FDA to Take a Hard Look at Its Food, Tobacco Programs

The U.S. Food and Drug Administration will begin a comprehensive review of its food and tobacco programs amid a high-profile infant formula shortage and recent rulings on e-cigarettes.

FDA Commissioner Robert Califf first announced the review on Tuesday, then appeared at a Senate subcommittee hearing on food safety on Wednesday, calling the food program “one of my absolute top priorities,” CNN reported.

“My assessment is that the foods program is staffed by highly dedicated people, I can’t stress enough how hard they work and the depth of their knowledge,” Califf said during the subcommittee hearing. “But they’re working in a suboptimal environment that needs to be reformed. Accordingly, we’ve 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 do better.”

“Lack of communication, outdated ways of thinking and overall lack of leadership have negatively impacted the agency,” Baldwin said.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 to import some formulas from other countries, and the agency plans to work with foreign manufacturers to allow their products to be permanently sold in the United States.

But food products aren’t the only area of concern at the agency.

The FDA also made news in June when it ordered a popular e-cigarette brand, Juul Labs, to remove all its products from the U.S. market. But in July, the agency temporarily suspended the ban while the company appeals the agency’s action.

“Just over 13 years ago, Congress tasked the FDA with regulating tobacco products,” Califf said in an agency news release announcing the reviews. “In the ensuing years, we have made important progress and reached regulatory decisions on a broad array of millions of products. But even greater challenges lie ahead as we determine 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 former President Barack Obama’s last year in office and was confirmed again to the post in February.

“In February 2022, I rejoined the U.S. Food and Drug Administration as Commissioner of Food and Drugs, having served in the role five years earlier. Since my return, the agency has taken many significant actions that benefit the public health. Yet at the same time, the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business,” Califf said.

During the subcommittee hearing, he added that a report on the review would be ready within 60 business days after it begins.

More information

The White House offered additional information on the infant formula shortage.

SOURCE: U.S. Food and Drug Administration, news release, July 19, 2022; CNN

Source: HealthDay