THE 21st July (Health Day News) — After a high-profile infant formula shortage and recent rulings on e-cigarettes, the U.S. Food and Drug Administration will review its food and tobacco programs.
The FDA’s Robert Califf announced the review on Tuesday, then appeared before a Senate subcommittee on food safety on Wednesday to call the food program “my top priority,” CNN reported.
“In my opinion, the foods program is staffed by highly dedicated employees. I can’t express enough how hard they work and how knowledgeable they are,” Califf said at the subcommittee hearing. but they’re operating in a suboptimal environment that needs reforming. Therefore, we have initiated a full review of the foods program.”
In opening comments at the hearing, Sen. Tammy Baldwin, chair of the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, said the “FDA needs to change for the better”.
There’s a lack of communication, there’s an outdated way of thinking and there’s a lack of leadership that has negatively impacted the agency, Baldwin said. “Serious concerns remain about the priority that FDA gives to food safety and the missteps that have led to outbreaks or critical shortages and individuals getting sick.”
During the infant formula shortage this spring, the FDA made it easier for some formulas to be imported, and the agency plans to work with foreign manufacturers to allow their products to be permanently sold in the United States.
And it’s not just food products that are of concern to the agency.
The FDA also made news in June when it ordered a popular e-cigarette brand, Juul Labs, to stop selling its products in the U.S. market. But in July, the agency temporarily suspended the ban while the company appeals the agency’s action.
‘The FDA was tasked with regulating tobacco products by Congress just over 13 years ago, Califf said in an announcement of the reviews. during the ensuing years, we have made important strides and reached regulatory decisions on millions of products. But even greater challenges lie ahead, and we still have a long way to go before determining how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health”.
Califf was FDA commissioner during the last year of President Barack Obama’s administration and was confirmed again to the post in February.
‘In February of 2022, I returned to the Food and Drug Administration as Commissioner of Food and Drugs, a role I had occupied five years earlier. Over the past five years, we have taken many significant actions that benefit the public health. And yet, the agency has encountered a number of challenges that have stressed its operations and tested its regulatory frameworks. “These challenges have caused me to take a closer look at how the agency operates,” Califf added.
During the subcommittee hearing, he said a report on the review would be ready within 60 business days of its start.
For more information
The White House provided additional information about the infant formula shortage.
From the source: U.S. FDA news release, July 19, 2022; CNN