On August 18, 2023, comments were due to Congress on the bipartisan and bicameral request for information (RFI), which sought written stakeholder comments and analysis to “asses[s] the potential for a regulatory pathway for hemp-derived [cannabidiol (CBD)] products that prioritizes consumer safety and provides certainty to the U.S. market.” By way of background on […]
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from July that should be highlighted. If you have any questions or would like more information, please do
July Food and Agriculture Regulatory Recap Read More »
On Friday, U.S. Food and Drug Administration (FDA) released its first draft guidance on the conduct of clinical trials for psychedelic drugs. The Draft Guidance for Industry, Psychedelic Drugs: Considerations for Clinical Investigations, if finalized, will guide researchers investigating psychedelics as potential treatments for medical conditions. There has been significant media, marketing, and legislative interest
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs Read More »
The United States Department of Agriculture (USDA) will include ‘Hemp’ in the title of one of the six Agricultural Technical Advisory Committees (ATACs) – noting a significant evolution in both agriculture and cannabis policy. Specifically, ‘Hemp’ has now earned a place within the ATAC titled ‘Tobacco, Cotton, Peanuts, and Hemp.’ The ATACs were established under
Hemp Now Included in Agricultural Technical Advisory Committee (ATAC) Read More »
Earlier this year, the U.S. Food and Drug Administration (FDA) concluded that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol” (CBD) and the agency will “work with Congress on a new way forward.” Since this announcement, speculation on how FDA and Congress will work to handle the ever-evolving over $9.1 billion
Cannabis Regulatory Update: CBD, The Farm Bill, and The Punt from FDA to Congress Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from March that should be highlighted. If you have any questions or would like more information, please do
March Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from February that should be highlighted. If you have any questions or would like more information, please do
February Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from January that should be highlighted. If you have any questions or would like more information, please do
January Food and Agriculture Regulatory Recap Read More »
Today, the United States Food and Drug Administration (FDA) announced their conclusion “that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol,” and the agency will “work with Congress on a new way forward.” This position was announced in a Statement by Dr. Janet Woodcock, Principal Deputy Commissioner, who chairs FDA’s cannabis
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from December that should be highlighted. If you have any questions or would like more information, please do
December Food and Agriculture Regulatory Recap Read More »
Today, December 2, 2022, President Biden signed into law H. R. 8454 to expand research on cannabidiol and marijuana, and for other purposes which will create cannabis research opportunities for medical cannabis and will protect doctors who advise their patients about medical cannabis. The bill was passed unanimously in both the House and the Senate
Federal Cannabis Research Bill Signed into Law Read More »
On November 1, 2022, the Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA) Janet Woodcock had a virtual meeting on “Regulatory Pathways for Hemp Products, including Cannabidiol (CBD)” with representatives of the U.S. Health and Human Services Office of the Secretary and the Executive Office of the President. This meeting was announced
FDA’s Woodcock Holds Meeting on Regulatory Pathways for Hemp and CBD Read More »
In October, the United States Securities and Exchange Commission (SEC) announced that it would be charging two (2) cannabis companies, Emerald Health and HighTimes, and six (6) associated individuals who worked with the companies, for their involvement in “stock promotion schemes.” Stock promotion schemes are “fraudulent schemes to promote the securities of issuers that were
SEC Stock Promotion Scheme Charges Against the Cannabis Industry Read More »
At the end of September, the United States Food and Drug Administration (FDA) hired cannabis policy expert Norman Birenbaum as a Senior Public Health Advisor at FDA’s Center for Regulatory Programs. Mr. Birenbaum comes to FDA with a deep background in regulation in several state cannabis departments. Most recently, in New York State he served
On July 26, 2022, the Senate Judiciary Committee’s Subcommittee on Criminal Justice and Terrorism held a hearing on “Decriminalizing Cannabis at the Federal Level: Necessary Steps to Address Past Harms.” The hearing largely addressed the recently introduced S. 4591, “Cannabis Administration and Opportunity Act” (the “CAOA”). The witnesses included: Malik Burnett, Medical Director, Maryland Department
On Thursday, July 21, 2022, Senators Chuck Schumer (D-NY) Cory Booker (D-NJ), and more officially filed the Cannabis Administration and Opportunity Act (CAOA) (S.4591) to legalize cannabis nationwide. OFW has prepared material on this bill and will be monitoring supplementary announcements and hearings for more information. Please note that OFW has provided other posts on key areas of interest in
CAOA Filed in the Senate Read More »
On May 4, 2022, the United States Food and Drug Administration (FDA) issued for the first time Warning Letters to companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC). While the FDA has sent warnings to companies utilizing hemp-derived cannabidiol (CBD) before, this is the first set of Warning Letters to those selling delta-8 THC products for
FDA Issues First Set of Warning Letters to Companies Selling Delta-8 THC Read More »
Background By the end of 2021, ninety-one percent of Americans reported favoring some form of marijuana legalization. To date, eighteen (18) states and Washington, DC, have legalized adult recreational use of marijuana, and thirty-seven (37) states and four (4) territories have medical use programs. More states will likely be expanding access to marijuana with ballot
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