Melamine contamination in China has been linked with ailments such as kidney stones in infants, because it artificially increases the formula’s protein profile. Kidney stones are extremely rare among infants and young children.
FDA advised that caregivers should refrain from using Chinese-made formula and replace it with “an appropriate infant formula manufactured in the United States”.
FDA was unavailable for further comment by the time of publication. It is not known whether adverse events caused the advisory to be issued.
The warning comes even though no Chinese-manufactured formula is legally available in the US as none have met FDA safety requirements. But it is believed Chinese formula is on-market regardless, a situation FDA officials are investigating, especially “specialty markets which serve the Asian community.”
“Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status,” FDA said.
The agency said it is investigating contamination reports and checking with infant formula manufacturers to ensure they are not sourcing China ingredients. It is working with state officials to remove any suspect product from store shelves.
FDA named US manufacturers Abbott Nutritionals, Mead Johnson Nutritionals, Nestle USA, PBM Nutritionals, Solus Products LLC as well as UK-based SHS/Nutricia, as the only companies that had met safety requirements.
FDA requires infant formula manufacturers to register with the agency and adhere to specific labeling and nutritional requirements as well as undergo an annual facility inspection.
The ban comes despite an accord signed between the US and Chinese governments in December to improve the safety of food items traded between the two nations.
Under that agreement, Chinese food and ingredient producers were to register with local authorities, which would then share data with the US Department of Health and Human Services (HHS).
Chinese authorities committed to notifying their US counterparts of potential hazardous events such as the failure of a facility to meet inspection standards.
“Chinese authorities will develop a comprehensive electronic tracking system to follow products from production to exportation," said secretary of HHS with the US government, Mike Leavitt, at the time the agreement was signed.
"This will help ensure that growers and manufacturers are building quality into their processes and that we can take action if they do not."