FDA Policy/General

Cannafyl Marketing Unapproved Human, Animal CBD Drugs

CDER and CVM compliance officials say their review of a Web site and social media pages maintained by Cannafyl, Scottsdale, AZ, indicated that it takes orders for various human and animal products containing cannabidiol. A 3/1 Warning Letter says the products being sold for humans are intended to mitigate, prevent, treat, diagnose, or cure Covid-19, and thus are legally considered unapproved new drugs. The letter also says the firm’s animal product is legally an unapproved new animal drug that is unsafe and adulterated.

Although the human products are marketed as dietary supplements, FDA says, they cannot be dietary supplements because they don’t meet the legal definition for such products.

The letter lists reasons why the firm’s human products are unapproved new drugs that are also misbranded. And it lists reasons why the pet product is an unapproved new animal drug.

Cannafyl was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the actions.

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