Drugs

FDA Enforcement Discretion for Some Hemp CBD Products

In a 4/1 letter to two FDA senior officials, FDA commissioner Marty Makary says the agency does not intend to enforce two sections of the Federal Food, Drug, and Cosmetic Act involving adequate directions for use and new drug approvals with respect to an orally administered, hemp-derived CBD (cannabidiol) product solely on the basis that it contains CBD, provided that the product:

is manufactured, marketed, and labeled in a manner that would be consistent with the dietary supplement framework, including bearing a supplement facts panel and structure/function claims;
is not contaminated;
is not packaged or labeled in a manner that would be attractive to or marketed for children; and
is provided to a beneficiary through a program of medical items or services payable under Title XVIII of the Social Security Act (research grants), under the direction of the patient’s treating doctor, in a manner ancillary to the covered items or services furnished under such program.

The letter to CDER acting director Tracy Beth Høeg and deputy commissioner for human foods Kyle Diamantas reviews the legislative background of hemp-derived CBD products in medical research models, including a 12/18/2025 Executive Order on “Increasing Medical Marijuana and Cannabidiol Research.” That order directed Makary and other HHS executives to “develop research methods and models utilizing real-world evidence to improve access to hemp-derived cannabidiol products in accordance with federal law and to inform standards of care.”

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