Specialised Infant Formulas: Overused, Overpriced and Obesogenic

In Europe, North America and China, most infants are wholly or partially fed with a commercial milk formula during their first year despite consistent public health recommendations promoting breastfeeding. For some nonbreastfed babies, a standard first infant formula may not meet their nutritional needs, because of cows' milk allergy, an inherited metabolic condition, illness or prematurity. These infants may need ‘specialised’ infant formulas, which are classified by the World Health Organization and Food and Agriculture Organization Codex Alimentarius as Foods for Special Medical Purposes (FSMP) [1]. FSMP include low-allergy formulas such as soya formula, extensively hydrolysed formula and amino-acid formula, used for formula-fed infants with cows' milk allergy.

Legal definitions and regulatory requirements for FSMP are that they should be used under medical supervision and there should be scientific evidence that they are safe and meet the nutritional requirements of the intended target population. In Europe, there is also guidance on how to assess products against these requirements [2]. However, there is a lack of regulatory oversight for FSMP, and they are frequently used without medical supervision. Commercial milk formula companies are often able to choose whether to market a product as FSMP or as a standard infant formula. Thus, in the United Kingdom, antireflux and comfort milks are marketed as FSMP, despite the lack of evidence that comfort milks alleviate colic or constipation, whereas soya formula and lactose-free formula are not marketed as FSMP despite falling under the international definition of FSMP set by Codex. All four product types can be purchased over the counter in pharmacies, and in shops and supermarkets. In the United States, a comprehensive national survey found that almost 60% of formula purchased in stores had reduced or absent lactose [3]. Low-allergy formulas are also lactose-free or lactose-reduced, posing health risks above standard infant formulas because nonlactose carbohydrate sources such as maltodextrin and glucose syrup are associated with dental caries and early childhood obesity [4].

Other health risks associated with infant FSMP include increased risk of bacterial contamination due to the addition of probiotics, making proper sterilisation impossible, and potential adverse effects from components such as phyto-oestrogens in soya formula and thickeners in antireflux formula. In general, the health risks associated with FSMP are not clearly communicated to consumers through product labelling.

Infant FSMP not only carry health risks but also are more expensive than their brand-equivalent first infant formulas (Table 1). The record high prices of first infant formula in the current cost of living crisis are a concern for parents and carers, and high prices may lead to unsafe feeding practices [5]. This concern is exacerbated if FSMP are used unnecessarily or without appropriate medical supervision and support by the public health system. For prescribed, low-allergy formulas such as amino-acid formula, the cost sometimes falls on public health systems. For example, the UK National Health Service spends about £100 ($127, EU119) for each baby born in the country on low-allergy formula prescribing, ~90% of which is prescribed to infants with no milk allergy [6].

To summarise, current FSMP regulation is failing to contain increasing, often unnecessary and usually unsupervised use of these products. This occurs because of industry-led misclassification of products, and ineffective controls on their sale to the public, including cross-promotion and inadequate health warnings [7]. The situation is compounded by weak legal restrictions on marketing of commercial milk formulas to healthcare professionals, who are misled about the nature and effectiveness of products, using information that is not scientific or factual [8]. Ultimately, this is leading to widespread exposure of the world's infants to unhealthy, unnecessary and expensive nutrition products.

With such a major public health focus on preventing obesity, and so few proven solutions, improving regulation and consumer information regarding risks associated with alternative carbohydrates in FSMP seems like a relatively simple step for governments to make. Considering the recent UK General Election, we recommend that the new Government takes a two-step approach to closer enforcement and improved regulation of the marketing practices of the commercial milk formula industry, as outlined in Table 2. Acting on these recommendations would better protect all infants however they are fed.

The high cost of infant FSMP relative to brand-equivalent infant formula also needs to be addressed by the new Government, especially considering the current cost of living crisis and profiteering by the commercial milk formula industry on its infant formula sales [5]. We are hopeful that the market survey currently underway by the UK Government watchdog, the Competition and Markets Authority, will include recommendations which the new Government can act on to better control infant formula costs while protecting infant health.

This editorial builds on this 2022 policy report by the Baby Feeding Law Group UK: Infant milks marketed as foods for special medical purposes (FSMP): The case for regulatory reform to protect infant health [9].

Victoria L. Sibson conceptualised and drafted the editorial. Susan Westland undertook the analysis of formula costs and reviewed the final editorial.

The authors declare no conflicts of interest.