FDA Policy/General

E-cigarette Rule Coming: Trump

President Donald Trump told reporters at the White House 11/8 that the administration’s new rules on e-cigarettes should be out within a week. An element in the plan will involve raising from 18 to 21 the legal age for purchasing vaping products, he said.

The Hill reports Trump said, “We’re going to be coming out with an important position on vaping. We have to take care of our kids, most importantly, so we’re going to have an age limit of 21 or so. We’re talking about the age, we’re talking about flavors, we’re also talking about keeping people working, and there’s some pretty good aspects. We’re coming out, we’re very close to a final report, and we’ll be giving it next week.”

According to The Hill, the comments potentially signal some sort of exemption for vape shops, which would be a softening of the initial proposal announced about two months ago by Trump and HHS secretary Alex Azar. Vaping industry groups and some of the president’s political officials and campaign allies have been urging Trump to exempt mint and menthol flavors and to carve out vape shops from flavor restrictions, the report says. They argued that removing all flavors from the market would lead to people losing jobs and could drive people back to smoking traditional cigarettes. Industry groups broadly support raising the purchasing age to 21, The Hill says.

In a related development, White House domestic policy council head Joe Grogan said FDA would be better off concentrating resources on approving drugs that help people, rather than regulating tobacco, which has “no redeeming value.” Stressing that he was speaking as an individual and had not discussed the issue with Trump, Grogan said the agency’s tobacco regulation efforts were “a huge waste of time.”

Former FDA commissioner Scott Gottlieb countered that regulating tobacco products was “one of the most productive uses of my time as FDA commissioner. It’s one of FDA’s most important public health missions … and must remain top priority for FDA.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome