Abbott Laboratories has been cleared to release about 300,000 cans of a specialized baby formula from its troubled plant in Michigan, as the country continues to grapple with a baby-formula crisis.
Meanwhile, the fact that a whistleblower’s report regarding conditions at the Abbott plant failed to reach the FDA’s top official for food safety is drawing criticism of the FDA’s structure and response to potential hazards.
Abbott plans to release 300,000 cans of EleCare, a formula for infants experiencing digestive problems. It had been retaining the product ever since the factory in Sturgis, Mich., was shut down in February, but says testing revealed the product to be safe for release.
“Releasing this product immediately will help families impacted by the lack of availability of EleCare,” Abbott CEO Robert Ford said in remarks quoted in the Wall Street Journal.
The FDA is coming under criticism because a whistleblower employed at the Sturgis plant sent the FDA a 34-page report alleging unsanitary conditions in October, and it didn’t reach the desk of Frank Yiannas, the FDA’s deputy commissioner for food policy and response, for four months.
“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Yiannas told the Washington Post.
The situation is being seen as representative of the fractured nature of food safety oversight at FDA. There is no clear line of command or responsibility, with several officials charged with safety reporting directly to the agency’s commissioner.
