The shortage of infant formula and the food safety reason behind it are front and center for groups like Consumer Reports and the Environmental Working Group, which are calling on Congress to take action.

Representatives from both organizations discussed problems with the internal structure at the Food and Drug Administration and how that complicated the situation involving Abbott Nutrition and the current shortage of infant formula that is plaguing parents across the country. In relation to an outbreak, the company initiated a massive recall that is behind the current formula shortage.

A media call yesterday gave the consumer advocates the chance to raise questions.

Scott Faber, senior vice president for governmental affairs with the Environmental Working Group (EWG), said there are four lines of questioning that should be pursued by lawmakers.

First, the EWG and other consumer groups want to know what happened with a 33-page whistleblower document that was sent to the FDA in October 2021. It laid out numerous violations of company policy and federal regulations at Abbott Nutrition’s infant formula plant in Sturgis, MI. Infant formula from the plant has been associated with an outbreak of cronobactor infections that put four babies in the hospital, with two dying.

The whistleblower document was sent to some officials at FDA but was apparently not shared with key food safety officials. Also, the agency did not appear to begin any investigation based on the document, which U.S. Rep. Rosa DeLauro, D-CT, entered into the congressional record this month.

Second, Faber and Brian Ronholm who is Director of Food Policy for Consumer Reports (CR) both want to know why the FDA took so long to begin investigating consumer complaints related to infant illnesses and formula produced at the Sturgis plant. The complaints span from 2019 through 2021, but the FDA did not begin inspections related to them until January this year.

Third, officials at both the EWG and CR want to know how much the fragmented organization of top food safety entities in FDA contributed to the mishandling of the investigation into Abbott. They said FDA Commissioner Robert Califf should immediately act to put a deputy director of food safety in place with that person directly reporting to the commissioner and serving as the immediate supervisor of the FDA’s Center for Food Safety and Nutrition. Currently there is a shotgun approach with people in charge of various food safety responsibilities at FDA reporting directly to the commissioner instead of having a chain of command structure.

Fourth, the consumer groups want to know why FDA inspections have dropped since the signing of the Food Safety Modernization Act in 2011. “Why is the FDA treating the inspection numbers in FSMA as a ceiling instead of a floor,” Faber asked.

Ronholm said it is clear that public confidence in the FDA is eroding and the situation with the Abbott infant formula contaminated plant and subsequent infant formula shortage is only making things worse.

“Those of us familiar with the situation often say that the ‘F’ in FDA is silent,” Ronholm said, adding that the agency is responsible for overseeing 80 percent of food in the country. He said the lack of a single, empowered person at the top of the food chain at FDA is crucial for better oversight and the safety of the U.S. food supply. 

Also, Ronholm said, the FDA Commissioner has in recent years been a medical professional focused on the drug side of the agency, which has further diminished the work of the food side. Current commissioner Califf has proposed that Janet Woodcock oversee possible changes for the food side of the agency.

“There’s no way that Dr. Woodcock can really lead the culture change that’s needed in the food program, or even lead things operationally given the scope and the responsibilities under that,” Ronholm said.

That’s our initial reaction to what Dr. Califf is proposing, I think, extremely disappointing and just an affront to anyone working on policy. Especially when you consider that Dr. Woodcock is extremely qualified on the medical products pharmaceutical products set of things, but she really has no real background on food policy. So it’s kind of an insult to those of us who dedicate our lives to working on food policy.”

Other related news
On Wednesday, the U.S. House of Representatives approved $28 million to help alleviate the infant formula shortage.

If approved by the Senate, the measure would provide emergency funding for the Food and Drug Administration in an effort to help alleviate the current shortfall and head off future shortages. The bill was approved by a tally of 231 to 192.

The emergency funding would be used to increase the number of FDA inspection staff, provide resources for personnel working on formula issues, help the agency stop fraudulent baby formula from entering the United States’ marketplace, and improve data collection on the formula market, according to a release from the House Appropriations Committee.

“This bill is the first step to help restock shelves and end this shortage,” House Appropriations Chair Rosa DeLauro, a Connecticut Democrat who introduced the legislation said.

“Parents and caretakers across the country cannot wait — they need our support now. This bill takes important steps to restore supply in a safe and secure manner. Additionally, with these funds, FDA will be able to help to prevent this issue from occurring again.”

The House is set to begin a hearing on the situation with Abbott, the infant formula shortage, and the reasons behind it on May 25.

On the Senate side of the Capitol, Senate Finance Committee Chair Ron Wyden sent a letter to Abbott CEO Robert Ford requesting information on the company’s tax practices and $8 billion stock buybacks the company has authorized since 2019.

Wyden also requested information on how much money Abbott spent to upgrade an infant formula plant Michigan prior to its closure due to bacterial contamination. The senator also asked whether Abbott used billions of dollars in tax cuts to buy back shares rather than to invest in improvements at the facility in Sturgis. 

Lastly, President Biden on Wednesday invoked the Defense Production Act to address the infant formula shortage in the United States. The White House announced in a fact sheet that Biden would use the Cold War-era law to require suppliers to “direct needed resources to infant formula manufacturers before any other customer who may have ordered that good.”

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