Drugs

New CBD Regulatory Framework Needed: Woodcock

FDA principal deputy commissioner Janet Woodcock says the agency has determined that current regulatory pathways are not appropriate for cannabidiol (CBD) products and it will work with Congress on a new cross-agency regulatory framework. In a statement, Woodcock says the need for a new framework was determined by a “high-level internal working group” that she chaired.

Consistent with the statement describing the need for a new CBD framework, FDA denied three citizen petitions that asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

“The use of CBD raises various safety concerns,” Woodcock writes, “especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications, and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”

The statement says a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools, it says, could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. Also, it adds, a new pathway could provide access and oversight for certain CBD-containing products for animals.

Woodcock says FDA’s existing food and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products.

“FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” Woodcock concludes. “We will remain diligent in monitoring the marketplace, identifying products that pose risks, and acting within our authorities. FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”

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