hemp cbd gmp label fda

Hemp-Derived Products: The Law Does Not Stop at Labeling Requirements

I work with many manufacturers and distributors of hemp-derived products and am often surprised by the fact that few understand their general obligations beyond labeling requirements. Every state that authorizes and formally regulates the manufacture, distribution, and sale of these products – Colorado is a good example – imposes stringent manufacturing requirements that squarely align

fda delta 8 hemp

The FDA Warns Consumers of the Risks Associated with Delta-8 THC Products

On Tuesday, the Food and Drug Administration (the “FDA”) released its first statement via a consumer update regarding Delta-8 tetrahydrocannabinol (“Delta-8 THC”). The agency decided to provide consumers with key information surrounding the popular cannabinoid following a sharp increase in adverse event reports involving the substance and unauthorized marketing practices directed at minors. If you

kratom fda ban

The FDA’s Proposed Kratom Ban is a Mistake

Trust in the U.S. Food and Drug Administration (FDA) declined after its approval of the controversial Alzheimer’s drug aducanumab. Three experts resigned amid allegations that the FDA had caved to industry pressure. Some argue that its credibility has reached a new low. These events should have prompted the FDA to pause, reflect, and work to repair its reputation. Instead, the

fda cbd ndi hemp

The FDA Continues to Show It Is Not Interested in Regulating Hemp-Derived Products

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

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