Heavy Metal Certification for Infant Formulas: Aluminium Study Original paper

Researched by:

  • Dr. Umar Aitsaam ID
    Dr. Umar Aitsaam

    User avatarClinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting.

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October 7, 2025

Researched by:

  • Dr. Umar Aitsaam ID
    Dr. Umar Aitsaam

    User avatarClinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting.

    Read More

Last Updated: 2025-10-07

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Dr. Umar Aitsaam

Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting.

What was studied?

This original research article systematically investigated the aluminium content in prescription infant formulas available in the United Kingdom, with a particular focus on specialised products intended for vulnerable infants. The study’s primary aim was to quantify the total aluminium present in both ready-to-drink and powdered prescription formulas, many of which are formulated for infants with specific medical or nutritional needs such as prematurity, intrauterine growth restriction, poor weight gain, allergies, and intolerance. The researchers used transversely heated graphite furnace atomic absorption spectrometry (TH-GFAAS) to accurately measure aluminium levels following microwave-assisted acid/peroxide digestion. By comparing aluminium concentrations across 24 different formula products, the study sought to provide the first comprehensive dataset on the extent of aluminium contamination in prescription infant formulas and to evaluate whether contamination is an unavoidable aspect of infant formula production. The findings are highly relevant for heavy metal certification programs as they directly address the prevalence, variability, and possible sources of aluminium contamination in a critical category of infant nutrition products.

Who was studied?

The study did not involve human participants but instead focused on a wide range of prescription infant formula products. Twenty-four different ready-to-drink and powdered formulas were sourced through a paediatric clinic at Russells Hall Hospital, United Kingdom. These products were chosen to reflect the diversity of prescription formulas available for infants with unique nutritional and medical needs, including those for preterm infants, infants with intrauterine growth restriction, those requiring nutritional supplements for weight gain, and formulas tailored for allergies, intolerance, or amino acid supplementation. The study’s findings are thus directly applicable to the products consumed by some of the most vulnerable infant populations, highlighting potential exposure risks in clinical and home settings.

Most important findings

Critical PointsDetails
Aluminium was detected in all 24 prescription infant formulas tested, with significant variability in concentration.Ready-to-drink formulas had aluminium concentrations ranging from 49.9 to 1,956.3 µg/L; powdered formulas ranged from 0.27 to 3.27 µg/g.
Ready-to-drink nutritional supplements for infants with poor weight gain showed the highest aluminium concentrations.Some products, such as Abbott Nutrition PediaSure Plus Juice Apple, contained up to 1,956.3 µg/L aluminium, with servings delivering as much as 391.3 µg.
Powdered formulas addressing allergies and intolerance generally contained more aluminium than those supplemented with amino acids.For instance, Nutramigen Pregestimil Lipil (allergy/intolerance formula) had 3.27 µg/g, while SMA Nutrition Alfamino (amino acid formula) had only 0.27 µg/g.
Aluminium distribution was more homogeneous in powdered formulas compared to ready-to-drink forms.This was indicated by lower relative standard deviations in powdered products, suggesting more consistent contamination across servings.
Some prescription formulas contained the lowest aluminium levels ever measured in the laboratory.There are currently no established safe guidelines for aluminium exposure in infants, raising concern for this population.
The source of aluminium contamination remains unclear but may stem from ingredients, packaging, processing equipment, or fruit flavourings.Testing of whey protein hydrolysates (a common ingredient) revealed 4.1–8.1 µg/g aluminium, and fruit flavourings were implicated in higher aluminium levels in some supplements.
There are currently no established safe guidelines for aluminium exposure in infants, raising concerns for this population.The study reiterates that aluminium is toxic to humans and that infant exposure via formula is a significant public health issue.
Breast milk, in comparison, contains an order of magnitude less aluminium than any formula product tested.The authors advocate for breastfeeding where possible due to its much lower aluminium content.

Key implications

The study demonstrates that aluminium contamination is widespread but not inevitable in prescription infant formulas. Some specialised products achieve very low aluminium levels, setting a benchmark for manufacturers. These findings underscore the urgent need for heavy metal certification programs to set strict limits, promote industry transparency, and encourage best practices to reduce infant exposure.

Citation

Redgrove J, Rodriguez I, Mahadevan-Bava S, Exley C. Prescription Infant Formulas Are Contaminated with Aluminium. Int J Environ Res Public Health. 2019;16(5):899. doi:10.3390/ijerph16050899

Heavy Metals

Heavy metals are high-density elements that accumulate in the body and environment, disrupting biological processes. Lead, cadmium, arsenic, mercury, nickel, tin, aluminum, and chromium are of greatest concern due to persistence, bioaccumulation, and health risks, making them central to the HMTC program’s safety standards.