Infant Formula Nutritional Claims: Has it Gone Too Far?

infant formula, nutritional claims

Infant formula shortage likely to persist through Spring 2023,” “Another baby formula shortage on the way in 2023,” “The US cannot figure out how to prevent formula shortages,” “We’ve failed mothers and children with no end in sight to formula shortage.” News headline upon headline still echoes how US parents are reeling from infant formula shortages.

Empty shelves, especially in the rural parts of the country, only prove how dependent people are on baby formulas. According to Future Market Insights, the projected value of the infant formula market will be $114.1 billion by 2033. This industry is growing at a robust CAGR of 8.5%.

Companies manufacturing these formulas are making bold claims about their nutritional value. This has raised eyebrows – people are questioning if profits are being placed over the life of the most vulnerable populace. This article will explore how far formula manufacturers have taken their claims and whether there are misleading marketing ploys at play.

Aggressive Promotion Undermining Breastfeeding

The British Medical Journal conducted a study to understand the specific ingredients listed in baby formula packages as well as their health claims. The study reviewed infant formulas from 20 different countries (including the US), from which 757 formula manufacturers participated.

As many as 41 ingredients listed on the different formula companies’ packages were associated with a nutritional claim. The study also found that every formula manufacturer made at least one bold health claim associated with their product.

Some of the top nutritional claims included –

  • Good source of Vitamin D
  • Good source of Calcium for bone development
  • Supports the development of the brain and eyes
  • Strengthens the infant’s immune system
  • Easy to digest
  • Good for the baby’s nervous system
  • Allergy management, including cow’s milk allergy

Now, the Food and Drug Administration (FDA) does specify certain nutrients that every formula package must contain. These requirements are mentioned under Section 412(i) of the FFDCA. There’s a total list of 29 nutrients, out of which formula companies must ensure that at least nine are included depending upon the age group (0-12 months).

Does this mean such requirements create room for bold claims? Not really. In contrast, study upon study has found that breast milk is a complete food for a newborn. It is composed of water, lipids, carbohydrates, proteins, and important minerals like potassium, calcium, sodium, magnesium, etc. John Hopkins Medicine confirms that breast milk is the healthiest option for a baby as its nutrients are better absorbed than formula.

Against all light and knowledge, formula companies continue to launch aggressive promotional campaigns.

Is Exploitative Marketing Causing Mothers to Choose Baby Formula?

The World Health Organization (WHO), in collaboration with the United Nations International Children’s Emergency Fund (UNICEF), conducted a study to understand how formula marketing influences breastfeeding decisions. Around 8,500 mothers participated in the study.

The report does shed light on the fact that some mothers do need to opt for baby formula because of –

  • Challenges with milk production
  • Health issues (baby, the mother, or both)
  • Challenges associated with work

In such legitimate instances, mothers need to rely on baby formulas. But some shocking discoveries were also made. A mother from Lagos stated that advertisements tempt her to purchase infant formulas. If she saw a beautiful, plump, and well-fed baby displayed in the advertisement, she wanted to feed her baby the same formula.

Tedros Adhanom Ghebreyesus, the Director General of WHO, made a conclusive statement that formula companies are crossing the line with their misleading and aggressive marketing tactics. He further reiterated that every infant must ideally be breastfed for the first six months to at least two years of their life to remain safe from childhood illnesses and malnutrition.

It was found that formula companies utilize the following marketing tactics to market directly to vulnerable mothers –

  • They read through nursing-related social media posts and directly message or email them regarding the benefits of infant formula.
  • Their messages include bold and false claims that formula is equivalent to or better than breast milk.
  • They offer healthcare workers incentives to promote their formula packages through conferences and gifts.

This marketing ploy is most dangerous in low-income countries where people scarcely have access to clean drinking water. Most of the formulas prepared in third-world nations use contaminated water which threatens the lives of infants.

A Lack of Regulatory Oversight

Formula manufacturers often prey upon parents’ emotional vulnerability while promoting their products. Plus, busy lifestyles make it difficult for parents or caregivers to scrutinize every single health claim. The WHO observed that self-regulation was clearly not working.

Does the FDA regulate the manufacture and production of infant formulas? Yes, all laws binding on food manufacturers apply to formula companies since infant formula also comes under food. But the problem is that the FDA only approves formula packages after it enters the market. In general, formula companies need to notify the FDA of the new product and ensure it meets the nutritional requirements specified under Section 42(i) of the FFDCA.

Since the regulatory demands on food are less strict as compared to medicines, formula manufacturers may not maintain complete transparency in their clinical trials. Again, the WHO has made it clear in its International Code for Marketing that formula companies must refrain from promoting their products to the public. Their approach towards healthcare professionals must remain factual and scientific.

But even this is a recommendation and hence, not legally binding on formula companies. Moreover, only a few countries strictly follow the WHO Code, so formula marketing is still prevalent in most countries.

Finally, the Codex Alimentarius food standards also include a list of requirements for infant formula ingredients. Though binding on regional and national levels, Codex does not give pre-market product approval. It also allows some ingredients such as DHA and reduced lactose. Hence, formula companies are again free to make nutritional claims about these permissible ingredients.

Peeling the Layers of Well-Resourced Formula Companies

In recent years, numerous mothers feeding their babies with formula have stepped forward, expressing concerns that their babies developed Necrotizing Enterocolitis or NEC. It is a gastro-intestinal condition where the tissue lining the intestines dies and sloughs off. Some of the common symptoms of this condition include –

  • A swollen belly
  • Belly discoloration
  • Food remaining in the stomach for extended periods
  • Diarrhea
  • Dark stools, generally with blood in it

Most parents of affected infants fed them with a formula marketed by Mead Johnson (Enfamil) or Abbott Laboratories (Similac). They are eligible to file a Similac and Enfamil lawsuit against the said manufacturers. Such cases completely lift the curtains off the dirty marketing game of formula companies.

According to TorHoerman Law, baby formula lawsuits are still in their nascent stages, but the Federal Court consolidated the two lawsuits in Illinois back in April 2022. Parents and caregivers are awaiting justice and relevant settlements.

As more such cases pour in, it only makes it clearer that mother’s milk is the most personalized medicine for the baby. No matter how many nutrients a formula package may contain, it can never beat the on-demand antibodies of breast milk prepared based on the pathogens the mother was exposed to.

What Formula Manufacturers Have to Say

At first, the problem was just about bold claims. Then with the rising number of formula lawsuits, manufacturers had to answer for their marketing games. So, the National Public Radio (NPR), a non-profit public media organization, reached out to formula companies.

Of the many formula manufacturers, Nestle (the one leading the pack) responded. According to the company’s Head of Food and Industry Affairs, Nestle maintained responsible marketing while publishing formula products, keeping in line with the WHO Code.

It was further stated that Nestle has completely stopped formula marketing for infants between 0 to 12 months in 163 countries. They are also planning to stop promoting formulas for infants between 0 to 6 months by the end of 2023. As for other formula manufacturers, it seems like they still wish to violate the International Code for Marketing.

The NPR and WHO (in response to Nestle) expressed their concerns that such claims only work when they align with the evidence. Skeptic of Nestlé’s commitment, the WHO has decided to run follow-up checks every year to ensure strict compliance.

The Key Takeaways

Combining the recent studies conducted by the BMJ, the WHO, and UNICEF, it is clear as day that no tight regulations are in place to protect vulnerable infants and their concerned parents. Even if a particular claim is backed by scientific evidence, it must still not be publicized aggressively so as to undermine breastfeeding.

These reports have proposed a proper pre-market approval process in place. Moreover, formula manufacturers should be required to maintain 100% transparency in their clinical trials to justify any claims.

Finally, bribing should be strictly monitored so that no unreliable claim reaches the public ears. Poorly substantiated claims and weak evidence dominate the current infant formula landscape. Only better regulations can help break this vicious cycle.

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