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
El 22 de diciembre, la Administración de Alimentos y Medicamentos (la «FDA») envió nuevas cartas de advertencia a cinco empresas que vendían y comercializaban ilegalmente productos de CBD no autorizados, sobre los que las empresas afirmaban que podían prevenir, diagnosticar, mitigar, tratar o curar diversas afecciones médicas. Esta última ronda de medidas coercitivas se puso en marcha a raíz de preocupaciones concretas sobre la forma en que
El 17 de diciembre, la FTC publicó un comunicado de prensa en el que anunciaba su primera campaña de control contra las afirmaciones engañosas en el creciente mercado de los productos de cannabidiol (CBD). Según el comunicado, varias «empresas realizaban afirmaciones sin fundamento según las cuales sus aceites, bálsamos, gominolas, café y otros productos podían tratar enfermedades graves como el cáncer y
Last week, Oregon Representative Kurt Schrader (D) and Virginia Representative Morgan Griffith (R) introduced The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 (“H.R. 8179”). If enacted in its current form, H.R. 8179 would legalize the manufacture, sale and marketing of hemp, hemp-derived cannabidiol and other hemp extracts (collectively referred to
Every week, clients ask us to review their hemp-derived cannabidiol (“Hemp CBD”) products to ensure “full compliance.” Unfortunately, given the patchwork of often conflicting state labeling laws, and the lack of a federal pathway for the sale and marketing of these products, it is virtually impossible for Hemp CBD stakeholders to meet compliance standards. Consequently,
