Rep. Dusty Johnson says FDA failed to act ahead of powdered baby formula recall that worsened shortage

A baby formula recall that's exacerbated a nationwide shortage might have been avoided with more action from federal regulators, according to U.S. Rep. Dusty Johnson, the South Dakota Republican who's home state is among the hardest hit by the shortage.

The second-term congressman last week penned a letter to the Food and Drug Administration in which he admonished the federal regulatory agency for not inspecting a Michigan baby formula plant until the last day in January despite being alerted of consumer complaints as early as Sept. 24, 2021.

Abbott Nutrition, accounting for 43% of the market for what's known as "powdered infant formula," voluntarily recalled those products in February 2022. 

Earlier:National baby formula shortage hitting hard in South Dakota: 'Most days it's a loss'

"I believe FDA dropped the ball given these concerns date back to 2021," Johnson said, noting that the regulator received at least three consumer complaints between September and Dec. 18. "But a follow-up facility inspection did not begin until January 31, 2022. Why was there a 44-delay to initiate this inspection?”

While formula shortage began cropping up last year, credited to supply-chain challenges brought about by public and private sector responses to the COVID-19 pandemic, the Abbott recall and subsequent plant recall deepened the shortage. And according to an April 24 market analysis, South Dakota was one of the eight states facing the worst shortages, with supply shortages higher than 50%.

The Sturgis, Michigan, plant remains closed, though Abbott and the FDA on Monday reached a deal to reopen the plant, which could restart operations in two weeks.

The FDA's office of media affairs in a statement sent to the Argus Leader did not address Johnson's letter or whether inspections of the Michigan plant could have been done sooner. However, it said its staff are performing "around-the-clock work" to improve supply of baby formula nationwide. Inspectors reportedly found deadly bacteria in the plant in February.

"The FDA expects that the measures and steps it's taking with infant formula manufacturers will help to increase supply," according to a statement, which also noted that it would be responding directly to the congressman.

As of Tuesday morning, Johnson had yet to hear back from the FDA, according to his press office.

The 45-year-old Pierre native is expected to introduce legislation this week that would require Abbott and other manufacturers of baby formulas and other essential medical foods to alert the Commissioner of the Food and Drug Administration and the public of anticipated recalls with at least 72 hours advance notice. 

Currently, companies do not have to inform the FDA about plans to do a voluntary recall or on potential problems with production and shortages.