The US Food and Drug Administration is proposing changes to nutrient requirements for infant formula – the first in almost three decades – but while the recommendations have been welcomed, an expert has criticised the “piecemeal” process, reports CNN.
The review, which is part of the Trump administration’s Operation Stork Speed initiative announced in March last year, makes changes to four of the 30 required nutrients in formula: iodine, manganese, vitamin A and vitamin D.
• Iodine is important for the production of thyroid hormone and brain development in infants. The proposed rule triples the amount of iodine from 5 micrograms to 15, and sets a new upper limit of 50 micrograms.
• Manganese is a trace mineral that supports enzyme function and bone development, and the proposal reduces the minimum required amount from 5 micrograms to 1 microgram per 100 calories, also establishing a new limit of 50 micrograms.
• Vitamin A supports vision, immune function and cell growth, and the proposal decreases the amount required in formula from 250 international units per 100 calories to 233 IU. It would also change the units of measure for vitamin A from IU to retinol activity equivalents, or RAE.
• Vitamin D helps with development of bones and teeth and helps prevent rickets – the proposed rule doubles the minimum required amount from 1 to 2 micrograms and increases the maximum amount allowed to 3 micrograms.
• The new recommendations also reaffirm requirements for chloride, potassium, selenium and sodium.
Dr Steven Abrams, a paediatrician and Professor at the University of Texas’ Dell Medical School, said the nutrition update was overdue and “very well thought-out”.
However, he said the review was tackling the nutrient list piecemeal. This first group of nutrients will be followed by 12 in the next year or so and another batch of 10 after that. That means parents aren’t likely to see any changes to infant formula anytime soon, he said.
“These changes … are not going to be something that’ll show up on the can of formula potentially for several years,” said Abrams, who is an expert on infant nutrition.
The nutrition review was conducted by the FDA’s staff scientists and will be submitted for peer review, as required by law.
The most consequential change in this first slate of recommendations is the proposal to increase vitamin D, Abrams said. Currently, the amount of vitamin D in infant formula is a little below the recommended amount for babies. Many parents supplement formula with extra vitamin D.
Adding more to formula could potentially save nearly $81m each year in medical costs tied to a diagnosis of late-onset hypocalcamia, or low blood calcium, the proposed rule said. Vitamin D helps the body absorb calcium and phosphorus from food.
The FDA looked at several lines of evidence supporting the planned nutrition changes, including the nutrient composition of human milk, nutrient standards used by other countries and new studies published since 1998.
Acting director Kyle Diamantas said the agency is seeking public input on nutrients not currently required to be added to formula but commonly added by manufacturers, including long-chain fatty acids like ARA and DHA, as well as L-carnitine, which helps the body break down fats and use them in tissues.
“There’s evidence that these nutrients contribute to neurodevelopment and health in infancy. And we want to hear from the scientific community, from clinicians, from industry, and the public, as we consider whether or not to make these nutrients mandatory in the US infant formula supply.”
The FDA said its nutrient review for infant formula is ongoing. Subsequent phases of this review will assess all of the remaining required nutrients, potential new nutrient requirements and carbohydrate sources, Diamantas added.
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