FDA needs to protect vulnerable newborns from aluminum toxicity

The Food and Drug Administration (FDA) has long recognized aluminum exposure as a serious toxicity risk for infants, especially those born prematurely. That’s why the agency has traditionally imposed tight limits on aluminum content in the specialized nutrition products that hospitals use to feed preterm babies.

But the FDA recently issued a new draft guidance that would boost the allowable amount of aluminum in some products by as much as 17 times more than before.

Without more rigorous research and analysis, this new approach could put some of the most vulnerable children at risk.

Over 7,000 preterm babies are born in the United States each week, accounting for roughly one in 10 live births. Of these, over 1,000 babies are born before 32 weeks. These preterm babies often require extensive stays in a neonatal intensive care unit and, despite the medical advances of recent decades, still face serious health issues such as developmental delays, chronic respiratory issues, vision problems and hearing loss. The estimated societal cost associated with preterm birth is $25 billion per year.

Infants born prematurely are especially susceptible to aluminum toxicity. Their digestive systems are not yet fully functional, so they require “parenteral nutrition,” in which nutrients are infused directly into the bloodstream. Aluminum is a common contaminant in injectable nutrition products and may be impossible to remove entirely. Because premature babies’ kidneys are not yet mature, the aluminum does not get filtered out through the kidneys. Instead, it accumulates in the body. Babies exposed to aluminum toxicity can suffer developmental delays, neurological issues and bone disorders as toddlers or elementary schoolers. These symptoms are difficult, if not impossible, to reverse.

For many years, the FDA took the position that preterm infants may not receive more than 4 to 5 micrograms of total aluminum exposure per kilogram of body weight per day.

However, the FDA is now poised to raise the allowable aluminum to roughly 17 times the previously approved standard. This dramatic change in policy is dangerous and unjustified. The FDA guidance suggests that high aluminum products can be labeled with an “adults only” restriction, even though very few adults require these products. As the FDA is no doubt aware, these products would almost certainly be used for infants, despite their labeling.  

Concerningly, this new draft guidance came just weeks before the FDA approved a generic version of a branded, “cysteine hydrochloride injection” an essential amino acid for premature infants, with aluminum levels that far exceeded the FDA’s previous toxicity threshold. While expediting the introduction of cheaper generics makes good sense — and brings health care costs down — the timing here is questionable. Boosting generic competition should never come at the expense of patient safety.

The health of our nation’s tiniest, most vulnerable patients depends on getting the question of aluminum toxicity right. Absent more evidence — made public — the FDA needs to pause on implementing this guidance.  

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest. He also serves as a visiting professor at University of Paris School of Medicine.