Infant formula industry accused of influencing milk allergy overdiagnosis as specialized products spike

19 Jul 2022 --- The formula industry may have a hand in the observed demand spike for specialized infant formula, researchers are flagging. The suggested influence ranges from shaping national guidelines which identify cow milk allergies and sponsoring online information to sway consumers to buy items they do not need.

Following a study detailing the overuse of specialized infant formula in Norway, Australia and the UK, NutritionInsight speaks to government agencies, scientists and industry representatives to shed light on the debate. 

“There is a significant problem with milk allergy overdiagnosis and concerns have been raised that milk allergy guidelines may be contributing to this overdiagnosis. Many guidelines have received support directly or indirectly from the formula industry,” says Dr. Hilary Allen, researcher and Ph.D. student, Imperial College London, UK, who was involved in the study. 

“There is a commercial interest in diagnosing milk allergy as this in turn can promote use of specialized infant formula and may undermine breastfeeding. Therefore, it is important that milk allergy guidelines are produced independently of any formula industry influence.” 

Industry refutes conflict of interest
However, the British Specialist Nutrition Association (BSNA), which describes itself as the “voice of the specialist nutrition industry in the UK,” says research demonstrates that specialty formula is safe and promotes normal growth in children with cow’s milk allergy.

Declan O’ Brien, spokesperson for the BSNA and SNE, notes that the specialized formulas provide no added benefit to infants who do not have the allergy.“Industry research on cow’s milk allergy complies with all relevant academic standards and aims to increase understanding of the condition and innovation in its treatment to improve infants’ health,” says Declan O’ Brien, BSNA’s director general, also commenting on behalf of Specialized Nutrition Europe (SNE). 

“It does not seek to influence prescribing guidelines.”

“BSNA and SNE members strongly support healthcare professionals to prescribe these formulas only where clinically indicated, in line with existing international clinical guidelines developed independently by medical societies.”

“Specialty formula for babies with cow’s milk allergy are products very specifically designed for babies diagnosed with cow’s milk protein allergy and do not provide any added value to babies without this condition,” he adds.

“When cow’s milk allergy is diagnosed, and exclusive breastfeeding is not possible, current guidelines recommend extensively hydrolyzed formulas as a first line management, or amino acid-based formulas, depending on the diagnosis and severity of symptoms,” O’ Brien underscores.

According to the study, in Norway, Australia and the UK, specialized formulas replace lactose with “free sugars,” which may place a greater burden on health care systems by increasing the amount of juvenile dental caries and rates of childhood obesity.

Shaping guidelines
Asked to comment on the findings, the National Health and Medical Research Council (NHMRC) of Australia explains that guidelines are intended to promote health, prevent harm, encourage best practice and reduce waste. 

“They are developed by multidisciplinary committees or panels that follow a rigorous evidence-based approach. NHMRC guidelines are based on a review of the available evidence, and follow transparent development and decision-making processes. They are informed by the judgment of evidence by experts, and the views of consumers, community groups and other people affected by the guidelines.” 

Meanwhile, a spokesperson from Food Standards Australia, New Zealand (FSANZ) says that though “FSANZ has no role in regulating the prescription of specialized infant formula products,” they are revising their infant formula regulations “to ensure infant formula products remain safe and suitable, in line with best available scientific evidence.” The new regulations should be complete by the end of 2023.

“We are aware formulas which are the subject of the study you cite – such as extensively hydrolyzed formulas (EHF) and amino acid formulas (AAH) – are generally not marketed by infant formula companies for consumption by healthy infants.” EHF and AAH are intended for infants with serious allergy conditions to be used under medical supervision.” 

“As such, they are mainly administered through the Australian Pharmaceutical Benefits Scheme, and their availability is restricted to prescription only.”

Commenting on the UK guidelines, Amber Mezbourian, media relations officer, Department of Health and Social Care (DHSC), states: “Prescribing clinicians are responsible for theirAllen and Santer hold that industry influence on the prescribing guidelines may be to blame for the uptick in unnecessary prescriptions.own prescribing decisions. The decision to prescribe a particular product is a clinical one and should be based on the patient’s medical needs.”

“Clinicians are expected to take account of appropriate local and national guidance on clinical and cost-effectiveness, and are accountable for their prescribing decisions, both professionally and to their service commissioners.”

Sponsoring online content
Promotion of specialized infant formula may undermine programs promoting breastfeeding.

For the authors of the study, one clear problem is the involvement of the formula industry in clinical trials and the creation of the guidelines for diagnosis and prescription.

“The formula industry has also been implicated in contributing to milk allergy overdiagnosis through sponsorship of healthcare educational events and dissemination of guidelines. Many milk allergy guidelines are sponsored by the formula industry and declared conflicts of interest with the formula industry are common amongst guideline authorship,” says Allen.

Dr. Miriam Santer, primary care research professor, University of Southampton, UK, and co-author of a similar study with Allen, explains how the internet may prime parents to believe their children are allergic before they even go and see a physician. 

“Parents are understandably concerned if their baby is unsettled and look online for information,” explains Santer. “But much of the information online is also sponsored by industry, for example, I just googled ‘baby symptom checkers’ and the top three are from the formula industry. So, even before they go to talk to a health professional, they may already think that their baby has an allergy.”

A report by the World Health Organization (WHO) previously flagged the infant formula industry as using underhanded tactics to gain access to pregnant women and mothers, using marketing techniques which should have long been prevented. It has also described a “deeply troubling” marketing landscape, urging governments to toughen regulations against industry impact.

Regulations and funding: keys to change?
Another area of concern for the study’s authors is breastfeeding. Breastfeeding has long been described as the best possible option for growing babies. Studies show that breastfeeding can enhance immunity and may even lower the impact of climate change. Increasing breastfeeding is also a target goal for the WHO.

The NHRMC states, “in regards to bottle-feeding, the Infant Feeding Guidelines advises the use of cow’s milk-based infant formulas until 12 months of age, and that special formulas may be used under medical supervision for infants who cannot take cow’s milk-based products for specific medical, cultural or religious reasons.” 

The study’s authors and other experts seem to agree that more regulation and oversight may be the only way to prevent specialized infant formula overprescription. 

FSANZ notes that the current standards were set almost 20 years ago. 

Similarly, the NHMRC states that their guidelines were originally published in 2003 and have not been revised in a decade.

“As the NHMRC relies on external funding to develop or revise public health guidelines, there are currently no plans to revise the Infant Feeding Guidelines,” stresses the spokesperson.

By William Bradford Nichols