America’s booming CBD market received a dose of reality this week when the FDA issued a letter to Curaleaf, a major US cannabis and CBD brand, warning that some of its product marketing violates the Federal Food, Drug, and Cosmetic Act. The FDA has made one thing clear: if you claim your product will heal […]
The Food and Drug Administration plans on expediting CBD rules and regulations, potentially by the end of summer or early fall. The previous update provided by the agency last month offered no insight into the FDA’s plans to regulate the cannabinoid but said they would apply a “rigorous and science-based approach” in crafting the rules […]
Just a week ago, it looked like the Food and Drug Administration was ready to revisit its policies around CBD-infused food and drinks. That may have changed this week, when FDA Commissioner Scott Gottlieb announced his resignation. Gottlieb told lawmakers last week he heard them “loud and clear” when Congress legalized hemp-derived CBD late last year. He said he’s […]
Speaking at a public hearing Friday in Silver Spring, Maryland, FDA Commissioner Scott Gottlieb said he could see the entire category of e-cigarette and vaping products removed from store shelves if companies don’t stop marketing such products to youth. The FDA has the ability to stop e-cigarette sales and mandate that producers go through a formal FDA approval process, though it has not yet done so. See […]
FDA Commissioner Scott Gottlieb said that the organization is beginning the process of creating a regulatory framework for the marketing and interstate sales of CBD products. The 2018 Farm Bill, signed by President Trump last week, placed CBD products under the FDA’s jurisdiction. See the original article at Ganjapreneur
Between now and Oct. 31, the US Food and Drug Administration is accepting public comments on how cannabis should be classified under international drug treaties. “These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs,” wrote FDA’s associate commissioner […]
According to a recently released internal government letter, the FDA concluded that cannabidiol, or CBD, doesn’t meet the criteria for federal control. Although the federal health regulatory agency’s review concluded that CBD shouldn’t be scheduled in any manner, the drug enforcement agency—citing international treaty obligations—opted to put Epidiolex in Schedule V and otherwise continue to […]
GW Pharmaceuticals has revealed the expected consumer price for Epidiolex, the first cannabidiol-based medication to be approved by the FDA, according to a Business Insider report. At a price tag of about $32,500 per year, it won’t be cheap, but company representatives said in a phone call with investors this week that its cost reflects […]
The US Food and Drug Administration announced today, Monday June 25, the approval of the country’s first marijuana-based prescription medication. The drug is called Epidiolex and is a plant-derived oral solution of cannabidiol (CBD)—a chemical component of marijuana that does not cause intoxication or a euphoric “high.” The FDA approved it for use in patients […]
The chances of the FDA every approving smokable marijuana were slim to none, according to FDA commissioner Scott Gottlieb. He explained that the agency is apprehensive about giving its approval to a supposed medicine that is consumed through combustible means. Gottlieb likened the act of smoking pot to crushing up a prescription medicine and smoking […]
U.S. regulators are studying whether restrictions on marijuana should be eased, a step toward decriminalizing the drug at the federal level. The Food and Drug Administration is conducting an analysis at the Drug Enforcement Administration’s request on whether the U.S. should downgrade the classification of marijuana as a Schedule 1 drug, said Douglas Throckmorton, Deputy […]
GW Pharmaceuticals, a bio-pharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its cannabinoid product platform, announced that the United States Food and Drug Administration (FDA) has granted their product, Epidiolex, Fast Track designation in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. FDA’s Fast Track program facilitates the […]
A survey of 1,339 people with fibromyalgia conducted by The National Pain Foundation and NationalPainReport.com, revealed that those who have used marijuana to treat their symptoms find it significantly more effective than any of the three drugs approved by the Food and Drug Administration to treat the disorder. The three drugs approved for the treatment […]
The FDA is Reopening the Public Comment Period on Rescheduling Marijuana
The Food and Drug Administration (FDA) is reopening the comment period for the rescheduling of marijuana. The Agency is taking this action to allow interested persons additional time to submit comments. Anyone who is interested can submit their comments either electronically or handwritten by September 30, 2019. See the original article at the Federal Register