mdma ecstacy fda

MDMA and the FDA Approval Process

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

cbd food drink supplement

2021: The Year Hemp-Derived Foods and Dietary Supplements Become Lawful… Maybe.

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

ketamine off label use

Ketamine and Off-Label Issues

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

MDMA Ecstasy fda maps

MDMA (Ecstasy) Nears FDA Approval for PTSD Treatment

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

Not All CBD Topicals Are Treated Equal

Not All CBD Topicals Are Treated Equal

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

delta 8 thc fda legal

Is Delta-8 THC a Controlled Substance? Yes. No. Maybe.

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

FDA FTC CBD Enforcement

Will the FTC Adopt Less Stringent Substantiation Requirements for CBD Claims?

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

Michigan Cannabis CBD

Michigan Authorizes Veterinarians to Discuss the Therapeutic Use of CBD with Pet Owners

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