FDA Proposes New Baby-Formula Safety Measures After Recall Led to US Shortages

The US is unlikely to be able prevent another baby formula shortage like the one last year that left parents across the country searching desperately for supplies, a former Food and Drug Administration official told House lawmakers.

(Bloomberg) — The US is unlikely to be able prevent another baby formula shortage like the one last year that left parents across the country searching desperately for supplies, a former Food and Drug Administration official told House lawmakers.

“The necessary safeguards have not been advanced at an adequate pace to prevent future illnesses,” Frank Yiannas, former deputy commissioner of FDA’s Office of Food Policy & Response, said Tuesday in a House oversight hearing. “The infant formula supply chain continues to lack serious resilience.”

The industry has been under scrutiny since Abbott Laboratories, the biggest maker of infant formula for the US market, withdrew products including bestselling Similac last year after reports of illness and deaths among a few babies who had consumed it. Before the recall ended, it left parents across the country scrambling to find supplies and forced the US to expand its sources of the products. 

Read More: How a Deadly Pathogen Spread at Abbott’s Infant Formula Plant

Yiannas stepped down from the FDA in February after an outside review of the agency found that its food division needed a stronger leader capable of ironing out interdepartmental conflicts that have inhibited the agency’s ability to protect consumers. 

In the hearing, lawmakers focused on areas where FDA oversight of the baby formula industry falls short. There is still no requirement for companies to report bacterial contamination found at manufacturing plants to the agency, Yiannas said.

“I think the abundance of evidence suggests that Abbott was operating under very unsanitary conditions and likely was sporadically contaminating infant formula,” Yiannas testified. 

Abbott didn’t immediately respond to a request for comment. The company has said there’s no evidence to show that its formulas caused the babies’ illnesses and deaths. The shares fell 0.6% at 11:26 a.m. in New York. 

Earlier Tuesday, the agency proposed an “immediate” strategy to ensure safe, adequate supplies of baby formula that were in nationwide shortage after reports of contamination led to recalls last year. The FDA is working to inspect all infant formula manufacturers at least annually, increase training for inspectors and improve communication with formula makers, according to a report.  

“We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage,” FDA Commissioner Robert Califf said in a statement before the hearing. “That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible.”  

 

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