Baby formula shortage sparks call for drastic changes at FDA

() — A new report recommends major changes to the Food and Drug ministration in light of a baby formula shortage that is continuing to frustrate families.

The most radical change would create separate food and drug administrations. The FDA has been accused of being too focused on the medicine side of its responsibilities, like often hiring leaders with medical backgrounds but no food industry experience.

Peter Pitts, former associate commissioner for the FDA, called the report an “excuse.’

“When I was at the FDA, the deputy commissioner, the number two person at the FDA, was a food expert and acted as the chief of that center for oversight purposes,” Pitts said.

Leadership and culture must also be restructured to better respond to food safety crises and chronic public health problems, according to the 51-page report by the Reagan-Udall Foundation, a group separate from but closely tied to the FDA.

The FDA was also criticized for making decisions by consensus and working too slowly to address problems.

It took four months for a whistleblower complaint about unsafe conditions at Abbotts baby formula plant to reach top food safety officials. At least four babies got sick and two died after drinking formula that was made at that plant in Michigan.

When Abbott’s Michigan plant shut down, it quickly left store shelves bare or with just a few cans for sale. Families were left scrambling for formula over the summer. The Biden administration enacted Operation Fly Formula, bringing in hundreds of thousands of pounds of formula from Europe.

The report faulted the FDA for being too cautious when enforcing regulations, for fear of lawsuits and pushback from industry.

“They’ve got to take charge and make sure that authority is understood, so that industry can’t undercut the FDAs mission of the safe and effective food supply for Americans,” Pitts said.

Pitts said a new enforcement arm would be needed for the FDA to take back control of the regulatory process.

“They need basically a whole new arm of enforcement to make sure that when they’re dealing with industry, they are the first among equals and industry says ‘yes, sir,’ when the FDA tells them to do something rather than litigating or dragging their feet,” Pitts said.

Other recommendations include identifying a single person to lead the food programs and creating accommodations for products considered life-sustaining like formula, so that the country is not in a situation where if formula runs short, there’s no backup plan.

Pitts agreed there was a critical need to address situations like the one created by the Abbott labs shutdown, where one regulatory action can cause a nationwide shortage because a product is produced by so few companies.

“We’ve got to really start thinking about identifying what types of supply line issues the FDA has, in general in the food sector, specifically,” Pitts said.

The Associated Press contributed to this report.

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