Drugs

Congress Must Regulate CBD Since FDA Won’t: Steve Mister

Responding to an FDA objection to a new dietary ingredient notification submitted by Charlotte’s Web to demonstrate that its full-spectrum hemp extract is reasonably expected to be safe, Council for Responsible Nutrition CEO Steve Mister says Congress must step in and regulate the CBD (cannabidiol) marketplace. Mister appeared with Charlotte’s Web CEO Deanie Elsner in a “Short Legal Briefs” video posted by Natural Products Insider.

In the video, Elsner said she was disappointed in the way the agency made its decision to object to the notification for two reasons: that CBD products are excluded from the definition of a dietary supplement and that there were concerns about the sufficiency of the safety evidence.

She indicated that her company met multiple times with FDA officials before the notification was submitted to share data. The agency “ignored big parts of our application,” she said.

Mister said the FDA denial letter showed that the agency is not going to solve the problem with CBD and thus Congress must act. He said the industry should turn its attention to persuading Congress to intervene. Regulation is needed, he said, because reputable companies that are concerned about the quality of their products are stuck in a “quagmire” with other companies that are not as concerned about quality, and consumers are being hurt.

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