As we previously explained, under the Food, Drug, and Cosmetic Act (“FDCA”), any substance that is intentionally added to food (including drinks) is a food additive. A food additive is subject to premarket review and approval by the Food and Drug Administration (“FDA”), unless the substance is generally recognized as safe (“GRAS”) by qualified experts
As everyone knows by now the 2018 Farm Bill legalized hemp production by de-scheduling the crop under the Controlled Substance Act. We’ve written extensively about federal hemp rules and regulations as well as those in California, Oregon and Washington. We’ve also addressed hemp in terms of USDA Organic Certification, international trade issues, and the FDA stance on
The deals in Oregon cannabis are getting very big and much of what we do these days involves mergers, acquisitions and cross border work. It’s amazing this happened so fast. Less than four years ago, as the OLCC began writing rules for the adult use marijuana industry, there was a distinct small business tenor to
We have been closely following California’s commercial hemp cultivation licensing law since it was proposed last year as Senate Bill 1409 (see here, here, and here). In March, I wrote about some of the roadblocks to implementing SB-1409’s commercial hemp cultivation programs, and the lengthy review process of the California Department of Food and Agriculture (“CDFA”) regulation which
Last Friday, the U.S. Department of Agriculture (“USDA”) released a statement, in which the agency clarified that the passage of the 2018 Farm Bill rendered the importation of hemp seeds legal. As we previously explained, the 2018 Farm Bill legalized hemp, hemp seeds, and other derivatives, by removing them from the Controlled Substance Act. Accordingly,
We’ve written previously about the inability of cannabis companies to receive United States Department of Agriculture (USDA) organic certification for their products (although there are alternative state-level and private certifications available to fill this gap), but what some of our clients are unaware of is that the USDA will provide organic certification for qualified industrial
We get a ton of questions about whether it’s legal to import hemp into the U.S. It’s a complicated question without a clear answer. We do know that the Drug Enforcement Administration has confirmed that the importation of cannabis plant material that falls outside of the Controlled Substance Act’s definition of “marihuana” (e.g., the mature
Last week, the departing Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, released a statement in which he announced that the agency, in collaboration with the Federal Trade Commission (“FTC”), had issued warning letters to three CBD manufacturers: Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc.. The letters were sent “in response to
In the last few weeks, two major drugstores publicly announced that they will start carrying products containing hemp-derived cannabidiol (“Hemp-CBD“). Both CVS and Walgreens announced that CBD topicals would be available in their stores, in a select number of states. Notably, both drug store chains limited products to non-ingestible topicals. Dr. Scott Gottleib, the outgoing head
On April 2, 2019, the federal Food & Drug Administration (“FDA”) Commissioner Scott Gottlieb issued a press release on hemp and hemp-derived cannabidiol (“Hemp CBD”). This is Gottlieb’s first major official press release since the now infamous December 20, 2018 press release which came just hours after the 2018 Farm Bill passed. In that December 20 press
