FDA Policy/General

FDA Hits Juul with Warning Letter

FDA 9/9 has issued a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products by “engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school.” The agency also sent a letter to the company requesting more information about several issues raised in a recent Congressional hearing about Juul’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers.

The letters follow stepped up criticism from Capitol Hill on the agency’s enforcement effortsto curb vaping by under-aged users. On 9/6, Senator Richard Durbin (D-IL) wrote FDA acting commissioner Ned Sharpless urging him to take immediate and decisive action to curb the e-cigarette and vaping epidemic that threatens young adults and children in the U.S. or resign (see story).

“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” an agency release says. “Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth.”

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