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Advocacy Letter: FDA Must Protect Vulnerable Newborns From Aluminum Toxicity

June 7, 2023 -- The MANA Action Fund joins 12 other diverse organizations across the country in a coalition letter to the FDA to express our profound concern with their recent actions supporting drug products that unnecessarily expose babies to high levels of toxic aluminum. This letter shows our collective commitment to improving and protecting the health and well-being of our nation’s underserved populations – and this includes our tiniest, most vulnerable patients—babies hospitalized in a neonatal intensive care unit (“NICU”).


This past December, the FDA issued draft guidance suggesting that they may approve “total parenteral nutrition” (TPN) products with high levels of aluminum, alarmingly near 17 times the previously approved standard.


Thirteen diverse organizations have united to urge the FDA to rescind and prohibit approval of high aluminum products promptly to eliminate the threat of aluminum toxicity for hundreds of thousands of preterm babies born each year. The facts are clear:


  • Preterm Birth is a Significant Contributor to Racial Disparities in Infant Mortality


  • Aluminum Exposure is a Serious Toxicity Risk for Infants, Especially Those Who Are Born Prematurely


  • The FDA Has Long Recognized These Risks, But New Guidance Would Substantially Boost Allowable Amounts of Aluminum—Deepening Racial and Ethnic Inequality


  • The FDA Should Ensure Drug Manufacturers Reduce Aluminum Contamination to the Fullest Extent Possible


The letter provides clear direction to the FDA to undertake a comprehensive review of its policy on aluminum contamination in TPN products as soon as possible, withdraw the 2022 draft guidance suggesting that FDA may approve TPN products with high levels of aluminum, adopt a formal policy that FDA will not grant or maintain approval of a high-aluminum TPN product that is unsafe to preterm babies when a lower-aluminum product is available, and remove such products from the market.


These actions are a necessary step in helping to address pervasive health disparities that continue to impact our vulnerable and underserved populations across the country.


Read The Letter Here

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