Last week, the Food and Drug Administration (the “FDA”) maintained its strict and narrow position on the legality of cannabidiol (“CBD”) by rejecting two new dietary ingredient (“NDI”) notifications submitted by Charlotte’s Web and Irwin Naturals. Both companies sought agency clearance to market their full-spectrum hemp extract as “dietary supplements.” In its letters to these
While the Food and Drug Administration (the FDA) continues to drag its feet in forging a legal path for the manufacture, sale, and distribution of hemp-derived products, state regulators are keeping up with the demands of this evolving market and adopting increasingly more nuanced and more sophisticated regulations for these products. Several states, including Oregon
Excitement abounds about the status of MDMA, otherwise known as Ecstasy. And for good reason. As noted last month in the New York Times: …those who received MDMA during therapy [in clinical trials] experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two
It has been well over two years since Congress enacted the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), which legalized the commercial production of hemp and tasked the Food and Drug Administration (the FDA) with the regulation of hemp-derived products intended for human consumption. Nevertheless, the FDA has yet to carve a legitimate
A common question that arises in Ketamine clinic transactions is whether a clinic or physician (collectively, “healthcare providers” or “providers”) can use or promote Ketamine for off-label uses. The short answer is yes, subject to several caveats, as discussed below. However, before reaching the answer, it is important to define what “off-label” use means and
Efforts by the Multidisciplinary Association for Psychedelic Studies (MAPS) to legalize prescription MDMA (Ecstasy) appear to have passed a gigantic hurdle earlier this month: MDMA is on track to meet the testing requirements to be a legalized prescription drug, specifically intended to treat the symptoms of post-traumatic stress disorder (PTSD). After analyzing the preliminary results
Last week, the Food and Drug Administration (“FDA”) released its latest round of warning letters to “cannabidiol” (“CBD”) companies. In letters dated March 15 and March 18, the FDA took issue with the sale and marketing of topicals commonly known as “over-the-counter” (“OTC”) (i.e., non-prescription) drug products that listed CBD as an “inactive ingredient,” yet
As anticipated, Delta-8 tetrahydrocannabinol (“Delta-8 THC”) has become the hottest, most flourishing cannabinoid currently found on the U.S. market. In the past few months, the sales of Delta-8 THC products have exploded, representing the fastest growing segment of hemp-derived products. Yet, despite its growing popularity, the legality of Delta-8 THC, including that of Delta-8 THC
If you follow our blog, you know we keep a close eye on enforcement actions taken by the Food and Drug Administration (the FDA) and the Federal Trade Commission (the FTC or the Commission) against companies selling and marketing cannabidiol (CBD) products. Back in December, we discussed the FTC’s decision to adopt new and more
On the last day of 2020, Michigan Governor Gretchen Whitmer signed into law a piece of legislation (“HB 5085”) that gives veterinarians permission to discuss the potential therapeutic benefits and risks of using marijuana and hemp, especially cannabidiol (“CBD”), with pet owners. The statutory language is sparse but its legislative analysis explains that HB 5085
