On February 21, the Natural Product Association (NPA) filed a citizen petition with the Food and Drug Administration (FDA) on specific cannabidiol (CBD) relief in which it requests enforcement discretion for the premarket approval of CBD products. In its petition, the NPA is asking the FDA to do one of three things: Determine that CBD
The CBD Product Safety and Standardization Act (the Act) indicates that the Feds might regulate CBD as a food ingredient, and that it may lead to regulation of other cannabinoids. If the Feds regulate CBD as a food ingredient, it could seriously change the game (in a good way) for hemp CBD companies. On December
Now that the holiday season is upon us, hemp-derived cannabinoid (Hemp Cannabinoid) companies are getting busy selling and shipping their products to consumers throughout the country. In addition to limiting the sale and distribution of their products to jurisdictions where these products are expressly allowed and regulated, Hemp Cannabinoid companies should also familiarize themselves with
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
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
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
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
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
On December 22, the Food and Drug Administration (the “FDA”) issued new warning letters to five companies that illegally sold and marketed unapproved CBD products, which the companies claimed could prevent, diagnose, mitigate, treat or cure various medical conditions. This latest round of enforcement actions was triggered by specific concerns with the manner in which
