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August 1, 2023 Big Pharma Views

Big Pharma

Most Infant Formula Health Claims Not Supported by Science — Study

A study by investigators at Imperial College London determined infant formula health claims are largely unsubstantiated, with poor-quality or biased studies backing them up. Public health groups say formula marketing undermines efforts to promote breastfeeding.

infant formula health science feature

Women who can’t breastfeed their newborns almost always choose infant formula from among the limited options available, perhaps believing the manufacturers’ numerous health claims.

But a recent investigation by researchers at Imperial College London found most infant formula health claims lacked supporting evidence.

The study, led by Daniel Munblit, Ph.D., and conducted from 2020 through 2022, found that of products touting at least one health benefit, barely one-quarter cited a supporting study.

For 24 different health claims, formal studies in infants conducted by the manufacturer made up fully half of the references, followed by review articles at 20%.

A review article summarizes results from several (or many) studies. Reviews can provide good scientific support for a health claim as long as the subject of the review is the product itself and not simply an ingredient; testing whether an ingredient works in a particular way or not is not the same as testing a product containing that ingredient.

And, according to the researchers, most of the clinical studies cited by manufacturers to support health claims were of poor quality.

Nutrition from breast milk a tough act to follow

Babies readily consume most formulas without apparent ill effects. But mothers considering formula for their children should be concerned with how well the product replaces the nutrition found in mother’s milk.

According to the Academy of Nutrition and Dietetics, a professional organization for dieticians and nutritionists, “exclusive breastfeeding provides optimal nutrition and health protection for the first 6 months of life, and … breastfeeding with complementary foods from 6 months until at least 12 months of age is the ideal feeding pattern for infants.”

Mother’s milk provides nutrition — including proteins and other nutrients that fulfill a newborn’s dietary requirements — that cannot be duplicated in a manufactured formula.

Breast milk also contains factors that protect against infection and inflammation, aid in organ development, and promote healthy microbial colonization in the gut and elsewhere.

And unlike factory-made products, the composition of mother’s milk can change quickly in response to the mother’s and child’s needs.

Assessing validity of infant formula health claims ‘next to impossible’

In addition to listing ingredients and amounts for certain nutrients as required by law, infant formula manufacturers usually add health claims in their messaging.

Claims are usually associated with one or more ingredients — for example, that probiotics promote a healthy immune system.

In some instances, this widespread practice leads mothers to choose formula instead of much healthier breast milk when both options are available.

And when formula is the only option, marketing messaging provides false assurance that a product provides exactly what babies need for optimal health.

Properly run nutritional studies are expensive and take years to demonstrate benefits, such as “promotes healthy bones.” Assessing the effects of “infant” formulas is inherently limited since the required long-term studies aren’t being carried out.

Even more difficult is quantifying the effects of any one of the 30 nutrients in infant formula required by the U.S. Food and Drug Administration — plus whatever else the manufacturer adds — making evidence of health claims next to impossible to prove.

To evaluate the evidence infant formula marketers used to support health claims, investigators visited formula manufacturer websites targeting consumers and doctors in 15 developed and developing countries, including the U.S., the U.K. and Canada.

Researchers counted each statement or suggestion “that a food or component of the food has, or may have, an effect on the human body” and assigned it to one of 31 claim categories.

Products averaged between one and four claims each, with an average of about two claims per product. Researchers also noted which ingredients were connected to each claim.

Overall, researchers found 608 of 757 infant formulas (80%) were associated with 1,884 health or nutrition claims.

The leading claim categories and the specific ingredients to which each is linked were:

  • “Helps/supports development of brain and/or eyes and/or nervous system” — 323 products (53% of the total), covering 13 ingredients.
  • “Strengthens/supports a healthy immune system” — 239 products (39%), 12 ingredients.
  • “Helps/supports growth and development” — 224 products (37%), 20 ingredients.
  • “Easy to digest” — 182 products (30%), 14 ingredients.
  • “Dietary management of allergy (including to cow’s milk)” — 96 products (16%), 4 ingredients.

These claims were associated with 41 different ingredients, the most common being:

  • Polyunsaturated fatty acids — 278 products (46%), 9 unique claims.
  • Probiotics, prebiotics, or synbiotics — 225 products (37%), 19 claims.
  • Hydrolyzed protein — 120 products (20%), 9 claims.

Manufacturers’ sources of evidence for health claims unreliable

Of the clinical trial reports comprising half of the references supporting health claims, only 28% were registered. Registration makes data publicly available and helps ensure clinical trials are high-quality.

According to the study, “46 of 51 claims (90%) referenced registered clinical trial outcomes at high risk of bias, and all cited systematic reviews and pooled analyses, carried a high risk of bias.”

“Two-thirds of products with at least one claim did not provide a reference to any evidence,” the authors wrote. When clinical evidence was provided the studies were typically industry-funded and carried additional, independent signs of bias, mostly a result of selective data reporting.

Studies suffer widespread conflicts of interest

Fifty-eight health claims were supported by 38 journal citations referencing 32 registered clinical trials. Normally this would be encouraging, but of those registered trials 28, or 88%, were either formula industry-funded or included one or more industry-affiliated authors.

Industry-supported research is not necessarily untrustworthy, but commercial and scientific interests often collide, forcing researchers to choose — often unconsciously — between the two.

Financial conflicts of interest were not the only issues noted. Investigators also scrutinized other measures of bias: how treatment and control subjects were selected (randomization), deviations from the treatment as described in the study protocol, missing data, how outcomes were measured, and selective data reporting.

They found that on these criteria alone nearly all studies demonstrated serious inherent biases, with only three categorized as “possible bias.”

Claims were based on earlier research on individual ingredients such as polyunsaturated fatty acids for brain development, or probiotics for immune support. But as the authors note, many of these associations have not been firmly established.

Another strategy used by manufacturers when solid evidence is unavailable is to say that a product or ingredient has been “widely studied” or that a claimed benefit has been “known for decades.”

Such claims can mislead mothers into making less-than-optimal decisions regarding their infant’s nutrition.

From the study’s conclusion:

“Parallels can be drawn with pharmaceutical companies, which have been criticised for drug advertising in medical journals, influencing readers’ understanding, and resulting in some ‘mythical associations’ between medical conditions and branded drugs.

“Unethical marketing strategies and political activities, including misinformation, lobbying, and donations are well documented features of the current interplay between corporations and public wellbeing.”

U.S. and international institutions support breastfeeding, formula transparency

Despite these marketing efforts by formula manufacturers, health claims for infant formula are frowned upon by international agreements.

According to the Centers for Disease Control and Prevention, “The commercial marketing of infant feeding products has been shown to have a negative impact on breastfeeding” and prevents mothers from making an informed decision on the best way to feed their newborn.

The World Health Organization’s International Code of Marketing of Breast-Milk Substitutes, adopted in 1981 by the World Health Assembly, makes its position on formula marketing abundantly clear: Informational materials dealing with the feeding of infants and intended to reach mothers must include “clear information” on the benefits and superiority of breastfeeding, the negative effects of intermittent bottle-feeding on breastfeeding, and the proper use of infant formulas.

The code also discourages:

  • direct-to-consumer advertising.
  • free samples.
  • promotion of products in healthcare facilities.
  • commercial product representatives advising mothers.
  • gifts or personal samples to health workers.
  • messaging that “idealizes” formulas, including pictures of infants on packaging.

The British Specialist Nutrition Association (BSNA), which represents U.K. formula manufacturers, was quick to comment on the Imperial College study through spokesperson Declan O’Brien.

Responding through The BMJ’s comments section, O’Brien noted that the study included formula products intended for use after 6 months of age, which technically do not fall under the legal definition of “infant formula” in the U.K.

He also acknowledged that the serious conflicts of interest and high risk of bias Munblit cited were “not in dispute,” yet O’Brien stated:

“Companies invest millions into high quality research on a yearly basis, to support the ongoing improvement and innovation of infant formulae products, for the benefit of infant health. Funding of this scale is unlikely to come from other sources.”

While O’Brien may be correct that only manufacturers have the right combination of interest and financial resources to conduct formal clinical investigations into their products, acknowledging bias while referring to such studies as “high quality research” is contradictory.

Whether to breastfeed or not is a highly personal decision that, ideally, should be made in consultation with a pediatrician and always on the basis of informed consent.

While health claims on products intended for use in children are not in themselves bad, those claims must be balanced against the available science.

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