’s Breastfeeding Report Card. Unfortunately for many families, incorporating formula into an infant’s diet can be cost prohibitive, leading to food insecurity. And the COVID-19 pandemic has only compounded this issue. In fact, the economic impact from the ongoing pandemic has left many individuals struggling to afford basic needs like infant nutrition, with food insecurity rising 40% for households with children younger than age 12 years.1

Government programs such as WIC and SNAP can help but were always intended to be supplemental, so it is likely not enough. Further, some struggling families may be at the cusp of meeting qualifications or face logistical or cultural barriers to accessing these programs.

To make matters worse for many families is cow’s milk allergy (CMA), one of the most common food allergies during infancy.2 Infants with CMA require a hypoallergenic formula, which until recently was produced by a limited number of commercial name brands at a price exceeding US$200 a month, costing parents almost 3 times as much as routine formulas.3 Thus, it is easy to see how CMA can be a source of stress because of a milk-free diet, which, if not treated properly, can lead to a subsequent nutritional deficiency.4

It is important to note that now, for the first time in nearly 80 years, there is a clinically studied, generic, extensively hydrolyzed infant formula that provides complete nutrition and is clinically tested to provide more than 98% nonreactivity in patients with confirmed CMA.5

Available as store-brand hypoallergenic infant formulas nationwide, this new formulation meets US Food and Drug Administration (FDA) nutritional and AAP hypoallergenic standards, is manufactured in the United States, and provides a safe, effective, lower-cost option for families of infants with CMA. Additionally, it helps calm colic caused by CMA, contains expert-recommended DHA for brain support6 and probiotics to help support digestive health, and is gluten and lactose free.

Any concerns around recommending store-brand formulas is unfounded, as all infant formula sold in the United States must meet the same FDA standards for quality, safety, and nutrition. That means both store and name brands are acceptable feeding options for formula-feeding families.

Having a new generic hypoallergenic formula can help broaden the options for the dietary management of infants with CMA. As a result, pediatric health care providers should be prepared to discuss all feeding options with their patients’ families to increase consumer choice while providing more affordable access to complete infant nutrition.

For more information, visit


1. COVID Impact Survey: Week 1, National Findings. NORC at the University of Chicago. April 30, 2021. Accessed November 29, 2021.

2. Flom JD, Sicherer SH. Epidemiology of cow's milk allergy. Nutrients. 2019;11(5):1051.

3. Committee on Nutrition. Hypoallergenic infant formulas. Pediatrics. 2000;106(2):346-349.

4. Edwards CW, Younus MA. Cow milk allergy. In: StatPearls. StatPearls Publishing; June 29, 2021.

5. Barber C, Prieto PA, Wallingford JC. A double-blind, randomized, crossover allergy study of an extensively hydrolyzed casein formula. J Nutr Food Sci. 2018;8(6). doi:10.4172/2155-9600.1000736

6. Joint FAO/WHO Expert Consultation on Fats and Fatty Acids in Human Nutrition. Interim summary of conclusions and dietary recommendations on total fat & fatty acids. November 8-10, 2008.