We at Budding Trends have been optimistic, and then cautiously optimistic, that the legalization of psychedelics was close. This month, however, the U.S. Food and Drug Administration dealt a blow to our predictions. FDA decided not to approve Lykos Therapeutics, Inc.’s MDMA-assisted PTSD therapy at this time. Instead, FDA asked Lykos to further
Federal Agencies
It Ain’t Over ‘til It’s Over: IRS reminds Taxpayers That Section 280E Applies to Marijuana Companies Until Rescheduling Becomes Law
This is a tax blog. Stay with me – it’s short.
While marijuana advocates celebrate the potential rescheduling of marijuana from Schedule I to Schedule III, the taxman has made clear that marijuana remains a Schedule I substance subject to Section 280E of the Internal Revenue Code. For those who aren’t cannabis tax specialists, 280E…
MDMA DOA at FDA Advisory Committee
Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a straight line.
As we previously reported, Lykos Therapeutics Inc. sponsored a new drug application for MDMA therapy. That application…
Now That It Appears Marijuana Is Being Rescheduled, How Does That Process Work?
“Get in loser, we’re rescheduling.” – Regina George (DEA)
As we at Budding Trends reported last week, the DEA is set to finally accept the recommendation of the U.S. Department of Health and Human Services (HHS) to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act. This is a monumental…
DEA Poised to Reschedule Marijuana
Cue the Ron Paul “It’s Happening” gif and shout it from the rooftops: DEA will reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act, per a report from the AP. The United States federal government, through two federal agencies, is officially recognizing that cannabis “has a currently accepted medical use…
FTC Moves to Strike Most Noncompetes: Considerations for Cannabis Companies
As Bradley previously reported, the Federal Trade Commission at the beginning of last year issued a notice of proposed rulemaking to effectively ban employee noncompete provisions as an unfair method of competition in violation of Section 5 of the FTC Act. Following a 16-month administrative process that drew more than 26,000 public comments, the…
FDA Chief Says CBD Is Not NBD, Urges Congressional Action
Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to…
DOJ Just Said the Quiet Part Out Loud in Massachusetts Cannabis Case
It turns out that if you want to know the Department of Justice’s policy on marijuana enforcement, you just have to sue them. In a remarkably candid showing of the DOJ’s current policy concerning marijuana enforcement, attorneys for DOJ recently wrote in a pleading in federal court in Massachusetts that marijuana businesses operating in accordance…
Legalizing LSD? FDA Says Mm-hmm to MM120
If you know either of us, you know neither of us would pass up a chance to say, “I told you so.” As we looked ahead to 2024 in January, we speculated that psychedelics could be legalized as a prescription medicine. Now, not even a quarter into 2024, proponents of the psychedelic industry should…
Big Brother Cancels Trip, Court Says Not So Fast My Friend
A few weeks ago, the Ninth Circuit Court of Appeals in Aggarwal v. U.S. DEA directed the U.S. Drug Enforcement Agency (DEA) to reconsider its decision not to transfer psilocybin from Schedule I to Schedule II.
Since at least 2021, Dr. Sunil Aggarwal has been working to legally obtain psilocybin for terminally ill cancer patients…