21-07-2022, 08:43 AM
By MATTHEW PERRONE
yesterday
WASHINGTON (AP) — The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.
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“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s food program, Califf said in a statement. The agency’s tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health,” he said.
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Parents and politicians also have expressed frustration over the agency’s handling of a recent decision to ban all e-cigarettes from Juul, the leading U.S. vaping company. A federal court quickly blocked the agency’s order. FDA then backtracked further in court, saying it needed more time to review Juul’s application due to its “unique scientific issues.”
The FDA has also struggled to review millions of other applications from vaping companies, prompting multiple missed regulatory deadlines over the last two years.
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“I don’t think anyone anticipated that there would be 6.7 million vaping product applications that came rolling in during a pandemic that was stressing the entire agency,” Califf said.
Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over those products, which had used a legal loophole to skirt regulation.
https://apnews.com/article/science-healt...82cd60cf02
yesterday
WASHINGTON (AP) — The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.
......
“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s food program, Califf said in a statement. The agency’s tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health,” he said.
......
Parents and politicians also have expressed frustration over the agency’s handling of a recent decision to ban all e-cigarettes from Juul, the leading U.S. vaping company. A federal court quickly blocked the agency’s order. FDA then backtracked further in court, saying it needed more time to review Juul’s application due to its “unique scientific issues.”
The FDA has also struggled to review millions of other applications from vaping companies, prompting multiple missed regulatory deadlines over the last two years.
......
“I don’t think anyone anticipated that there would be 6.7 million vaping product applications that came rolling in during a pandemic that was stressing the entire agency,” Califf said.
Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over those products, which had used a legal loophole to skirt regulation.
https://apnews.com/article/science-healt...82cd60cf02