Supporters want answers from the federal government on the epidemic and the shortage of infant formula; Congress and Biden act to calm the situation

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

Representatives from both organizations discussed issues with the internal structure of the Food and Drug Administration and how this has complicated the situation involving Abbott Nutrition and the current infant formula shortage plaguing parents across the country. In connection with an outbreak, the company has issued a massive recall that is causing the current shortage of formulas.

A media call yesterday gave consumer rights advocates an opportunity to ask questions.

Scott Faber, senior vice president for government affairs for the Environment Working Group (EWG), said there were 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 lays out numerous violations of company policy and federal regulations at Abbott Nutrition’s infant formula facility in Sturgis, MI. Infant formula from the plant has been linked to an outbreak of cronobacteria infections that have taken four babies to hospital, two of whom have died.

The whistleblower document was sent to some FDA officials but apparently has not been shared with key food safety officials. Additionally, the agency does not appear to have opened an investigation based on the document, which U.S. Representative Rosa DeLauro, D-CT, placed on the Congressional record this month.

Second, Faber and Brian Ronholm, director of food policy for Consumer Reports (CR), both want to know why the FDA took so long to begin investigating consumer complaints about childhood illnesses and formulas produced at the factory. Sturgis. The complaints span from 2019 to 2021, but the FDA didn’t begin inspections on them until January of this year.

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

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

Ronholm said it’s clear that public trust in the FDA is eroding and that the situation with the factory contaminated with Abbott infant formula and the resulting shortage of infant formula only exacerbates the things.

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

In addition, Ronholm said, the FDA commissioner has in recent years been a medical professional focused on the drug side of the agency, further reducing work on the food side. Current commissioner Califf has proposed that Janet Woodcock oversee possible changes to the food side of the agency.

“There’s no way 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 that come with it,” said said Ronholm.

This is our first reaction to what Dr. Califf is proposing, I think, extremely disappointing and just an affront to anyone working on politics. Especially considering that Dr. Woodcock is extremely knowledgeable on all medical and pharmaceutical products, but really has no experience in 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 ease the infant formula shortage.

If approved by the Senate, the measure would provide emergency funding to the Food and Drug Administration to help ease the current deficit and prevent future shortages. The bill was approved by a count of 231 to 192.

The emergency funding would be used to increase the number of FDA inspectors, provide resources for staff working on formula issues, help the agency prevent fraudulent infant formula from entering the US market. States and improve preparations market data collection. according to a statement of the House Appropriations Committee.

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

“Parents and caregivers across the country can’t wait – they need our support now. This bill takes important steps to restore supply in a safe and secure manner. Also, with these funds, the FDA will be able to help prevent this problem from happening again.

The House is due 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 Chairman Ron Wyden sent a letter to Abbott CEO Robert Ford requesting information about the company’s tax practices and $8 billion stock buybacks. dollars the company has authorized since 2019.

Wyden also requested information on how much Abbott spent upgrading a Michigan infant formula plant before it closed due to bacterial contamination. The senator also questioned whether Abbott used billions of dollars in tax cuts to buy back stock rather than invest in improvements at the Sturgis facility.

Finally, President Biden on Wednesday invoked the Defense Production Act to address the shortage of infant formula in the United States. The White House announced in a fact sheet that Biden would use Cold War-era law to require suppliers to “direct necessary resources to infant formula makers before any other customers who may have order this product”.

(To sign up for a free subscription to Food Safety News, Click on here)