FDA rebuffs full-spectrum CBD as a dietary supplement

HEMPINDUSTRYDAILY (WEB) AUGUST 12, 2021 Federal health regulators have rejected the sale of full-spectrum CBD as a dietary supplement, a signal that CBD products will remain legal under federal law only by prescription in the U.S. The Food and Drug Administration announced the decision this week in letters to CBD makers Charlotte’s Web of Colorado and Irwin Naturals, which sought agency clearance to market its extract as a “new dietary ingredient.” The FDA pointed to two reasons for the rejections: CBD is the active ingredient in a pharmaceutical drug and therefore should not be available over the counter.Insufficient data about CBD

Catalent Signs Agreement with JOS Pharmaceuticals to Develop Fast-Dissolve Zydis® Formulation for Cannabidiol as an Anesthesia Premedication

SOMERSET, N.J. (PRWEB) JULY 13, 2021 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it has signed a development agreement with JOS Pharmaceuticals, a clinical stage biopharmaceutical company focusing on anesthesiology. Under the agreement, Catalent will undertake a feasibility study for the potential development of a licensed cannabidiol (CBD) product for use as an anesthetic premedication using Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology. Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water, and is

Australia Legalizes Over-the-Counter (OTC) Sales of CBD

In late December of 2020, the Australian Therapeutic Goods Agency (TGA), the regulatory equivalent of the Food and Drug Administration (FDA), determined that naturally extracted hemp oil CBD could be sold over-the-counter in pharmacies. Once a given product has submitted for approval it must first be determined as both safe and effective through a series of trials. The size of the initial Australian OTC CBD market is estimated at $145 million annually.