FDA starts outside review of Food and Tobacco regulatory divisions

The US Food and Drug Administration (FDA) is beginning an outside review of its divisions responsible for safety and inspection activities for food and tobacco, reports Bloomberg.

Commissioner Robert Califf has hired external experts to conduct a comprehensive evaluation for the agency’s Human Foods Program, as well as parts of the Office of Regulatory Affairs, and the Center for Tobacco Products, according to a statement on the agency’s website.
According to the report, Califf has long been considered tough on the tobacco industry, bringing e-cigarettes and vapes under the agency’s purview in an earlier term as director. More recently, the FDA has come under scrutiny for its response to a shortage of infant formula that arose after questions about safety at an Abbott Laboratories manufacturing site.
“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 in the statement. Inspection activities need to be evaluated, particularly in light of stresses related to the Covid-19 pandemic, he said. Califf continued it “may take some time to implement any recommended changes”, but he is committed to addressing them and communicating them to the public in a timely manner.
The FDA has faced increasing pressure to prevent vaping products like those made by Juul Labs Inc. from getting into the hands of kids On June 23, the FDA banned Juul’s products from the market, noting their “disproportionate role in the rise in youth vaping.” However, earlier in July, the agency suspended its ban after determining there was more science to be reviewed, effectively allowing the company to continue selling its products.
The FDA began regulating e-cigarettes as tobacco products in 2016, requiring companies to submit applications to continue selling existing or new products. The agency has sent thousands of warning letters to retailers who have illegally sold e-cigarettes to minors, the report said.

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