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Int. J. Environ. Res. Public Health 2019, 16, 899; doi:10.3390/ijerph16050899 www.mdpi.com/journal/ijerph
Article
Prescription Infant Formulas Are Contaminated with
Aluminium
James Redgrove 1, Isabel Rodriguez 2, Subramanian Mahadevan-Bava 3 and Christopher Exley 2,*
1 Life Sciences, Huxley Building, Keele University, Staffordshire, ST5 5BG, UK; jamesredgrove11@gmail.com
2 The Birchall Centre, Lennard-Jones Laboratories, Keele University, Staffordshire, ST5 5BG, UK;
i.rodriguez.nunez-milara@keele.ac.uk
3 Russells Hall Hospital, Dudley Group Foundation NHS Trust, Pensnett Road, Dudley, DY1 2HQ,
West Midlands, UK; s.mahadevan@nhs.net
* Correspondence: c.exley@keele.ac.uk
Received: 6 February 2019; Accepted: 10 March 2019; Published: 12 March 2019
Abstract: Historical and recent data demonstrate that off-the-shelf infant formulas are heavily
contaminated with aluminium. The origin of this contamination remains to be elucidated though
may be imported via ingredients, packaging and processing. Specialised infant formulas exist to
address health issues, such as low birth weight, allergy or intolerance and medical conditions, such
as renal insufficiency. The aluminium content of these prescription infant formulas is measured here
for the first time. We obtained 24 prescription infant formulas through a paediatric clinic and
measured their total aluminium content by transversely heated graphite furnace atomic absorption
spectrometry following microwave assisted acid/peroxide digestion. The aluminium content of
ready-to-drink formulas ranged from 49.9 (33.7) to 1956.3 (111.0) μg/L. The most heavily
contaminated products were those designed as nutritional supplements for infants struggling to
gain weight. The aluminium content of powdered formulas ranged from 0.27 (0.04) to 3.27 (0.19)
μg/g. The most heavily contaminated products tended to be those addressing allergies and
intolerance. Prescription infant formulas are contaminated with aluminium. Ready-made formulas
available as nutritional supplements to aid infant growth contained some of the highest
concentrations of aluminium in infant formulas measured in our laboratory. However, a number of
prescription infant formulas contained the lowest concentrations of aluminium yet measured in our
laboratory. These higher cost specialist preparations demonstrate that the contamination of infant
formulas by aluminium is not inevitable. They represent what is achievable should manufacturers
wish to address the threat posed to health through infant exposure to aluminium.
Keywords: aluminium contamination; infant formulas; infant nutirion; aluminium toxicity; human
exposure to aluminium
1. Introduction
It is five years since we last reported the significant contamination of infant formulas by
aluminium [1,2]. Recent research, though limited in its scope, suggests that off-the-shelf formulas
remain heavily contaminated [3]. There exists a wide range of specialised infant formulas that are
often only available through paediatric clinics and prescription. These are designed to address a
number of nutritional issues including low birth weight, perceived intolerances, gastrointestinal
disorders, allergies and renal insufficiency [4]. Many of these products are fed to vulnerable infants
under the expected guidance of a paediatrician. Some may be combined with medication [5].
Human exposure to aluminium is a serious health concern [6]. Aluminium exposure in infants
is understandably a burgeoning issue [7,8]. While infant exposure to aluminium continues to be
Int. J. Environ. Res. Public Health 2019, 16, 899 2 of 7
documented, its consequences, immediate and in the future, have received only scant attention [1,2]
and research is required to understand the biological availability of aluminium through formula
feeding. For example, how much aluminium is absorbed across the neonate gut and its subsequent
fate, including excretion.
There is already too much aluminium in infant formulas [1,2] and herein we have measured its
content in a large number of prescription formulas, products which are fed to vulnerable infants in
their first months of life. Many of these products are heavily contaminated with aluminium.
2. Materials and Methods
We obtained 24 prescription infant formulas through the Paediatric Clinic of Russells Hall
Hospital, Dudley, United Kingdom. Both ready-to-drink and powdered products were supplied as
pristine, unopened samples. They included ready-made drinks for preterm infants and those having
intrauterine growth restriction (IUGR), supplements in the form of ready-made drinks for infants
having poor weight gain, powdered formulas for allergy and intolerance and powdered formulas
with additional amino acids (see Tables 1–5 for brand names).
Each unopened product (to avoid potential extraneous contamination) was mixed manually
before being opened and sampled according to needs. The total aluminium content of all formulas
was measured by transversely heated graphite furnace atomic absorption spectrometry (TH GFAAS)
following acid/peroxide microwave digestion. Analytical methods and quality assurance data are
identical to those used previously in our laboratory [1,2,9] and so are not detailed here. Data are
presented according to product specialisation (Tables 1–4) and by way of comparing ready-made and
powdered formulations (Table 5).
3. Results
3.1. Ready-Made Drinks for Preterm and IUGR Infants
The concentration of aluminium (mean and SD) ranged from 49.9 (33.7) to 249.4 (64.0) μg/L while
the amount of aluminium per serving varied from 3.5 to 45.7 μg depending upon serving volume
(Table 1). The %RSD (relative standard deviation) was consistently high across all products and
probably reflects the inhomogeneous nature of the milks and the non-uniform distribution of
aluminium throughout the bulk volume.
Table 1. Aluminium in ready-to-drink infant formulas designed for preterm and intrauterine growth
restriction (IUGR) infants. Mean and SD are given, n = 5.
Brand [Al] μg/L
Mean (SD)
Al μg/Serving
(Serving Size mL)
Cow & Gate
Nutriprem 1 49.9 (33.7) 3.5 (70 mL)
Cow & Gate
Nutriprem 2 139.3 (143.6) 27.9 (200 mL)
Cow & Gate
Nutriprem Hydrolysed 167.1 (10.6) 15.0 (90 mL)
Danone Nutricia
Infatrini Peptisorb 228.5 (48.3) 45.7 (200 mL)
SMA Pro
First Infant Milk 249.4 (64.0) 17.5 (70 mL)
3.2. Ready-Made Drinks as Supplements for Weight Gain
The concentration of aluminium (mean and SD) ranged from 153.5 (161.3) to 1956.3 (111.0) μg/L
while the amount of aluminium per serving varied from 25.6 to 391.3 μg depending upon serving
volume (Table 2). Again the %RSD (relative standard deviation) was high across all but one product
Int. J. Environ. Res. Public Health 2019, 16, 899 3 of 7
and probably demonstrates the uneven distribution of aluminium throughout the bulk volume of a
product.
Table 2. Aluminium in ready-to-drink infant formulas designed as supplements for infants struggling
to gain weight. Mean and SD are given, n = 5.
Brand [Al] μg/L
Mean (SD)
Al μg/Serving
(Serving Size mL)
Danone Nutricia Fortini
Smoothie 709.6 (180.3) 141.9 (200 mL)
Danone Nutricia Fortini
Multi Fibre 703.4 (53.7) 140.7 (200 mL)
Danone Nutricia Fortini
Compact Multi Fibre Strawberry 568.2 (65.4) 71.0 (125 mL)
Danone Nutricia Fortini
Compact Multi Fibre Neutral 784.5 (121.7) 98.1 (125 mL)
Nutrinovo
ProSource TF Unflavoured 569.2 (18.1) 25.6 (45 mL)
Abbott Nutrition
PediaSure Plus Juice Strawberry 153.5 (161.3) 30.7 (200 mL)
Abbott Nutrition
PediaSure Plus Juice Apple 1956.3 (111.0) 391.3 (200 mL)
Nestlé Health Sciences
Resource Fruit 180.2 (62.5) 36.0 (200 mL)
3.3. Powdered Formulas for Allergies and Intolerance
The concentration of aluminium (mean and SD) in the powders ranged from 0.35 (0.03) to 3.27
(0.19) μg/g (Table 3). The amount of aluminium per serving varied from approximately 4–71 μg at
birth to 12–92 μg at six months of age. Where data were available aluminium per day ranged from
26–231 μg at birth to 47–367 μg at six months of age. The %RSD (relative standard deviation) for these
products were not especially high which suggested a more even distribution of contaminating
aluminium in powdered products.
Table 3. Aluminium in powdered formulas designed for infants with allergies and intolerances. Mean
and SD are given, n = 5.
Brand [Al] μg/g
Mean (SD)
Al μg/Serving *
Birth/6 Months
Al μg/Day *
Birth/6 Months
SMA Nutrition
Althera 0.46 (0.14) 6/14 53/69
Abbott Nutrition
Similac Alimentum 1.65 (0.76) 12/38 na/na
Cow & Gate
Pepti Junior 0.53 (0.40) 6/15 35/59
Nestlé Health Sciences
Peptamen Junior 1.48 (0.24) 71 (no age spec) na/na
Nutramigen
Pregestimil Lipil 3.27 (0.19) 39/92 231/367
Danone
Aptamil Pepti 1 0.35 (0.03) 4/12 26/47
SMA Nutrition
Lactose Free 1.07 (0.15) 13/35 77/106
* Based upon manufacturer’s instructions.
Int. J. Environ. Res. Public Health 2019, 16, 899 4 of 7
3.4. Powdered Formulas with Additional Amino Acids
The concentration of aluminium (mean and SD) in the powders ranged from 0.27 (0.04) to 2.23
(1.23) μg/g (Table 4). The amount of aluminium per serving varied from approximately 4–28 μg at
birth to 8–64 μg at six months of age. Where data were available aluminium per day ranged from 21–
167 μg at birth to 24–256 μg at six months of age. The %RSD (relative standard deviation) for these
products were not especially high which suggested a more even distribution of contaminating
aluminium in powdered products.
Table 4. Aluminium in powdered formulas supplemented with additional amino acids. Mean and
SD are given, n = 5.
Brand [Al] μg/g
Mean (SD)
Al μg/Serving *
Birth/6 Months
Al μg/Day *
Birth/6 Months
SMA Nutrition
Alfamino 0.27 (0.04) 4/8 21/24
Danone Nutricia
Neocate LCP 0.29 (0.12) 4/9 24/47
Danone Nutricia
Neocate Junior 0.61 (0.11) 19 (no age spec) na/na
Nutramigen
Puramino 2.23 (1.23) 28/64 167/256
* Based upon manufacturer’s instructions.
4. Discussion
Prescription infant formulas are contaminated with aluminium. Among the ready-made milks
those prescribed as supplements to aid slow growth rate (Table 2) were, with few exceptions,
significantly more contaminated than those for pre-term or IUGR infants (Table 1). The Nutricia
Fortini range of products was consistently high in aluminium with concentrations between 500 and
800 μg/L. One apple-flavoured product from Abbott Nutrition was contaminated to a level of 2 mg/L
aluminium. For the powdered formulas, those with additional amino acids (Table 4) contained less
aluminium than those designed for allergies and intolerance (Table 3). The Nutramigen Puramino
product was an exception to this rule, while another Nutramigen product (Pregestimil Lipil) was also
the most contaminated of the allergy formulas. When the aluminium contents of all products as
ready-to-use formulas are compared it is interesting to note that powdered products are generally
less contaminated than ready-to-drink products (Table 5). This distinguishes this group of
prescription formulas from previous off-the-shelf products where the powdered forms were found
to contain the highest contents of aluminium [2,3]. Intriguingly some of the prescription formulas
measured herein were lower in aluminium content (e.g., 41.4 (6.1) to 67.5 (20.5) μg/L) than any other
formula product measured previously in our laboratory (Table 5). This may be indicative that the
contamination of infant formulas by aluminium is not inevitable. It may suggest that selected
ingredients added to premium products can reduce contamination by aluminium and, apparently,
irrespective of the aluminium-based packaging used in all these products. Since all manufacturers of
infant formulas deny the knowing addition of aluminium to their products, it remains a mystery as
to its source. The ingredients supplied to infant formula manufacturers are likely sources of
aluminium contamination. For example, we recently measured the aluminium content of whey
protein hydrolysates (on behalf of a major manufacturer of such products) and found they contained
between 4.1 and 8.1 μg/g aluminium. This represents one ingredient of infant formulas that could be
contributing significant amounts of aluminium to the final product. In the products measured herein
and especially the ready-to-drink supplements (Table 2) it is clear that the inclusion of fruit or fruit
flavourings may be importing aluminium into the final product. Finally, the equipment used in
processing of formulas could be a significant source of contamination and especially if the containers
and utensils used in these operations are aluminium-based.
Int. J. Environ. Res. Public Health 2019, 16, 899 5 of 7
Table 5. The concentration of aluminium in prescription formulas prepared as per the manufacturer’s
instructions. Powdered formulas are identified in the table as bold script. Mean and SD are given, n = 5.
Brand [Al] μg/L
Mean (SD)
SMA Nutrition
Alfamino 41.4 (6.1)
Danone Nutricia
Neocate LCP 44.4 (18.4)
Cow & Gate
Nutriprem 1 49.9 (33.7)
Danone
Aptamil Pepti 1 52.5 (4.5)
SMA Nutrition
Althera 67.5 (20.5)
Cow & Gate
Pepti Junior 75.9 (57.3)
Danone Nutricia
Neocate Junior 130.1 (23.6)
Cow & Gate
Nutriprem 2 139.3 (143.6)
SMA Nutrition
Lactose Free 153.2 (21.5)
Abbott Nutrition
PediaSure Plus Juice Strawberry 153.5 (161.3)
Cow & Gate
Nutriprem Hydrolysed 167.1 (10.6)
Nestlé Health Sciences
Resource Fruit 180.2 (62.5)
Danone Nutricia
Infatrini Peptisorb 228.5 (48.3)
Abbott Nutrition
Similac Alimentum 230.8 (106.3)
SMA Nutrition
Pro First Infant Milk 249.4 (64.0)
Nestlé Health Sciences
Peptamen Junior 325.6 (52.8)
Nutramigen
Puramino 334.2 (184.3)
Nutramigen
Pregestimil Lipil 468.2 (27.2)
Danone Nutricia Fortini
Compact Multi Fibre Strawberry 568.2 (65.4)
Nutrinovo
ProSource TF Unflavoured 569.2 (18.1)
Danone Nutricia Fortini
Multi Fibre 703.4 (53.7)
Danone Nutricia Fortini
Smoothie 709.6 (180.3)
Danone Nutricia Fortini
Compact Multi Fibre Neutral 784.5 (121.7)
Abbott Nutrition
PediaSure Plus Juice Apple 1956.3 (111.0)
Int. J. Environ. Res. Public Health 2019, 16, 899 6 of 7
5. Conclusions
Aluminium is toxic in humans [10]. There are no acceptable guidelines for human exposure to
aluminium in adults never mind in newborn infants and we have discussed many times the
inadequacies of such published recommendations [6]. In the meantime, research continues to
highlight the need to reduce exposure to aluminium in infants [7]. We do not know the form of
aluminium in infant formulas and we can only speculate upon how much of this aluminium is
absorbed across the infant gastrointestinal tract [6]. Until such much-needed research is available,
precautions should be taken to reduce infant exposure to aluminium through formula feeding. All
infant formula products reported upon herein were, as appropriate, reconstituted using ultrapure
water. Formulas prepared in the home or elsewhere may use potable, as opposed to ultrapure, water
in which the content of aluminium may additionally be high. Where possible, breast milk feeding
should be prioritised, as the aluminium content of breast milk is invariably an order of magnitude
lower than in formula feeds [7]. Where infant formulas are the only source of nutrition for many
infants in their first weeks and months of life [11], aluminium ingested in formula feeds will be the
major contributor to their body burden of aluminium. The last thing that vulnerable infants fed
specialised formulas for their specific nutritional/medicinal need is additional aluminium in their
diet. The encouraging news is that some of these prescription infant formulas are much less
contaminated than their off-the-shelf counterparts and this highlights what can be achieved in
reducing aluminium contamination of formula feeds. While prescription formulas are invariably
more expensive than off-the-shelf products, this should not preclude future attempts to reduce their
contamination and the contamination of infants by aluminium.
Author Contributions: Conceptualization, C.E.; Data curation, J.R. and I.R.; Formal analysis, J.R. and C.E.;
Investigation, I.R., S.M.-B. and C.E.; Methodology, J.R., I.R. and C.E.; Project administration, S.M.-B.; Resources,
S.M.-B. and C.E.; Supervision, C.E.; Writing—original draft, C.E.; Writing—review & editing, J.R., I.R., S.M.-B.
and C.E.
Funding: The study did not receive any project-specific funding
Acknowledgments: IR is in receipt of an ACORN/CMSRI PhD studentship.
Conflicts of Interest: The authors declare no conflicts of interest.
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